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A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy (COSMOS)

Primary Purpose

Arthritis, Psoriatic

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Guselkumab 100 mg
Placebo
Sponsored by
Janssen Pharmaceutica N.V., Belgium
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 psoriatic arthritis (PsA) for at least 6 months before the first administration of study intervention 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
  • 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 an inadequate response to anti-TNF alpha therapy, defined as presence of active PsA despite previous treatment with either 1 or 2 anti-TNF alpha agents and either of the following: a) Lack of benefit of an anti-TNF alpha therapy, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilars) and/or at least a 14-week dosage regimen (i.e., at least 4 doses) of infliximab (or biosimilars). Documented lack of benefit may include inadequate improvement in joint counts, skin response, physical function, or disease activity, b) Intolerance to an anti-TNF alpha therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars, if available)
  • Be willing to refrain from the use of complementary therapies for PsA or psoriasis including ayurvedic medicine, traditional Taiwanese, Korean, or Chinese medications and acupuncture within 2 weeks before the first study intervention administration and through Week 48

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 different anti-TNF alpha 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 tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX 509), or any other a Janus kinase (JAK) inhibitor
  • 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 intervention

Sites / Locations

  • CHU Saint Pierre BXL
  • Reuma Clinic
  • Universitair Ziekenhuis Gent
  • UZ Leuven
  • Diagnostic - Consulting Center II-Pleven
  • Medical Center Medconsult-Pleven
  • Multiprofile Hospital for Active Treatment - Plovdiv
  • Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
  • Medical Center 'Teodora'
  • Diagnostic Consulting Center No 17
  • Military Medical Academy
  • Hopital Pellegrin Tripode - CHU de Bordeaux
  • CHU Lapeyronie
  • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
  • Hopital Lariboisiere
  • Hôpital Pitié-Salpétrière
  • Hopital Cochin
  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
  • CHU Trousseau - Service de Rhumatologie
  • Universitätsklinikum Düsseldorf
  • Hamburger Rheuma Forschungszentrum II
  • Medizinische Hochschule Hannover
  • Rheumazentrum Ruhrgebiet
  • Rheumatologische Schwerpunktpraxis
  • Krankenhaus St. Josef
  • 424 Military Hospital of Thessaloniki
  • Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
  • MAV Korhaz es Rendelointezet
  • Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz
  • Vital Medical Center Orvosi es Fogaszati Kozpont
  • Barzilai Medical Center
  • Bnai Zion Medical Center
  • Carmel Medical Center
  • Hadassah Medical Center
  • Sheba Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliera Universitaria Federico II
  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
  • Policlinico Tor Vergata
  • Complesso Integrato Columbus
  • Humanitas Hospital
  • Szpital Uniwersytecki Nr 2 w Bydgoszczy
  • Centrum Kliniczno Badawcze
  • Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • Dermed Centrum Medyczne Sp. z o.o
  • NZOZ Lecznica MAK-MED. S.C.
  • Medycyna Kliniczna
  • Mazowieckie Centrum Reumatologii i Osteoporozy
  • WroMedica I.Bielicka, A.Strzałkowska s.c.
  • Hosp. Garcia de Orta
  • Chbv - Hosp. Infante D. Pedro
  • Ccab - Hosp. de Braga
  • Ipr - Inst. Port. de Reumatologia
  • Chlo - Hosp. Egas Moniz
  • Chln - Hosp. Santa Maria
  • Ulsam - Hosp. Conde de Bertiandos
  • Chelyabinck Regional Clinical Hospital
  • Kemerovo State Medical University
  • Medical Centre Maximum Health
  • Family polyclinic #4
  • Krasnodar Clinical Dermatovenerologic Dispensary
  • Krasnoyarsk State Medical University
  • Orenburg State Medical Academy
  • Rostov Regional Clinical Dermatovenerological Dispensary
  • Ryazan Regional Clinical Dermatovenerological Dispensary
  • Samara Regional Clinical Hospital Named After V.D.Seredavin
  • Sararov Regional Clinical Hospital
  • Smolensk regional hospital on Smolensk railway station
  • Leningrad region clinical hospital
  • Tula Regional Clinical Dermatovenerological Dispensary
  • Republican Clinical Hospital - G.G. Kuvatov
  • Ulyanovsk Regional Clinical Hospital
  • Regional Clinical Hospital
  • Clinical Emergency Hospital n.a. N.V. Solovyev
  • Clinical Hospital #3
  • Hosp. Univ. A Coruña
  • Hosp. Univ. de Cruces
  • Hosp. Univ. Germans Trias I Pujol
  • Hosp. Univ. de Basurto
  • Hosp. Reina Sofia
  • Hosp. Univ. Ramon Y Cajal
  • Hosp. Univ. 12 de Octubre
  • Hosp. Univ. de Getafe
  • Hosp. Regional Univ. de Malaga
  • Hosp. Clinico Univ. de Santiago
  • Hosp. Virgen Macarena
  • Hosp. Infanta Luisa
  • Hosp. Virgen Del Rocio
  • Hosp. Ntra. Sra. de Valme
  • Hosp. Do Meixoeiro
  • Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council'
  • Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
  • City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS
  • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • Khmelnitckiy regional hospital
  • Kyiv City Clinical Hospital #3, National Medical University
  • Medical Center 'Consylium Medical'
  • Kyiv Railway Station Clinical Hospital #2
  • SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine
  • ME 'Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil'
  • Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital
  • Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council
  • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
  • VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council
  • Municipal institution Central Clinical Hospital #1 Zhytomir
  • Royal National Hospital for Rheumatic Diseases
  • Cambridge University Hospitals NHS Foundation Trust
  • Cannock Chase Hospital
  • Chapel Allerton Hospital
  • Barts Health NHS Trust Whipps Cross University Hospital NHS Trust
  • Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic
  • North Tyneside General Hospital
  • Peterborough City Hospital
  • Haywood Hospital
  • Torbay Hospital-Devon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1: Guselkumab

