A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s)
NCT ID: NCT03162796
Last Updated: 2021-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
383 participants
INTERVENTIONAL
2017-08-24
2019-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Guselkumab
Participants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 48.
Guselkumab
Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.
Group 2: Guselkumab and Placebo
Participants will receive SC guselkumab 100 mg at Weeks 0 and 4, then once every 8 weeks (q8w) (Weeks 12, 20, 28, 36, and 44) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48) to maintain the blind.
Guselkumab
Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.
Placebo
Participants will receive matching placebo as SC injection.
Group 3: Placebo Followed by Guselkumab
Participants will receive SC placebo q4w from Week 0 to Week 20, and will crossover at Week 24 to receive guselkumab 100 mg q4w from Week 24 through Week 48.
Guselkumab
Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.
Placebo
Participants will receive matching placebo as SC injection.
Interventions
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Guselkumab
Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.
Placebo
Participants will receive matching placebo as SC injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have active PsA as defined by: at least 3 swollen joints and at least 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligram per deciLitre (mg/dL) at screening from the central laboratory
* 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 active plaque psoriasis, with at least one psoriatic plaque of \>= 2 centimeter (cm) diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis
* Have active PsA despite previous non-biologic disease-modifying antirheumatic drugs (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy : Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 3 months or evidence of intolerance; Apremilast therapy is defined as taking apremilast at the marketed dose approved in the country where the study is being conducted for at least 4 months or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
* Participants may have been previously treated with up to 2 anti-TNF (tumor necrosis factor) alpha agents (approximately 30 percent \[%\] of the overall study population), and must document the reason for discontinuation
Exclusion Criteria
* Has ever received more than 2 anti-TNFalpha 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 any systemic immunosuppressants (for example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
* Has received apremilast within 4 weeks prior to the first administration of study agent
* Has previously received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
18 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Rheumatology Associates
Birmingham, Alabama, United States
Arizona Arthritis & Rheumatology Associates PC
Glendale, Arizona, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, United States
Clinical Research Center of Connecticut
Danbury, Connecticut, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Arthritis Consultants
St Louis, Missouri, United States
Arthritis and Osteoporosis Associates
Freehold, New Jersey, United States
Austin Regional Clinic
Austin, Texas, United States
Barwon Rheumatology Services
Geelong, , Australia
Southern Clinical Research
Hobart, , Australia
Liverpool Hospital
Liverpool, , Australia
Rheumatology Research Unit
Maroochydore, , Australia
Eastern Health - Box Hill Hospital
Melbourne, , Australia
Queen Elizabeth Hospital
Woodville South, , Australia
Eastern Regional Health Authority, St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, Canada
The Waterside Clinic
Barrie, Ontario, Canada
Dermatrials Research
Hamilton, Ontario, Canada
Skin Centre for Dermatology
Peterborough, Ontario, Canada
K. Papp Clinical Research
Waterloo, Ontario, Canada
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Québec, , Canada
Revmaclinic
Brno, , Czechia
MUDr. Rosypalova, s.r.o
Ostrava, , Czechia
Revmatologicky ustav
Prague, , Czechia
Revmatologicka ambulance
Prague, , Czechia
Medical Plus S.R.O.
Uherské Hradiště, , Czechia
PV-Medical S.R.O
Zlín, , Czechia
ISA GmbH
Berlin, , Germany
Universitatsklinikum Frankfurt
Frankfurt, , Germany
MVZ Rheuma
Hamburg, , Germany
Rheumazentrum Ruhrgebiet
Herne, , Germany
Krankenhaus St. Josef
Wuppertal, , Germany
Orszagos Reumatologia es Fizioterapias Intezet
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, , Hungary
Martinus Medicus Health Center
Szombathely, , Hungary
Hospital Selayang
Batu Caves, , Malaysia
Hospital Pulau Pinang
George Town, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Hospital Melaka
Malacca, , Malaysia
Hospital Tuanku Jaafar
Seremban, , Malaysia
Nzoz Osteo-Medic
Bialystok, , Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, , Poland
NSZOZ Unica CR
Dąbrówka, , Poland
Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag, , Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, , Poland
Centrum Medyczne Hetmańska
Poznan, , Poland
Nasz Lekarz Przychodnie Medyczne
Torun, , Poland
Medycyna Kliniczna
Warsaw, , Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, , Poland
Centrum Medyczne WroMedica
Wroclaw, , Poland
Nzoz Biogenes Sp. Z O. O.
