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Arthritis, PsoriaticPhase 3COSMOSNCT03796858

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

A Phase 3 study testing Guselkumab 100 mg in people with Arthritis, Psoriatic, run by Janssen Pharmaceutica N.V., Belgium at 117 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arthritis, Psoriatic
What is being tested?
Guselkumab 100 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
285 participants
Where
117 sitesin 14 countries
Study dates
22 Mar 2019to 11 Nov 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

117 sites in 14 countries.

117 sites in 14 countries

Russia19 sites

  • Chelyabinck Regional Clinical Hospital

    Chelyabinsk, 454076

  • Kemerovo State Medical University

    Kemerovo, 650000

  • Medical Centre Maximum Health

    Kemerovo, 650066

  • Family polyclinic #4

    Korolyov, 141060

  • Krasnodar Clinical Dermatovenerologic Dispensary

    Krasnodar, 350020

  • Krasnoyarsk State Medical University

    Krasnoyarsk, 660022

  • Orenburg State Medical Academy

    Orenburg, 460000

  • Rostov Regional Clinical Dermatovenerological Dispensary

    Rostov-on-Don, 344007

  • Ryazan Regional Clinical Dermatovenerological Dispensary

    Ryazan, 390046

  • Leningrad region clinical hospital

    Saint Petersburg, 194291

  • Samara Regional Clinical Hospital Named After V.D.Seredavin

    Samara, 443095

  • Sararov Regional Clinical Hospital

    Saratov, 410053

  • Smolensk regional hospital on Smolensk railway station

    Smolensk, 214025

  • Tula Regional Clinical Dermatovenerological Dispensary

    Tula, 300053

  • Republican Clinical Hospital - G.G. Kuvatov

    Ufa, 450005

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, 432063

  • Regional Clinical Hospital

    Velikiy Novgorod, 173008

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

    Yaroslavl, 150003

  • Clinical Hospital #3

    Yaroslavl, 150007

Other trials in Russia

Spain15 sites

  • Hosp Univ A Coruna

    A Coruña, 15006

  • Hosp. Univ. de Cruces

    Barakaldo, 48902

  • Hosp. Univ. Germans Trias I Pujol

    Barcelona, 08916

  • Hosp. Univ. de Basurto

    Bilbao, 48013

  • Hosp Reina Sofia

    Córdoba, 14004

  • Hosp. Univ. Ramon Y Cajal

    Madrid, 28034

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. de Getafe

    Madrid, 28905

  • Hosp Regional Univ de Malaga

    Málaga, 29009

  • Hosp. Clinico Univ. de Santiago

    Santiago de Compostela, 15706

  • Hosp. Virgen Macarena

    Seville, 41009

  • Hosp. Infanta Luisa

    Seville, 41010

  • Hosp. Virgen Del Rocio

    Seville, 41013

  • Hosp. Ntra. Sra. de Valme

    Seville, 41014

  • Hosp. Do Meixoeiro

    Vigo, 36312

Other trials in Spain

Ukraine15 sites

  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

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

    Ivano-Frankivsk, 76018

  • City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS

    Kharkiv, 61029

  • Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058

  • Khmelnitckiy regional hospital

    Khmelnytsky, 29000

  • Kyiv City Clinical Hospital #3, National Medical University

    Kyiv, 02125

  • Medical Center 'Consylium Medical'

