Principal Investigator: Will Pendergraft, MD, PhD
Sponsor: National Institute of Allergy and Infectious Diseases
Age Range: 18 and older
Purpose: To assess the safety of belimumab administration following treatment with rituximab and cyclophosphamide in terms of infectious adverse events. The combination of rituximab and cyclophosphamide, with and without belimumab, will be evaluated for safety, in terms of B cell reconstitution, hypogammaglobulinemia, and all adverse events.
Study Procedures: All participants will receive infusions of Solumedrol 100mg, rituximab 1000mg and cyclophosphamide 750mg intravenously at week 0 and week 2. Prednisone 40mg per day will be administered with a guided steroid taper to 10mg/day by week 12. Participants will be randomized at week 4 to either the Rituximab/Cyclophosphamide (RC) group or the Rituximab/Cyclophosphamide/Belimumab (RCB) group. The RBC group will receive belimumab 10mg/kg at weeks 4, 6, 8 and then every 4 weeks through week 48.
Participation: Patients will be expected to complete 20 visits over a 2 year period. The week 0 and week 2 visits will take approximately 6-8 hours. Belimumab infusion visits will take about 3-4 hours. Non-infusion visits will last about 1 hour.
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