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NCT01663623 · ClinicalTrials.gov registry record · Phase 3
Belimumab in Remission of VASculitis
A Phase 3 study, sponsored by Human Genome Sciences Inc., a GSK Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT01663623: Completed Phase 3 study, sponsored by Human Genome Sciences Inc., a GSK Company.
NCT01663623 is a Phase 3 study that has completed, run by Human Genome Sciences Inc., a GSK Company. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01663623, a Phase 3 study, has completed, sponsored by Human Genome Sciences Inc., a GSK Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
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.
Primary Outcome
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
Interventions
- BIOLOGICAL Placebo
- DRUG Azathioprine
- BIOLOGICAL Belimumab 10 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2013-03-20 |
| Est. Completion | 2017-02-06 |
| Phase | Phase 3 |
What the finished NCT01663623 record still lists
NCT01663623 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01663623 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01663623 about?
NCT01663623 is a clinical study titled "Belimumab in Remission of VASculitis". 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...
What is the current status of trial NCT01663623?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2013-03-20. Estimated completion is 2017-02-06.
What interventions are being tested in trial NCT01663623?
The interventions under investigation include: Placebo (BIOLOGICAL), Azathioprine (DRUG), Belimumab 10 mg/kg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01663623?
This trial is sponsored by Human Genome Sciences Inc., a GSK Company, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01663623's enrollment target sits among peer trials
106 1666th of 2000 higher than 331 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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