Back to results

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s) (Discover-1)

Primary Purpose

Arthritis, Psoriatic

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Guselkumab

Placebo

About this trial

This is an interventional treatment trial for Arthritis, Psoriatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciLitre (mg/dL) at screening from the central laboratory
Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
Have active PsA despite previous non-biologic disease-modifying antirheumatic drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent [%] of the overall study population), and must document the reason for discontinuation

Exclusion Criteria:

Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease
Has ever received more than 2 anti-TNFalpha agents
Has previously received any biologic treatment (other than anti-TNF alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment
Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
Has received apremilast within 4 weeks prior to the first administration of study agent
Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor

Sites / Locations

Rheumatology Associates
Arizona Arthritis & Rheumatology Associates PC
Arizona Arthritis & Rheumatology Research, PLLC
Clinical Research Center of Connecticut
Dawes Fretzin Clinical Research Group, LLC
University of Michigan
Arthritis Consultants
Arthritis and Osteoporosis Associates
Austin Regional Clinic
Barwon Rheumatology Services
Southern Clinical Research
Liverpool Hospital
Rheumatology Research Unit
Eastern Health - Box Hill Hospital
Queen Elizabeth Hospital
Eastern Regional Health Authority, St. Clare's Mercy Hospital
The Waterside Clinic
Dermatrials Research
Skin Centre for Dermatology
K. Papp Clinical Research
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Revmaclinic
MUDr. Rosypalova, s.r.o
Revmatologicka ambulance
Revmatologicky ustav
Medical Plus S.R.O.
PV-Medical S.R.O
ISA GmbH
Universitatsklinikum Frankfurt
MVZ Rheuma
Rheumazentrum Ruhrgebiet
Krankenhaus St. Josef
Orszagos Reumatologia es Fizioterapias Intezet
Magyar Honvedseg Egeszsegugyi Kozpont
Debreceni Egyetem Klinikai Kozpont
Pest Megyei Flor Ferenc Korhaz
Martinus Medicus Health Center
Seoul National University Bundang Hospital
Hanyang University Hospital for rheumatic Diseases
The Catholic University of Korea Seoul St. Mary's Hospital
SMG - SNU Boramae Medical Center
Ajou University Hospital
Hospital Selayang
Hospital Pulau Pinang
Hospital Raja Permaisuri Bainun
Hospital Melaka
Hospital Tuanku Jaafar
Nzoz Osteo-Medic
Szpital Uniwersytecki Nr 2 w Bydgoszczy
NSZOZ Unica CR
Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Etyka Osrodek Badan Klinicznych
Centrum Medyczne Hetmańska
Nasz Lekarz Przychodnie Medyczne
Medycyna Kliniczna
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Centrum Medyczne WroMedica
Nzoz Biogenes Sp. Z O. O.
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Medical and Sanitary Unit ''Severstal''
Research Institute of Dermatovenerology, Immunology
Krasnoyarsk State Medical University
Lipetsk Regional Dermatovenerological Dispensary
Rostov Regional Clinical Dermatovenerological Dispensary
Ryazan Regional Clinical Dermatovenerological Dispensary
Republican Clinical Hospital - G.G. Kuvatov
Clinical Emergency Hospital n.a. N.V. Solovyev
Clinical Hospital #10
Hosp. Univ. A Coruña
Hosp. Del Mar
Hosp. Gral. Univ. Gregorio Marañon
Hosp. Univ. Ramon Y Cajal
Hospital Regional Carlos Haya
Hosp. Clinico Univ. de Santiago
Hosp. Infanta Luisa
Hosp. Unv. de Valme
Hosp. de Manises
Hualien Tzu Chi Hospital
Kaohsiung Veterans General Hospital
Chang Gung Memorial Hospital Kaohsiung Branch
Chung Shan Medical University Hospital
National Cheng Kung University Medical Center
National Taiwan University Hospital
Chang Kung Memorial Hospital
Chang-Gung Memorial Hospital, LinKou Branch
Municipal health care institution Chernihiv Regional Hospital
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
Communal Institution of Health Kharkiv City multifield hospital №18
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Khmelnitckiy regional hospital
Clinic of SI 'NSC 'The M.D.Strazhesko Institute of Cardiology' of NAMS of Ukraine'
Kyiv Railway Station Clinical Hospital #2
Danylo Halytsky Lviv National Medical University
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Group 1: Guselkumab

Group 2: Guselkumab and Placebo

Group 3: Placebo Followed by Guselkumab

Arm Description

Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 48.

Participants will receive SC guselkumab 100 mg at Weeks 0 and 4, then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, and 44) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48) to maintain the blind.

Participants will receive SC placebo q4w from Week 0 to Week 20, and will crossover at Week 24 to receive guselkumab 100 mg q4w from Week 24 through Week 48.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

ACR 20 response: >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.

Secondary Outcome Measures

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24

ACR 50 response was defined as greater than or equal to (>=)50 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and C-Reactive Protein (CRP).

Percentage of Participants With Psoriasis Response of IGA (Score: 0[Cleared] or 1[Minimal] and >=2 Grade Reduction From Baseline) at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline

A psoriasis Investigator's Global Assessment (IGA) response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >=2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16

ACR 20 response: >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform task in that area), and C-reactive protein (CRP).

Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24

The Disease Activity Index Score (DAS28) based on C-Reactive Protein (CRP) is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. The values are 0=best to 10=worst. Negative changes from baseline indicate improvement of arthritis.

Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24

ACR 70 response was defined as >= 70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline

Enthesitis was assessed using the Leeds Enthesitis Index (LEI), a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI greater than (>) 0.

Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). Negative changes from baseline indicates improvement of enthesitis.

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. Higher score indicates more severe dactylitis. Resolution of dactylitis was defined as a dactylitis score of 0 with the baseline dactylitis score >0.

Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative change from baseline indicates improvement in dactylitis.

Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24

ACR 20 response was defined as >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24

ACR components including swollen joint count (66 joints) and tender joint count (68 joints) were measured.

ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24

ACR components included patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment (PtGA) of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment (PGA) of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis).

ACR Component- C-reactive Protein (CRP) Through Week 24

ACR component including CRP was measured.

ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24

Patient's assessment of physical function was measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI). HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function.

Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24

ACR components include swollen joint count (66 joints), tender joint count (68 joints), patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of the Health Assessment Questionnaire (HAQ-DI; a 20-question instrument assessing 8 functional areas; range: 0-3, 0=no difficulty, 3=inability to perform a task in that area), and CRP.

Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24

Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score by Visit Over Time Through Week 24 Among Participants With HAQ-DI Score >=0.35 at Baseline

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: less than or equal to (<=) 3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.

Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24

Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24

Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24

The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline

Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline

Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis.

Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24

PASDAS (score range of 0 to 10, where higher score indicated more severe disease) is a compositive score of overall disease activity combining Patient's Global Assessment of Disease Activity (arthritis and psoriasis, using VAS [0-100 mm, 0=excellent and 100= poor), Physician's Global Assessment of Disease Activity (using VAS [0-100 mm, 0=no arthritis activity and 100=extremely active arthritis]), swollen joint count (0-66 joints), tender joint count (0-68 joints), CRP (mg/L), enthesitis based on LEI (0-6), tender dactylitis count (scoring each digit from 0-3 and recoding to 0-1, where any score > 0 equaled 1), and the PCS score of the SF-36 health survey. The cutoffs for disease activity were 3.2 (low) to 5.4 (high). Negative changes from baseline indicate improvement of overall disease activity.

Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24

GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of Desirability Function (AMDF), derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100=poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL=25.355 + [2.367*HAQ-DI]-[0.234*SF-PCS]-[0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0-100, higher scores= better quality of life) and SF-MCS (score ranges from 0-100, higher scores= better quality of life). Total score is from 0-10, lower score=better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.

Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24

DAPSA assessed the joint domain of psoriatic arthritis (PsA) and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL, value <lower limit of quantification [LLOQ] is considered equal to half of the value of LLOQ for numerical calculations), patient assessment of pain (0-10 centimeter [cm] VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24

MDA was considered achieved if at least 5 of the following 7 criteria were met at the analysis visit: tender joint count <=1; swollen joint count <=1; psoriasis activity and severity index <=1; patient's assessment of pain VAS score of <=15; patient's global assessment of disease activity VAS (arthritis and psoriasis) score of <=20; HAQ-DI <=0.5; and tender entheseal points <=1.

Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score Through Week 24 Among the Participants With Spondylitis and Peripheral Arthritis and BASDAI Score >0 at Baseline

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) is a self-assessment tool that consists of 6 questions relating to the 5 major symptoms of ankylosing spondylitis: fatigue, spinal pain, joint pain, enthesitis, qualitative morning stiffness and quantitative morning stiffness. The first 5 items were scored on a 10 centimeter (cm) VAS ranging from 0=none to 10=very severe. Quantitative morning stiffness was scored on a 10cm VAS ranging from 0=0 hours to 10=2 or more hours. The 2 scores for qualitative and quantitative morning stiffness were averaged, and the total BASDAI score was the average of the 5 scores of each symptom, ranging from 0 (none) to 10 (very severe). Higher scores indicate greater disease severity and an improvement of 50% from baseline is considered clinically meaningful. Only participants with spondylitis with peripheral arthritis as their primary arthritic presentation of PsA completed the BASDAI indicate the degree of their symptoms over the past week.

Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline

Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24

Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index by Visit Over Time Through Week 24

GRACE index is a composite PsA disease activity score converted from Arithmetic Mean of the Desirability Function (AMDF), which was derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100= poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL =25.355 + [2.367*HAQ-DI] - [0.234*SF-PCS] - [0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0 to 100, higher scores= better quality of life) and SF-MCS (score ranges from 0 to 100, higher scores= better quality of life). The total score is from 0-10, where lower score indicates better response. Higher score indicates more active disease activity.

Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24

DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10 cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10 cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. The assessment does not have a score range with an upper or lower bound.

Percentage of Participants With Very Low Disease Activity (VLDA) by Visit Over Time Through Week 24

A measurement that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved VLDA at a visit if the participant fulfilled all 7 criteria (tender joint count <=1; swollen joint count <=1; PASI <=1; patient pain VAS score of <=15; patient global disease activity VAS [arthritis and psoriasis] score of <=20; Health Assessment Questionnaire (HAQ) score <=0.5; and tender entheseal points <=1) at that visit.

Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 75 response: >=75% improvement in PASI score from baseline.

Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline.

Percentage of Participants Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response: 100% improvement in PASI score from baseline.

Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline

In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in swollen joint count (SJC) (66 joints) + tender joint count (TJC) (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline

In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline

The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4). Participants who achieved IGA Score of 0 (cleared) at a specific timepoint and did not meet any TF criteria before, were considered as responders at that time point. Participants who met 1 or more TF criteria before or with missing data at that time point were considered as non-responders.

Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales: physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health. The scores 0-100 (where higher scores indicated a better quality of life) from each subscale of SF-36 were normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better health status. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Positive changes from baseline indicate improvement of fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 numeric rating scale (NRS). The raw score of each domain is converted into a standardized score with a mean of 50 and a standard deviation (SD) of 10 for the general population in the US (T-Score).

Change From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52

Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52

Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52

Percentage of Participants Who Achieved a Clinically Meaningful Improvement (>=0.35 Improvement From Baseline) in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52 Among Participants With HAQ-DI Score >=0.35 at Baseline

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52

Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.

Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52

Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52

The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52

DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in SJC (66 joints)+TJC (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

Change From Baseline in PASI Score at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative changes from baseline indicate improvement of psoriasis.

Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline.

Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: >=90% improvement in PASI score from baseline.

Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52

MDA is a measure that defines a satisfactory state of disease activity that includes the 5 domains of PsA (joint symptoms, skin psoriasis, patient's perspective of pain and disease activity, physical function, and enthesitis). A participant was considered as having achieved the PsA MDA at a visit if the participant has fulfilled at least 5 of the following 7 criteria at that visit: Tender joint count (68 joints)<=1, Swollen joint count (66 joints) <=1, Psoriasis activity and severity index <=1, Patient's Assessment of Pain <=15 on a 100-unit VAS, Patient's Global Assessment of Disease Activity (arthritis and psoriasis) <=20 on a 100-unit VAS, HAQ-DI score <=0.5, and Tender entheseal points <= 1 (LEI index score <= 1).

Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52

GRACE index is a composite PsA disease activity score converted from AMDF, which was derived from TJC (0-68) and SJC (0-66), HAQ-DI (0-3), patient's global assessment of disease activity on arthritis and psoriasis (0-100 mm, 0=excellent and 100= poor), patient's assessment of skin disease activity (0-100 mm, 0=excellent and 100=poor), patient's global assessment of disease activity on arthritis (0-100 mm, 0=excellent and 100=poor), PASI (0-72), and PsA Quality of Life Index (derived as PsAQOL =25.355 + [2.367*HAQ-DI] - [0.234*SF-PCS] - [0.244*SF-MCS]), where HAQ-DI: HAQ-DI score (0-3, 0=least difficulty and 3=extreme difficulty), SF-PCS (Score ranges from 0 to 100, higher scores= better quality of life) and SF-MCS (score ranges from 0 to 100, higher scores= better quality of life). The total score is from 0-10, where lower score indicates better response. Higher score indicates more active disease activity. Negative change from baseline indicates improvement of PsA disease activity.

Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52

Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24

Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Percentage of Participants Who Achieved >= 20%, >=50%, >=70%, and >=90% Improvement From Baseline in BASDAI Score at Weeks 24 and 52 Among Participants With Spondylitis and Peripheral Arthritis as Their Primary Arthritic Presentation of PsA

Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline

Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline

Enthesitis was assessed using the Spondyloarthritis Research Consortium of Canada (SPARCC). The SPARCC developed a measure for enthesitis in general spondyloarthritis which evaluates the presence or absence of pain by applying local pressure to the following entheses: supraspinatus insertion (left and right), medial epicondyle humerus (left and right), lateral epicondyle humerus (left and right), greater trochanter (left and right), quadriceps-to-patella (left and right), patellar-tibia (left and right), achilles tendon insertion (left and right), plantar fascia (left and right). Tenderness on examination was recorded as either present (1) or absent (0) for each of the 16 sites for an overall score range of 0-16. Higher scores indicate more severe enthesitis. Negative changes from baseline indicate improvement of enthesitis.

Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline

Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis.

Percentage of Participants With an IGA Score of 0 (Cleared) or 1 (Cleared) at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

A psoriasis IGA response was defined as an IGA score of 0 (cleared) or 1 (minimal) and >= 2 grade reduction from baseline in the IGA psoriasis score. The IGA documents the investigator's assessment of the patient's psoriasis and lesions are graded for induration, erythema and scaling, each using a 5 point scale: 0 (no evidence), 1 (minimal), 2 (mild), 3 (moderate), and 4 (severe). The IGA score of psoriasis was based upon the average of induration, erythema and scaling scores. The participant's psoriasis was assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).

Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52

Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Full Information

NCT ID

NCT03162796

First Posted

May 19, 2017

Last Updated

January 15, 2021

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03162796

Brief Title

A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)

Acronym

Discover-1

Official Title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti-TNF Alpha Agents

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

August 24, 2017 (Actual)

Primary Completion Date

March 14, 2019 (Actual)

Study Completion Date

November 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active Psoriatic Arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Detailed Description

This is a study of guselkumab in participants with active Psoriatic Arthritis (PsA) who had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms and the safety profile of guselkumab in the treatment of PsA. The study will consists of 4 phases: a screening phase of up to 6 weeks, a blinded treatment phase of approximately 1 year (that is, 52 weeks), including a placebo controlled period from Week 0 to Week 24 and double-blind active treatment period from Week 24 to Week 52, and a safety follow-up phase of 8 weeks after Week 52 (Week 52 to 60) and will be 12 weeks from the last administration of study agent (at Week 48) to the final safety follow-up visit. Efficacy, safety, pharmacokinetic, immunogenicity, and biomarker evaluations will be performed in the study at defined schedule.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Psoriatic

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

383 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group 1: Guselkumab

Arm Type

Experimental

Arm Description

Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 48.

Arm Title

Group 2: Guselkumab and Placebo

Arm Type

Experimental

Arm Description

Arm Title

Group 3: Placebo Followed by Guselkumab

Arm Type

Experimental

Arm Description

Participants will receive SC placebo q4w from Week 0 to Week 20, and will crossover at Week 24 to receive guselkumab 100 mg q4w from Week 24 through Week 48.

Intervention Type

Drug

Intervention Name(s)

Guselkumab

Other Intervention Name(s)

CNTO 1959

Intervention Description

Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants will receive matching placebo as SC injection.

Primary Outcome Measure Information:

Title

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24

Description

Time Frame

Week 24

Secondary Outcome Measure Information:

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 24

Description

Time Frame

Week 24

Title

Description

Time Frame

Week 24

Title

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16

Description

ACR 20 response: >=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform task in that area), and C-reactive protein (CRP).

Time Frame

Week 16

Title

Change From Baseline in Disease Activity Score (DAS28) (C-reactive Protein [CRP]) Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 70 Response at Week 24

Description

Time Frame

Week 24

Title

Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 50 Response at Week 16

Description

Time Frame

Week 16

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants With Resolution of Enthesitis at Week 24 Among the Participants With Enthesitis at Baseline

Description

Time Frame

Week 24

Title

Change From Baseline in Enthesitis Score (Based on LEI) at Week 24 Among the Participants With Enthesitis at Baseline

Description

Time Frame

Baseline and Week 24

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) Score at Week 24

Description

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Time Frame

Baseline and Week 24

Title

Percentage of Participants With Resolution of Dactylitis at Week 24 Among the Participants With Dactylitis at Baseline

Description

Time Frame

Week 24

Title

Change From Baseline in Dactylitis Scores at Week 24 Among the Participants With Dactylitis at Baseline

Description

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative change from baseline indicates improvement in dactylitis.

Time Frame

Baseline and Week 24

Title

Percentage of Participants Who Achieved ACR 20 Response by Visit Over Time Through Week 24

Description

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Who Achieved ACR 50 Response by Visit Over Time Through Week 24

Description

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Who Achieved ACR 70 Response by Visit Over Time Through Week 24

Description

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

ACR Components- Swollen Joint Count and Tender Joint Count Through Week 24

Description

ACR components including swollen joint count (66 joints) and tender joint count (68 joints) were measured.

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

ACR Components- Patient's Assessment of Pain, Patient's Global Assessment of Disease Activity, Physician's Global Assessment of Disease Activity Through Week 24

Description

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

ACR Component- C-reactive Protein (CRP) Through Week 24

Description

ACR component including CRP was measured.

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

ACR Component- Patient's Assessment of Physical Function as Assessed by HAQ-DI Scale Score at Weeks 4, 8, 12, 16, 20 and 24

Description

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

Percent Change From Baseline in ACR Components at Weeks 4, 8, 12, 16, 20 and 24

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20 and 24

Title

Change From Baseline in HAQ-DI Score at Weeks 4, 8, 12, 16, 20 and 24

Description

Time Frame

Baseline, Week 4, 8, 12, 16, 20 and 24

Title

Description

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3, where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning. Negative change from baseline indicates improvement of physical function and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Time Frame

Week 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Who Achieved a DAS28 (CRP) Response by Visit Over Time Through Week 24

Description

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Who Achieved a DAS28 (CRP) Remission by Visit Over Time Through Week 24

Description

Time Frame

Week 4, 8, 12, 16, 20 and 24

Title

Change From Baseline in DAS28 (CRP) Score at Weeks 4, 8, 12, 16, 20 and 24

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) by Visit Over Time Through Week 24

Description

Time Frame

Weeks 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Who Achieved Resolution of Enthesitis at Weeks 4, 8, 16, and 24 Among the Participants With Enthesitis at Baseline

Description

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

Time Frame

Weeks 4, 8, 16, and 24

Title

Change From Baseline in Enthesitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Enthesitis at Baseline

Description

Time Frame

Baseline, Weeks 4, 8, 16 and 24

Title

Percentage of Participants With Resolution of Dactylitis by Visit Over Time Through Week 24 Among the Participants With Dactylitis at Baseline

Description

Time Frame

Weeks 4, 8, 16 and 24

Title

Change From Baseline in Dactylitis Score at Weeks 4, 8, 16 and 24 Among the Participants With Dactylitis at Baseline

Description

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis.

