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.

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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.

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 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

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

741

Study ID:

NCT03158285

Recruitment Status:

Completed

Sponsor:

Janssen Research & Development, LLC

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There are 122 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
Austin Regional Clinic
Austin Texas, 78731, United States
Multiprofile Hospital for Active Treatment - Plovdiv
Plovdiv , 4003, Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv
Plovdiv , 4004, Bulgaria
Medical Center Teodora
Ruse , 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
Revmacentrum MUDr. Mostera, s.r.o.
Brno - Zidenice , 615 0, Czechia
Revmaclinic
Brno , 61141, Czechia
MUDr. Rosypalova, s.r.o
Ostrava , 70800, Czechia
Revmatologicka ambulance
Praha 4 , 14000, Czechia
Revmatologicky institut
Praha , 12850, Czechia
Medical Plus S.R.O.
Uherske Hradiste , 68601, Czechia
PV-Medical S.R.O
Zlin , 76001, Czechia
Parnu Hospital
Parnu , 80010, Estonia
OU Innomedica
Tallinn , 10117, Estonia
East Tallinn Central Hospital
Tallinn , 11312, Estonia
Clinical Research Centre
Tartu , 50106, Estonia
Daugavpils Regional Hospital
Daugavpils , LV541, Latvia
Derma Clinic Riga
Riga , LV100, Latvia
J Kisis Ltd
Riga , LV100, Latvia
Orto Clinic Ltd
Riga , LV100, Latvia
Vakk, Jsc
Kaunas , LT501, Lithuania
Siauliai Republican Hospital, Public Institution
Siauliai , LT-76, Lithuania
Central Outpatient Clinic
Vilnius , LT011, Lithuania
National Osteoporosis Centre
Vilnius , LT093, Lithuania
Hospital Selayang
Batu Caves , 68100, Malaysia
Hospital Raja Permaisuri Bainun
Ipoh , 30990, Malaysia
Sarawak General Hospital
Kuching , Saraw, Malaysia
Hospital Melaka
Melaka , 75400, Malaysia
Hospital Putrajaya
Putrajaya , 62250, Malaysia
Hospital Tuanku Jaafar
Seremban , 70300, Malaysia
Szpital Uniwersytecki Nr 2 w Bydgoszczy
Bydgoszcz , 85-16, Poland
NSZOZ Unica CR
Dabrowka , 62-06, Poland
Centrum Kliniczno Badawcze
Elblag , 82-30, Poland
Centrum Badań Klinicznych PI-House sp. z o.o.
Gdansk , 80-54, Poland
Centrum Badawcze Wspolczesnej Terapii
Lodz , 90-24, Poland
Centrum Medyczne AMED oddzial w Lodzi
Lodz , 91-36, Poland
NZOZ Lecznica MAK-MED. S.C.
Nadarzyn , 05-83, Poland
Etyka Osrodek Badan Klinicznych
Olsztyn , 10-11, Poland
Centrum Medyczne Hetmańska
Poznań , 60-21, Poland
Lubelskie Centrum Diagnostyczne
Swidnik , 21-04, 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 AMED Warszawa Targowek
Warszawa , 03-29, Poland
Wromedica
Wroclaw , 51-68, Poland
Biogenes Sp. z o. o.
Wrocław , 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
Regional Clinical Hospital for War Veterans
Kemerovo , 65000, Russian Federation
Medical Centre Maximum Health
Kemerovo , 65006, Russian Federation
Family polyclinic #4
Korolev , 14106, Russian Federation
Krasnodar Clinical Dermatovenerologic Dispensary
Krasnodar , 35002, Russian Federation
Krasnoyarsk State Medical University
Krasnoyarsk , 66002, Russian Federation
Lipetsk Regional Dermatovenerological Dispensary
Lipetsk , 39800, Russian Federation
Moscow State Medical and Stomatological University
Moscow , 11139, Russian Federation
Clinical Diagnostic Center 'Ultramed'
Omsk , 64402, Russian Federation
Orenburg State Medical University
Orenburg , 46000, Russian Federation
Republican Hospital n.a.V.A.Baranov
Petrozavodsk , 18501, Russian Federation
Rostov Regional Clinical Dermatovenerological Dispensary
Rostov , 34400, Russian Federation
Ryazan Regional Clinical Dermatovenerological Dispensary
Ryazan , 39004, Russian Federation
Saratov Regional Clinical Hospital
Saratov , 41005, Russian Federation
Smolensk regional hospital on Smolensk railway station
Smolensk , 21402, Russian Federation
City Clinic â„–25 - City Rheumatology Centre
St-Petersburg , 19006, Russian Federation
Leningrad region clinical hospital
St-Petersburg , 19429, Russian Federation
Tula Regional Clinical Dermatovenerological Dispensary
Tula , 30005, Russian Federation
Regional Clinical Hospital
Tver , 17003, 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 #3
Yaroslavl , 15000, Russian Federation
Clinical Hospital #10
Yaroslavl , 15002, Russian Federation
Hosp. Univ. A Coruña
A Coruna , 15006, Spain
Hosp. Univ. de Cruces
Barakaldo , 48903, Spain
Hosp. Univ. de Basurto
Bilbao , 48013, Spain
Hosp. Reina Sofia
Cordoba , 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
Sevilla , 41010, Spain
Hosp. Unv. de Valme
Sevilla , 41401, 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 , 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 , 333, Taiwan
Ankara Bilkent City Hospital
Ankara , 06800, Turkey
Hacettepe University Medical Faculty
Ankara , 6100, Turkey
Akdeniz University Medical Faculty
Antalya , 7059, Turkey
Uludag University Medical Faculty
Bursa , 16059, Turkey
Osmangazi University Medical Faculty
Eskisehir , 26480, Turkey
Bakirkoy Training and Research Hospital
Istanbul , 34147, Turkey
Marmara University Medical Faculty
Istanbul , 34899, Turkey
Dokuz Eylul Universitesi Tip Fakultesi
Izmir , 35340, Turkey
Izmir Katip Celebi University Medical Faculty Ataturk Training and Research Hospital
Izmir , 35360, Turkey
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 â„–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
Odessa , 65025, Ukraine
Multidisciplinary Medical Center of Odessa National Medical University
Odessa , 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
Uzhgorod , 88000, Ukraine
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology
Vinnytsya , 21009, Ukraine
VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council
Vinnytsya , , Ukraine
Zaporizhzhya Regional Clinical Hospital
Zaporizhzhya , , Ukraine
Municipal institution Central Clinical Hospital #1 Zhytomir
Zhytomyr , 10002, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

741

Study ID:

NCT03158285

Recruitment Status:

Completed

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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