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Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent (SOLSTICE)

Primary Purpose

Arthritis, Psoriatic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Guselkumab
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

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 active 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 milligrams per deciliter (mg/dL) at screening from the central laboratory
  • Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
  • Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis
  • Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent

Exclusion Criteria:

  • Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
  • Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars)
  • Has ever received Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor
  • Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
  • Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients
  • Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers

Sites / Locations

  • Rheumatology Associates
  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Arizona Arthritis and Rheumatology Research, PLLC
  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Arizona Arthritis and Rheumatology Research, PLLCRecruiting
  • Arizona Arthritis & Rheumatology AssociatesRecruiting
  • Southern Arizona VA Healthcare SystemRecruiting
  • Unity Health-White County Medical CenterRecruiting
  • Newport Huntington Medical GroupRecruiting
  • Medvin Clinical ResearchRecruiting
  • Medvin Clinical ResearchRecruiting
  • Clinical Research Center of Connecticut
  • Bay Pines VA Healthcare SystemRecruiting
  • Clinical Research of West FloridaRecruiting
  • Omega Research ConsultantsRecruiting
  • Advanced Clinical Research of OrlandoRecruiting
  • Integral Rheumatology & Immunology SpecialistsRecruiting
  • Clinical Research of West FloridaRecruiting
  • Florida Medical Clinic, P.A.Recruiting
  • Great Lakes Clinical Trials
  • Clinic of Robert HozmanRecruiting
  • The Arthritis and Diabetes ClinicRecruiting
  • Johns Hopkins UniversityRecruiting
  • Klein & Associates, M.D., P.A.Recruiting
  • Great Lakes Center of RheumatologyRecruiting
  • Arthritis and Rheumatology Center of MIRecruiting
  • Clinical Research Institute of Michigan, LLCRecruiting
  • St. Paul Rhuematology, P.A.Recruiting
  • Arthritis Consultants
  • Arthritis Rheumatic And Back Disease AssociatesRecruiting
  • Albuquerque Center for RheumatologyRecruiting
  • Arthritis and Osteoperosis Associates of New MexicoRecruiting
  • Buffalo Rheumatology and Medicine PLLCRecruiting
  • DJL Clinical Research, PLLCRecruiting
  • STAT Research, Inc.
  • Health Research of OklahomaRecruiting
  • Dr. Ramesh GuptaRecruiting
  • Precision Comprehensive Clinical Research SolutionsRecruiting
  • Adriana Pop Moody MD Clinic PARecruiting
  • Metroplex Clinical Research Center
  • Precision Comprehensive Clinical Research Solutions
  • West Texas Clinical ResearchRecruiting
  • Southwest Rheumatology Research LLCRecruiting
  • Texas Rheumatology CareRecruiting
  • Advanced Rheumatology of HoustonRecruiting
  • DM Clinical ResearchRecruiting
  • Arthritis & Osteoporosis ClinicRecruiting
  • Arthritis Northwest PLLCRecruiting
  • Rheumatology & Pulmonary ClinicRecruiting
  • Cosultorios Reumatologógicos PampaRecruiting
  • Centro Privado de Medicina FamiliarRecruiting
  • Hospital Central Militar Cirujano Mayor Dr Cosme ArgerichRecruiting
  • CIPRECRecruiting
  • OMIRecruiting
  • Instituto de Reumatología MendozaRecruiting
  • Centro de Investigaciones Medicas TucumanRecruiting
  • Southern Clinical Research
  • Liverpool Hospital
  • Skin Health Institute Inc.
  • Eastern Health - Box Hill Hospital
  • UMHAT 'Dr. Georgi Stranski', EADRecruiting
  • Medical Center Unimed PlovdivRecruiting
  • UMHAT KaspelaRecruiting
  • Diagnosis-consulting centre-1Recruiting
  • UMHAT St. Ivan RilskiRecruiting
  • Military Medical Academy
  • ASIMP Rheumatology Centre "St Irina" EOODRecruiting
  • University Multiprofile Hospital Sofiamed Sofia
  • Medical Centre Synexus
  • RHEUMA s.r.o.Recruiting
  • L.K.N ArthrocentrumRecruiting
  • MUDr. Rosypalova, s.r.oRecruiting
  • Arthrohelp S.R.O.Recruiting
  • Revmatologicky ustavRecruiting