Time Frame

Baseline, Weeks 4, 8, 16 and 24

Title

Change From Baseline in the Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 8, 16 and 24

Description

Time Frame

Baseline, Weeks 8, 16 and 24

Title

Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score at Weeks 16 and 24

Description

Time Frame

Baseline, Weeks 16 and 24

Title

Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 4, 8, 12, 16, 20 and 24

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 16 and 24

Description

Time Frame

Weeks 16 and Week 24

Title

Description

Time Frame

Weeks 8, 16 and 24

Title

Change From Baseline in BASDAI Score at Week 8, 16, and Week 24 Among Participants With Spondylitis and Peripheral Arthritis at Baseline

Description

Time Frame

Baseline, Weeks 8, 16, and 24

Title

Percentage of Participants With Low or Very Low Disease Activity Based on Psoriatic Arthritis Disease Activity Score (PASDAS) by Visit Over Time Through Week 24

Description

Time Frame

Weeks 8, 16 and 24

Title

Percentage of Participants With Low Disease Activity Based on Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index by Visit Over Time Through Week 24

Description

Time Frame

Weeks 16 and 24

Title

Percentage of Participants With Low Disease Activity or Remission Based on Disease Activity Index for Psoriatic Arthritis (DAPSA) by Visit Over Time Through Week 24

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20 and 24

Title

Percentage of Participants With Very Low Disease Activity (VLDA) by Visit Over Time Through Week 24

Description

Time Frame

Weeks 16 and 24

Title

Percentage of Participants Who Achieved PASI 75 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

Time Frame

Weeks 16 and 24

Title

Percentage of Participants Who Achieved PASI 90 Response at Weeks 16 and 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 90 response: >=90% improvement in PASI score from baseline.

Time Frame

Weeks 16 and 24

Title

Percentage of Participants Who Achieved PASI 100 Response by Visit Over Time Through Week 24 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. A PASI 100 response: 100% improvement in PASI score from baseline.

Time Frame

Weeks 16 and 24

Title

Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline

Description

Time Frame

Weeks 16 and 24

Title

Description

Time Frame

Weeks 16 and 24

Title

Percentage of Participants With an IGA Score of 0 (Cleared) at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline

Description

Time Frame

Weeks 16 and 24

Title

Change From Baseline in PASI Score at Weeks 16 and 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline

Description

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severtiy. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative change from baseline indicates improvement of psoriasis.

Time Frame

Baseline, Weeks 16 and 24

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) at Weeks 8, 16 and 24

Description

Time Frame

Baseline, Weeks 8, 16 and 24

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Mental Component Summary (MCS) at Weeks 8, 16 and 24

Description

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Time Frame

Baseline, Weeks 8, 16 and 24

Title

Change From Baseline in Norm Based Scores of SF-36 Scales at Weeks 8, 16 and 24

Description

Time Frame

Baseline, Week 8, 16 and 24

Title

Percentage of Participants Who Achieved >=5-point Improvement From Baseline in SF-36 MCS Score by Visit Over Time Through Week 24

Description

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Time Frame

Weeks 8, 16 and 24

Title

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score Through Week 24

Description

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Time Frame

Weeks 8, 16 and 24

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 8, 16, and 24

Description

Time Frame

Baseline, Weeks 8, 16 and 24

Title

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 8, 16, and 24

Description

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Time Frame

Weeks 8, 16, and 24

Title

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 8, 16 and 24

Description

Time Frame

Baseline, Weeks 8, 16 and 24

Title

Change From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24

Description

Time Frame

Baseline and Week 24

Title

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Week 24 by ACR 20 Response at Week 24

Description

The FACIT-Fatigue is a questionnaire that assesses self-reported tiredness, weakness, and difficulty conducting usual activities due to fatigue. The subscale consists 13-item instrument to measure fatigue. Each of the 13 items has a set of five response categories: Not at all (=0), A little bit (=1), Somewhat (=2), Quite a bit (=3) and Very much (=4). A total FACIT-Fatigue subscale score was calculated as the sum of the 13 item scores (reserved scores [4 - score]) and ranges from 0 to 52, with a higher score indicating less fatigue. Items were reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.

Time Frame

Week 24

Title

Percentage of Participants Who Achieved an Improvement of >=3 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24

Description

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Time Frame

Weeks 8, 16, and 24

Title

Percentage of Participants Who Achieved an Improvement of >=5 Points From Baseline in PROMIS-29 Domain Scores at Weeks 8, 16, and 24

Description

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Time Frame

Weeks 8, 16, and 24

Title

Percentage of Participants Who Achieved ACR 20 Response at Weeks 24, 28, 36, 44 and 52

Description

Time Frame

Weeks 24, 28, 36, 44 and 52

Title

Percentage of Participants Who Achieved ACR 50 Response at Weeks 24, 28, 36, 44 and 52

Description

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Time Frame

Weeks 24, 28, 36, 44 and 52

Title

Percentage of Participants Who Achieved ACR 70 Response at Weeks 24, 28, 36, 44 and 52

Description

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Time Frame

Weeks 24, 28, 36, 44 and 52

Title

Percent Change From Baseline in ACR Components at Weeks 24, 28, 36, 44 and 52

Description

Time Frame

Baseline, Weeks 24, 28, 36, 44 and 52

Title

Change From Baseline in HAQ-DI Score at Weeks 24, 28, 36, 44 and 52

Description

Time Frame

Baseline, Weeks 24, 28, 36, 44 and 52

Title

Description

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Time Frame

Weeks 24, 28, 36, 44 and 52

Title

Change From Baseline in DAS28 (CRP) Score at Weeks 24, 28, 36, 44 and 52

Description

Time Frame

Baseline, Weeks 24, 28, 36, 44 and 52

Title

Percentage of Participants Who Achieved a DAS28 (CRP) Response at Weeks 24, 28, 36, 44 and 52

