71
Participants
Start Date
October 31, 2012
Primary Completion Date
March 31, 2016
Study Completion Date
September 30, 2016
Rituximab
The Rituximab dosing regimen identified is that used in the proof of concept study, which is also the established treatment regimen for Rituximab use in rheumatoid arthritis. All interventions will be administered with a clinician present throughout the infusion in participants who have been encouraged to have adequate oral hydration in the 24 hours prior to attendance. Resuscitation equipment will be immediately available during the infusion period. Blood pressure, heart rate and temperature will be monitored during the infusion. Participants will continue to be observed in the Clinical Research Facility for at least 1 hour after the infusion.
Placebo
Participants will be randomised to Rituximab therapy (1000 mg IV on day 1 and 15) or placebo (0.9% Sodium Chloride 250 mls) control
Newcastle Clinical Trials Unit, Newcastle upon Tyne
National Institute for Health Research, United Kingdom
OTHER_GOV
Department of Health, United Kingdom
OTHER_GOV
Newcastle University
OTHER
Newcastle-upon-Tyne Hospitals NHS Trust
OTHER