A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Subjects With Active Psoriatic Arthritis
3 other identifiers
interventional
741
12 countries
134
Brief Summary
The primary purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2017
Typical duration for phase_3
134 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2017
CompletedFirst Posted
Study publicly available on registry
May 18, 2017
CompletedStudy Start
First participant enrolled
July 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2019
CompletedResults Posted
Study results publicly available
November 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2020
CompletedDecember 22, 2022
December 1, 2022
1.6 years
May 16, 2017
August 12, 2020
December 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 24
ACR 20 response: \>=20% improvement from baseline in both swollen joint count (66 joints) and tender joint count (68 joints), and \>=20% improvement from baseline in 3 of 5 assessments: patient's assessment of pain using visual analog scale (VAS; 0-100 mm, 0=no pain and 100=worst possible pain), patient's global assessment of disease activity (arthritis, VAS; 0-100 mm, 0=excellent and 100= poor), physician's global assessment of disease activity (VAS; 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), patient's assessment of physical function measured by Disability Index of Health Assessment Questionnaire (HAQ-DI; 20-question instrument assessing 8 functional areas; range: 0-3, 0= no difficulty, 3= inability to perform task in that area), and CRP. Treatment Failure (TF) criteria- discontinued study drug, initiated/increased dose of non-biologic disease-modifying antirheumatic drugs (DMARDs) or oral corticosteroids, initiated prohibited psoriatic arthritis treatment.
Week 24
Secondary Outcomes (208)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
Baseline and Week 24
Percentage of Participants Who Achieved an ACR 50 Response at Week 24
Week 24
Percentage of Participants Who Achieved Psoriasis Response With IGA Score of 0 (Cleared) or 1 (Minimal) and >=2 Grade Reduction From Baseline at Week 24 Among Participants With >=3% BSA Psoriatic Involvement and IGA Score of >=2 (Mild) at Baseline
Week 24
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16
Week 16
Change From Baseline in Modified Van Der Heijde-Sharp (vdH-S) Score at Week 24
Baseline and Week 24
- +203 more secondary outcomes
Study Arms (3)
Group 1: Guselkumab
EXPERIMENTALParticipants will receive subcutaneous (SC) guselkumab 100 milligram (mg) once every 4 weeks (q4w) from Week 0 through Week 100.
Group 2: Guselkumab and Placebo
EXPERIMENTALParticipants 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.
Group 3: Placebo Followed by Guselkumab
EXPERIMENTALParticipants 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.
Interventions
Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
Participants will receive matching placebo as SC injection.
Eligibility Criteria
You may qualify if:
- Have a diagnosis of Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study agent and meet Classification criteria for Psoriatic Arthritis (CASPAR) at screening
- 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
You may not qualify if:
- Has other inflammatory diseases that might confound the evaluations or 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 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (138)
Rheumatology Associates
Birmingham, Alabama, 35205, United States
Arizona Arthritis & Rheumatology Associates PC
Glendale, Arizona, 85306, United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, 85210, United States
Clinical Research Center of Connecticut
Danbury, Connecticut, 06810, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46256-4697, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Arthritis Consultants
St Louis, Missouri, 63141, United States
Austin Regional Clinic
Austin, Texas, 78731-3146, United States
Multiprofile Hospital for Active Treatment - Plovdiv
Plovdiv, 4003, Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv, 4004, Bulgaria
Medical Center Teodora
Rousse, 7003, Bulgaria
Diagnostic Consulting Center No 17
Sofia, 1505, Bulgaria
Military Medical Academy
Sofia, 1606, Bulgaria
Medical Centre Synexus
Sofia, 1794, Bulgaria
MHAT-Targovishte, AD
Targovishte, 7700, Bulgaria
Revmaclinic
Brno, 61141, Czechia
Revmacentrum MUDr. Mostera, s.r.o.
Brno-Židenice, 615 00, Czechia
MUDr. Rosypalova, s.r.o
Ostrava, 70800, Czechia
Revmatologicky institut
Prague, 12850, Czechia
Revmatologicka ambulance
Prague, 14000, Czechia
Medical Plus S.R.O.