Description

DAS28 based on CRP is an index combining tender joints (28 joints), swollen joints (28 joints), CRP and patient's global assessment of disease activity. The set of 28 joint count is based on evaluation of the shoulder, elbow, wrist, metacarpophalangeal (MCP) MCP1 to MCP5, proximal interphalangeal (PIP) PIP1 to PIP5 joints of both the upper right extremity and the upper left extremity as well as the knee joints of lower right and lower left extremities. DAS28 (CRP) response criteria was defined as follows: Good response: <=3.2 at visit and >1.2 improvement; Moderate response: >3.2 at visit and >1.2 improvement or <=5.1 at visit and >0.6-1.2 improvement; No response: <=0.6 improvement, or >5.1 at visit and <=1.2 improvement. The values are 0=best to 10=worst. A DAS28 (CRP) responder was defined as achieving a good or moderate DAS28 response at a specific visit.

Time Frame

Weeks 24, 28, 36, 44 and 52

Title

Percentage of Participants Who Achieved a DAS28 (CRP) Remission at Weeks 24, 28, 36, 44 and 52

Description

Time Frame

Weeks 24, 28, 36, 44 and 52

Title

Percentage of Participants Who Maintained a HAQ-DI Response (>=0.35 Improvement From Baseline in HAQ-DI Score) at Week 52 Among Participants Who Achieved a HAQ-DI Response at Week 24

Description

HAQ-DI score assess functional status of participant. It is 20 question instrument that assess degree of difficulty a person has in accomplishing tasks in 8 functional areas (dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living). Responses in each functional area were scored from 0=indicating no difficulty, to 3=indicating inability to perform a task in that area. Total HAQ score is average of the computed categories scores ranging from 0-3 where 0=least difficulty and 3=extreme difficulty. Lower scores are indicative of better functioning and a decrease of 0.35 from baseline in HAQ-DI score indicates a meaningful improvement.

Time Frame

Week 52

Title

Percentage of Participants Who Achieved a Response Based on Modified Psoriatic Arthritis Responder Criteria (PsARC) at Weeks 24, 28, 36, 44 and 52

Description

The modified PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) on a VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria.

Time Frame

Weeks 24, 28, 36, 44 and 52

Title

Change From Baseline in the Disease Activity Index for Psoriatic Arthritis (DAPSA) Score at Weeks 24, 28, 36, 44 and 52

Description

DAPSA assessed the joint domain of PsA and was derived from the sum of the following components: tender joint count (0-68), swollen joint count (0-66), CRP level (mg/dL), patient assessment of pain (0-10cm VAS, 0=no pain, 10=worst possible pain), and patient's global assessment of disease activity on arthritis (0 to 10cm VAS, 0=excellent and 10=poor). A higher score indicates more active disease activity. Negative changes from baseline indicate improvement of PsA disease activity. The assessment does not have a score range with an upper or lower bound.

Time Frame

Baseline, Weeks 24, 28, 36, 44 and 52

Title

Percentage of Participants Who Achieved Both PASI 75 and Modified PsARC Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

In PASI, each area (head, trunk, upper and lower extremities) was assessed separately for % of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90-100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score range from 0 to 72. Higher scores=more severe disease. PASI75 response: >=75% improvement in PASI score from baseline. Modified PsARC response: improvement in at least 2 of 4 criteria: >=30% decrease in SJC and TJC, >=20% improvement in PtGA of Disease Activity (arthritis) on VAS (0-100 mm, 0=excellent and 100=poor), >=20% improvement in PGA of Disease Activity on VAS (VAS: 0-100 mm, 0=no arthritis and 100=extremely active arthritis), and at least 1 of 2 joint criteria with no deterioration in other criteria.

Time Frame

Weeks 24 and 52

Title

Percentage of Participants Who Achieved Both PASI 75 and ACR 20 Responses at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

In PASI, each area (head, trunk, upper and lower extremities) was assessed for % of area involved and translated to numeric score from 0 (no involvement) to 6 (90-100% involvement) and for erythema, induration, and scaling, each rated on scale of 0 to 4. PASI produces numeric score from 0 to 72. Higher scores=more severe disease. PASI 75: >=75% improvement in PASI score from baseline. ACR 20: >=20% improvement in SJC (66 joints)+TJC (68 joints) and >=20% improvement in 3 of 5: patient's assessment of pain (VAS; 0-100 mm, 0=no pain to 100=worst possible pain), PtGA of disease activity (VAS; 0-100 mm, 0=excellent to 100=poor), PGA of disease activity (VAS; 0-100 mm, 0=no arthritis to 100=extremely active arthritis), patient's assessment of physical function (HAQ-DI -20-question instrument; range- 0=no difficulty to 3=inability to perform task) and CRP.

Time Frame

Weeks 24 and 52

Title

Change From Baseline in PASI Score at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. Negative changes from baseline indicate improvement of psoriasis.

Time Frame

Baseline, Weeks 24 and 52

Title

Percentage of Participants Who Achieved PASI 75 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 75 response: >=75% improvement in PASI score from baseline.

Time Frame

Weeks 24 and 52

Title

Percentage of Participants Who Achieved PASI 90 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 90 response: >=90% improvement in PASI score from baseline.

Time Frame

Weeks 24 and 52

Title

Percentage of Participants Who Achieved PASI 100 Response at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

PASI is a tool to assess and grade severity of psoriasis and response to therapy. In PASI, body is divided into 4 areas: head, trunk, upper extremities, lower extremities. Each area was assessed separately for percentage of area involved and translated to numeric score ranging from 0 (no involvement) to 6 (90 to 100% involvement), and for erythema, induration, and scaling, each rated on scale of 0 to 4 that is none to maximum severity. PASI numeric score range from 0 (no psoriasis) to 72. Higher scores indicate more severe disease. PASI 100 response: 100% improvement in PASI score from baseline.

Time Frame

Weeks 24 and 52

Title

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 PCS Score at Weeks 24, 36 and 52

Description

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The PCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Time Frame

Weeks 24, 36 and 52

Title

Percentage of Participants Who Achieved >=5 Point Improvement From Baseline in SF-36 MCS Score at Weeks 24, 36 and 52

Description

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. Higher score indicates better outcome, with an increase of 5 points considered to be clinically meaningful.

