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Brief Title: A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy
Official Title: Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy
Study ID: NCT03796858
Brief Summary: The purpose of this study is to evaluate guselkumab efficacy versus placebo in participants with active psoriatic arthritis (PsA) and an inadequate response to Anti-Tumor Necrosis Factor Alpha (TNF-alpha) therapy by assessing the reduction in signs and symptoms of joint disease.
Detailed Description: Psoriatic arthritis is a multi-faceted disease that impacts the joints, soft tissues, and skin, all of which not only results in functional disability and impaired quality of life, but participants with this disease also have increased mortality. Guselkumab is a monoclonal antibody that binds to human interleukin 23 (IL-23) and inhibits IL-23 specific intracellular signaling and subsequent activation and cytokine production. Investigation of guselkumab in this Phase 3b PsA clinical study is supported by the favorable efficacy and safety results from Phase 2 study of guselkumab in PsA and Phase 2 and Phase 3 studies in psoriasis including the subset of participants with PsA. The primary hypothesis is that guselkumab 100 milligram (mg) at Weeks 0, 4, and every 8 weeks (q8w) thereafter is superior to placebo which will be assessed by the proportion of participants achieving an American College of Rheumatology (ACR 20) response at Week 24. The study includes 2 periods: A 24-week double-blind, placebo-controlled period for the primary analysis of the efficacy and safety of guselkumab, compared with placebo and a 32-week active-treatment and safety follow-up period for additional analysis of the efficacy and safety of guselkumab. Safety will be monitored throughout the study (Up to Week 56).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
CHU Saint Pierre BXL, Brussels, , Belgium
Reuma Clinic, Genk, , Belgium
Universitair Ziekenhuis Gent, Gent, , Belgium
UZ Leuven, Leuven, , Belgium
Diagnostic - Consulting Center II-Pleven, Pleven, , Bulgaria
Medical Center Medconsult-Pleven, Pleven, , Bulgaria
Multiprofile Hospital for Active Treatment - Plovdiv, Plovdiv, , Bulgaria
Multiprofile Hosptal for Active Treatment Eurohospital Plovdiv, Plovdiv, , Bulgaria
Medical Center 'Teodora', Ruse, , Bulgaria
Diagnostic Consulting Center No 17, Sofia, , Bulgaria
Military Medical Academy, Sofia, , Bulgaria
Hopital Pellegrin Tripode - CHU de Bordeaux, Bordeaux, , France
CHU Lapeyronie, Montpellier, Herault, , France
Centre Hospitalier Regional d'Orleans (CHRO) - Hopital La Source, Orleans, , France
Hopital Lariboisiere, Paris, , France
Hôpital Pitié-Salpétrière, Paris, , France
Hopital Cochin, Paris, , France
Centre Hospitalier Universitaire de Toulouse - Hopital Purpan, Toulouse, , France
CHU Trousseau - Service de Rhumatologie, Tours, , France
Universitätsklinikum Düsseldorf, Dusseldorf, , Germany
Hamburger Rheuma Forschungszentrum II, Hamburg, , Germany
Medizinische Hochschule Hannover, Hannover, , Germany
Rheumazentrum Ruhrgebiet, Herne, , Germany
Rheumatologische Schwerpunktpraxis, Rendsburg, , Germany
Krankenhaus St. Josef, Wuppertal, , Germany
424 Military Hospital of Thessaloniki, Thessaloniki, , Greece
Betegapolo Irgalmas Rend - Budai Irgalmasrendi Korhaz, Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz, Gyula, , Hungary
Szabolcs-Szatmar-Bereg Megyei Korhazak es Egyetemi Oktatokorhaz, Nyiregyhaza, , Hungary
MAV Korhaz es Rendelointezet, Szolnok, , Hungary
Fejer Megyei Szent Gyorgy Egyetemi Oktatokorhaz, Székesfehérvár, , Hungary
Vital Medical Center Orvosi es Fogaszati Kozpont, Veszprem, , Hungary
Barzilai Medical Center, Ashkelon, , Israel
Bnai Zion Medical Center, Hifa, , Israel
Carmel Medical Center, Hifa, , Israel
Hadassah Medical Center, Jerusalem, , Israel
Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera Universitaria Federico II, Napoli, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone, Palermo, , Italy
Policlinico Tor Vergata, Roma, , Italy
Complesso Integrato Columbus, Rome, , Italy
Humanitas Hospital, Rozzano (MI), , Italy
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Bydgoszcz, , Poland
Centrum Kliniczno Badawcze, Elblag, , Poland
Centrum Terapii Wspolczesnej J. M. Jasnorzewska J. M. Jasnorzewska Spolka Komandytowo-Akcyjna, Lodz, , Poland
Dermed Centrum Medyczne Sp. z o.o, Lodz, , Poland
NZOZ Lecznica MAK-MED. S.C., Nadarzyn, , Poland
Medycyna Kliniczna, Warsaw, , Poland
Mazowieckie Centrum Reumatologii i Osteoporozy, Warszawa, , Poland
WroMedica I.Bielicka, A.Strzałkowska s.c., Wrocław, , Poland
Hosp. Garcia de Orta, Almada, , Portugal
Chbv - Hosp. Infante D. Pedro, Aveiro, , Portugal
Ccab - Hosp. de Braga, Braga, , Portugal
Ipr - Inst. Port. de Reumatologia, Lisboa, , Portugal
Chlo - Hosp. Egas Moniz, Lisboa, , Portugal
Chln - Hosp. Santa Maria, Lisboa, , Portugal
Ulsam - Hosp. Conde de Bertiandos, Ponte de Lima, , Portugal
Chelyabinck Regional Clinical Hospital, Chelyabinsk, , Russian Federation
Kemerovo State Medical University, Kemerovo, , Russian Federation
Medical Centre Maximum Health, Kemerovo, , Russian Federation
Family polyclinic #4, Korolev, , Russian Federation
Krasnodar Clinical Dermatovenerologic Dispensary, Krasnodar, , Russian Federation
Krasnoyarsk State Medical University, Krasnoyarsk, , Russian Federation
Orenburg State Medical Academy, Orenburg, , Russian Federation
Rostov Regional Clinical Dermatovenerological Dispensary, Rostov, , Russian Federation
Ryazan Regional Clinical Dermatovenerological Dispensary, Ryazan, , Russian Federation
Samara Regional Clinical Hospital Named After V.D.Seredavin, Samara, , Russian Federation
Sararov Regional Clinical Hospital, Saratov, , Russian Federation
Smolensk regional hospital on Smolensk railway station, Smolensk, , Russian Federation
Leningrad region clinical hospital, St-Petersburg, , Russian Federation
Tula Regional Clinical Dermatovenerological Dispensary, Tula, , Russian Federation
Republican Clinical Hospital - G.G. Kuvatov, Ufa, , Russian Federation
Ulyanovsk Regional Clinical Hospital, Ulyanovsk, , Russian Federation
Regional Clinical Hospital, Velikiy Novgorod, , Russian Federation
Clinical Emergency Hospital n.a. N.V. Solovyev, Yaroslavl, , Russian Federation
Clinical Hospital #3, Yaroslavl, , Russian Federation
Hosp. Univ. A Coruña, A Coruña, , Spain
Hosp. Univ. de Cruces, Barakaldo, , Spain
Hosp. Univ. Germans Trias I Pujol, Barcelona, , Spain
Hosp. Univ. de Basurto, Bilbao, , Spain
Hosp. Reina Sofia, Córdoba, , Spain
Hosp. Univ. Ramon Y Cajal, Madrid, , Spain
Hosp. Univ. 12 de Octubre, Madrid, , Spain
Hosp. Univ. de Getafe, Madrid, , Spain
Hosp. Regional Univ. de Malaga, Málaga, , Spain
Hosp. Clinico Univ. de Santiago, Santiago de Compostela, , Spain
Hosp. Virgen Macarena, Sevilla, , Spain
Hosp. Infanta Luisa, Sevilla, , Spain
Hosp. Virgen Del Rocio, Sevilla, , Spain
Hosp. Ntra. Sra. de Valme, Sevilla, , Spain
Hosp. Do Meixoeiro, Vigo, , Spain
Communal Noncommercial Enterprise 'Cherkasy Regional Hospital of Cherkasy Regional Council', Cherkasy, , Ukraine
Ivano-Frankivsk National Medical University, Ivano-Frankivsk City Clinical Hospital, Ivano-Frankivsk, , Ukraine
City Multifield Hospital #18, Mechnikov Institute of Microbiology and Immunology of NAMS, Kharkiv, , Ukraine
Municipal non-commercial enterprise of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv, , Ukraine
Khmelnitckiy regional hospital, Khmelnytsky, , Ukraine
Kyiv City Clinical Hospital #3, National Medical University, Kyiv, , Ukraine
Medical Center 'Consylium Medical', Kyiv, , 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
ME 'Poltava Regional Clinical Hospital named after M.V. Sklifosovsky of Poltava Regional Consuil', Poltava, , Ukraine
Municipal Institution of Sumy Regional Council Sumy Regional Clinical Hospital, Sumy, , Ukraine
Municipal Non-commercial Enterprise 'Ternopil University Hospital' of Ternopil Regional Council, Ternopil, , Ukraine
Medical Center LTD Health Clinic Department of Cardiology and Rheumatology, Vinnytsya, , Ukraine
VNMUn.af.Pyrogova,CNE Vinnytsia Regional Clinical Hospital n.af.Pyrogova Vinnytsia Regional Council, Vinnytsya, , Ukraine
Municipal institution Central Clinical Hospital #1 Zhytomir, Zhytomir, , Ukraine
Royal National Hospital for Rheumatic Diseases, Bath, , United Kingdom
Cambridge University Hospitals NHS Foundation Trust, Cambridge, , United Kingdom
Cannock Chase Hospital, Cannock, , United Kingdom
Chapel Allerton Hospital, Leeds, , United Kingdom
Barts Health NHS Trust Whipps Cross University Hospital NHS Trust, London, , United Kingdom
Guy's and St Thomas' NHS Foundation Trust - Rheumatoid Arthritis (RA) Clinic, London, , United Kingdom
North Tyneside General Hospital, Newcastle, , United Kingdom
Peterborough City Hospital, Peterborough, , United Kingdom
Haywood Hospital, Stoke on Trent, , United Kingdom
Torbay Hospital-Devon, Torquay, , United Kingdom
Name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
Affiliation: Janssen Pharmaceutica N.V., Belgium
Role: STUDY_DIRECTOR