Clinical trial NCT01598857: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Granulomatosis With Polyangiitis
Microscopic Polyangiitis
Keywords: granulomatosis with polyangiitis
microscopic polyangiitis
anti-neutrophil cytoplasmic antibodies
ANCA-associated vasculitis
Wegener Granulomatosis
Lead sponsor: Anthera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-05-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Induction of clinical remission
timeFrame: 24 weeks
Secondary outcomes:
measure: Time to complete remission
timeFrame: Various timepoints to 24 weeks
measure: Time to treatment failure
timeFrame: Various timepoints to 24 weeks
measure: Ability to taper corticosteroids
timeFrame: Various timepoints to 24 weeks
measure: Change in baseline BVAS/WG score
timeFrame: Various timepoints to 24 weeks
measure: Safety profile
timeFrame: Various timepoints to 24 weeks
measure: Compare biomarker changes from baseline
timeFrame: Various timepoints to 24 weeks
Other outcomes:
Locations:
Study officials:
References: