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Spots Global Cancer Trial Database for A Study of Guselkumab in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNF Alpha) Therapy

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Trial Identification

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

Study Description

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).

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Janssen Pharmaceutica N.V., Belgium Clinical Trial

Affiliation: Janssen Pharmaceutica N.V., Belgium

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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