A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
NCT ID: NCT03158285
Last Updated: 2022-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
741 participants
INTERVENTIONAL
2017-07-12
2020-11-10
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 100.
Guselkumab
Participants will receive 100 mg 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, 44, 52, 60, 68, 76, 84, 92, and 100) and placebo injections at other visits (Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72, 80, 88, and 96) to maintain the blind.
Guselkumab
Participants will receive 100 mg 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 cross over at Week 24 to receive SC guselkumab 100 mg q4w from Week 24 through Week 100.
Guselkumab
Participants will receive 100 mg 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 100 mg 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 5 swollen joints and at least 5 tender joints at screening and at baseline, and CRP greater than or equal to (\>=) 0.6 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 (confirmation of sacroiliitis should be performed at the screening visit by a locally performed pelvic x-ray \[single anterior-posterior view\] unless a pelvic or SI joint x-ray or pelvic magnetic resonance imaging (MRI) has been previously performed. Results must be documented)
* 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 drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy
Exclusion Criteria
* Has previously received any biologic treatment
* Has ever received tofacitinib, baricitinib, filgotinib, peficitinib (ASP015K), decernotinib (VX-509), or any other Janus kinase (JAK) inhibitor
* Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study agent
* Is currently receiving 2 or more non-biologic DMARDs (other than methotrexate \[MTX\], sulfasalazine \[SSZ\], Hydroxychloroquine \[HCQ\], leflunomide \[LEF\]) including, but not limited to chloroquine, gold preparations, and penicillamine within 4 weeks before the first administration of study agent
* Has received apremilast within 4 weeks prior to the first administration of study agent
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
Austin Regional Clinic
Austin, Texas, United States
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
Medical Centre Synexus
Sofia, , Bulgaria
MHAT-Targovishte, AD
Targovishte, , Bulgaria
Revmaclinic
Brno, , Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno - Zidenice, , Czechia
MUDr. Rosypalova, s.r.o
Ostrava, , Czechia
Revmatologicky institut
Prague, , Czechia
Revmatologicka ambulance
Prague, , Czechia
Medical Plus S.R.O.
Uherské Hradiště, , Czechia
PV-Medical S.R.O
Zlín, , Czechia
Parnu Hospital
Pärnu, , Estonia
OU Innomedica
Tallinn, , Estonia
East Tallinn Central Hospital
Tallinn, , Estonia
Clinical Research Centre
Tartu, , Estonia
Daugavpils Regional Hospital
Daugavpils, , Latvia
Derma Clinic Riga
Riga, , Latvia
J Kisis Ltd
Riga, , Latvia
Orto Clinic Ltd
Riga, , Latvia
Vakk, Jsc
Kaunas, , Lithuania
Siauliai Republican Hospital, Public Institution
Šiauliai, , Lithuania
Central Outpatient Clinic
Vilnius, , Lithuania
National Osteoporosis Centre
Vilnius, , Lithuania
Hospital Selayang
Batu Caves, , Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, , Malaysia
Sarawak General Hospital
Kuching, , Malaysia
Hospital Melaka
Malacca, , Malaysia
Hospital Putrajaya
Putrajaya, , Malaysia
Hospital Tuanku Jaafar
Seremban, , Malaysia
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, , Poland
NSZOZ Unica CR
Dąbrówka, , Poland
Centrum Kliniczno Badawcze
Elblag, , Poland
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, , Poland
Centrum Badawcze Wspolczesnej Terapii
Lodz, , Poland
Centrum Medyczne AMED oddzial w Lodzi
Lodz, , Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, , Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, , Poland
Centrum Medyczne Hetmańska
Poznan, , Poland
Lubelskie Centrum Diagnostyczne
Świdnik, , 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 AMED Warszawa Targowek
Warsaw, , Poland
Wromedica
Wroclaw, , Poland
Biogenes Sp. z o. o.
