A phase-3, randomized, double-blind, study comparing Risankizumab to Placebo in subjects with active psoriatic arthritis (PsA) who have a history of inadequate response to or intolerance to at least on disease modifying anti-rheumatic drug (DMARD) therapy (KEEPsAKE 1)
- Conditions
- Arthritis psoriaticapsoriatic arthritis1000381610023213
- Registration Number
- NL-OMON55512
- Lead Sponsor
- AbbVie Deutschland GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
• 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.
• Subject has active disease at Baseline
• Diagnosis of active plaque psoriasis with at least one psoriatic plaque of >=
2 centimeter (cm) diameter or nail changes consistent with psoriasis at
Screening Visit.
• Presence of either at Screening:
1. >= 1 erosion on radiograph as determined by central imaging review or;
2. hs-CRP >= 3.0 mg/L.
• Subject has demonstrated an inadequate response to previous or current
treatment with at least 1 csDMARD OR subject must have an intolerance to or
contraindication for csDMARDs as determined by the investigator.
• Subject is considered by investigator, for any reason, to be an unsuitable
candidate for the study.
• Subject has a known hypersensitivity to Risankizumab.
• Subject has previous treatment with biologic agent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the proportion of subjects achieving American College<br /><br>of Rheumatology (ACR)20 Response (ACR20) at Week 24.</p><br>
- Secondary Outcome Measures
Name Time Method