Psoriasis Clinical Trial
A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis
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.
Full Description
This is a study of guselkumab in participants with active PsA who are biologically naive and have had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms, structural damage inhibition and the safety profile of guselkumab in the treatment of PsA. The study will consist of a screening phase (up to 6 weeks), a blinded treatment phase (approximately 100 weeks) including a placebo controlled period from Week 0 to Week 24 and an active treatment period from Week 24 to Week 100 and a safety follow-up phase of 12 weeks after the last administration of study agent. Efficacy, health economics, safety, pharmacokinetics, immunogenicity, biomarker and pharmacogenomics evaluations will be performed in the study at defined schedule.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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There are 122 Locations for this study
Birmingham Alabama, 35205, United States
Glendale Arizona, 85306, United States
Mesa Arizona, 85210, United States
Danbury Connecticut, 06810, United States
Indianapolis Indiana, 46256, United States
Ann Arbor Michigan, 48109, United States
Saint Louis Missouri, 63141, United States
Austin Texas, 78731, United States
Plovdiv , 4003, Bulgaria
Plovdiv , 4004, Bulgaria
Ruse , 7003, Bulgaria
Sofia , 1505, Bulgaria
Sofia , 1606, Bulgaria
Sofia , 1794, Bulgaria
Targovishte , 7700, Bulgaria
Brno - Zidenice , 615 0, Czechia
Brno , 61141, Czechia
Ostrava , 70800, Czechia
Praha 4 , 14000, Czechia
Praha , 12850, Czechia
Uherske Hradiste , 68601, Czechia
Zlin , 76001, Czechia
Parnu , 80010, Estonia
Tallinn , 10117, Estonia
Tallinn , 11312, Estonia
Tartu , 50106, Estonia
Daugavpils , LV541, Latvia
Riga , LV100, Latvia
Riga , LV100, Latvia
Riga , LV100, Latvia
Kaunas , LT501, Lithuania
Siauliai , LT-76, Lithuania
Vilnius , LT011, Lithuania
Vilnius , LT093, Lithuania
Batu Caves , 68100, Malaysia
Ipoh , 30990, Malaysia
Kuching , Saraw, Malaysia
Melaka , 75400, Malaysia
Putrajaya , 62250, Malaysia
Seremban , 70300, Malaysia
Bydgoszcz , 85-16, Poland
Dabrowka , 62-06, Poland
Elblag , 82-30, Poland
Gdansk , 80-54, Poland
Lodz , 90-24, Poland
Lodz , 91-36, Poland
Nadarzyn , 05-83, Poland
Olsztyn , 10-11, Poland
Poznań , 60-21, Poland
Swidnik , 21-04, Poland
Torun , 87-10, Poland
Warsaw , 00-87, Poland
Warszawa , 02-63, Poland
Warszawa , 03-29, Poland
Wroclaw , 51-68, Poland
Wrocław , 53-22, Poland
Chelyabinsk , 45409, Russian Federation
Cherepovets , 16260, Russian Federation
Ekaterinburg , 62007, Russian Federation
Kemerovo , 65000, Russian Federation
Kemerovo , 65006, Russian Federation
Korolev , 14106, Russian Federation
Krasnodar , 35002, Russian Federation
Krasnoyarsk , 66002, Russian Federation
Lipetsk , 39800, Russian Federation
Moscow , 11139, Russian Federation
Omsk , 64402, Russian Federation
Orenburg , 46000, Russian Federation
Petrozavodsk , 18501, Russian Federation
Rostov , 34400, Russian Federation
Ryazan , 39004, Russian Federation
Saratov , 41005, Russian Federation
Smolensk , 21402, Russian Federation
St-Petersburg , 19006, Russian Federation
St-Petersburg , 19429, Russian Federation
Tula , 30005, Russian Federation
Tver , 17003, Russian Federation
Ufa , 45000, Russian Federation
Yaroslavl , 15000, Russian Federation
Yaroslavl , 15000, Russian Federation
Yaroslavl , 15002, Russian Federation
A Coruna , 15006, Spain
Barakaldo , 48903, Spain
Bilbao , 48013, Spain
Cordoba , 14004, Spain
Madrid , 28031, Spain
Madrid , 28034, Spain
Málaga , 29009, Spain
Mérida , 06800, Spain
San Sebastián de los Reyes , 28702, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41010, Spain
Sevilla , 41401, Spain
Valencia , 46017, Spain
Valencia , 46026, Spain
Vigo , 36214, Spain
Hualien City , 970, Taiwan
Kaohsiung , 833, Taiwan
Tainan , 704, Taiwan
Taipei , 105, Taiwan
Taoyuan , 333, Taiwan
Ankara , 06800, Turkey
Ankara , 6100, Turkey
Antalya , 7059, Turkey
Bursa , 16059, Turkey
Eskisehir , 26480, Turkey
Istanbul , 34147, Turkey
Istanbul , 34899, Turkey
Izmir , 35340, Turkey
Izmir , 35360, Turkey
Cherkasy , 18009, Ukraine
Chernihiv , 14029, Ukraine
Ivano-Frankivsk , , Ukraine
Kharkiv , 61029, Ukraine
Kharkiv , 61029, Ukraine
Kharkiv , 61039, Ukraine
Kharkiv , , Ukraine
Kherson , 73000, Ukraine
Khmelnytsky , 29000, Ukraine
Kryvyi Rih , 50056, Ukraine
Kyiv , 02125, Ukraine
Kyiv , 04050, Ukraine
Kyiv , 04107, Ukraine
Kyiv , , Ukraine
Kyiv , , Ukraine
Lviv , , Ukraine
Lviv , , Ukraine
Odessa , 65025, Ukraine
Odessa , 65026, Ukraine
Poltava , , Ukraine
Sumy , , Ukraine
Ternopil , 46002, Ukraine
Ternopil , , Ukraine
Uzhgorod , 88000, Ukraine
Vinnytsya , 21009, Ukraine
Vinnytsya , , Ukraine
Zaporizhzhya , , Ukraine
Zhytomyr , 10002, Ukraine
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