Group 2: Placebo followed by Guselkumab

Arm Description

Participants will receive guselkumab 100 milligram (mg) Subcutaneous (SC) injection at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo SC at Week 24 to maintain the blind. At Week 16, Participants who meet the early escape criteria will receive placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).

Participants will receive placebo SC injection at Weeks 0, 4, 12, and 20, and will crossover to receive guselkumab 100 mg SC injection at Weeks 24, 28, 36, and 44. At Week 16, Participants who meet the early escape criteria will receive guselkumab at Weeks 16 and 20, then guselkumab q8w.

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 in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, 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 C-reactive protein (CRP).

Secondary Outcome Measures

Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
The HAQ-DI is a 20-question instrument that assesses the 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 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Percentage of Participants who Achieve an ACR 50 Response at Week 24
The ACR 50 Response is defined as greater than or equal to (>=) 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, 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 C-reactive protein (CRP).
Change from Baseline in 36-Item Short form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the participant's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The physical component summary measure is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
Percentage of Participants who Achieve Psoriatic Area and Severity Index (PASI) 100 Response at Week 24 Among Participants with >=3% body Surface area Psoriatic Involvement and an Investigator's Global Assessment (IGA) Score of >=2 (Mild) at Baseline
PASI 100 response is defined as 100% improvement in PASI score from baseline (PASI score of 0). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI scoring system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.

Full Information

First Posted
January 7, 2019
Last Updated
November 29, 2021
Sponsor
Janssen Pharmaceutica N.V., Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT03796858
Brief Title
A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy
Acronym
COSMOS
Official Title
Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 22, 2019 (Actual)
Primary Completion Date
November 11, 2020 (Actual)
Study Completion Date
November 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutica N.V., Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
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 guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.
Detailed Description
Psoriatic arthritis is a multi-faceted disease that impacts the joints, soft tissues, and skin, all of which not only results in functional disability and impaired quality of life, but participants with this disease also have increased mortality. Guselkumab is a monoclonal antibody that binds to human interleukin 23 (IL-23) and inhibits IL-23 specific intracellular signaling and subsequent activation and cytokine production. Investigation of guselkumab in this Phase 3b PsA clinical study is supported by the favorable efficacy and safety results from Phase 2 study of guselkumab in PsA and Phase 2 and Phase 3 studies in psoriasis including the subset of participants with PsA. The primary hypothesis is that guselkumab 100 milligram (mg) at Weeks 0, 4, and every 8 weeks (q8w) thereafter is superior to placebo which will be assessed by the proportion of participants achieving an American College of Rheumatology (ACR 20) response at Week 24. The study includes 2 periods: A 24-week double-blind, placebo-controlled period for the primary analysis of the efficacy and safety of guselkumab, compared with placebo and a 32-week active-treatment and safety follow-up period for additional analysis of the efficacy and safety of guselkumab. Safety will be monitored throughout the study (Up to Week 56).

