Clinical Trial: BI 655066/ABBV-066/Risankizumab Compared to Placebo in Patients With Active Psoriatic Arthritis
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Randomised, Double-blind, Placebo-controlled, Proof-of-concept, Dose-ranging Study of BI 655066/ABBV-066/Risankizumabin Patients With Active Psoriatic Arthritis
Brief Summary: The overall purpose of this trial is to assess clinical efficacy and safety of different subcutaneous doses of BI 655066/ABBV-066/risankizumab in adult patients with psoriatic arthritis in order to select doses for further clinical trials.
Detailed Summary:
Sponsor: AbbVie
Current Primary Outcome: American College of Rheumatology (ACR) 20 response at Week 16 [ Time Frame: 16 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in Tender Joint Count at Week 16 as compared to baseline [ Time Frame: 16 weeks ]
- Change in Swollen Joint Count at Week 16 as compared to baseline [ Time Frame: 16 weeks ]
- Change in Dactylitis Count at Week 16 as compared to baseline (in patients with dactylitis at baseline) [ Time Frame: 16 weeks ]
- American College of Rheumatology (ACR) 50 response at Week 16 [ Time Frame: 16 weeks ]
- American College of Rheumatology (ACR) 70 response at Week 16 [ Time Frame: 16 weeks ]
- Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 16 as compared to baseline [ Time Frame: 16 weeks ]
- Change in Short Form-36 Health Survey (SF-36) at Week 16 as compared to baseline [ Time Frame: 16 weeks ]
- Change in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index at Week 16 as compared to baseline (in patients with enthesitis at baseline) [ Time Frame: 16 weeks ]
- Change in modified Nail Psoriasis Severity Index (mNAPSI) at Week 16 as compared to baseline (in patients with nail psoriasis) [ Time Frame: 16 weeks ]
- Psoriasis Area and Severity Index (PASI) 90 response at Week 16 assessed in patients with a >/= 3% baseline psoriasis Body Surface Area (BSA) [ Time Frame: 16 weeks ]
Original Secondary Outcome: Same as current
Information By: AbbVie
Dates:
Date Received: March 18, 2016
Date Started: April 2016
Date Completion: August 2017
Last Updated: April 5, 2017
Last Verified: April 2017