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

NCT03796858 | Completed Phase 3

• 3 other identifiers: CR1085732018-003214-41CNTO1959PSA3003
• Study Type: interventional
• Target: 285
• Locations: 14 countries
• Sites: 117

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.

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (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).

  Week 24

Secondary Outcomes (4)

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

  Baseline, Week 24

• Percentage of Participants who Achieve an ACR 50 Response at Week 24

  Week 24

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

  Baseline, Week 24

• 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

  Week 24

Study Arms (2)

Group 1: Guselkumab

EXPERIMENTAL

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).

Drug: Guselkumab 100 mg; Drug: Placebo

Group 2: Placebo followed by Guselkumab

EXPERIMENTAL

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.

Drug: Guselkumab 100 mg; Drug: Placebo

Interventions

Guselkumab 100 mg DRUG

Participants will receive guselkumab 100mg as SC injection.

Also known as: CNTO 1959

Group 1: Guselkumab; Group 2: Placebo followed by Guselkumab

Placebo DRUG

Participants will receive placebo as SC injection.

Group 1: Guselkumab; Group 2: Placebo followed by Guselkumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

Study Sites (117)

CHU Saint Pierre BXL

Brussels, 1000, Belgium

Location

Reuma Clinic

Genk, 3600, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, 9000, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

Diagnostic - Consulting Center II-Pleven

Pleven, 5800, Bulgaria

Location

Medical Center Medconsult-Pleven

Pleven, 5800, Bulgaria

Location

Multiprofile Hospital for Active Treatment Plovdiv

Plovdiv, 4003, Bulgaria

Location

Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

Plovdiv, 4004, Bulgaria

Location

Medical Center Teodora

Rousse, 7003, Bulgaria

Location

Diagnostic Consulting Center No 17

Sofia, 1505, Bulgaria

Location

Military Medical Academy

Sofia, 1606, Bulgaria

Location

Hopital Pellegrin Tripode - CHU de Bordeaux

Bordeaux, 33076, France

Location

CHU Lapeyronie

Montpellier, 34295, France

Location

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

Orléans, 45067, France

Location

Hopital Lariboisiere

Paris, 75010, France

Location

Hôpital Pitié-Salpétrière

Paris, 75013, France

Location

Hopital Cochin

Paris, 75014, France

Location

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, 30159, France

Location

CHU Trousseau - Service de Rhumatologie

Tours, 37044, France

Location

Universitatsklinikum Dusseldorf

Düsseldorf, 40225, Germany

Location

Hamburger Rheuma Forschungszentrum II

Hamburg, 20095, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Rheumatologische Schwerpunktpraxis

Rendsburg, 24768, Germany

Location

Krankenhaus St. Josef

Wuppertal, 42105, Germany

Location

424 Military Hospital of Thessaloniki

Thessaloniki, 56429, Greece

Location

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, 1023, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5700, Hungary

Location

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, 4400, Hungary

Location

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, 8000, Hungary

Location

MAV Korhaz es Rendelointezet

Szolnok, 5000, Hungary

Location

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, 8200, Hungary

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Bnai Zion Medical Center

Haifa, 31048, Israel

Location

Carmel Medical Center

Haifa, 34362, Israel

Location

Hadassah Medical Center

Jerusalem, 91120, Israel

Location

Sheba Medical Center

Ramat Gan, 5265601, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Azienda Ospedaliera Universitaria Federico II

