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

NCT ID: NCT03796858

Last Updated: 2025-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 285 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-22
• Study Completion Date: 2020-11-11

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).

Conditions

Arthritis, Psoriatic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Guselkumab

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).

Group Type: EXPERIMENTAL

Guselkumab 100 mg

Intervention Type: DRUG

Participants will receive guselkumab 100mg as SC injection.

Placebo

Intervention Type: DRUG

Participants will receive placebo as SC injection.

Group 2: Placebo followed by Guselkumab

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.

Group Type: EXPERIMENTAL

Guselkumab 100 mg

Intervention Type: DRUG

Participants will receive guselkumab 100mg as SC injection.

Placebo

Intervention Type: DRUG

Participants will receive placebo as SC injection.

Interventions

Guselkumab 100 mg

Participants will receive guselkumab 100mg as SC injection.

Intervention Type: DRUG

Placebo

Participants will receive placebo as SC injection.

Intervention Type: DRUG

Other Intervention Names

CNTO 1959

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Pharmaceutica N.V., Belgium

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Pharmaceutica N.V., Belgium Clinical Trial

Role: STUDY_DIRECTOR

Janssen Pharmaceutica N.V., Belgium

Locations

CHU Saint Pierre BXL

Brussels, , Belgium

Reuma Clinic

Genk, , Belgium

Universitair Ziekenhuis Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

Diagnostic - Consulting Center II-Pleven

Pleven, , Bulgaria

Medical Center Medconsult-Pleven

Pleven, , Bulgaria

Multiprofile Hospital for Active Treatment Plovdiv

Plovdiv, , Bulgaria

Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv

Plovdiv, , Bulgaria

Medical Center Teodora

Rousse, , Bulgaria

Diagnostic Consulting Center No 17

Sofia, , Bulgaria

Military Medical Academy

Sofia, , Bulgaria

Hopital Pellegrin Tripode - CHU de Bordeaux

Bordeaux, , France

CHU Lapeyronie

Montpellier, , France

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

Orléans, , France

Hopital Lariboisiere

Paris, , France

Hôpital Pitié-Salpétrière

Paris, , France

Hopital Cochin

Paris, , France

Centre Hospitalier Universitaire de Toulouse - Hopital Purpan

Toulouse, , France

CHU Trousseau - Service de Rhumatologie

Tours, , France

Universitatsklinikum Dusseldorf

Düsseldorf, , Germany

Hamburger Rheuma Forschungszentrum II

Hamburg, , Germany

Medizinische Hochschule Hannover

Hanover, , Germany

Rheumazentrum Ruhrgebiet

Herne, , Germany

Rheumatologische Schwerpunktpraxis

Rendsburg, , Germany

Krankenhaus St. Josef

Wuppertal, , Germany

424 Military Hospital of Thessaloniki

Thessaloniki, , Greece

Betegapolo Irgalmas Rend Budai Irgalmasrendi Korhaz

Budapest, , Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz

Nyíregyháza, , Hungary

Fejer Varmegyei Szent Gyorgy Egyetemi Oktatokorhaz

Székesfehérvár, , Hungary

MAV Korhaz es Rendelointezet

Szolnok, , Hungary

Vital Medical Center Orvosi es Fogaszati Kozpont

Veszprém, , Hungary

Barzilai Medical Center

Ashkelon, , Israel

Bnai Zion Medical Center

Haifa, , Israel

Carmel Medical Center

Haifa, , Israel

Hadassah Medical Center

Jerusalem, , Israel

Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Ospedaliera Universitaria Federico II