Wroclaw, , Poland
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk, , Russia
Medical and Sanitary Unit ''Severstal''
Cherepovets, , Russia
Krasnoyarsk State Medical University
Krasnoyarsk, , Russia
Lipetsk Regional Dermatovenerological Dispensary
Lipetsk, , Russia
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov, , Russia
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, , Russia
Republican Clinical Hospital - G.G. Kuvatov
Ufa, , Russia
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, , Russia
Clinical Hospital #10
Yaroslavl, , Russia
Research Institute of Dermatovenerology, Immunology
Yekaterinburg, , Russia
Seoul National University Bundang Hospital
Bundang, , South Korea
Hanyang University Hospital for rheumatic Diseases
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
SMG - SNU Boramae Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Hosp. Univ. A Coruña
A Coruña, , Spain
Hosp. Del Mar
Barcelona, , Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hospital Regional Carlos Haya
Málaga, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Infanta Luisa
Seville, , Spain
Hosp. Unv. de Valme
Seville, , Spain
Hosp. de Manises
Valencia, , Spain
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Medical Center
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Kung Memorial Hospital
Taipei, , Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, , Taiwan
Municipal health care institution Chernihiv Regional Hospital
Chernihiv, , Ukraine
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
Ivano-Frankivsk, , Ukraine
Communal Institution of Health Kharkiv City multifield hospital №18
Kharkiv, , Ukraine
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv, , Ukraine
Khmelnitckiy regional hospital
Khmelnytsky, , Ukraine
Clinic of SI 'NSC 'The M.D.Strazhesko Institute of Cardiology' of NAMS of Ukraine'
Kyiv, , Ukraine
Kyiv Railway Station Clinical Hospital #2
Kyiv, , Ukraine
Danylo Halytsky Lviv National Medical University
Lviv, , Ukraine
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Odesa, , Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, , Ukraine
Countries
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References
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Mease P, Korotaeva T, Shesternya P, Kokhan M, Rukavitsyn A, Vasilchenkov D, Sharaf M, Lavie F, Deodhar A. Guselkumab in Biologic-Naive Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials. Rheumatol Ther. 2024 Dec;11(6):1551-1567. doi: 10.1007/s40744-024-00713-x. Epub 2024 Sep 25.
Curtis JR, Deodhar A, Soriano ER, Rampakakis E, Shawi M, Shiff NJ, Han C, Tillett W, Gladman DD. Early Improvements with Guselkumab Associate with Sustained Control of Psoriatic Arthritis: Post hoc Analyses of Two Phase 3 Trials. Rheumatol Ther. 2024 Dec;11(6):1501-1517. doi: 10.1007/s40744-024-00702-0. Epub 2024 Sep 11.
Baraliakos X, Gladman DD, Chakravarty SD, Gong C, Shawi M, Rampakakis E, Kishimoto M, Soriano ER, Mease PJ. BASDAI versus ASDAS in evaluating axial involvement in patients with psoriatic arthritis: a pooled analysis of two phase 3 studies. Rheumatol Adv Pract. 2024 Apr 23;8(2):rkae058. doi: 10.1093/rap/rkae058. eCollection 2024.
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.
Kavanaugh A, Baraliakos X, Gao S, Chen W, Sweet K, Chakravarty SD, Song Q, Shawi M, Rahman P. Genetic and Molecular Distinctions Between Axial Psoriatic Arthritis and Radiographic Axial Spondyloarthritis: Post Hoc Analyses from Four Phase 3 Clinical Trials. Adv Ther. 2023 May;40(5):2439-2456. doi: 10.1007/s12325-023-02475-4. Epub 2023 Mar 30.
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.