  • Medical Plus S.R.O.Recruiting
  • PV-Medical S.R.O
  • Betegapolo Irgalmas Rend - Budai Irgalmasrendi KorhazRecruiting
  • Uno Medical Trials Ltd.Recruiting
  • Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
  • Bekes Megyei Kozponti Korhaz Pandy Kalman TagkorhazRecruiting
  • Pest Megyei Flor Ferenc KorhazRecruiting
  • Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai KözpontRecruiting
  • Fejer Varmegyei Szent Gyorgy Egyetemi OktatokorhazRecruiting
  • Vital Medical Center Orvosi es Fogaszati KozpontRecruiting
  • Bnai Zion Medical CenterRecruiting
  • Rambam Health Care CampusRecruiting
  • Carmel Medical CenterRecruiting
  • Meir Medical Center
  • Sheba Medical CenterRecruiting
  • Hospital Selayang
  • Hospital Pulau Pinang
  • Hospital Raja Permaisuri BainunRecruiting
  • Hospital Tuanku Jaafar
  • Nzoz Bif-MedRecruiting
  • Centrum Kliniczno BadawczeRecruiting
  • Malopolskie Badania Kliniczne Sp. z o.o.Recruiting
  • Malopolskie Centrum KliniczneRecruiting
  • Centrum Medyczne PromedRecruiting
  • Dermed Centrum Medyczne Sp. z o.oRecruiting
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-AkcyjnaRecruiting
  • NZOZ Lecznica MAK-MED. S.C.Recruiting
  • Twoja Przychodnia - Centrum Medyczne Nowa SolRecruiting
  • Centrum MedyczneRecruiting
  • Twoja PrzychodniaRecruiting
  • Lubelskie Centrum DiagnostyczneRecruiting
  • MICS Centrum Medyczne WarszawaRecruiting
  • Rheuma-Medicus, Zaklad Opieki ZdrowotnejRecruiting
  • Centrum Medyczne Reuma ParkRecruiting
  • WroMedica I.Bielicka, A.Strzałkowska s.c.Recruiting
  • GCM Medical GroupRecruiting
  • Mindful Medical ResearchRecruiting
  • FDI Clinical ResearchRecruiting
  • Altay Medical State University
  • Chelyabinck Regional Clinical Hospital
  • Chelyabinsk Regional Clinical Dermatovenerological Dispensary
  • Kemerovo State Medical University
  • LLL Medical Center Revma-Med
  • LLC Family Outpatient Clinic # 4
  • Krasnodar Clinical Dermatovenerologic Dispensary
  • Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
  • Clinical-Diagnostic Center Euromedservice, JSC
  • FGBU Research Institute of Rheumatology named V.A.Nasonova
  • GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
  • GBOU VPO Orenburg State Medical University
  • Rostov Regional Clinical Dermatovenerological Dispensary
  • Saratov Regional Clinical Hospital
  • Smolensk regional hospital on Smolensk railway station
  • St. Petersburg GBUZ Clinical Reumatological Hospital 25
  • X7 Clinical Research Company Limited
  • GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
  • Tula Regional Clinical Dermatovenerological Dispensary
  • Republican Clinical Hospital - G.G. Kuvatov
  • Hosp. Univ. de CrucesRecruiting
  • Hosp. Univ. de La PrincesaRecruiting
  • Hosp. Quiron Madrid PozueloRecruiting
  • Hosp. Regional Univ. de MalagaRecruiting
  • Clinica GaiasRecruiting
  • Hosp. Quiron Sagrado CorazonRecruiting
  • Hosp. Clinico Univ. de ValenciaRecruiting
  • Adana City HospitalRecruiting
  • Gulhane Training and Research HospitalRecruiting
  • Ankara Bilkent City HospitalRecruiting
  • Hacettepe University Medical FacultyRecruiting
  • Akdeniz University Medical FacultyRecruiting
  • Uludag University Medical FacultyRecruiting
  • Pamukkale University Medical FacultyRecruiting
  • Osmangazi University Medical FacultyRecruiting
  • Istanbul University Istanbul Medical Faculty
  • Istanbul University Cerrahpasa Medical Faculty
  • Kartal Dr. Lutfi Kirdar sehir HastanesiRecruiting
  • Marmara University Medical FacultyRecruiting
  • Kocaeli University Medical FacultyRecruiting
  • Necmettin Erbakan University Meram Medical FacultyRecruiting
  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
  • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Khmelnitckiy regional hospital
  • City Clinical Hospital No. 2
  • Medical Center LLC 'Harmony of Beauty'
  • Medical Center of 'Institute of Rheumatology', LLC
  • Kyiv City Clinical Hospital #3
  • Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
  • Medical Center 'Consylium Medical'
  • Volyn Regional Clinical Hospital
  • LLC Medical House
  • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
  • Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
  • Medical Center LLC 'Modern Clinic'