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
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
285 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive guselkumab 100 milligram (mg) Subcutaneous (SC) injection at Weeks 0, 4, 12, 20, 28, 36, and 44 and placebo SC at Week 24 to maintain the blind. At Week 16, Participants who meet the early escape criteria will receive placebo at Week 16 and guselkumab at Week 20, then guselkumab every 8 weeks (q8w).
Arm Title
Group 2: Placebo followed by Guselkumab
Arm Type
Experimental
Arm Description
Participants will receive placebo SC injection at Weeks 0, 4, 12, and 20, and will crossover to receive guselkumab 100 mg SC injection at Weeks 24, 28, 36, and 44. At Week 16, Participants who meet the early escape criteria will receive guselkumab at Weeks 16 and 20, then guselkumab q8w.
Intervention Type
Drug
Intervention Name(s)
Guselkumab 100 mg
Other Intervention Name(s)
CNTO 1959
Intervention Description
Participants will receive guselkumab 100mg as SC injection.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants will receive 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 in swollen joint count (66 joints) and tender joint count (68 joints) and >=20 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, 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 C-reactive protein (CRP).
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
The HAQ-DI is a 20-question instrument that assesses the 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 to 3 (0=no difficulty and 3=inability to perform a task in that area). Overall score is computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
Time Frame
Baseline, Week 24
Title
Percentage of Participants who Achieve an ACR 50 Response at Week 24
Description
The ACR 50 Response is defined as greater than or equal to (>=) 50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and >=50 percent improvement in 3 of following 5 assessments: participant's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter [mm], 0 mm=no pain and 10 mm=worst possible pain), participant's global assessment of disease activity by using VAS (scale ranges from 0 mm to 100 mm, [0 mm=no pain to 100 mm=worst possible pain]), physician's global assessment of disease activity using VAS, 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 C-reactive protein (CRP).
Time Frame
Week 24
Title
Change from Baseline in 36-Item Short form Health Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Description
The SF-36 is a generic health survey with 36 items that measure functional health and well-being from the participant's perspective. The survey is summarized into 8 dimensions/scales: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH). The physical component summary measure is derived from 4 of the 8 health dimensions (aggregate of PF, RP, BP, and GH scales). The minimum score is 0 and the maximum score is 100. A higher score indicates a better health state.
Time Frame
Baseline, Week 24
Title
Percentage of Participants who Achieve Psoriatic Area and Severity Index (PASI) 100 Response at Week 24 Among Participants with >=3% body Surface area Psoriatic Involvement and an Investigator's Global Assessment (IGA) Score of >=2 (Mild) at Baseline
Description
PASI 100 response is defined as 100% improvement in PASI score from baseline (PASI score of 0). The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI scoring system, the body is divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas is assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produces a numeric score that could range from 0 (no psoriasis) to 72. A higher score indicates more severe disease.
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a diagnosis of psoriatic arthritis (PsA) for at least 6 months before the first administration of study intervention 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 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 an inadequate response to anti-TNF alpha therapy, defined as presence of active PsA despite previous treatment with either 1 or 2 anti-TNF alpha agents and either of the following: a) Lack of benefit of an anti-TNF alpha therapy, as documented in the participant history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilars) and/or at least a 14-week dosage regimen (i.e., at least 4 doses) of infliximab (or biosimilars). Documented lack of benefit may include inadequate improvement in joint counts, skin response, physical function, or disease activity, b) Intolerance to an anti-TNF alpha therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars, if available) Be willing to refrain from the use of complementary therapies for PsA or psoriasis including ayurvedic medicine, traditional Taiwanese, Korean, or Chinese medications and acupuncture within 2 weeks before the first study intervention administration and through Week 48 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 different anti-TNF alpha 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 tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX 509), or any other a Janus kinase (JAK) inhibitor 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 intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutica N.V., Belgium Clinical Trial
