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 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 versus belimumab plus rituximab-placebo. Approximately 280 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). Arm A and Arm B will be double-blinded and Arm C will be open-labeled. The open-label arm will provide a qualitative reference to standard therapy. 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. Double-blinded phase will be for 52-weeks with subjects from Arm A and B who cannot tolerate discontinuation of immunosuppressant or taper of corticosteroids. Subjects in Arm C will continue to receive belimumab SC and their stable immunosuppressant during Weeks 53 through 104.
Study Type: Interventional (Clinical Trial)
Actual Enrollment: 292 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 104-Week Study to Evaluate the Efficacy and Safety of Belimumab Administered in Combination With Rituximab to Adult Subjects With Systemic Lupus Erythematosus (SLE)
Actual Study Start Date: March 1, 2018
Actual Primary Completion Date: May 29, 2020
Estimated Study Completion Date: July 12, 2021
Arm:
- Placebo Comparator: Arm A (Control) 0-52 Weeks
- Placebo Comparator: Arm A (Control) 53-104 Weeks
- Experimental: Arm B (Combination) 0-52 Weeks
- Experimental: Arm B (Combination) 53-104 Weeks
- Experimental: Arm C (Reference) 0-52 Weeks
- Experimental: Arm C (Reference) 53-104 Weeks
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 292 |
| Actual Study start date | 01 March 2018 |
| Estimated Study Completion Date | 12 July 2021 |