A Phase 3, Randomized, Double-Blind, Study Comparing ABT-494 to Placebo in Subjects with Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD) - SELECT - PsA 2
- Conditions
- Artritis Psoriaticapsoriatic arthritis10003816
- Registration Number
- NL-OMON45660
- Lead Sponsor
- AbbVie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
1. Male or female, at least 18 years of age
2. Diagnosed with psoriatic arthritis with symptom onset at least 6 months prior to the Screening Visit and fulfillment of the Classification Criteria for PsA (CASPAR)
3. Subject has active disease at Baseline defined as >= 3 tender joints (based on 68 joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and Baseline Visits
4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis
5. Subject has had an inadequate response or an intolerance to treatment with at least 1 bDMARD
1. Prior exposure to any Janus Kinase (JAK) inhibitor
2. Current treatment with > 2 non-biologic DMARDs; or use of DMARDs other than MTX, SSZ, LEF, apremilast, HCQ, bucillamine, or iguratimod; or use of MTX in combination with LEF.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The proportion of subjects achieving ACR20 response</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Change from baseline in HAQ-DI<br /><br>2. Proportion of subjects achieving a static Investigator Global Assessment<br /><br>(sIGA) of Psoriasis of 0 or 1 and at least a 2-point improvement from baseline<br /><br>3. Psoriasis Area Severity Index (PASI) 75 response (for subjects with >= 3% BSA<br /><br>psoriasis at baseline)<br /><br>4. Change from baseline in SF-36 PCS<br /><br>5. Proportion of subjects achieving Minimal Disease Activity (MDA)<br /><br>6. Change from baseline in FACIT-Fatigue Questionnaire;<br /><br>7. Change from baseline in Self-Assessment of Psoriasis Symptoms (SAPS)<br /><br>Questionnaire<br /><br>8. ACR 50/70 response rate<br /><br>9. ACR 20 response rate at Week 1</p><br>