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Активно (без набиране) Фаза 3 NCT03671148

A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis Including Those Who Have a History of Inadequate Response or Intolerance to Biologic Therapy(Ies)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Psoriatic Arthritis (PsA)

Спонсор: AbbVie

Налично на: БГ
Обобщение
The purpose of this study is to evaluate the safety and efficacy of risankizumab in adults with moderately to severely active psoriatic arthritis (PsA).
Описание
The study consists of a Screening Period (approximately 35 days), Period 1, Period 2, and a 20-week Follow-up Period. Period 1 is a 24-week randomized, double-blind, placebo-controlled, parallel-group period. Period 2 is the long-term period and starts at Week 24. To maintain the blind to the original treatment allocation, treatment at the Week 24 Visit is blinded: participants randomized to placebo receive blinded risankizumab 150 mg, and participants randomized to risankizumab receive blinded placebo. At Week 28 and for the remaining dosing visits (to Week 316), all participants receive open-label risankizumab 150 mg every 12 weeks. Participants remain blinded to the original randomization allocation for the duration of the study. The total study duration is 336 weeks including a telephone call 140 days (20 weeks) after last dose of study drug.
Кой може да участва
Inclusion Criteria: * Clinical diagnosis of psoriatic arthritis (PsA) with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at Screening Visit. * Participant has active disease defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts) at both the Screening Visit and Baseline. * Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥ 2 cm diameter or nail changes consistent with psoriasis at Screening Visit. * Participant has demonstrated an inadequate response or intolerance to biologic therapy(ies) or conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies). Exclusion Criteria: * Participant is considered by investigator, for any reason, to be an unsuitable candidate for the study. * Participant has a known hypersensitivity to risankizumab.
Места на провеждане 23
Argentina (1)
Hospital General de Agudos J. M. Ramos Mejia /ID# 169152
Buenos Aires , Ciuadad Autonoma de Buenos Aires
Австралия (1)
The Canberra Hospital /ID# 207591
Garran , Australian Capital Territory
Белгия (1)
UZ Gent /ID# 210037
Ghent , Oost-Vlaanderen
Бразилия (1)
CIP - Centro Internacional de Pesquisa /ID# 169524
Goiânia , Goiás
Канада (1)
Percuro Clinical Research, Ltd /ID# 169530
Victoria , British Columbia
Дания (1)
Bispebjerg and Frederiksberg Hospital /ID# 168763
Frederiksberg , Capital Region
Estonia (1)
East Tallinn Central Hospital /ID# 208317
Tallinn , Harju
Финландия (1)
Ite Pihlajanlinna Kuopio /ID# 208316
Kuopio
Франция (1)
Duplicate_CHU Bordeaux-Hopital Pellegrin /ID# 211159
Bordeaux
Гърция (1)
University General Hospital of Heraklion PA.G.N.I /ID# 206930
Heraklion , Crete
Унгария (1)
CRU Hungary Egeszsegugyi és Szolgaltato Kft. /ID# 169248
Miskolc , Borsod-Abauj Zemplen county
Израел (1)
Sheba Medical Center /ID# 207468
Ramat Gan , Tel Aviv
Италия (1)
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207800
Modena , Emilia-Romagna
Нидерландия (1)
Antonius Ziekenhuis /ID# 208581
Sneek , Provincie Friesland
New Zealand (1)
Waikato Hospital /ID# 214276
Hamilton , Waikato Region
Полша (1)
Malopolskie Centrum Kliniczne /ID# 208011
Krakow , Lesser Poland Voivodeship
Puerto Rico (1)
GCM Medical Group PSC - Hato Rey /ID# 208461
San Juan
Сингапур (1)
Changi General Hospital /ID# 208966
Singapore
South Africa (1)
Dr Jenny Potts /ID# 167628
Port Elizabeth , Eastern Cape
Испания (1)
Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 207822
Sabadell , Barcelona
Швеция (1)
Duplicate_Karolinska Univ Sjukhuset /ID# 208174
Solna
Великобритания (1)
Duplicate_Barts Health NHS Trust /ID# 210794
London , London, City of
САЩ (1)
Pinnacle Research Group /ID# 167953
Anniston , 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
07.03.2019
Крайна дата
01.06.2026
Регистрационен номер
NCT03671148
Източник
anzctr
Запитване за медицински туризъм

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