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Group 1: Guselkumab and Placebo

Group 2: Guselkumab

Group 3: Placebo Followed by Guselkumab

Arm Description

Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.

Participants will receive guselkumab SC.

Participants will receive placebo SC and will cross over to receive guselkumab SC.

Outcomes

Primary Outcome Measures

Percentage of Participants Who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent (%) improvement from baseline in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and CRP.

Secondary Outcome Measures

Percentage of Participants who Achieve a Psoriasis Response of IGA Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 at Baseline
Psoriasis response is defined as an Investigator's Global Assessment (IGA) psoriasis score of 0 (cleared) or 1 (minimal) and >=2- grade reduction from baseline. The IGA documents the investigator's assessment of the participants 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 is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Percentage of Participants who Achieve PASI 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Psoriasis Area and Severity Index (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 is 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. A PASI 90 response: >=90% improvement in PASI score from baseline.
Change From Baseline in 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 are 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.
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 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.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score at Week 24
The FACIT-F 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 is 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 are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
MDA is 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 pain VAS score of <=15; patient's global disease activity VAS (arthritis and psoriasis) score of <=20; HAQ-DI <=0.5; and tender entheseal points <=1.
Percentage of Participants who Achieve 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 CRP.
Percentage of Participants who Achieve ACR 50 Response at Week 16
ACR 50 response is 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.
Percentage of Participants who Achieve ACR 50 Response at Week 24
ACR 50 response is defined as >=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 CRP.
Percentage of Participants who Achieve ACR 70 Response at Week 24
ACR 70 response is 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 With Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
Percentage of participants with AEs, SAEs reasonably related AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. Reasonably related AEs are those AEs which are judged related to study treatment by the investigator.
Percentage of Participants With AEs leading to Discontinuation of Study Intervention
Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
Percentage of Participants With Infections
Percentage of participants with infections will be reported.
Percentage of Participants With Injection-site Reactions
Percentage of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
Percentage of Participants With Change from Baseline in Clinical Laboratory Abnormalities
Percentage of participants with change from baseline in clinical laboratory abnormalities including chemistry and hematology will be reported.
Percentage of participants With Laboratory Abnormalities With Maximum Toxicity Grades as per Common Terminology Criteria for Adverse Events (CTCAE) Toxicity
Percentage of participants with laboratory abnormalities (hematology, chemistry) with maximum toxicity grades as per CTCAE will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Serum Guselkumab Concentration
Serum guselkumab concentration will be measured.
Percentage of Participants With Anti-guselkumab Antibodies
Percentage of participants with anti-guselkumab antibodies to guselkumab will be reported.

Full Information

First Posted
June 16, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04936308
Brief Title
Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent
Acronym
SOLSTICE
Official Title
A Phase 3B, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Who Had an Inadequate Response and/or Intolerance to One Prior Anti-Tumor Necrosis Factor Alpha Agent
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
December 24, 2025 (Anticipated)
Study Completion Date
September 7, 2026 (Anticipated)

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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) and inadequate response (IR) and/or intolerance to a prior anti-tumor necrosis factor (TNF) by assessing the reduction in signs and symptoms of PsA.
Detailed Description
PsA is a chronic, immune-mediated inflammatory disease characterized by peripheral joint inflammation, enthesitis, dactylitis, axial disease, and the skin lesions associated with psoriasis. Guselkumab is a fully human monoclonal antibody (mAb) that binds to p19 protein subunit of interleukin (IL)-23 and blocks the binding of extracellular IL-23 to the cell surface IL-23 receptor, inhibiting IL-23 specific intracellular signaling, subsequent activation, and cytokine production. The primary hypothesis of this study is that guselkumab is superior to placebo as assessed by the proportion of participants who had an inadequate response (IR) and/or intolerance to one prior anti-tumor necrosis factor (anti-TNF) achieving an American College of Rheumatology 20 (ACR 20) response at Week 24. This study will consist of a screening phase (up to 6 weeks), blinded treatment phase (approximately up to 2 years), which includes a placebo-controlled period from Week 0 to Week 24, and an active-controlled treatment phase from Week 24 to Week 100, and safety follow-up phase (Week 112). Safety assessments will include physical examinations, vital signs, height, weight, electrocardiograms, and clinical safety laboratory assessments. The total duration of the study will be up to 118 weeks.