Time Frame

Weeks 24, 36 and 52

Title

Percentage of Participants Who Achieved Minimal Disease Activity (MDA) at Weeks 24 and 52

Description

Time Frame

Weeks 24 and 52

Title

Change From Baseline in Group of Research and Assessment of Psoriasis and Psoriatic Arthritis Composite (GRACE) Score Index at Weeks 24 and 52

Description

Time Frame

Baseline, Weeks 24 and 52

Title

Change From Baseline in Psoriatic Arthritis Disease Activity (PASDAS) Score at Weeks 24 and 52

Description

Time Frame

Baseline, Weeks 24 and 52

Title

Percentage of Participants Who Maintained an ACR 20 Response at Week 52 Among Participants Who Achieved an ACR 20 Response at Week 24

Description

Time Frame

Week 52

Title

Percentage of Participants Who Maintained an ACR 50 Response at Week 52 Among Participants Who Achieved an ACR 50 Response at Week 24

Description

ACR 50 response was defined as >=50% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=50% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Time Frame

Week 52

Title

Percentage of Participants Who Maintained an ACR 70 Response at Week 52 Among Participants Who Achieved an ACR 70 Response at Week 24

Description

ACR 70 response was defined as >=70% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and >=70% improvement from baseline in 3 of the 5 assessments: patient's assessment of pain using VAS (0-100 millimeters [mm], 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by HAQ-DI (defined as a 20-question instrument assessing 8 functional areas; range: 0-3, 0=indicating no difficulty, 3=indicating inability to perform a task in that area), and CRP.

Time Frame

Week 52

Title

Description

Time Frame

Weeks 24 and 52

Title

Percentage of Participants With Resolution of Enthesitis at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline

Description

Enthesitis was assessed using the LEI, a tool developed to assess enthesitis in participants with PsA and evaluates the presence (score of 1) or absence (score of 0) of pain by applying local pressure to the following entheses: left and right lateral epicondyle humerus, left and right medial femoral condyle, and left and right achilles tendon insertion. The enthesitis index score is a total score of the 6 evaluated sites from 0 (0 sites with tenderness) to 6 (worst possible score; 6 sites with tenderness). A LEI score of 0 at a post baseline visit indicates resolution of enthesitis when baseline LEI>0.

Time Frame

Weeks 24, 36, 44 and 52

Title

Percentage of Participants With Resolution of Dactylitis at Weeks 24, 36, 44 and 52 Among Participants With Dactylitis at Baseline

Description

Time Frame

Weeks 24, 36, 44 and 52

Title

Change From Baseline in Enthesitis Score (Based on SPARCC) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline

Description

Time Frame

Baseline, Weeks 24, 36, 44 and 52

Title

Change From Baseline in Enthesitis Score (Based on LEI) at Weeks 24, 36, 44 and 52 Among the Participants With Enthesitis at Baseline

Description

Time Frame

Baseline, Weeks 24, 36, 44 and 52

Title

Change From Baseline in Dactylitis Score at Weeks 24, 36, 44 and 52 Among the Participants With Dactylitis at Baseline

Description

The presence and severity of dactylitis was assessed in both hands and feet using a scoring system from 0 to 3 (0-no dactylitis, 1-mild dactylitis, 2-moderate dactylitis, and 3-severe dactylitis) for each digit. The results were summed to produce a final score ranging from 0 to 60. A higher score indicates more severe dactylitis. Negative changes from baseline indicate improvement in dactylitis.

Time Frame

Baseline, Weeks 24, 36, 44 and 52

Title

Percentage of Participants With an IGA Score of 0 (Cleared) or 1 (Cleared) at Weeks 24 and 52 Among Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 at Baseline

Description

Time Frame

Weeks 24 and 52

Title

Change From Baseline in SF-36 Physical Component Summary (PCS) Score at Weeks 24, 36 and 52

Description

Time Frame

Baseline, Weeks 24, 36 and 52

Title

Change From Baseline in SF-36 Mental Component Summary (MCS) Score at Weeks 24, 36 and 52

Description

SF-36 is a multi-domain instrument with 36 items to evaluate the health status and quality of life. It included 8 subscales (physical functioning, physical role functioning, bodily pain, general health perception, vitality, social functioning, emotional role functioning, and mental health), which yielded a Physical Component Summary (PCS) with score range 0-100 (higher score-better quality of life) and a Mental Component Summary (MCS) with score range 0-100 (higher score-better quality of life) in addition to subscale scores. The MCS scores are normalized to a mean of 50 and standard deviations of 10, based upon general US population norms. A positive change indicates improvement while a negative change indicates worsening of health status and quality of life.

Time Frame

Baseline, Weeks 24, 36 and 52

Title

Change From Baseline in Norm Based Scores of SF-36 Scales at Week 24, 36 and 52

Description

Time Frame

Baseline, Weeks 24, 36 and 52

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 24, 36 and 52

Description

Time Frame

Baseline, Weeks 24, 36 and 52

Title

Percentage of Participants Who Achieved >=4-point Improvement From Baseline in FACIT-Fatigue Score at Weeks 24, 36 and 52

Description

Time Frame

Weeks 24, 36 and 52

Title

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS)-29 Scores at Weeks 24, 36 and 52

Description

PROMIS-29 contains 4 items for each of seven PROMIS domains (Anxiety, Depression, Fatigue, Pain Interference, Physical Function, Sleep Disturbance, and Satisfaction-Social Role and Activity. PROMIS-29 also includes an additional pain intensity 0-10 NRS. The raw score of each domain is converted into a standardized score with a mean of 50 and a SD of 10 for the general population in the US (T-Score).

Time Frame

Baseline, Weeks 24, 36 and 52

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram per deciLitre (mg/dL) at screening from the central laboratory Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis Have active PsA despite previous non-biologic disease-modifying antirheumatic drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent [%] of the overall study population), and must document the reason for discontinuation Exclusion Criteria: Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (this does not include a primary diagnosis of PsA with spondylitis), systemic lupus erythematosus, or Lyme disease Has ever received more than 2 anti-TNFalpha agents Has previously received any biologic treatment (other than anti-TNF alpha agents), including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment Has previously received any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent Has received apremilast within 4 weeks prior to the first administration of study agent Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Research & Development, LLC Clinical Trial

Organizational Affiliation

Janssen Research & Development, LLC

Official's Role

Study Director

Facility Information:

Facility Name

Rheumatology Associates

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Associates PC

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Arizona Arthritis & Rheumatology Research, PLLC

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85210

Country

United States

Facility Name

Clinical Research Center of Connecticut

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Dawes Fretzin Clinical Research Group, LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46256-4697

Country

United States

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Arthritis Consultants

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Arthritis and Osteoporosis Associates