Orbai AM, Coates LC, Deodhar A, Helliwell PS, Ritchlin CT, Leibowitz E, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Jiang Y, Liu Y, Han C. Meaningful Improvement in General Health Outcomes with Guselkumab Treatment for Psoriatic Arthritis: Patient-Reported Outcomes Measurement Information System-29 Results from a Phase 3 Study. Patient. 2022 Nov;15(6):657-668. doi: 10.1007/s40271-022-00588-6. Epub 2022 Jun 30.
Coates LC, Ritchlin CT, Gossec L, Helliwell PS, Rahman P, Kollmeier AP, Xu XL, Shawi M, Karyekar CS, Contre C, Noel W, Sheng S, Wang Y, Xu S, Mease PJ. Guselkumab provides sustained domain-specific and comprehensive efficacy using composite indices in patients with active psoriatic arthritis. Rheumatology (Oxford). 2023 Feb 1;62(2):606-616. doi: 10.1093/rheumatology/keac375.
Ritchlin CT, Mease PJ, Boehncke WH, Tesser J, Schiopu E, Chakravarty SD, Kollmeier AP, Xu XL, Shawi M, Jiang Y, Sheng S, Wang Y, Xu S, Merola JF, McInnes IB, Deodhar A. Sustained and improved guselkumab response in patients with active psoriatic arthritis regardless of baseline demographic and disease characteristics: pooled results through week 52 of two phase III, randomised, placebo-controlled studies. RMD Open. 2022 Mar;8(1):e002195. doi: 10.1136/rmdopen-2022-002195.
Rahman P, Mease PJ, Helliwell PS, Deodhar A, Gossec L, Kavanaugh A, Kollmeier AP, Hsia EC, Zhou B, Lin X, Shawi M, Karyekar CS, Han C. Guselkumab demonstrated an independent treatment effect in reducing fatigue after adjustment for clinical response-results from two phase 3 clinical trials of 1120 patients with active psoriatic arthritis. Arthritis Res Ther. 2021 Jul 14;23(1):190. doi: 10.1186/s13075-021-02554-3.
Sweet K, Song Q, Loza MJ, McInnes IB, Ma K, Leander K, Lakshminarayanan V, Franks C, Cooper P, Siebert S. Guselkumab induces robust reduction in acute phase proteins and type 17 effector cytokines in active psoriatic arthritis: results from phase 3 trials. RMD Open. 2021 May;7(2):e001679. doi: 10.1136/rmdopen-2021-001679.
Rahman P, Ritchlin CT, Helliwell PS, Boehncke WH, Mease PJ, Gottlieb AB, Kafka S, Kollmeier AP, Hsia EC, Xu XL, Shawi M, Sheng S, Agarwal P, Zhou B, Ramachandran P, Zhuang Y, McInnes IB. Pooled Safety Results Through 1 Year of 2 Phase III Trials of Guselkumab in Patients With Psoriatic Arthritis. J Rheumatol. 2021 Dec;48(12):1815-1823. doi: 10.3899/jrheum.201532. Epub 2021 May 1.
McGonagle D, McInnes IB, Deodhar A, Schett G, Shawi M, Kafka S, Karyekar CS, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Agarwal P, Zhou B, Ritchlin CT, Rahman P, Mease PJ. Resolution of enthesitis by guselkumab and relationships to disease burden: 1-year results of two phase 3 psoriatic arthritis studies. Rheumatology (Oxford). 2021 Nov 3;60(11):5337-5350. doi: 10.1093/rheumatology/keab285.
Deodhar A, Helliwell PS, Boehncke WH, Kollmeier AP, Hsia EC, Subramanian RA, Xu XL, Sheng S, Agarwal P, Zhou B, Zhuang Y, Ritchlin CT; DISCOVER-1 Study Group. Guselkumab in patients with active psoriatic arthritis who were biologic-naive or had previously received TNFalpha inhibitor treatment (DISCOVER-1): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 Apr 4;395(10230):1115-1125. doi: 10.1016/S0140-6736(20)30265-8. Epub 2020 Mar 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001163-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNTO1959PSA3001
Identifier Type: OTHER
Identifier Source: secondary_id
CR108218
Identifier Type: -
Identifier Source: org_study_id
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