Organizational Affiliation
Janssen Pharmaceutica N.V., Belgium
Official's Role
Study Director
Facility Information:
Facility Name
CHU Saint Pierre BXL
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Reuma Clinic
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Diagnostic - Consulting Center II-Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Medical Center Medconsult-Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment - Plovdiv
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
City
Plovdiv
ZIP/Postal Code
4004
Country
Bulgaria
Facility Name
Medical Center 'Teodora'
City
Ruse
ZIP/Postal Code
7003
Country
Bulgaria
Facility Name
Diagnostic Consulting Center No 17
City
Sofia
ZIP/Postal Code
1505
Country
Bulgaria
Facility Name
Military Medical Academy
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Hopital Pellegrin Tripode - CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Lapeyronie
City
Montpellier, Herault
ZIP/Postal Code
34295
Country
France
Facility Name
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source
City
Orleans
ZIP/Postal Code
45067
Country
France
Facility Name
Hopital Lariboisiere
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Hôpital Pitié-Salpétrière
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Hopital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan
City
Toulouse
ZIP/Postal Code
30159
Country
France
Facility Name
CHU Trousseau - Service de Rhumatologie
City
Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Universitätsklinikum Düsseldorf
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Hamburger Rheuma Forschungszentrum II
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
ZIP/Postal Code
44649
Country
Germany
Facility Name
Rheumatologische Schwerpunktpraxis
City
Rendsburg
ZIP/Postal Code
24768
Country
Germany
Facility Name
Krankenhaus St. Josef
City
Wuppertal
ZIP/Postal Code
42105
Country
Germany
Facility Name
424 Military Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz
City
Budapest
ZIP/Postal Code
1023
Country
Hungary
Facility Name
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz
City
Gyula
ZIP/Postal Code
5700
Country
Hungary
Facility Name
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
MAV Korhaz es Rendelointezet
City
Szolnok
ZIP/Postal Code
5000
Country
Hungary
Facility Name
Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz
City
Székesfehérvár
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Vital Medical Center Orvosi es Fogaszati Kozpont
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Barzilai Medical Center
City
Ashkelon
ZIP/Postal Code
7830604
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Hifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Carmel Medical Center
City
Hifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
5265601
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Azienda Ospedaliera Universitaria Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Complesso Integrato Columbus
City
Rome
ZIP/Postal Code
00168
Country
Italy
Facility Name
Humanitas Hospital
City
Rozzano (MI)
ZIP/Postal Code
20089
Country
Italy
Facility Name
Szpital Uniwersytecki Nr 2 w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Kliniczno Badawcze
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
City
Lodz
ZIP/Postal Code
90-242
Country
Poland
Facility Name
Dermed Centrum Medyczne Sp. z o.o
City
Lodz
ZIP/Postal Code
90-265
Country
Poland
Facility Name
NZOZ Lecznica MAK-MED. S.C.
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Medycyna Kliniczna
City
Warsaw
ZIP/Postal Code
00-874
Country
Poland
Facility Name
Mazowieckie Centrum Reumatologii i Osteoporozy
City
Warszawa
ZIP/Postal Code
04-030
Country
Poland
Facility Name
WroMedica I.Bielicka, A.Strzałkowska s.c.
City
Wrocław
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Hosp. Garcia de Orta
City
Almada
ZIP/Postal Code
2805-267
Country
Portugal
Facility Name
Chbv - Hosp. Infante D. Pedro
City
Aveiro
ZIP/Postal Code
3814-501
Country
Portugal
Facility Name
Ccab - Hosp. de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Ipr - Inst. Port. de Reumatologia
City
Lisboa
ZIP/Postal Code
1050-034
Country
Portugal
Facility Name
Chlo - Hosp. Egas Moniz
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Chln - Hosp. Santa Maria
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
Ulsam - Hosp. Conde de Bertiandos
City
Ponte de Lima
ZIP/Postal Code
4990-041
Country
Portugal
Facility Name
Chelyabinck Regional Clinical Hospital
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Kemerovo State Medical University
City
Kemerovo
ZIP/Postal Code
650000
Country
Russian Federation
Facility Name
Medical Centre Maximum Health
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
Family polyclinic #4
City
Korolev
ZIP/Postal Code
141060
Country
Russian Federation
Facility Name
Krasnodar Clinical Dermatovenerologic Dispensary
City
Krasnodar
ZIP/Postal Code
350020
Country
Russian Federation
Facility Name
Krasnoyarsk State Medical University
City