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Austin Regional Clinic

City

Austin

State/Province

Texas

ZIP/Postal Code

78731-3146

Country

United States

Facility Name

Barwon Rheumatology Services

City

Geelong

ZIP/Postal Code

3220

Country

Australia

Facility Name

Southern Clinical Research

City

Hobart

ZIP/Postal Code

7000

Country

Australia

Facility Name

Liverpool Hospital

City

Liverpool

ZIP/Postal Code

2170

Country

Australia

Facility Name

Rheumatology Research Unit

City

Maroochydore

ZIP/Postal Code

4558

Country

Australia

Facility Name

Eastern Health - Box Hill Hospital

City

Melbourne

ZIP/Postal Code

3128

Country

Australia

Facility Name

Queen Elizabeth Hospital

City

Woodville South

ZIP/Postal Code

5011

Country

Australia

Facility Name

Eastern Regional Health Authority, St. Clare's Mercy Hospital

City

St. John's

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C 5B8

Country

Canada

Facility Name

The Waterside Clinic

City

Barrie

State/Province

Ontario

ZIP/Postal Code

L4M 6L2

Country

Canada

Facility Name

Dermatrials Research

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8N 1Y2

Country

Canada

Facility Name

Skin Centre for Dermatology

City

Peterborough

State/Province

Ontario

ZIP/Postal Code

K9J 5K2

Country

Canada

Facility Name

K. Papp Clinical Research

City

Waterloo

State/Province

Ontario

ZIP/Postal Code

N2J 1C4

Country

Canada

Facility Name

G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

Revmaclinic

City

Brno

ZIP/Postal Code

61141

Country

Czechia

Facility Name

MUDr. Rosypalova, s.r.o

City

Ostrava

ZIP/Postal Code

70800

Country

Czechia

Facility Name

Revmatologicka ambulance

City

Praha 4

ZIP/Postal Code

14000

Country

Czechia

Facility Name

Revmatologicky ustav

City

Praha

ZIP/Postal Code

12850

Country

Czechia

Facility Name

Medical Plus S.R.O.

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

PV-Medical S.R.O

City

Zlin

ZIP/Postal Code

76001

Country

Czechia

Facility Name

ISA GmbH

City

Berlin

ZIP/Postal Code

10789

Country

Germany

Facility Name

Universitatsklinikum Frankfurt

City

Frankfurt

ZIP/Postal Code

60590

Country

Germany

Facility Name

MVZ Rheuma

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

Rheumazentrum Ruhrgebiet

City

Herne

ZIP/Postal Code

44649

Country

Germany

Facility Name

Krankenhaus St. Josef

City

Wuppertal

ZIP/Postal Code

42105

Country

Germany

Facility Name

Orszagos Reumatologia es Fizioterapias Intezet

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

Magyar Honvedseg Egeszsegugyi Kozpont

City

Budapest

ZIP/Postal Code

1062

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Pest Megyei Flor Ferenc Korhaz

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Martinus Medicus Health Center

City

Szombathely

ZIP/Postal Code

9700

Country

Hungary

Facility Name

Seoul National University Bundang Hospital

City

Bundang

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Hanyang University Hospital for rheumatic Diseases

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

The Catholic University of Korea Seoul St. Mary's Hospital

City

Seoul

ZIP/Postal Code

06591

Country

Korea, Republic of

Facility Name

SMG - SNU Boramae Medical Center

City

Seoul

ZIP/Postal Code

7061

Country

Korea, Republic of

Facility Name

Ajou University Hospital

City

Suwon

ZIP/Postal Code

16499

Country

Korea, Republic of

Facility Name

Hospital Selayang

City

Batu Caves

ZIP/Postal Code

68100

Country

Malaysia

Facility Name

Hospital Pulau Pinang

City

Georgetown

ZIP/Postal Code

10990

Country

Malaysia

Facility Name

Hospital Raja Permaisuri Bainun

City

Ipoh

ZIP/Postal Code

30990

Country

Malaysia

Facility Name

Hospital Melaka

City

Melaka

ZIP/Postal Code

75400

Country

Malaysia

Facility Name

Hospital Tuanku Jaafar

City

Seremban

ZIP/Postal Code

70300

Country

Malaysia

Facility Name

Nzoz Osteo-Medic

City

Bialystok

ZIP/Postal Code

15-351

Country

Poland

Facility Name

Szpital Uniwersytecki Nr 2 w Bydgoszczy

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

NSZOZ Unica CR

City

Dabrowka

ZIP/Postal Code

62-069

Country

Poland

Facility Name

Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Etyka Osrodek Badan Klinicznych

City

Olsztyn

ZIP/Postal Code

10-117

Country

Poland

Facility Name

Centrum Medyczne Hetmańska

City

Poznań

ZIP/Postal Code

60-218

Country

Poland

Facility Name

Nasz Lekarz Przychodnie Medyczne

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Medycyna Kliniczna

City

Warsaw

ZIP/Postal Code

00-874

Country

Poland

Facility Name

Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher

City

Warszawa

ZIP/Postal Code

02-637

Country

Poland

Facility Name

Centrum Medyczne WroMedica

City

Wroclaw

ZIP/Postal Code

51-685

Country

Poland

Facility Name

Nzoz Biogenes Sp. Z O. O.

City

Wroclaw

ZIP/Postal Code

53-224

Country

Poland

Facility Name

Chelyabinsk Regional Clinical Dermatovenerological Dispensary

City

Chelyabinsk

ZIP/Postal Code

454092

Country

Russian Federation

Facility Name

Medical and Sanitary Unit ''Severstal''

City

Cherepovets

ZIP/Postal Code

162600

Country

Russian Federation

Facility Name

Research Institute of Dermatovenerology, Immunology

City

Ekaterinburg

ZIP/Postal Code

620076

Country

Russian Federation

Facility Name

Krasnoyarsk State Medical University

City

Krasnoyarsk

ZIP/Postal Code

660022

Country

Russian Federation

Facility Name

Lipetsk Regional Dermatovenerological Dispensary

City

Lipetsk

ZIP/Postal Code

398005

Country

Russian Federation

Facility Name

Rostov Regional Clinical Dermatovenerological Dispensary

City

Rostov

ZIP/Postal Code

344007

Country

Russian Federation

Facility Name

Ryazan Regional Clinical Dermatovenerological Dispensary

City

Ryazan

ZIP/Postal Code

390046

Country

Russian Federation

Facility Name

Republican Clinical Hospital - G.G. Kuvatov

City

Ufa

ZIP/Postal Code

450005

Country

Russian Federation

Facility Name

Clinical Emergency Hospital n.a. N.V. Solovyev

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

Clinical Hospital #10

City

Yaroslavl

ZIP/Postal Code

150023

Country

Russian Federation

Facility Name

Hosp. Univ. A Coruña

City

A Coruna

ZIP/Postal Code

15006

Country

Spain

Facility Name

Hosp. Del Mar

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Hosp. Gral. Univ. Gregorio Marañon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hosp. Univ. Ramon Y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Hospital Regional Carlos Haya

