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

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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

, , 



Administrative Informations


NCT ID

NCT01598857

Organization ID

AN-VAS3321


Responsible Party

Sponsor

Study Sponsor

Anthera Pharmaceuticals


Study Sponsor

, , 


Verification Date

July 2015