    Kyiv, 04050

  • Kyiv Railway Station Clinical Hospital #2

    Kyiv

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv

  • ME Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil

    Poltava, 36011

  • Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

    Sumy, 40031

  • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

    Ternopil, 46002

  • Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

    Vinnytsia, 21009

  • VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council

    Vinnytsia, 21018

  • Municipal institution Central Clinical Hospital #1 Zhytomir

    Zhytomyr, 10002

Other trials in Ukraine

United Kingdom10 sites

  • Royal National Hospital for Rheumatic Diseases

    Bath, BA1 1RL

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Cannock Chase Hospital

    Cannock, WS11 5XY

  • Chapel Allerton Hospital

    Leeds, LS7 4SA

  • Barts Health NHS Trust Whipps Cross University Hospital NHS Trust

    London, E11 1NR

  • Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic

    London, SE1 9RS

  • North Tyneside General Hospital

    Newcastle, NE29 8NH

  • Peterborough City Hospital

    Peterborough, PE3 9GZ

  • Haywood Hospital

    Stoke-on-Trent, ST6 7AG

  • Torbay Hospital-Devon

    Torquay, TQ2 7AA

Other trials in United Kingdom

France8 sites

  • Hopital Pellegrin Tripode - CHU de Bordeaux

    Bordeaux, 33076

  • CHU Lapeyronie

    Montpellier, 34295

  • Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source

    Orléans, 45067

  • Hopital Lariboisiere

    Paris, 75010

  • Hôpital Pitié-Salpétrière

    Paris, 75013

  • Hopital Cochin

    Paris, 75014

  • Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

    Toulouse, 30159

  • CHU Trousseau - Service de Rhumatologie

    Tours, 37044

Other trials in France

Poland8 sites

  • Szpital Uniwersytecki Nr 2 w Bydgoszczy

    Bydgoszcz, 85 168

  • Centrum Kliniczno Badawcze

    Elblag, 82-300

  • Dermed Centrum Medyczne Sp z o o

    Lodz, 90 265

  • Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

    Lodz, 90-242

  • NZOZ Lecznica MAK MED S C

    Nadarzyn, 05 830

  • Medycyna Kliniczna

    Warsaw, 00-874

  • Mazowieckie Centrum Reumatologii i Osteoporozy

    Warsaw, 04-030

  • WroMedica I Bielicka A Strzalkowska s c

    Wroclaw, 51 685

Other trials in Poland

Bulgaria7 sites

  • Diagnostic - Consulting Center II-Pleven

    Pleven, 5800

  • Medical Center Medconsult-Pleven

    Pleven, 5800

  • Multiprofile Hospital for Active Treatment Plovdiv

    Plovdiv, 4003

  • Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

    Plovdiv, 4004

  • Medical Center Teodora

    Rousse, 7003

  • Diagnostic Consulting Center No 17

    Sofia, 1505

  • Military Medical Academy

    Sofia, 1606

Other trials in Bulgaria

Portugal7 sites

  • Uls Almada Seixal - Hosp. Garcia de Orta

    Almada, 2805 267

  • Uls Regiao Aveiro - Hosp. Infante D. Pedro

    Aveiro, 3814-501

  • Uls Braga - Hosp. Braga

    Braga, 4710 243

  • Ipr Inst Port de Reumatologia

    Lisbon, 1050 034

  • Uls Lisboa Ocidental - Hosp. Egas Moniz

    Lisbon, 1349 019

  • Uls Santa Maria - Hosp. Santa Maria

    Lisbon, 1649 035

  • Ulsam - Hosp. Conde de Bertiandos

    Ponte de Lima, 4990-041

Other trials in Portugal

Germany6 sites

  • Universitatsklinikum Dusseldorf

    Düsseldorf, 40225

  • Hamburger Rheuma Forschungszentrum II

    Hamburg, 20095

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Rheumazentrum Ruhrgebiet

    Herne, 44649

  • Rheumatologische Schwerpunktpraxis

    Rendsburg, 24768

  • Krankenhaus St. Josef

    Wuppertal, 42105

Other trials in Germany

Hungary6 sites

  • Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

    Budapest, 1023

  • Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

    Gyula, 5700

  • Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

    Nyíregyháza, 4400

  • Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

    Székesfehérvár, 8000

  • MAV Korhaz es Rendelointezet

    Szolnok, 5000

  • Vital Medical Center Orvosi es Fogaszati Kozpont

    Veszprém, 8200

Other trials in Hungary

Israel6 sites

  • Barzilai Medical Center

    Ashkelon, 7830604

  • Bnai Zion Medical Center

    Haifa, 31048

  • Carmel Medical Center

    Haifa, 34362

  • Hadassah Medical Center

    Jerusalem, 91120

  • Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Italy5 sites

  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

  • Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

    Palermo, 90127

  • Policlinico Tor Vergata

    Roma, 00133

  • Complesso Integrato Columbus

    Rome, 00168

  • Humanitas Hospital

    Rozzano (MI), 20089

Other trials in Italy

Belgium4 sites

  • CHU Saint Pierre BXL

    Brussels, 1000

  • Reuma Clinic

    Genk, 3600

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Greece1 site

  • 424 Military Hospital of Thessaloniki

    Thessaloniki, 56429

Other trials in Greece

About this study

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

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.

Read the 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).

Being tested
Guselkumab 100 mg, Placebo
Medical subject headings
Arthritis, Psoriatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Guselkumab 100 mgDrug

    Also called CNTO 1959

    Participants will receive guselkumab 100mg as SC injection.

  • PlaceboDrug

    Participants will receive placebo as SC injection.

Study groups in NCT03796858
Study groupRoleWhat they receive
Group 1: GuselkumabExperimentalParticipants 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).
Receives: Drug: Guselkumab 100 mg; Drug: Placebo
Group 2: Placebo followed by GuselkumabExperimentalParticipants 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.
Receives: Drug: Guselkumab 100 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Week 24

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, Week 24

  2. 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).