Uherské Hradiště, 68601, Czechia
PV-Medical S.R.O
Zlín, 76001, Czechia
Parnu Hospital
Pärnu, 80010, Estonia
OU Innomedica
Tallinn, 10117, Estonia
East Tallinn Central Hospital
Tallinn, 11312, Estonia
Clinical Research Centre
Tartu, 50106, Estonia
Daugavpils Regional Hospital
Daugavpils, LV5417, Latvia
Derma Clinic Riga
Riga, LV1003, Latvia
J Kisis Ltd
Riga, LV1003, Latvia
Orto Clinic Ltd
Riga, LV1005, Latvia
Vakk, Jsc
Kaunas, LT50128, Lithuania
Siauliai Republican Hospital, Public Institution
Šiauliai, LT-76231, Lithuania
Central Outpatient Clinic
Vilnius, LT01117, Lithuania
National Osteoporosis Centre
Vilnius, LT09310, Lithuania
Hospital Selayang
Batu Caves, 68100, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh, 30990, Malaysia
Sarawak General Hospital
Kuching, Sarawak, Malaysia
Hospital Melaka
Malacca, 75400, Malaysia
Hospital Putrajaya
Putrajaya, 62250, Malaysia
Hospital Tuanku Jaafar
Seremban, 70300, Malaysia
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz, 85-168, Poland
NSZOZ Unica CR
Dąbrówka, 62-069, Poland
Centrum Kliniczno Badawcze
Elblag, 82-300, Poland
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk, 80-546, Poland
Centrum Badawcze Wspolczesnej Terapii
Lodz, 90-242, Poland
Centrum Medyczne AMED oddzial w Lodzi
Lodz, 91-363, Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn, 05-830, Poland
Etyka Osrodek Badan Klinicznych
Olsztyn, 10-117, Poland
Centrum Medyczne Hetmańska
Poznan, 60-218, Poland
Lubelskie Centrum Diagnostyczne
Świdnik, 21-040, Poland
Nasz Lekarz Przychodnie Medyczne
Torun, 87-100, Poland
Medycyna Kliniczna
Warsaw, 00-874, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warsaw, 02-637, Poland
Centrum Medyczne AMED Warszawa Targowek
Warsaw, 03-291, Poland
Wromedica
Wroclaw, 51-685, Poland
Biogenes Sp. z o. o.
Wroclaw, 53-224, Poland
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk, 454092, Russia
Medical and Sanitary Unit ''Severstal''
Cherepovets, 162600, Russia
Regional Clinical Hospital for War Veterans
Kemerovo, 650000, Russia
Medical Centre Maximum Health
Kemerovo, 650066, Russia
Family polyclinic #4
Korolyov, 141060, Russia
Krasnodar Clinical Dermatovenerologic Dispensary
Krasnodar, 350020, Russia
Krasnoyarsk State Medical University
Krasnoyarsk, 660022, Russia
Lipetsk Regional Dermatovenerological Dispensary
Lipetsk, 398005, Russia
Moscow State Medical and Stomatological University
Moscow, 111398, Russia
Clinical Diagnostic Center 'Ultramed'
Omsk, 644024, Russia
Orenburg State Medical University
Orenburg, 460000, Russia
Republican Hospital n.a.V.A.Baranov
Petrozavodsk, 185019, Russia
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov, 344007, Russia
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan, 390046, Russia
City Clinic №25 - City Rheumatology Centre
Saint Petersburg, 190068, Russia
Leningrad region clinical hospital
Saint Petersburg, 194291, Russia
Saratov Regional Clinical Hospital
Saratov, 410053, Russia
Smolensk regional hospital on Smolensk railway station
Smolensk, 214025, Russia
Tula Regional Clinical Dermatovenerological Dispensary
Tula, 300053, Russia
Regional Clinical Hospital
Tver', 170036, Russia
Republican Clinical Hospital - G.G. Kuvatov
Ufa, 450005, Russia
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl, 150003, Russia
Clinical Hospital #3
Yaroslavl, 150007, Russia
Clinical Hospital #10
Yaroslavl, 150023, Russia
Research Institute of Dermatovenerology, Immunology
Yekaterinburg, 620076, Russia
Hosp. Univ. A Coruña
A Coruña, 15006, Spain
Hosp. Univ. de Cruces
Barakaldo, 48903, Spain
Hosp. Univ. de Basurto
Bilbao, 48013, Spain
Hosp. Reina Sofia
Córdoba, 14004, Spain
Hosp. Univ. Infanta Leonor
Madrid, 28031, Spain
Hosp. Univ. Ramon Y Cajal
Madrid, 28034, Spain
Hosp. Regional. Carlos Haya
Málaga, 29009, Spain
Hosp. de Merida
Mérida, 06800, Spain
H.U. Infanta Sofía
San Sebastián de los Reyes, 28702, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela, 15706, Spain
Hosp. Infanta Luisa
Seville, 41010, Spain
Hosp. Unv. de Valme
Seville, 414014, Spain
Hosp. Univ. Dr. Peset
Valencia, 46017, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Hosp. Do Meixoeiro
Vigo, 36214, Spain
Hualien Tzu Chi Hospital
Hualien City, 970, Taiwan
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung City, 833, Taiwan
National Cheng Kung University Medical Center
Tainan, 704, Taiwan
Chang Kung Memorial Hospital
Taipei, 105, Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan District, 333, Taiwan
Ankara Bilkent City Hospital
