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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 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 292 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03312907
The ClinicalTrials.gov registry entry for NCT03312907 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 292 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Rituximab is the first listed.
NCT03312907 reports 0 study locations.
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.
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