Wroclaw, , Poland
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk, , Russia
Medical and Sanitary Unit ''Severstal''
Cherepovets, , Russia
Regional Clinical Hospital for War Veterans
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
Lipetsk Regional Dermatovenerological Dispensary
Lipetsk, , Russia
Moscow State Medical and Stomatological University
Moscow, , Russia
Clinical Diagnostic Center 'Ultramed'
Omsk, , Russia
Orenburg State Medical University
Orenburg, , Russia
Republican Hospital n.a.V.A.Baranov
Petrozavodsk, , Russia
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov, , Russia
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, , Russia
City Clinic №25 - City Rheumatology Centre
Saint Petersburg, , Russia
Leningrad region clinical hospital
Saint Petersburg, , Russia
Saratov Regional Clinical Hospital
Saratov, , Russia
Smolensk regional hospital on Smolensk railway station
Smolensk, , Russia
Tula Regional Clinical Dermatovenerological Dispensary
Tula, , Russia
Regional Clinical Hospital
Tver', , Russia
Republican Clinical Hospital - G.G. Kuvatov
Ufa, , Russia
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, , Russia
Clinical Hospital #3
Yaroslavl, , Russia
Clinical Hospital #10
Yaroslavl, , Russia
Research Institute of Dermatovenerology, Immunology
Yekaterinburg, , Russia
Hosp. Univ. A Coruña
A Coruña, , Spain
Hosp. Univ. de Cruces
Barakaldo, , Spain
Hosp. Univ. de Basurto
Bilbao, , Spain
Hosp. Reina Sofia
Córdoba, , Spain
Hosp. Univ. Infanta Leonor
Madrid, , Spain
Hosp. Univ. Ramon Y Cajal
Madrid, , Spain
Hosp. Regional. Carlos Haya
Málaga, , Spain
Hosp. de Merida
Mérida, , Spain
H.U. Infanta Sofía
San Sebastián de los Reyes, , Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, , Spain
Hosp. Infanta Luisa
Seville, , Spain
Hosp. Unv. de Valme
Seville, , Spain
Hosp. Univ. Dr. Peset
Valencia, , Spain
Hosp. Univ. I Politecni La Fe
Valencia, , Spain
Hosp. Do Meixoeiro
Vigo, , Spain
Hualien Tzu Chi Hospital
Hualien City, , Taiwan
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung City, , Taiwan
National Cheng Kung University Medical Center
Tainan City, , Taiwan
Chang Kung Memorial Hospital
Taipei, , Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, , Taiwan
Ankara Bilkent City Hospital
Ankara, , Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, , Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, , Turkey (Türkiye)
Osmangazi University Medical Faculty
Eskişehir, , Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, , Turkey (Türkiye)
Marmara University Medical Faculty
Istanbul, , Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, , Turkey (Türkiye)
Izmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital
Izmir, , Turkey (Türkiye)
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, , Ukraine
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
Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'
Kharkiv, , Ukraine
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Kharkiv, , Ukraine
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv, , Ukraine
Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
Kherson, , Ukraine
Khmelnitckiy regional hospital
Khmelnytsky, , Ukraine
City Clinical Hospital No. 2
Kryvyi Rih, , Ukraine
Kyiv City Clinical Hospital #3
Kyiv, , Ukraine
Medical Center 'Consylium Medical'
Kyiv, , Ukraine
Kyiv Regional Clinical Hospital
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
Danylo Halytsky Lviv National Medical University
Lviv, , Ukraine
Lviv Communcal City Clinical Hospital #4
Lviv, , Ukraine
Municipal Non-profit Enterprise 'Odesa Regional Clinical Hospital' Odesa Regional Council
Odesa, , Ukraine
Multidisciplinary Medical Center of Odessa National Medical University
Odesa, , Ukraine
Poltava Regional Clinical Hospital HSEI of Ukraine Ukrainian Medical Stomatological Academy
Poltava, , Ukraine
Sumy State University
Sumy, , Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil, , Ukraine
Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
Ternopil, , Ukraine
MNCE Zakarpatska Regional Clinical Hospital named after A Novak of Zakarpatska Regional Council
Uzhhorod, , 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
Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya, , Ukraine
Municipal institution Central Clinical Hospital #1 Zhytomir
Zhytomyr, , Ukraine
Countries
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References
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Crauwels H, Ringold S, Howard S, Van Hartingsveldt B, Smith V, Jett M, Baguet T, Adamson E, Chakravarty SD, Leu JH. Extrapolating Guselkumab Efficacy to Juvenile Psoriatic Arthritis from Adult Psoriatic Arthritis and Adult and Pediatric Psoriasis Data. Paediatr Drugs. 2025 Oct 28. doi: 10.1007/s40272-025-00725-2. Online ahead of print.
