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.

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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.

View Eligibility Criteria

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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

383

Study ID:

NCT03162796

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There are 87 Locations for this study

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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, United States
University of Michigan
Ann Arbor Michigan, 48109, United States
Arthritis Consultants
Saint Louis Missouri, 63141, United States
Arthritis and Osteoporosis Associates
Freehold New Jersey, 07728, United States
Austin Regional Clinic
Austin Texas, 78731, United States
Barwon Rheumatology Services
Geelong , 3220, Australia
Southern Clinical Research
Hobart , 7000, Australia
Liverpool Hospital
Liverpool , 2170, Australia
Rheumatology Research Unit
Maroochydore , 4558, Australia
Eastern Health - Box Hill Hospital
Melbourne , 3128, Australia
Queen Elizabeth Hospital
Woodville South , 5011, Australia
Eastern Regional Health Authority, St. Clare's Mercy Hospital
St. John's Newfoundland and Labrador, A1C 5, Canada
The Waterside Clinic
Barrie Ontario, L4M 6, Canada
Dermatrials Research
Hamilton Ontario, L8N 1, Canada
Skin Centre for Dermatology
Peterborough Ontario, K9J 5, Canada
K. Papp Clinical Research
Waterloo Ontario, N2J 1, Canada
G.R.M.O. (Groupe de recherche en maladies osseuses) Inc.
Quebec , G1V 3, Canada
Revmaclinic
Brno , 61141, Czechia
MUDr. Rosypalova, s.r.o
Ostrava , 70800, Czechia
Revmatologicka ambulance
Praha 4 , 14000, Czechia
Revmatologicky ustav
Praha , 12850, Czechia
Medical Plus S.R.O.
Uherske Hradiste , 68601, Czechia
PV-Medical S.R.O
Zlin , 76001, Czechia
ISA GmbH
Berlin , 10789, Germany
Universitatsklinikum Frankfurt
Frankfurt , 60590, Germany
MVZ Rheuma
Hamburg , 20095, Germany
Rheumazentrum Ruhrgebiet
Herne , 44649, Germany
Krankenhaus St. Josef
Wuppertal , 42105, Germany
Orszagos Reumatologia es Fizioterapias Intezet
Budapest , 1023, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest , 1062, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
Pest Megyei Flor Ferenc Korhaz
Kistarcsa , 2143, Hungary
Martinus Medicus Health Center
Szombathely , 9700, Hungary
Seoul National University Bundang Hospital
Bundang , 13620, Korea, Republic of
Hanyang University Hospital for rheumatic Diseases
Seoul , 04763, Korea, Republic of
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul , 06591, Korea, Republic of
SMG - SNU Boramae Medical Center
Seoul , 7061, Korea, Republic of
Ajou University Hospital
Suwon , 16499, Korea, Republic of
Hospital Selayang
Batu Caves , 68100, Malaysia
Hospital Pulau Pinang
Georgetown , 10990, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh , 30990, Malaysia
Hospital Melaka
Melaka , 75400, Malaysia
Hospital Tuanku Jaafar
Seremban , 70300, Malaysia
Nzoz Osteo-Medic
Bialystok , 15-35, Poland
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz , 85-16, Poland
NSZOZ Unica CR
Dabrowka , 62-06, Poland
Centrum Kliniczno Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska
Elblag , 82-30, Poland
Etyka Osrodek Badan Klinicznych
Olsztyn , 10-11, Poland
Centrum Medyczne Hetmańska
Poznań , 60-21, Poland
Nasz Lekarz Przychodnie Medyczne
Torun , 87-10, Poland
Medycyna Kliniczna
Warsaw , 00-87, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher
Warszawa , 02-63, Poland
Centrum Medyczne WroMedica
Wroclaw , 51-68, Poland
Nzoz Biogenes Sp. Z O. O.
Wroclaw , 53-22, Poland
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk , 45409, Russian Federation
Medical and Sanitary Unit ''Severstal''
Cherepovets , 16260, Russian Federation
Research Institute of Dermatovenerology, Immunology
Ekaterinburg , 62007, Russian Federation
Krasnoyarsk State Medical University
Krasnoyarsk , 66002, Russian Federation
Lipetsk Regional Dermatovenerological Dispensary
Lipetsk , 39800, Russian Federation
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov , 34400, Russian Federation
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan , 39004, Russian Federation
Republican Clinical Hospital - G.G. Kuvatov
Ufa , 45000, Russian Federation
Clinical Emergency Hospital n.a. N.V. Solovyev
Yaroslavl , 15000, Russian Federation
Clinical Hospital #10
Yaroslavl , 15002, Russian Federation
Hosp. Univ. A Coruña
A Coruna , 15006, Spain
Hosp. Del Mar
Barcelona , 08003, Spain
Hosp. Gral. Univ. Gregorio Marañon
Madrid , 28007, Spain
Hosp. Univ. Ramon Y Cajal
Madrid , 28034, Spain
Hospital Regional Carlos Haya
Málaga , 29009, Spain
Hosp. Clinico Univ. de Santiago
Santiago de Compostela , 15706, Spain
Hosp. Infanta Luisa
Sevilla , 41010, Spain
Hosp. Unv. de Valme
Sevilla , 41401, Spain
Hosp. de Manises
Valencia , 46940, Spain
Hualien Tzu Chi Hospital
Hualien City , 970, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung , 81362, Taiwan
Chang Gung Memorial Hospital Kaohsiung Branch
Kaohsiung , 833, Taiwan
Chung Shan Medical University Hospital
Taichung , 402, Taiwan
National Cheng Kung University Medical Center
Tainan , 704, Taiwan
National Taiwan University Hospital
Taipei , 10002, Taiwan
Chang Kung Memorial Hospital
Taipei , 105, Taiwan
Chang-Gung Memorial Hospital, LinKou Branch
Taoyuan , 333, 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 â„–18
Kharkiv , 61029, 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
Odessa , 65025, Ukraine
Municipal institution of Tepnopil Regional Council 'Ternopil University Hospital'
Ternopil , , Ukraine

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

383

Study ID:

NCT03162796

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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