Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01663623 | Belimumab in Remission of VASculitis | PHASE3 | COMPLETED | 106 | — | — | Mar 20, 2013 | Feb 6, 2017 | Apr 17, 2018 | 89 | United States, Australia +18 |
Time to relapse is defined as the number of days from Day 0 until the participant experienced a relapse (relapse date - treatment start date +1). Only post-baseline relapses were considered in these analyses. Only relapses occurring up to and including the last visit date in the double-blind treatment period were considered in these analyses. Intent-to-treat population comprised of all randomized participants who received at least one dose of study agent (belimumab or placebo). NA indicates that the data was not available as the Number of events is too low to estimate the value. Median and Inter-quartile range were presented and were based on Kaplan Meier estimates.
| Arm | Type | Description |
|---|---|---|
| Placebo plus azathioprine | PLACEBO_COMPARATOR | Placebo IV plus oral azathioprine 2 mg/kg/day; placebo administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to receive treatment with belimumab in a 6-month open-label extension phase. Placebo patients who opt to participate in the extension will receive belimumab 10 mg/kg IV every 28 days plus oral azathioprine 2 mg/kg/day for an additional 6 months. |
| Belimumab 10 mg/kg plus azathioprine | EXPERIMENTAL | Belimumab 10 mg/kg IV plus oral azathioprine 2 mg/kg/day; belimumab administered on Days 0, 14, 28, and then every 28 days until the end of the study. If the results in the double-blind period show that belimumab is safe and effective, then participants have the option to continue treatment with belimumab in a 6-month open-label extension phase. Patients who opt to participate in the extension will continue to receive belimumab 10 mg/kg IV every 28 plus oral azathioprine 2 mg/kg/day days for an additional 6 months. |
| Name | Type | Description |
|---|---|---|
| Placebo | BIOLOGICAL | Placebo |
| Belimumab 10 mg/kg | BIOLOGICAL | Belimumab 10 mg/kg |
| Azathioprine | DRUG | Azathioprine |
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 cyclophospham...