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
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Guselkumab and Placebo
Arm Type
Experimental
Arm Description
Participants will receive guselkumab and placebo subcutaneously (SC) to maintain the blind.
Arm Title
Group 2: Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive guselkumab SC.
Arm Title
Group 3: Placebo Followed by Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive placebo SC and will cross over to receive guselkumab SC.
Intervention Type
Drug
Intervention Name(s)
Guselkumab
Other Intervention Name(s)
Tremfya, CNTO1959
Intervention Description
Participants will receive guselkumab as 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 Achieve an American College of Rheumatology (ACR) 20 Response at Week 24
Description
The ACR 20 Response is defined as greater than or equal to (>=) 20 percent (%) improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent (%) improvement from baseline in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-100 millimeter [mm], 0 mm=no pain and 100 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm= very well to 100 mm= very poor]), physician's global assessment of disease activity using VAS (scale ranges from 0 to 100), [0 = no arthritis to 100 = extremely active arthritis], participant's assessment of physical function measured by Health Assessment Questionnaire-disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and CRP.
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve a Psoriasis Response of IGA Psoriasis Score of 0 or 1 and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% Body Surface Area (BSA) Psoriatic Involvement and IGA Score of >=2 at Baseline
Description
Psoriasis response is defined as an Investigator's Global Assessment (IGA) psoriasis score of 0 (cleared) or 1 (minimal) and >=2- grade reduction from baseline. The IGA documents the investigator's assessment of the participants 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 is based upon the average of induration, erythema and scaling scores. The participant's psoriasis is assessed as cleared (0), minimal (1), mild (2), moderate (3), or severe (4).
Time Frame
Week 24
Title
Percentage of Participants who Achieve PASI 90 Response at Week 24 Among the Participants With >=3% BSA Psoriatic Involvement and an IGA Score of >=2 (Mild) at Baseline
Description
Psoriasis Area and Severity Index (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 is 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. A PASI 90 response: >=90% improvement in PASI score from baseline.
Time Frame
Week 24
Title
Change From Baseline in HAQ-DI Score 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 are 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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in 36-item Short Form Health Survey (SF-36) Physical Component Summary (PCS) 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 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.
Time Frame
Baseline and Week 24
Title
Change From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Score at Week 24
Description
The FACIT-F 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 is 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 are reverse scored when appropriate to provide a scale in which higher scores represent better functioning or less fatigue.
Time Frame
Baseline and Week 24
Title
Percentage of Participants Achieving Minimal Disease Activity (MDA) at Week 24
Description
MDA is 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 pain VAS score of <=15; patient's global disease activity VAS (arthritis and psoriasis) score of <=20; HAQ-DI <=0.5; and tender entheseal points <=1.
Time Frame
Week 24
Title
Percentage of Participants who Achieve 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 CRP.
Time Frame
Week 16
Title
Percentage of Participants who Achieve ACR 50 Response at Week 16
Description
ACR 50 response is 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.
Time Frame
Week 16
Title
Percentage of Participants who Achieve ACR 50 Response at Week 24
Description
ACR 50 response is defined as >=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 CRP.
Time Frame
Week 24
Title
Percentage of Participants who Achieve ACR 70 Response at Week 24
Description
ACR 70 response is 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.
Time Frame
Week 24
Title
Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Reasonably Related AEs, as a Measure of Safety and Tolerability
Description
Percentage of participants with AEs, SAEs reasonably related AEs will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, and suspects transmission of any infectious agent via a medicinal product. Reasonably related AEs are those AEs which are judged related to study treatment by the investigator.
Time Frame
Up to 112 weeks
Title
Percentage of Participants With AEs leading to Discontinuation of Study Intervention
Description
Percentage of participants with AEs leading to discontinuation of study intervention will be reported.
Time Frame
Up to 112 weeks
Title
Percentage of Participants With Infections
Description
Percentage of participants with infections will be reported.
Time Frame
Up to 112 weeks
Title
Percentage of Participants With Injection-site Reactions
Description