Ankara, 06800, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 6100, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, 7059, Turkey (Türkiye)
Uludag University Medical Faculty
Bursa, 16059, Turkey (Türkiye)
Osmangazi University Medical Faculty
Eskişehir, 26480, Turkey (Türkiye)
Bakirkoy Training and Research Hospital
Istanbul, 34147, Turkey (Türkiye)
Marmara University Medical Faculty
Istanbul, 34899, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi
Izmir, 35340, Turkey (Türkiye)
Izmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital
Izmir, 35360, Turkey (Türkiye)
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
Municipal health care institution Chernihiv Regional Hospital
Chernihiv, 14029, Ukraine
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital
Ivano-Frankivsk, Ukraine
Communal Institution of Health Kharkiv City multifield hospital №18
Kharkiv, 61029, Ukraine
Kharkiv Railway Clinical Hospital N1 Of Brance 'Health Center'
Kharkiv, 61029, Ukraine
State Institution Institute of therapy named after L.T.Malaya AMS Ukraine
Kharkiv, 61039, Ukraine
Municipal Institution Regional hospital-center of emergency care and disasters medicine
Kharkiv, Ukraine
Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh'
Kherson, 73000, Ukraine
Khmelnitckiy regional hospital
Khmelnytsky, 29000, Ukraine
City Clinical Hospital No. 2
Kryvyi Rih, 50056, Ukraine
Kyiv City Clinical Hospital #3
Kyiv, 02125, Ukraine
Medical Center 'Consylium Medical'
Kyiv, 04050, Ukraine
Kyiv Regional Clinical Hospital
Kyiv, 04107, 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, 65025, Ukraine
Multidisciplinary Medical Center of Odessa National Medical University
Odesa, 65026, 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, 46002, 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, 88000, Ukraine
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
Vinnytsia, 21009, 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, 10002, Ukraine
Related Publications (27)
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: 41396391DERIVEDCrauwels 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.
PMID: 41152645DERIVEDRitchlin 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.
PMID: 40690163DERIVEDSiebert 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.
PMID: 39493888DERIVEDMease 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.
PMID: 39320583DERIVEDCurtis 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.
PMID: 39261446DERIVEDRitchlin 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.
PMID: 38844682DERIVEDBaraliakos 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.
PMID: 38765190DERIVEDWarren 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: 38488975DERIVEDRahman 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.
PMID: 38472528DERIVEDCurtis 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.
PMID: 38386178DERIVEDCoates 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.
PMID: 38310261DERIVEDStrober 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: 37906417DERIVEDMease 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.
PMID: 37819505DERIVEDGottlieb 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.
PMID: 36828643DERIVEDRahman 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: 36642439DERIVEDCurtis 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.
PMID: 35947349DERIVEDCurtis 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.
PMID: 35947348DERIVEDCoates 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.
PMID: 35766811DERIVEDSchett 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.
PMID: 35352313DERIVEDRitchlin 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.
PMID: 35296534DERIVEDRahman 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.
PMID: 34261541DERIVEDSweet 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.
PMID: 34011674DERIVEDRahman 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.
PMID: 33934076DERIVEDMcGonagle 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.
PMID: 33822898DERIVEDMcInnes 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.
PMID: 33043600DERIVEDMease 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.
PMID: 32178766DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head Rheumatology Clinical Development
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2017
First Posted
May 18, 2017
Study Start
July 12, 2017
Primary Completion
February 25, 2019
Study Completion
November 10, 2020
Last Updated
December 22, 2022
Results First Posted
November 5, 2020
Record last verified: 2022-12