43
Participants
Start Date
July 9, 2015
Primary Completion Date
March 12, 2018
Study Completion Date
February 8, 2019
Rituximab
Rituximab 1000mg intravenously (IV) at week 0 and week 2
Cyclophosphamide
Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
Prednisone
"* 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"
Methylprednisolone
"Week 0 and Week 2:~Solumedrol (100 mg) IV"
Diphenhydramine
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
Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
Rituximab
Rituximab 1000mg intravenously (IV) at week 0 and week 2.
Cyclophosphamide
Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
Prednisone
"* 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"
Methylprednisolone
Week 0 and Week 2: Solumedrol (100 mg) IV
Diphenhydramine
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
Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
Belimumab
The RCB Group will receive IV belimumab 10mg/kg at weeks 4, 6, 8, and then every 4 weeks through week 48
New York University, Langone Medical Center, New York
Weill Cornell Medical College: Hospital for Special Surgery -, New York
Feinstein Institute, North Shore Hospital, Manhasset
Columbia University Medical Center, New York
University of North Carolina School of Medicine:, Chapel Hill
Medical University of South Carolina, Charleston
Emory University School of Medicine, Atlanta
University of Alabama, Birmingham, Birmingham
Washington University in St. Louis, St Louis
Ohio State University Wexner Medical Center:, Columbus
University of Texas Southwestern, Dallas
University of Colorado Denver: School of Medicine: Division of Rheumatology, Aurora
Colorado Kidney Care, Denver
UCLA Medical Center: Division of Rheumatology, Los Angeles
University of California, San Francisco, San Francisco
Immune Tolerance Network (ITN)
NETWORK
National Institute of Allergy and Infectious Diseases (NIAID)
NIH