Percentage of participants with injection-site reactions will be reported. An injection-site reaction is any adverse reaction at a subcutaneous (SC) study intervention injection-site.
Time Frame
Up to 100 weeks
Title
Percentage of Participants With Change from Baseline in Clinical Laboratory Abnormalities
Description
Percentage of participants with change from baseline in clinical laboratory abnormalities including chemistry and hematology will be reported.
Time Frame
Up to 112 weeks
Title
Percentage of participants With Laboratory Abnormalities With Maximum Toxicity Grades as per Common Terminology Criteria for Adverse Events (CTCAE) Toxicity
Description
Percentage of participants with laboratory abnormalities (hematology, chemistry) with maximum toxicity grades as per CTCAE will be reported. Grade refers to the severity of the AE as follows: Grade 1- Mild, asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2- Moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental Activities of Daily Living (ADL); Grade 3- Severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated, disabling, limiting self-care ADL; Grade 4- Life-threatening consequences, urgent intervention indicated; Grade 5- Death related to AE.
Time Frame
Up to 112 weeks
Title
Serum Guselkumab Concentration
Description
Serum guselkumab concentration will be measured.
Time Frame
Up to 112 weeks
Title
Percentage of Participants With Anti-guselkumab Antibodies
Description
Percentage of participants with anti-guselkumab antibodies to guselkumab will be reported.
Time Frame
Up to 112 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of active 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 milligrams per deciliter (mg/dL) at screening from the central laboratory Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis Have active plaque psoriasis, with at least one psoriatic plaque of >= 2 centimeters (cm) diameter and/or nail changes consistent with psoriasis, or documented history of plaque psoriasis Have an inadequate response and/or intolerance to anti-tumor necrosis factor alpha (TNF alpha) therapy, defined as presence of active PsA despite previous treatment with one prior anti-TNF alpha agent Exclusion Criteria: Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy in the treatment of PsA, including but not limited to rheumatoid arthritis, ankylosing spondylitis/nonradiographic axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease Has received more than 1 prior anti-tumor necrosis factor (TNF) alpha agent (or biosimilars) Has ever received Janus kinase (JAK) inhibitor including but not limited to tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other investigational JAK inhibitor Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention Has known allergies, hypersensitivity, or intolerance to guselkumab or its excipients Has a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infection (example, bronchiectasis), recurrent urinary tract infection (example, recurrent pyelonephritis or chronic non-remitting cystitis), fungal infection (example, mucocutaneous candidiasis), or open, draining, or infected skin wounds or ulcers
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
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
Individual Site Status
Completed
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001-6218
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Individual Site Status
Completed
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis and Rheumatology Research, PLLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85037
Country
United States
Individual Site Status
Recruiting
Facility Name
Arizona Arthritis & Rheumatology Associates
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Individual Site Status
Recruiting
Facility Name
Southern Arizona VA Healthcare System
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85723
Country
United States
Individual Site Status
Recruiting
Facility Name
Unity Health-White County Medical Center
City
Searcy
State/Province
Arkansas
ZIP/Postal Code
72143
Country
United States
Individual Site Status
Recruiting
Facility Name
Newport Huntington Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92648
Country
United States
Individual Site Status
Recruiting
Facility Name
Medvin Clinical Research
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
Country
United States
Individual Site Status
Recruiting
Facility Name
Medvin Clinical Research
City
Tujunga
State/Province
California
ZIP/Postal Code
91042
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Center of Connecticut
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Individual Site Status
Completed
Facility Name
Bay Pines VA Healthcare System
City
Bay Pines
State/Province
Florida
ZIP/Postal Code
33744
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Omega Research Consultants
City
DeBary
State/Province
Florida
ZIP/Postal Code
32713
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Clinical Research of Orlando
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Individual Site Status
Recruiting
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of West Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Medical Clinic, P.A.
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Clinical Trials
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60640
Country
United States
Individual Site Status
Completed