Krasnoyarsk
ZIP/Postal Code
660022
Country
Russian Federation
Facility Name
Orenburg State Medical Academy
City
Orenburg
ZIP/Postal Code
460000
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
Samara Regional Clinical Hospital Named After V.D.Seredavin
City
Samara
ZIP/Postal Code
443095
Country
Russian Federation
Facility Name
Sararov Regional Clinical Hospital
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Smolensk regional hospital on Smolensk railway station
City
Smolensk
ZIP/Postal Code
214025
Country
Russian Federation
Facility Name
Leningrad region clinical hospital
City
St-Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Tula Regional Clinical Dermatovenerological Dispensary
City
Tula
ZIP/Postal Code
300053
Country
Russian Federation
Facility Name
Republican Clinical Hospital - G.G. Kuvatov
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Regional Clinical Hospital
City
Velikiy Novgorod
ZIP/Postal Code
173008
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 #3
City
Yaroslavl
ZIP/Postal Code
150007
Country
Russian Federation
Facility Name
Hosp. Univ. A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hosp. Univ. de Cruces
City
Barakaldo
ZIP/Postal Code
48902
Country
Spain
Facility Name
Hosp. Univ. Germans Trias I Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hosp. Univ. de Basurto
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hosp. Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hosp. Univ. Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hosp. Univ. 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hosp. Univ. de Getafe
City
Madrid
ZIP/Postal Code
28905
Country
Spain
Facility Name
Hosp. Regional Univ. de Malaga
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. Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hosp. Infanta Luisa
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Hosp. Virgen Del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hosp. Ntra. Sra. de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hosp. Do Meixoeiro
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council'
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS
City
Kharkiv
ZIP/Postal Code
61029
Country
Ukraine
Facility Name
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
Khmelnitckiy regional hospital
City
Khmelnytsky
ZIP/Postal Code
29000
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital #3, National Medical University
City
Kyiv
ZIP/Postal Code
02125
Country
Ukraine
Facility Name
Medical Center 'Consylium Medical'
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Kyiv Railway Station Clinical Hospital #2
City
Kyiv
Country
Ukraine
Facility Name
SI 'National Scientific Center Institute of Cardiology of M.D. Strazhesko' of NAMS of Ukraine
City
Kyiv
Country
Ukraine
Facility Name
ME 'Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil'
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital
City
Sumy
ZIP/Postal Code
40031
Country
Ukraine
Facility Name
Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
City
Vinnytsya
ZIP/Postal Code
21009
Country
Ukraine
Facility Name
VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council
City
Vinnytsya
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Municipal institution Central Clinical Hospital #1 Zhytomir
City
Zhytomir
ZIP/Postal Code
10002
Country
Ukraine
Facility Name
Royal National Hospital for Rheumatic Diseases
City
Bath
ZIP/Postal Code
BA1 1RL
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Cannock Chase Hospital
City
Cannock
ZIP/Postal Code
WS11 5XY
Country
United Kingdom
Facility Name
Chapel Allerton Hospital
City
Leeds
ZIP/Postal Code
LS7 4SA
Country
United Kingdom
Facility Name
Barts Health NHS Trust Whipps Cross University Hospital NHS Trust
City
London
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic
City
London
ZIP/Postal Code
SE1 9RS
Country
United Kingdom
Facility Name
North Tyneside General Hospital
City
Newcastle
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Peterborough City Hospital
City
Peterborough
ZIP/Postal Code
PE3 9GZ
Country
United Kingdom
Facility Name
Haywood Hospital
City
Stoke on Trent
ZIP/Postal Code
ST6 7AG
Country
United Kingdom
Facility Name
Torbay Hospital-Devon
City
Torquay
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom

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 Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Citations:
PubMed Identifier
34819273
Citation
Coates LC, Gossec L, Theander E, Bergmans P, Neuhold M, Karyekar CS, Shawi M, Noel W, Schett G, McInnes IB. Efficacy and safety of guselkumab in patients with active psoriatic arthritis who are inadequate responders to tumour necrosis factor inhibitors: results through one year of a phase IIIb, randomised, controlled study (COSMOS). Ann Rheum Dis. 2022 Mar;81(3):359-369. doi: 10.1136/annrheumdis-2021-220991. Epub 2021 Nov 24.
Results Reference
derived
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003214-41/results
Description
Link to results on EudraCT registry.

Learn more about this trial

A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy

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