NCT01598857
Withdrawn
Phase 2
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-Associated Small Vessel Vasculitis
Overview
- Phase
- Phase 2
- Intervention
- Blisibimod
- Conditions
- Granulomatosis With Polyangiitis
- Sponsor
- Anthera Pharmaceuticals
- Primary Endpoint
- Induction of clinical remission
- Status
- Withdrawn
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 years of age or older (male or female).
- •Granulomatosis with polyangiitis (GPA, or Wegener's granulomatosis) or microscopic polyangiitis (MPA) according to the definitions of the American College of Rheumatology and Chapel Hill Consensus Conference.
- •Active GPA or MPA disease at screening.
- •Positive for either PR3-ANCA or MPO-ANCA at screening.
- •Subject willing to initiate corticosteroids and methotrexate (MTX) if not already on corticosteroids and/or MTX at baseline.
- •Clinical intention to prescribe MTX therapy for treatment of GPA or MPA.
Exclusion Criteria
- •Diagnosed with Churg Strauss syndrome.
- •Severe GPA or MPA disease that would conventionally be treated with cyclophosphamide.
- •Nursing or pregnant.
- •Active systemic infection or deep-space infection.
- •Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C.
- •Liver disease.
- •History of documented anti-glomerular basement membrane (GBM) disease.
- •Malignancy within the past 5 years.
- •History of active tuberculosis (TB) or history of TB infection.
- •Anemia, neutropenia, or thrombocytopenia.
Arms & Interventions
Blisibimod
Intervention: Blisibimod
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Induction of clinical remission
Time Frame: 24 weeks
Clinical remission includes the ability to taper corticosteroids.
Secondary Outcomes
- Time to treatment failure(Various timepoints to 24 weeks)
- Ability to taper corticosteroids(Various timepoints to 24 weeks)
- Change in baseline BVAS/WG score(Various timepoints to 24 weeks)
- Safety profile(Various timepoints to 24 weeks)
- Compare biomarker changes from baseline(Various timepoints to 24 weeks)
- Time to complete remission(Various timepoints to 24 weeks)
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