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Study Status: Withdrawn
Recruit Status: Withdrawn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 ]

Clinical remission includes the ability to taper corticosteroids.


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