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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Induction of clinical remission
Clinical remission includes the ability to taper corticosteroids.
Time frame: 24 weeks
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
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