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Активно (без набиране) Фаза 3 NCT04882098

A Study of Guselkumab in Participants With Active Psoriatic Arthritis

Фаза 3 – широко изпитване преди одобрение
Заболявания: Arthritis, Psoriatic

Спонсор: Janssen Research & Development, LLC

Налично на: БГ
Обобщение
The 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.
Кой може да участва
Inclusion Criteria: * Have active psoriatic arthritis (PsA) despite previous non-biologic disease-modifying antirheumatic drug (DMARD), apremilast, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy * Have a diagnosis of 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 3 tender joints at screening and at baseline; and C-reactive protein (CRP) greater than or equal to (\>=) 0.3 milligrams per deciliter (mg/dL) at screening from the central laboratory * Have \>= 2 joints with erosions on baseline radiographs of the hands and feet as determined by central read * Have at least one of the following 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 Exclusion Criteria: * Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients * Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease * Has previously received any biologic treatment * Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor * Has received any systemic immunosuppressants (example, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention
Места на провеждане 28
Австралия (1)
The Queen Elizabeth Hospital
Adelaide
Bosnia and Herzegovina (1)
University Clinical center Republic of Srpska 1
Banja Luka
България (1)
Medical Center Medconsult-Pleven
Pleven
Канада (1)
Eastern Regional Health Authority St Clares Mercy Hospital
St. John's , Newfoundland and Labrador
Китай (1)
Affiliated Hospital of Hebei University
Baoding
Хърватия (1)
Ch Osijek
Osijek
Чехия (1)
Revmaclinic
Brno
Estonia (1)
OU Innomedica
Tallinn
Georgia (1)
LTD Unimed Adjara
Batumi
Германия (1)
Rheumatologische Schwerpunktpraxis
Berlin
Гърция (1)
Democritus University of Thrace
Alexandroupoli
Унгария (1)
Revita Rendelo
Budapest
Израел (1)
Barzilai Medical Center
Ashkelon
Италия (1)
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania
Catania
Latvia (1)
M & M Centrs Ltd
Adazi
Lithuania (1)
Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik
Kaunas
Malaysia (1)
Hospital Selayang
Batu Caves
Philippines (1)
Angeles University Foundation Medical Center
Angeles
Полша (1)
Osteo-Medic s.c A. Racewicz, J Supronik
Bialystok
Russia (1)
Chelyabinsk Regional Clinical Dermatovenerological Dispensary
Chelyabinsk
Сърбия (1)
Institute Of Rheumatology 1
Belgrade
Словакия (1)
Paediatric University Hospital
Košice
Южна Корея (1)
Soonchunhyang University Cheonan Hospital
Cheonan-si
Испания (1)
Hosp Univ A Coruna
A Coruña
Taiwan (1)
Kaohsiung Veterans General Hospital
Kaohsiung City
Турция (1)
Akdeniz University Medical Faculty
Istanbul
Ukraine (1)
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy
САЩ (1)
Rheumatology Associates
Birmingham , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
17.06.2021
Крайна дата
05.10.2027
Регистрационен номер
NCT04882098
Източник
anzctr
Запитване за медицински туризъм

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