    Measured: Week 24

  3. 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.

    Measured: Baseline, Week 24

  4. 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.

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2019
  2. Study start22 Mar 2019
  3. Primary completion11 Nov 2020
  4. Study completion11 Nov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
285 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03796858
Sponsor's protocol ID
CR108573
Other IDs
2018-003214-41, CNTO1959PSA3003, 2018
Acronym
COSMOS
Status last verified
Jan 2025
First submitted
7 Jan 2019
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Publications

  • Gossec L, Baraliakos X, Galloway J, Oke V, Sfikakis P, Rampakakis E, Sharaf M, Lavie F, McInnes IB. Guselkumab Improves Patient-Reported Outcomes Among Participants with Psoriatic Arthritis and Inadequate Response to Tumor Necrosis Factor Inhibitors in the COSMOS Study. Rheumatol Ther. 2026 Apr;13(2):347-360. doi: 10.1007/s40744-025-00821-2. Epub 2026 Jan 23.

    PubMed 41575731

  • Gladman DD, Eder L, Selmi C, Mease PJ, Ogdie A, Lozenski K, Adamson E, Sharaf M, Rampakakis E, Pina Vegas L, Coates LC. Influence of Biological Sex on Participant Characteristics, Guselkumab Efficacy and Radiographic Progression in Active Psoriatic Arthritis: Post Hoc Analysis of Three Randomized Trials. Rheumatol Ther. 2026 Feb;13(1):213-229. doi: 10.1007/s40744-025-00812-3. Epub 2025 Dec 15.

    PubMed 41396391

  • Tillett W, Coates LC, Vis M, Zimmermann M, Lozenski K, Rampakakis E, Soriano ER, Merola JF, Sharaf M, Nash P, Helliwell PS. Validity and Psychometric Properties of 3 and 4 Visual Analog Scale in Participants With Psoriatic Arthritis Treated With Guselkumab. J Rheumatol. 2026 Apr 1;53(4):400-408. doi: 10.3899/jrheum.2025-0695.

    PubMed 41326161

  • Warren RB, McInnes IB, Nash P, Grouin JM, Lyris N, Willems D, Taieb V, Eells J, Mease PJ. Comparative Effectiveness of Bimekizumab and Guselkumab in Patients with Psoriatic Arthritis at 52 Weeks Assessed Using a Matching-Adjusted Indirect Comparison. Rheumatol Ther. 2024 Jun;11(3):829-839. doi: 10.1007/s40744-024-00659-0. Epub 2024 Mar 15.

    PubMed 38488975

  • Strober B, Coates LC, Lebwohl MG, Deodhar A, Leibowitz E, Rowland K, Kollmeier AP, Miller M, Wang Y, Li S, Chakravarty SD, Chan D, Shawi M, Yang YW, Thaҫi D, Rahman P. Long-Term Safety of Guselkumab in Patients with Psoriatic Disease: An Integrated Analysis of Eleven Phase II/III Clinical Studies in Psoriasis and Psoriatic Arthritis. Drug Saf. 2024 Jan;47(1):39-57. doi: 10.1007/s40264-023-01361-w. Epub 2023 Oct 31.

    PubMed 37906417

  • Schett G, Chen W, Gao S, Chakravarty SD, Shawi M, Lavie F, Zimmermann M, Sharaf M, Coates LC, Siebert S. Effect of guselkumab on serum biomarkers in patients with active psoriatic arthritis and inadequate response to tumor necrosis factor inhibitors: results from the COSMOS phase 3b study. Arthritis Res Ther. 2023 Aug 16;25(1):150. doi: 10.1186/s13075-023-03125-4.

    PubMed 37587493

  • Rahman P, Boehncke WH, Mease PJ, Gottlieb AB, McInnes IB, Shawi M, Wang Y, Sheng S, Kollmeier AP, Theander E, Yu J, Leibowitz E, Marrache AM, Coates LC. Safety of Guselkumab With and Without Prior Tumor Necrosis Factor Inhibitor Treatment: Pooled Results Across 4 Studies in Patients With Psoriatic Arthritis. J Rheumatol. 2023 Jun;50(6):769-780. doi: 10.3899/jrheum.220928. Epub 2023 Jan 15.

    PubMed 36642439

  • 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.

    PubMed 34819273

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Guselkumab 100 mg in people with Arthritis, Psoriatic, run by Janssen Pharmaceutica N.V., Belgium at 117 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in Russia, Spain, Ukraine, United Kingdom, France and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03796858, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

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