Psoriasis Clinical Trial
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)
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 Psoriatic Arthritis (PsA) who had inadequate response to standard therapies. It will evaluate the clinical efficacy of guselkumab in the reduction of signs and symptoms and the safety profile of guselkumab in the treatment of PsA. The study will consists of 4 phases: a screening phase of up to 6 weeks, a blinded treatment phase of approximately 1 year (that is, 52 weeks), including a placebo controlled period from Week 0 to Week 24 and double-blind active treatment period from Week 24 to Week 52, and a safety follow-up phase of 8 weeks after Week 52 (Week 52 to 60) and will be 12 weeks from the last administration of study agent (at Week 48) to the final safety follow-up visit. Efficacy, safety, pharmacokinetic, immunogenicity, and biomarker 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 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 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 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
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There are 87 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
Freehold New Jersey, 07728, United States
Austin Texas, 78731, United States
Geelong , 3220, Australia
Hobart , 7000, Australia
Liverpool , 2170, Australia
Maroochydore , 4558, Australia
Melbourne , 3128, Australia
Woodville South , 5011, Australia
St. John's Newfoundland and Labrador, A1C 5, Canada
Barrie Ontario, L4M 6, Canada
Hamilton Ontario, L8N 1, Canada
Peterborough Ontario, K9J 5, Canada
Waterloo Ontario, N2J 1, Canada
Quebec , G1V 3, Canada
Brno , 61141, Czechia
Ostrava , 70800, Czechia
Praha 4 , 14000, Czechia
Praha , 12850, Czechia
Uherske Hradiste , 68601, Czechia
Zlin , 76001, Czechia
Berlin , 10789, Germany
Frankfurt , 60590, Germany
Hamburg , 20095, Germany
Herne , 44649, Germany
Wuppertal , 42105, Germany
Budapest , 1023, Hungary
Budapest , 1062, Hungary
Debrecen , 4032, Hungary
Kistarcsa , 2143, Hungary
Szombathely , 9700, Hungary
Bundang , 13620, Korea, Republic of
Seoul , 04763, Korea, Republic of
Seoul , 06591, Korea, Republic of
Seoul , 7061, Korea, Republic of
Suwon , 16499, Korea, Republic of
Batu Caves , 68100, Malaysia
Georgetown , 10990, Malaysia
Ipoh , 30990, Malaysia
Melaka , 75400, Malaysia
Seremban , 70300, Malaysia
Bialystok , 15-35, Poland
Bydgoszcz , 85-16, Poland
Dabrowka , 62-06, Poland
Elblag , 82-30, Poland
Olsztyn , 10-11, Poland
Poznań , 60-21, Poland
Torun , 87-10, Poland
Warsaw , 00-87, Poland
Warszawa , 02-63, Poland
Wroclaw , 51-68, Poland
Wroclaw , 53-22, Poland
Chelyabinsk , 45409, Russian Federation
Cherepovets , 16260, Russian Federation
Ekaterinburg , 62007, Russian Federation
Krasnoyarsk , 66002, Russian Federation
Lipetsk , 39800, Russian Federation
Rostov , 34400, Russian Federation
Ryazan , 39004, Russian Federation
Ufa , 45000, Russian Federation
Yaroslavl , 15000, Russian Federation
Yaroslavl , 15002, Russian Federation
A Coruna , 15006, Spain
Barcelona , 08003, Spain
Madrid , 28007, Spain
Madrid , 28034, Spain
Málaga , 29009, Spain
Santiago de Compostela , 15706, Spain
Sevilla , 41010, Spain
Sevilla , 41401, Spain
Valencia , 46940, Spain
Hualien City , 970, Taiwan
Kaohsiung , 81362, Taiwan
Kaohsiung , 833, Taiwan
Taichung , 402, Taiwan
Tainan , 704, Taiwan
Taipei , 10002, Taiwan
Taipei , 105, Taiwan
Taoyuan , 333, Taiwan
Chernihiv , , Ukraine
Ivano-Frankivsk , , Ukraine
Kharkiv , 61029, Ukraine
Kharkiv , , Ukraine
Khmelnytsky , , Ukraine
Kyiv , , Ukraine
Kyiv , , Ukraine
Lviv , , Ukraine
Odessa , 65025, Ukraine
Ternopil , , Ukraine
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