Facility Name
Clinic of Robert Hozman
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Individual Site Status
Recruiting
Facility Name
The Arthritis and Diabetes Clinic
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71203
Country
United States
Individual Site Status
Recruiting
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Name
Klein & Associates, M.D., P.A.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Great Lakes Center of Rheumatology
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48911
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis and Rheumatology Center of MI
City
Okemos
State/Province
Michigan
ZIP/Postal Code
48864
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research Institute of Michigan, LLC
City
Saint Clair Shores
State/Province
Michigan
ZIP/Postal Code
48081
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Paul Rhuematology, P.A.
City
Eagan
State/Province
Minnesota
ZIP/Postal Code
55121
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Completed
Facility Name
Arthritis Rheumatic And Back Disease Associates
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Individual Site Status
Recruiting
Facility Name
Albuquerque Center for Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis and Osteoperosis Associates of New Mexico
City
Las Cruces
State/Province
New Mexico
ZIP/Postal Code
88011
Country
United States
Individual Site Status
Recruiting
Facility Name
Buffalo Rheumatology and Medicine PLLC
City
Orchard Park
State/Province
New York
ZIP/Postal Code
14127
Country
United States
Individual Site Status
Recruiting
Facility Name
DJL Clinical Research, PLLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Individual Site Status
Recruiting
Facility Name
STAT Research, Inc.
City
Vandalia
State/Province
Ohio
ZIP/Postal Code
45377
Country
United States
Individual Site Status
Completed
Facility Name
Health Research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Individual Site Status
Recruiting
Facility Name
Dr. Ramesh Gupta
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Individual Site Status
Recruiting
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Colleyville
State/Province
Texas
ZIP/Postal Code
76034
Country
United States
Individual Site Status
Recruiting
Facility Name
Adriana Pop Moody MD Clinic PA
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78404
Country
United States
Individual Site Status
Recruiting
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Completed
Facility Name
Precision Comprehensive Clinical Research Solutions
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Individual Site Status
Completed
Facility Name
West Texas Clinical Research
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79424
Country
United States
Individual Site Status
Recruiting
Facility Name
Southwest Rheumatology Research LLC
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Rheumatology Care
City
Plano
State/Province
Texas
ZIP/Postal Code
75024
Country
United States
Individual Site Status
Recruiting
Facility Name
Advanced Rheumatology of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77382
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis & Osteoporosis Clinic
City
Waco
State/Province
Texas
ZIP/Postal Code
76710
Country
United States
Individual Site Status
Recruiting
Facility Name
Arthritis Northwest PLLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Individual Site Status
Recruiting
Facility Name
Rheumatology & Pulmonary Clinic
City
Beckley
State/Province
West Virginia
ZIP/Postal Code
25801
Country
United States
Individual Site Status
Recruiting
Facility Name
Cosultorios Reumatologógicos Pampa
City
Buenos Aires
ZIP/Postal Code
1428
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro Privado de Medicina Familiar
City
Buenos Aires
ZIP/Postal Code
C1417EYG
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Hospital Central Militar Cirujano Mayor Dr Cosme Argerich
City
Buenos Aires
ZIP/Postal Code
C1426BOS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
CIPREC
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1061AAS
Country
Argentina
Individual Site Status
Recruiting
Facility Name
OMI
City
Ciudad Autónoma de Buenos Aires
ZIP/Postal Code
C1015ABO
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Instituto de Reumatología Mendoza
City
Ciudad de Mendoza
ZIP/Postal Code
M5631AHF
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Medicas Tucuman
City
San Miguel De Tucuman
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Southern Clinical Research
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Individual Site Status
Terminated
Facility Name
Liverpool Hospital
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Individual Site Status
Terminated
Facility Name
Skin Health Institute Inc.
City
Melbourne
ZIP/Postal Code
3053
Country
Australia
Individual Site Status
Terminated
Facility Name
Eastern Health - Box Hill Hospital
City
Melbourne
ZIP/Postal Code
3128
Country
Australia
Individual Site Status
Terminated
Facility Name
UMHAT 'Dr. Georgi Stranski', EAD
City
Pleven
ZIP/Postal Code
5804
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Medical Center Unimed Plovdiv
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT Kaspela
City
Plovdiv
ZIP/Postal Code
4001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Diagnosis-consulting centre-1
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
