Phase 3
Completed N=105
Belimumab in Remission of VASculitis
Source: ClinicalTrials.gov NCT01663623 ↗Enrolled (actual)
105
Serious AEs
32.4%
Results posted
Apr 2018
Primary outcomePrimary: Time to First Relapse — NA; NA Days — p=0.884
◆ Published Evidence
Highly cited
139citations · ~20 / year
Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study.
Summary
The purpose of this study is to evaluate the efficacy and safety of belimumab, in combination with azathioprine, for the maintenance of remission following a standard induction regimen in patients with Wegener's granulomatosis or microscopic polyangiitis. The random assignment in this study is "1 to 1" which means that participants have an equal chance of receiving belimumab or placebo.
Linked Publications
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Efficacy and Safety of Belimumab and Azathioprine for Maintenance of Remission in Antineutrophil Cytoplasmic Antibody-Associated Vasculitis: A Randomized Controlled Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to First Relapse |
NA; NA | 0.884 |
| SECONDARY Number of Participants With Major Relapse During the Double-blind Phase of the Study |
0; 1 | — |
Eligibility Criteria
Key Inclusion Criteria
- Clinical diagnosis Wegener's granulomatosis or microscopic polyangiitis by Chapel Hill criteria.
- Disease flare in the past 26 weeks requiring treatment with high dose corticosteroids and 1 of the following medications: rituximab, oral cyclophosphamide OR IV cyclophosphamide.
- Tested positive for anti-proteinase 3 (anti-PR3) or anti-myeloperoxidase (anti-MPO) antibodies at any time prior to enrollment.
- Achieve remission no more than 26 weeks after first dose of induction treatment. Remission is defined as a Birmingham Vasculitis Activity (BVAS) score of 0 and receiving less than 10 mg/day of oral prednisone (or equivalent) on 2 consecutive visits 21 to 35 days apart.
- Maintenance therapy on this study must start no more than 2 weeks after confirmation of remission.
Key Exclusion Criteria
- Pregnant or nursing.
- Receipt of a B cell targeted therapy (other than rituximab) at anytime
- Receipt of an investigational biological agent within the past 60 days.
- Required management of acute or chronic infections within the past 60 days.
- Current drug or alcohol abuse or dependence.
- Current or past positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- History of severe allergic reaction to contrast agents or biological medicines.
Data sourced from ClinicalTrials.gov (NCT01663623) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.