At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Rituximab Plus Cyclophosphamide Followed by Belimumab for the Treatment of Lupus Nephritis (ITN055AI)
In Brief
A Phase 2 clinical trial evaluating Rituximab, Cyclophosphamide, and 5 other interventions for Lupus Nephritis. Completed, enrolled 43 participants across 15 sites.
Detailed Summary
In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.
Study Details
Timeline
Interventions
Rituximab 1000mg intravenously (IV) at week 0 and week 2
Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
* Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12) * Continue prednisone 10 mg/day to week 96
Week 0 and Week 2: Solumedrol (100 mg) IV
Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
Rituximab 1000mg intravenously (IV) at week 0 and week 2.
Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
* Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12) * Continue prednisone 10 mg/day to week 96
Week 0 and Week 2: Solumedrol (100 mg) IV
Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
The RCB Group will receive IV belimumab 10mg/kg at weeks 4, 6, 8, and then every 4 weeks through week 48