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NCT03312907 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 292
- Enrollment target
NCT03312907: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT03312907 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 292 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03312907, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 292 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab versus belimumab plus rituximab-placebo. Approximately 292 subjects will be randomized in a 1:2:1 ratio to 1 of 3 treatment arms; belimumab plus rituximab-placebo (Arm A, control), belimumab plus rituximab (Arm B, combination), or belimumab plus standard therapy (Arm C, reference). Belimumab will be administered as subcutaneous (SC) and rituximab-placebo or rituximab will be administered by intravenous (IV) infusions. The total duration of the study is for 104 weeks.
Primary Outcome
Percentage of participants with a state of disease control (Independent blinded assessor \[IBA\]) was defined as the percentage of participants with a Systemic Lupus Erythematosus Disease Activity Index 2000(SLEDAI-2K)score less than or equal to(\<=)2 achieved without immunosuppressants and with corticosteroids at a prednisone equivalent dose of \<=5 mg/day at Week 52. SLEDAI-2K was a weighted, cumulative index for measuring systemic lupus erythematosus (SLE) disease activity in previous 10 days
Interventions
- DRUG Rituximab
- DRUG Belimumab
- DRUG Rituximab-placebo
- DRUG Standard therapy (Including Immunosuppressants)
- DRUG Standard therapy (Excluding Immunosuppressants)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2021-07-07 |
| Phase | Phase 3 |
What the finished NCT03312907 record still lists
NCT03312907 is an interventional study that assigns participants to a tested intervention. The registered 292 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 (62% lower).
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT03312907 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03312907 about?
NCT03312907 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE) - BLISS-BELIEVE". The purpose of this study is to assess whether co-administration of belimumab and a single cycle of rituximab will optimize treatment with belimumab, which will result in improvements of clinical status with a favorable safety profile, by comparing subjects randomized to belimumab plus rituximab ver...
What is the current status of trial NCT03312907?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 292 participants. The study started on 2018-03-01. Estimated completion is 2021-07-07.
What interventions are being tested in trial NCT03312907?
The interventions under investigation include: Rituximab (DRUG), Belimumab (DRUG), Rituximab-placebo (DRUG), Standard therapy (Including Immunosuppressants) (DRUG), Standard therapy (Excluding Immunosuppressants) (DRUG).
Who is sponsoring clinical trial NCT03312907?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03312907's enrollment target sits among peer trials
292 1166th of 2000 higher than 833 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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