A Study Comparing Risankizumab to Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Have a History of Inadequate Response to or Intolerance to at Least One Disease Modifying Anti-Rheumatic Drug (DMARD) Therapy
Phase 3 – large-scale trial before approval
Conditions:
Psoriatic Arthritis
Sponsor: AbbVie
trial.available_in:
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Overview
The purpose of this study is to compare the safety and efficacy of risankizumab versus placebo in participants with moderately to severely active psoriatic arthritis (PsA).
Description
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 treatment period. Period 2 is the long-term treatment 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 are to receive open-label risankizumab 150 mg every 12 weeks. Participants will 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.
Who can participate
Inclusion Criteria:
* Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR) at the Screening Visit.
* Participant has active disease at Baseline defined as ≥ 5 tender joints (based on 68 joint counts) and ≥ 5 swollen joints (based on 66 joint counts)
* 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 or contraindication for conventional synthetic disease modifying anti-rheumatic drugs (csDMARD) therapy(ies).
* Presence of either at Screening:
* ≥ 1 erosion on radiograph as determined by central imaging review or;
* High sensitivity C-reactive protein (hsCRP) ≥ 3.0 mg/L.
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.
* Participant has previous treatment with biologic agent.
Locations
37
Argentina (1)
Framingham Centro Medico /ID# 210409
La Plata , Buenos Aires
Australia (1)
The Canberra Hospital /ID# 207592
Garran , Australian Capital Territory
Belgium (1)
Duplicate_UZ Ghent /ID# 210036
Ghent , Oost-Vlaanderen
Bosnia and Herzegovina (1)
University Clinical Centre of the Republic of Srpska /ID# 208268
Banja Luka , Republika Srpska
Brazil (1)
SER - Serviços Especializados em Reumatologia /ID# 207489
Salvador , Estado de Bahia
Bulgaria (1)
Medical center Medconsult /ID# 211399
Pleven
Canada (1)
Percuro Clinical Research, Ltd /ID# 169601
Victoria , British Columbia
Chile (1)
CTR Estudios Clinicos /ID# 208166
Providencia
Croatia (1)
Poliklinika Repromed /ID# 208628
Zagreb , City of Zagreb
Czech Republic (1)
Revmacentrum MUDr. Mostera, s.r.o. /ID# 209025
Brno
Denmark (1)
Bispebjerg and Frederiksberg Hospital /ID# 207576
Frederiksberg , Capital Region
Estonia (1)
North Estonia Medical Centre /ID# 208325
Mustamäe , Harju
Finland (1)
Helsinki University Hospital /ID# 207724
Helsinki , Uusimaa
Greece (1)
General Hospital Asklepieio Voulas /ID# 212956
Athens , Attica
Israel (1)
Sheba Medical Center /ID# 207474
Ramat Gan , Tel Aviv
Italy (1)
Duplicate_Azienda Ospedaliero-Universitaria Policlinico di Modena /ID# 207799
Modena , Emilia-Romagna
Latvia (1)
M & M Centrs LTD /ID# 208733
Adazi
Lithuania (1)
VAKK Dr. Kilda's Clinic /ID# 207330
Kaunas
Malaysia (1)
Hospital Tuanku Jaafar /ID# 207919
Seremban , Negeri Sembilan
Mexico (1)
Centro Integral en Reumatologia S.A de C.V /ID# 208346
Guadalajara , Jalisco
Netherlands (1)
Antonius Ziekenhuis /ID# 208587
Sneek , Provincie Friesland
New Zealand (1)
Middlemore Clinical Trials /ID# 213256
Papatoetoe , Auckland
Poland (1)
Spolka Lekarzy INTERCOR /ID# 210191
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Puerto Rico (1)
Mindful Medical Research /ID# 211129
San Juan
Romania (1)
Cabinet Medical Dr Triff Carina /Id# 207528
Timișoara , Timiș County
Russia (1)
LLC Family Outpatient Clinic № /ID# 169510
Korolev , Moscow
Serbia (1)
Institute for Rheumatology /ID# 168194
Belgrade , Beograd
Singapore (1)
National University Hospital /ID# 208599
Singapore
Slovakia (1)
REUMA-GLOBAL, s.r.o. /ID# 208017
Biely Kostol
South Africa (1)
Dr Jenny Potts /ID# 168691
Port Elizabeth , Eastern Cape
South Korea (1)
Hanyang University Seoul Hospital /ID# 209263
Seoul , Seoul Teugbyeolsi
Spain (1)
Hospital Universitario Germans Trias i Pujol /ID# 208543
Badalona , Barcelona
Sweden (1)
Skane University hospital /ID# 210070
Malmo , Skåne County
Taiwan (1)
Dalin Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation /ID# 207567
Chiayi City
Ukraine (1)
State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 209556
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