Brief Title
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
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-Associated Small Vessel Vasculitis
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Induction of clinical remission
Secondary Outcome
Time to complete remission
Condition
Granulomatosis With Polyangiitis
Intervention
Blisibimod
Study Arms / Comparison Groups
Blisibimod
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
December 2014
Primary Completion Date
June 2015
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older (male or female). 2. 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. 3. Active GPA or MPA disease at screening. 4. Positive for either PR3-ANCA or MPO-ANCA at screening. 5. Subject willing to initiate corticosteroids and methotrexate (MTX) if not already on corticosteroids and/or MTX at baseline. 6. Clinical intention to prescribe MTX therapy for treatment of GPA or MPA. Exclusion Criteria: 1. Diagnosed with Churg Strauss syndrome. 2. Severe GPA or MPA disease that would conventionally be treated with cyclophosphamide. 3. Nursing or pregnant. 4. Active systemic infection or deep-space infection. 5. Active hepatitis B, active hepatitis C or a documented history of HIV, hepatitis B, or hepatitis C. 6. Liver disease. 7. History of documented anti-glomerular basement membrane (GBM) disease. 8. Malignancy within the past 5 years. 9. History of active tuberculosis (TB) or history of TB infection. 10. Anemia, neutropenia, or thrombocytopenia. 11. Serum creatinine level greater than 2.5 mg/dL. 12. Prior administration of a B-cell modulating therapy other than rituximab. 13. Subject has not yet completed at least 3 months or 5 half-lives (whichever is longer) since ending other investigational study. 14. History of congenital immunodeficiency.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Administrative Informations
NCT ID
NCT01598857
Organization ID
AN-VAS3321
Responsible Party
Sponsor
Study Sponsor
Anthera Pharmaceuticals
Study Sponsor
, ,
Verification Date
July 2015