City

Málaga

ZIP/Postal Code

29009

Country

Spain

Facility Name

Hosp. Clinico Univ. de Santiago

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hosp. Infanta Luisa

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

Hosp. Unv. de Valme

City

Sevilla

ZIP/Postal Code

414014

Country

Spain

Facility Name

Hosp. de Manises

City

Valencia

ZIP/Postal Code

46940

Country

Spain

Facility Name

Hualien Tzu Chi Hospital

City

Hualien City

ZIP/Postal Code

970

Country

Taiwan

Facility Name

Kaohsiung Veterans General Hospital

City

Kaohsiung

ZIP/Postal Code

81362

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital Kaohsiung Branch

City

Kaohsiung

ZIP/Postal Code

833

Country

Taiwan

Facility Name

Chung Shan Medical University Hospital

City

Taichung

ZIP/Postal Code

402

Country

Taiwan

Facility Name

National Cheng Kung University Medical Center

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

Facility Name

National Taiwan University Hospital

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Chang Kung Memorial Hospital

City

Taipei

ZIP/Postal Code

105

Country

Taiwan

Facility Name

Chang-Gung Memorial Hospital, LinKou Branch

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Municipal health care institution Chernihiv Regional Hospital

City

Chernihiv

Country

Ukraine

Facility Name

Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital

City

Ivano-Frankivsk

Country

Ukraine

Facility Name

Communal Institution of Health Kharkiv City multifield hospital №18

City

Kharkiv

ZIP/Postal Code

61029

Country

Ukraine

Facility Name

Municipal Institution Regional hospital-center of emergency care and disasters medicine

City

Kharkiv

Country

Ukraine

Facility Name

Khmelnitckiy regional hospital

City

Khmelnytsky

Country

Ukraine

Facility Name

Clinic of SI 'NSC 'The M.D.Strazhesko Institute of Cardiology' of NAMS of Ukraine'

City

Kyiv

Country

Ukraine

Facility Name

Kyiv Railway Station Clinical Hospital #2

City

Kyiv

Country

Ukraine

Facility Name

Danylo Halytsky Lviv National Medical University

City

Lviv

Country

Ukraine

Facility Name

Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council

City

Odessa

ZIP/Postal Code

65025

Country

Ukraine

Facility Name

Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'

City

Ternopil

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

35768650

Citation

Orbai AM, Coates LC, Deodhar A, Helliwell PS, Ritchlin CT, Leibowitz E, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Jiang Y, Liu Y, Han C. Meaningful Improvement in General Health Outcomes with Guselkumab Treatment for Psoriatic Arthritis: Patient-Reported Outcomes Measurement Information System-29 Results from a Phase 3 Study. Patient. 2022 Nov;15(6):657-668. doi: 10.1007/s40271-022-00588-6. Epub 2022 Jun 30.

Results Reference

derived

PubMed Identifier

35766811

Citation

Coates LC, Ritchlin CT, Gossec L, Helliwell PS, Rahman P, Kollmeier AP, Xu XL, Shawi M, Karyekar CS, Contre C, Noel W, Sheng S, Wang Y, Xu S, Mease PJ. Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis. Rheumatology (Oxford). 2023 Feb 1;62(2):606-616. doi: 10.1093/rheumatology/keac375.

Results Reference

derived

PubMed Identifier

35296534

Citation

Ritchlin CT, Mease PJ, Boehncke WH, Tesser J, Schiopu E, Chakravarty SD, Kollmeier AP, Xu XL, Shawi M, Jiang Y, Sheng S, Wang Y, Xu S, Merola JF, McInnes IB, Deodhar A. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies. RMD Open. 2022 Mar;8(1):e002195. doi: 10.1136/rmdopen-2022-002195.

Results Reference

derived

PubMed Identifier

34261541

Citation

Rahman P, Mease PJ, Helliwell PS, Deodhar A, Gossec L, Kavanaugh A, Kollmeier AP, Hsia EC, Zhou B, Lin X, Shawi M, Karyekar CS, Han C. Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response-results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis. Arthritis Res Ther. 2021 Jul 14;23(1):190. doi: 10.1186/s13075-021-02554-3.

Results Reference

derived

PubMed Identifier

34011674

Citation

Sweet K, Song Q, Loza MJ, McInnes IB, Ma K, Leander K, Lakshminarayanan V, Franks C, Cooper P, Siebert S. Guselkumab induces robust reduction in acute phase proteins and type 17 effector cytokines in active psoriatic arthritis: results from phase 3 trials. RMD Open. 2021 May;7(2):e001679. doi: 10.1136/rmdopen-2021-001679.

Results Reference

derived

PubMed Identifier

33934076

Citation

Rahman P, Ritchlin CT, Helliwell PS, Boehncke WH, Mease PJ, Gottlieb AB, Kafka S, Kollmeier AP, Hsia EC, Xu XL, Shawi M, Sheng S, Agarwal P, Zhou B, Ramachandran P, Zhuang Y, McInnes IB. Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in Patients With Psoriatic Arthritis. J Rheumatol. 2021 Dec;48(12):1815-1823. doi: 10.3899/jrheum.201532. Epub 2021 May 1.

Results Reference

derived

PubMed Identifier

33822898

Citation

McGonagle D, McInnes IB, Deodhar A, Schett G, Shawi M, Kafka S, Karyekar CS, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Agarwal P, Zhou B, Ritchlin CT, Rahman P, Mease PJ. Resolution of enthesitis by guselkumab and relationships to disease burden: 1-year results of two phase 3 psoriatic arthritis studies. Rheumatology (Oxford). 2021 Nov 3;60(11):5337-5350. doi: 10.1093/rheumatology/keab285.

Results Reference

derived

PubMed Identifier

32178765

Citation

Deodhar A, Helliwell PS, Boehncke WH, Kollmeier AP, Hsia EC, Subramanian RA, Xu XL, Sheng S, Agarwal P, Zhou B, Zhuang Y, Ritchlin CT; DISCOVER-1 Study Group. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFalpha inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 Apr 4;395(10230):1115-1125. doi: 10.1016/S0140-6736(20)30265-8. Epub 2020 Mar 13. Erratum In: Lancet. 2020 Apr 4;395(10230):1114.

Results Reference

derived

Learn more about this trial

We'll reach out to this number within 24 hrs