UMHAT St. Ivan Rilski
City
Sfia
ZIP/Postal Code
1612
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Completed
Facility Name
ASIMP Rheumatology Centre "St Irina" EOOD
City
Sofia
ZIP/Postal Code
1750
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University Multiprofile Hospital Sofiamed Sofia
City
Sofia
ZIP/Postal Code
1770
Country
Bulgaria
Individual Site Status
Completed
Facility Name
Medical Centre Synexus
City
Sofia
ZIP/Postal Code
1794
Country
Bulgaria
Individual Site Status
Completed
Facility Name
RHEUMA s.r.o.
City
Breclav
ZIP/Postal Code
691 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
L.K.N Arthrocentrum
City
Hlucin
ZIP/Postal Code
748 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
MUDr. Rosypalova, s.r.o
City
Ostrava
ZIP/Postal Code
70800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Arthrohelp S.R.O.
City
Pardubice
ZIP/Postal Code
53002
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Revmatologicky ustav
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Medical Plus S.R.O.
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Individual Site Status
Recruiting
Facility Name
PV-Medical S.R.O
City
Zlin
ZIP/Postal Code
76001
Country
Czechia
Individual Site Status
Completed
Facility Name
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Uno Medical Trials Ltd.
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem, Kenézy Gyula Egyetemi Oktatókórház
City
Debrecen
ZIP/Postal Code
4031
Country
Hungary
Individual Site Status
Completed
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Pest Megyei Flor Ferenc Korhaz
City
Kistarcsa
ZIP/Postal Code
2143
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Szegedi Tudományegyetem, ÁOK, Szent-Györgyi Albert Klinikai Központ
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz
City
Székesfehérvár
ZIP/Postal Code
H-8000
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Vital Medical Center Orvosi es Fogaszati Kozpont
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Individual Site Status
Recruiting
Facility Name
Rambam Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Carmel Medical Center
City
Hifa
ZIP/Postal Code
34362
Country
Israel
Individual Site Status
Recruiting
Facility Name
Meir Medical Center
City
Kfar-Sava
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Completed
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Hospital Selayang
City
Batu Caves
ZIP/Postal Code
68100
Country
Malaysia
Individual Site Status
Completed
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Individual Site Status
Completed
Facility Name
Hospital Raja Permaisuri Bainun
City
Ipoh
ZIP/Postal Code
30450
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Hospital Tuanku Jaafar
City
Seremban
ZIP/Postal Code
70300
Country
Malaysia
Individual Site Status
Completed
Facility Name
Nzoz Bif-Med
City
Bytom
ZIP/Postal Code
41-902
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Kliniczno Badawcze
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Individual Site Status
Recruiting
Facility Name
Malopolskie Badania Kliniczne Sp. z o.o.
City
Krakow
ZIP/Postal Code
30-002
Country
Poland
Individual Site Status
Recruiting
Facility Name
Malopolskie Centrum Kliniczne
City
Krakow
ZIP/Postal Code
30-149
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Promed
City
Krakow
ZIP/Postal Code
31-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Dermed Centrum Medyczne Sp. z o.o
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
ZIP/Postal Code
90-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Lecznica MAK-MED. S.C.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia
City
Poznan
ZIP/Postal Code
61-293
Country
Poland
Individual Site Status
Recruiting
Facility Name
Lubelskie Centrum Diagnostyczne
City
Swidnik
ZIP/Postal Code
21-040
Country
Poland
Individual Site Status
Recruiting
Facility Name
MICS Centrum Medyczne Warszawa
City
Warsaw
ZIP/Postal Code
00-874
Country
Poland
Individual Site Status
Recruiting
Facility Name
Rheuma-Medicus, Zaklad Opieki Zdrowotnej
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Reuma Park
City
Warszawa
ZIP/Postal Code
02-665
Country
Poland
Individual Site Status
Recruiting
Facility Name
WroMedica I.Bielicka, A.Strzałkowska s.c.
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Individual Site Status
Recruiting
Facility Name
GCM Medical Group
City
San Juan
ZIP/Postal Code
00917
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Mindful Medical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
FDI Clinical Research
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Altay Medical State University
City
Barnaul
ZIP/Postal Code
656038
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Chelyabinck Regional Clinical Hospital
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
City
Chelyabinsk
ZIP/Postal Code
454092
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Kemerovo State Medical University
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
LLL Medical Center Revma-Med
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
LLC Family Outpatient Clinic # 4
City
Korolev
ZIP/Postal Code
141060
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Krasnodar Clinical Dermatovenerologic Dispensary
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Regional SBI of PH Krasnoyarsk Regional Clinical hospital #20 named after I.S. Berzon