Ritchlin CT, Lubrano E, Chimenti MS, Leibowitz E, Sharaf M, Rampakakis E, Nantel F, Lavie F, Deodhar A. Guselkumab Efficacy in Biologic-Naive Participants with Psoriatic Arthritis and Severe Disease Activity: Post Hoc Analysis of a Phase 3 Study. Rheumatol Ther. 2025 Oct;12(5):925-940. doi: 10.1007/s40744-025-00777-3. Epub 2025 Jul 21.
Siebert S, Schett G, Raychaudhuri SP, Guma M, Chen W, Gao S, Chakravarty SD, Lavie F, Rahman P. Correlation of changes in inflammatory and collagen biomarkers with durable guselkumab efficacy through 2 years in participants with active psoriatic arthritis: results from a phase III randomized controlled trial. Ther Adv Musculoskelet Dis. 2024 Oct 27;16:1759720X241283536. doi: 10.1177/1759720X241283536. eCollection 2024.
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.
Ritchlin CT, Mease PJ, Boehncke WH, Tesser J, Chakravarty SD, Rampakakis E, Shawi M, Schiopu E, Merola JF, McInnes IB, Deodhar A. Durable control of psoriatic arthritis with guselkumab across domains and patient characteristics: post hoc analysis of a phase 3 study. Clin Rheumatol. 2024 Aug;43(8):2551-2563. doi: 10.1007/s10067-024-06991-8. Epub 2024 Jun 7.
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.
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.
Rahman P, McInnes IB, Deodhar A, Schett G, Mease PJ, Shawi M, Cua DJ, Sherlock JP, Kollmeier AP, Xu XL, Sheng S, Ritchlin CT, McGonagle D. Association between enthesitis/dactylitis resolution and patient-reported outcomes in guselkumab-treated patients with psoriatic arthritis. Clin Rheumatol. 2024 May;43(5):1591-1604. doi: 10.1007/s10067-024-06921-8. Epub 2024 Mar 12.
Curtis JR, McInnes IB, Rahman P, Gladman DD, Peterson S, Yang F, Adejoro O, Kollmeier AP, Shiff NJ, Han C, Shawi M, Tillett W, Mease PJ. Work Productivity and General Health Through 2 Years of Guselkumab Treatment in a Phase 3 Randomized Trial of Patients With Active Psoriatic Arthritis. Rheumatol Ther. 2024 Apr;11(2):425-441. doi: 10.1007/s40744-024-00642-9. Epub 2024 Feb 22.
Coates LC, Rahman P, Mease PJ, Shawi M, Rampakakis E, Kollmeier AP, Xu XL, Chakravarty SD, McInnes IB, Tam LS. Continuous improvement through differential trajectories of individual minimal disease activity criteria with guselkumab in active psoriatic arthritis: post hoc analysis of a phase 3, randomized, double-blind, placebo-controlled study. BMC Rheumatol. 2024 Feb 4;8(1):6. doi: 10.1186/s41927-024-00375-w.
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.
