57
Participants
Start Date
June 24, 2011
Primary Completion Date
June 5, 2018
Study Completion Date
December 15, 2019
Rituximab
"Participants receive rituximab intravenous (IV) infusions, 1000 mg each, 14 days apart (Day 0 and Week 2).~Rituximab is supplied as a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials, which must be diluted before administration~Standard rituximab pre-medications will be provided in preparation for the rituximab infusions."
Placebo
"Participants receive placebo intravenous (IV) infusions 14 days apart (Day 0 and Week 2).~Standard pre-medications will be provided in preparation for the infusions."
CMRI
Up to 20 participants from each treatment arm will be assessed by CMRI at Baseline and at Week 24.
prednisone
Prednisone dose of 40 mg (or equivalent) by mouth administered the night before and the morning of each study drug infusion.
methylprednisolone
Methylprednisolone (or equivalent corticosteroid) administered intravenously 30 minutes prior to each study drug infusion.
diphenhydramine
"Diphenhydramine 50 mg (or equivalent) administered by mouth approximately thirty to sixty minutes prior to each study drug infusion.~Dose may be repeated every four hours, as needed."
acetaminophen
"Acetaminophen 650 mg (or equivalent) administered by mouth approximately thirty to sixty minutes prior to each study drug infusion.~Dose may be repeated every four hours, as needed."
Columbia University Medical Center, New York
Weill Cornell Medical College, New York
University of Rochester Medical Center, Rochester
University of Pittsburgh Medical Center, Pittsburgh
Johns Hopkins University, Pulmonary and Critical Care Medicine, Baltimore
University of North Carolina at Chapel Hill: UNC Hospitals, Chapel Hill
Medical University of South Carolina, Charleston
Ohio State University, Columbus
University of Michigan, Ann Arbor
University of Iowa, Iowa City
University of Minnesota Health Clinics and Surgery Center, Minneapolis
University of Texas Southwestern Medical Center-William P. Clements University Hospital, Dallas
University of Texas: Memorial Herman Hospital, Houston
University of Colorado Health Sciences Center, Aurora
University of Utah, Salt Lake City
Stanford Health Care, Stanford
Boston University Medical Center, Boston
Autoimmunity Centers of Excellence
OTHER
Rho Federal Systems Division, Inc.
INDUSTRY
National Institute of Allergy and Infectious Diseases (NIAID)
NIH