Clinical Trial: BIANCA-SC: A Study of the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-Associated Small Vessel Vasculitis
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Blisibimod in Addition to Methotrexate During Induction of Remission in Subjects With ANCA-As
Brief Summary: The purpose of this study is to evaluate efficacy, safety and tolerability of blisibimod when taken with methotrexate in the induction of remission in ANCA-Associated Small Vessel Vasculitis.
Detailed Summary:
Sponsor: Anthera Pharmaceuticals
Current Primary Outcome: Induction of clinical remission [ Time Frame: 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Time to complete remission [ Time Frame: Various timepoints to 24 weeks ]
- Time to treatment failure [ Time Frame: Various timepoints to 24 weeks ]
- Ability to taper corticosteroids [ Time Frame: Various timepoints to 24 weeks ]
- Change in baseline BVAS/WG score [ Time Frame: Various timepoints to 24 weeks ]
- Safety profile [ Time Frame: Various timepoints to 24 weeks ]
- Compare biomarker changes from baseline [ Time Frame: Various timepoints to 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Anthera Pharmaceuticals
Dates:
Date Received: May 11, 2012
Date Started: December 2014
Date Completion:
Last Updated: July 28, 2015
Last Verified: July 2015