Mease PJ, Gladman DD, Poddubnyy D, Chakravarty SD, Shawi M, Kollmeier AP, Xu XL, Xu S, Deodhar A, Baraliakos X. Efficacy of Guselkumab on Axial-Related Symptoms Through up to 2 Years in Adults with Active Psoriatic Arthritis in the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Study. Rheumatol Ther. 2023 Dec;10(6):1637-1653. doi: 10.1007/s40744-023-00592-8. Epub 2023 Oct 11.
Gottlieb AB, McInnes IB, Rahman P, Kollmeier AP, Xu XL, Jiang Y, Sheng S, Shawi M, Chakravarty SD, Lavie F, Mease PJ. Low rates of radiographic progression associated with clinical efficacy following up to 2 years of treatment with guselkumab: results from a phase 3, randomised, double-blind, placebo-controlled study of biologic-naive patients with active psoriatic arthritis. RMD Open. 2023 Feb;9(1):e002789. doi: 10.1136/rmdopen-2022-002789.
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.
Curtis JR, McInnes IB, Rahman P, Gladman DD, Peterson S, Agarwal P, Yang F, Kollmeier AP, Hsia EC, Shiff NJ, Zhou B, Han C, Shawi M, Tillett W, Mease PJ. The Effect of Guselkumab on Work Productivity in Biologic-Naive Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial. Adv Ther. 2022 Oct;39(10):4613-4631. doi: 10.1007/s12325-022-02270-7. Epub 2022 Aug 10.
Curtis JR, McInnes IB, Rahman P, Gladman DD, Yang F, Peterson S, Agarwal P, Kollmeier AP, Hsia EC, Han C, Shiff NJ, Shawi M, Tillett W, Mease PJ. The Effect of Guselkumab on General Health State in Biologic-Naive Patients with Active Psoriatic Arthritis Through Week 52 of the Phase 3, Randomized, Placebo-Controlled DISCOVER-2 Trial. Adv Ther. 2022 Oct;39(10):4632-4644. doi: 10.1007/s12325-022-02269-0. Epub 2022 Aug 10.
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.
Schett G, Loza MJ, Palanichamy A, FitzGerald O, Ritchlin C, Bay-Jensen AC, Nielsen SH, Gao S, Hsia EC, Kollmeier AP, Xu XL, Baribaud F, Sweet K. Collagen Turnover Biomarkers Associate with Active Psoriatic Arthritis and Decrease with Guselkumab Treatment in a Phase 3 Clinical Trial (DISCOVER-2). Rheumatol Ther. 2022 Aug;9(4):1017-1030. doi: 10.1007/s40744-022-00444-x. Epub 2022 Mar 30.
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.
McInnes IB, Rahman P, Gottlieb AB, Hsia EC, Kollmeier AP, Chakravarty SD, Xu XL, Subramanian RA, Agarwal P, Sheng S, Jiang Y, Zhou B, Zhuang Y, van der Heijde D, Mease PJ. Efficacy and Safety of Guselkumab, an Interleukin-23p19-Specific Monoclonal Antibody, Through One Year in Biologic-Naive Patients With Psoriatic Arthritis. Arthritis Rheumatol. 2021 Apr;73(4):604-616. doi: 10.1002/art.41553. Epub 2021 Mar 17.
Mease PJ, Rahman P, Gottlieb AB, Kollmeier AP, Hsia EC, Xu XL, Sheng S, Agarwal P, Zhou B, Zhuang Y, van der Heijde D, McInnes IB; DISCOVER-2 Study Group. Guselkumab in biologic-naive patients with active psoriatic arthritis (DISCOVER-2): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet. 2020 Apr 4;395(10230):1126-1136. doi: 10.1016/S0140-6736(20)30263-4. 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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CNTO1959PSA3002
Identifier Type: OTHER
Identifier Source: secondary_id
2016-001224-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CR108219
Identifier Type: -
Identifier Source: org_study_id