City
Krasnoyarsk
ZIP/Postal Code
660123
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Clinical-Diagnostic Center Euromedservice, JSC
City
Moscow
ZIP/Postal Code
115419
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
FGBU Research Institute of Rheumatology named V.A.Nasonova
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
GBUZ of Moscow Region 'Moscow Region SRI n.a. Vladimirskyi'
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
GBOU VPO Orenburg State Medical University
City
Orenburg
ZIP/Postal Code
460000
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Rostov Regional Clinical Dermatovenerological Dispensary
City
Rostov
ZIP/Postal Code
344007
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Saratov Regional Clinical Hospital
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Smolensk regional hospital on Smolensk railway station
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
St. Petersburg GBUZ Clinical Reumatological Hospital 25
City
St. Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
X7 Clinical Research Company Limited
City
St. Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
GBUZ of Samara Region 'Tolyatti City Clinical Hospital 5'
City
Tolyatti
ZIP/Postal Code
445846
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Tula Regional Clinical Dermatovenerological Dispensary
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Individual Site Status
Terminated
Facility Name
Republican Clinical Hospital - G.G. Kuvatov
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
Hosp. Univ. de Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Quiron Madrid Pozuelo
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Regional Univ. de Malaga
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Individual Site Status
Recruiting
Facility Name
Clinica Gaias
City
Santiago de Compostela
ZIP/Postal Code
15702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Quiron Sagrado Corazon
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinico Univ. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Adana City Hospital
City
Adana
ZIP/Postal Code
01370
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Gulhane Training and Research Hospital
City
Ankara
ZIP/Postal Code
06010
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Ankara Bilkent City Hospital
City
Ankara
ZIP/Postal Code
06800
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Hacettepe University Medical Faculty
City
Ankara
ZIP/Postal Code
6100
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Akdeniz University Medical Faculty
City
Antalya
ZIP/Postal Code
7059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Uludag University Medical Faculty
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Pamukkale University Medical Faculty
City
Denizli
ZIP/Postal Code
20070
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Osmangazi University Medical Faculty
City
Eskisehir
ZIP/Postal Code
26040
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Istanbul University Istanbul Medical Faculty
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Individual Site Status
Suspended
Facility Name
Istanbul University Cerrahpasa Medical Faculty
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Individual Site Status
Completed
Facility Name
Kartal Dr. Lutfi Kirdar sehir Hastanesi
City
Istanbul
ZIP/Postal Code
34865
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Marmara University Medical Faculty
City
Istanbul
ZIP/Postal Code
34899
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Kocaeli University Medical Faculty
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Necmettin Erbakan University Meram Medical Faculty
City
Konya
ZIP/Postal Code
42080
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
ZIP/Postal Code
61204
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Khmelnitckiy regional hospital
City
Khmelnytsky
ZIP/Postal Code
29000
Country
Ukraine
Individual Site Status
Completed
Facility Name
City Clinical Hospital No. 2
City
Kryvyi Rih
ZIP/Postal Code
50056
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Medical Center LLC 'Harmony of Beauty'
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Medical Center of 'Institute of Rheumatology', LLC
City
Kyiv
ZIP/Postal Code
02081
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kyiv City Clinical Hospital #3
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway'
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Individual Site Status
Suspended
Facility Name
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Medical Center 'Consylium Medical'
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Volyn Regional Clinical Hospital
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
LLC Medical House
City
Odessa
ZIP/Postal Code
65026
Country
Ukraine
Individual Site Status
Terminated
Facility Name
ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Vinnitsia Regional Clinical Hospital n.a. M. I. Pyrogov
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Medical Center LLC 'Modern Clinic'
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Individual Site Status
Suspended

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

Guselkumab in Active Psoriatic Arthritis Participants With Inadequate Response/Intolerance to One Prior Anti-TNF Alpha Agent

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