Napoli, , Italy

Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

Palermo, , Italy

Policlinico Tor Vergata

Roma, , Italy

Complesso Integrato Columbus

Rome, , Italy

Humanitas Hospital

Rozzano (MI), , Italy

Szpital Uniwersytecki Nr 2 w Bydgoszczy

Bydgoszcz, , Poland

Centrum Kliniczno Badawcze

Elblag, , Poland

Dermed Centrum Medyczne Sp z o o

Lodz, , Poland

Centrum Terapii Wspolczesnej J M Jasnorzewska Spolka Komandytowo Akcyjna

Lodz, , Poland

NZOZ Lecznica MAK MED S C

Nadarzyn, , Poland

Medycyna Kliniczna

Warsaw, , Poland

Mazowieckie Centrum Reumatologii i Osteoporozy

Warsaw, , Poland

WroMedica I Bielicka A Strzalkowska s c

Wroclaw, , Poland

Uls Almada Seixal - Hosp. Garcia de Orta

Almada, , Portugal

Uls Regiao Aveiro - Hosp. Infante D. Pedro

Aveiro, , Portugal

Uls Braga - Hosp. Braga

Braga, , Portugal

Ipr Inst Port de Reumatologia

Lisbon, , Portugal

Uls Lisboa Ocidental - Hosp. Egas Moniz

Lisbon, , Portugal

Uls Santa Maria - Hosp. Santa Maria

Lisbon, , Portugal

Ulsam - Hosp. Conde de Bertiandos

Ponte de Lima, , Portugal

Chelyabinck Regional Clinical Hospital

Chelyabinsk, , Russia

Kemerovo State Medical University

Kemerovo, , Russia

Medical Centre Maximum Health

Kemerovo, , Russia

Family polyclinic #4

Korolyov, , Russia

Krasnodar Clinical Dermatovenerologic Dispensary

Krasnodar, , Russia

Krasnoyarsk State Medical University

Krasnoyarsk, , Russia

Orenburg State Medical Academy

Orenburg, , Russia

Rostov Regional Clinical Dermatovenerological Dispensary

Rostov, , Russia

Ryazan Regional Clinical Dermatovenerological Dispensary

Ryazan, , Russia

Leningrad region clinical hospital

Saint Petersburg, , Russia

Samara Regional Clinical Hospital Named After V.D.Seredavin

Samara, , Russia

Sararov Regional Clinical Hospital

Saratov, , Russia

Smolensk regional hospital on Smolensk railway station

Smolensk, , Russia

Tula Regional Clinical Dermatovenerological Dispensary

Tula, , Russia

Republican Clinical Hospital - G.G. Kuvatov

Ufa, , Russia

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, , Russia

Regional Clinical Hospital

Veliky Novgorod, , Russia

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

Yaroslavl, , Russia

Clinical Hospital #3

Yaroslavl, , Russia

Hosp Univ A Coruna

A Coruña, , Spain

Hosp. Univ. de Cruces

Barakaldo, , Spain

Hosp. Univ. Germans Trias I Pujol

Barcelona, , Spain

Hosp. Univ. de Basurto

Bilbao, , Spain

Hosp Reina Sofia

Córdoba, , Spain

Hosp. Univ. Ramon Y Cajal

Madrid, , Spain

Hosp. Univ. 12 de Octubre

Madrid, , Spain

Hosp. Univ. de Getafe

Madrid, , Spain

Hosp Regional Univ de Malaga

Málaga, , Spain

Hosp. Clinico Univ. de Santiago

Santiago de Compostela, , Spain

Hosp. Virgen Macarena

Seville, , Spain

Hosp. Infanta Luisa

Seville, , Spain

Hosp. Virgen Del Rocio

Seville, , Spain

Hosp. Ntra. Sra. de Valme

Seville, , Spain

Hosp. Do Meixoeiro

Vigo, , Spain

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, , Ukraine

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

Ivano-Frankivsk, , Ukraine

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

Kharkiv, , Ukraine

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

Kharkiv, , Ukraine

Khmelnitckiy regional hospital

Khmelnytsky, , Ukraine

Kyiv City Clinical Hospital #3, National Medical University

Kyiv, , Ukraine

Medical Center 'Consylium Medical'

Kyiv, , Ukraine

Kyiv Railway Station Clinical Hospital #2

Kyiv, , Ukraine

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

Kyiv, , Ukraine

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

Poltava, , Ukraine

Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital

Sumy, , Ukraine

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

Ternopil, , Ukraine

Medical Center LTD Health Clinic Department of Cardiology and Rheumatology

Vinnytsia, , Ukraine

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

Vinnytsia, , Ukraine

Municipal institution Central Clinical Hospital #1 Zhytomir

Zhytomyr, , Ukraine

Royal National Hospital for Rheumatic Diseases

Bath, , United Kingdom

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Cannock Chase Hospital

Cannock, , United Kingdom

Chapel Allerton Hospital

Leeds, , United Kingdom

Barts Health NHS Trust Whipps Cross University Hospital NHS Trust

London, , United Kingdom

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

London, , United Kingdom

North Tyneside General Hospital

Newcastle, , United Kingdom

Peterborough City Hospital

Peterborough, , United Kingdom

Haywood Hospital

Stoke-on-Trent, , United Kingdom

Torbay Hospital-Devon

Torquay, , United Kingdom

Countries

Belgium; Bulgaria; France; Germany; Greece; Hungary; Israel; Italy; Poland; Portugal; Russia; Spain; Ukraine; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 38488975 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37906417 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37587493 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36642439 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34819273 (View on PubMed)

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-003214-41/results

Link to results on EudraCT registry.

Other Identifiers

2018-003214-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CNTO1959PSA3003

Identifier Type: OTHER

Identifier Source: secondary_id

CR108573

Identifier Type: -

Identifier Source: org_study_id