Napoli, 80131, Italy

Location

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Policlinico Tor Vergata

Roma, 00133, Italy

Location

Complesso Integrato Columbus

Rome, 00168, Italy

Location

Humanitas Hospital

Rozzano (MI), 20089, Italy

Location

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, 85 168, Poland

Location

Centrum Kliniczno Badawcze

Elblag, 82-300, Poland

Location

Dermed Centrum Medyczne Sp z o o

Lodz, 90 265, Poland

Location

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, 90-242, Poland

Location

NZOZ Lecznica MAK MED S C

Nadarzyn, 05 830, Poland

Location

Medycyna Kliniczna

Warsaw, 00-874, Poland

Location

Mazowieckie Centrum Reumatologii i Osteoporozy

Warsaw, 04-030, Poland

Location

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, 51 685, Poland

Location

Uls Almada Seixal - Hosp. Garcia de Orta

Almada, 2805 267, Portugal

Location

Uls Regiao Aveiro - Hosp. Infante D. Pedro

Aveiro, 3814-501, Portugal

Location

Uls Braga - Hosp. Braga

Braga, 4710 243, Portugal

Location

Ipr Inst Port de Reumatologia

Lisbon, 1050 034, Portugal

Location

Uls Lisboa Ocidental - Hosp. Egas Moniz

Lisbon, 1349 019, Portugal

Location

Uls Santa Maria - Hosp. Santa Maria

Lisbon, 1649 035, Portugal

Location

Ulsam - Hosp. Conde de Bertiandos

Ponte de Lima, 4990-041, Portugal

Location

Chelyabinck Regional Clinical Hospital

Chelyabinsk, 454076, Russia

Location

Kemerovo State Medical University

Kemerovo, 650000, Russia

Location

Medical Centre Maximum Health

Kemerovo, 650066, Russia

Location

Family polyclinic #4

Korolyov, 141060, Russia

Location

Krasnodar Clinical Dermatovenerologic Dispensary

Krasnodar, 350020, Russia

Location

Krasnoyarsk State Medical University

Krasnoyarsk, 660022, Russia

Location

Orenburg State Medical Academy

Orenburg, 460000, Russia

Location

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov, 344007, Russia

Location

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, 390046, Russia

Location

Leningrad region clinical hospital

Saint Petersburg, 194291, Russia

Location

Samara Regional Clinical Hospital Named After V.D.Seredavin

Samara, 443095, Russia

Location

Sararov Regional Clinical Hospital

Saratov, 410053, Russia

Location

Smolensk regional hospital on Smolensk railway station

Smolensk, 214025, Russia

Location

Tula Regional Clinical Dermatovenerological Dispensary

Tula, 300053, Russia

Location

Republican Clinical Hospital - G.G. Kuvatov

Ufa, 450005, Russia

Location

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432063, Russia

Location

Regional Clinical Hospital

Veliky Novgorod, 173008, Russia

Location

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

Yaroslavl, 150003, Russia

Location

Clinical Hospital #3

Yaroslavl, 150007, Russia

Location

Hosp Univ A Coruna

A Coruña, 15006, Spain

Location

Hosp. Univ. de Cruces

Barakaldo, 48902, Spain

Location

Hosp. Univ. Germans Trias I Pujol

Barcelona, 08916, Spain

Location

Hosp. Univ. de Basurto

Bilbao, 48013, Spain

Location

Hosp Reina Sofia

Córdoba, 14004, Spain

Location

Hosp. Univ. Ramon Y Cajal

Madrid, 28034, Spain

Location

Hosp. Univ. 12 de Octubre

Madrid, 28041, Spain

Location

Hosp. Univ. de Getafe

Madrid, 28905, Spain

Location

Hosp Regional Univ de Malaga

Málaga, 29009, Spain

Location

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, 15706, Spain

Location

Hosp. Virgen Macarena

Seville, 41009, Spain

Location

Hosp. Infanta Luisa

Seville, 41010, Spain

Location

Hosp. Virgen Del Rocio

Seville, 41013, Spain

Location

Hosp. Ntra. Sra. de Valme

Seville, 41014, Spain

Location

Hosp. Do Meixoeiro

Vigo, 36312, Spain

Location

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, 18009, Ukraine

Location

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

Ivano-Frankivsk, 76018, Ukraine

Location

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

Kharkiv, 61029, Ukraine

Location

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

Kharkiv, 61058, Ukraine

Location

Khmelnitckiy regional hospital

Khmelnytsky, 29000, Ukraine

Location

Kyiv City Clinical Hospital #3, National Medical University

Kyiv, 02125, Ukraine

Location

Medical Center 'Consylium Medical'

Kyiv, 04050, Ukraine

Location

Kyiv Railway Station Clinical Hospital #2

Kyiv, Ukraine

Location

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

Kyiv, Ukraine

Location

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

Poltava, 36011, Ukraine

Location

Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

Sumy, 40031, Ukraine

Location

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

Ternopil, 46002, Ukraine

Location

Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

Vinnytsia, 21009, Ukraine

Location

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

Vinnytsia, 21018, Ukraine

Location

Municipal institution Central Clinical Hospital #1 Zhytomir

Zhytomyr, 10002, Ukraine

Location

Royal National Hospital for Rheumatic Diseases

Bath, BA1 1RL, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Cannock Chase Hospital

Cannock, WS11 5XY, United Kingdom

Location

Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

Location

Barts Health NHS Trust Whipps Cross University Hospital NHS Trust

London, E11 1NR, United Kingdom

Location

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

London, SE1 9RS, United Kingdom

Location

North Tyneside General Hospital

Newcastle, NE29 8NH, United Kingdom

Location

Peterborough City Hospital

Peterborough, PE3 9GZ, United Kingdom

Location

Haywood Hospital

Stoke-on-Trent, ST6 7AG, United Kingdom

Location

Torbay Hospital-Devon

Torquay, TQ2 7AA, United Kingdom

Location

Related Publications (7)

• 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 Jan 23. doi: 10.1007/s40744-025-00821-2. Online ahead of print.

  PMID: 41575731 DERIVED

• 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. 2025 Dec 15. doi: 10.1007/s40744-025-00812-3. Online ahead of print.

  PMID: 41396391 DERIVED

• 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.

  PMID: 38488975 DERIVED

• 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.

  PMID: 37906417 DERIVED

• 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.

  PMID: 37587493 DERIVED

• 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.

  PMID: 36642439 DERIVED

• 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.

  PMID: 34819273 DERIVED

Related Links

• Link to results on EudraCT registry.

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

guselkumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 8, 2019
• Study Start: March 22, 2019
• Primary Completion: November 11, 2020
• Study Completion: November 11, 2020
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

BE (4); HU (6); IL (6); BU (7); UA (15); GB (10); PL (8); DE (6); GR (1); IT (5); PT (7); FR (8); RU (19); ES (15)