RITUXILUP, Version 1.1
Research type
Research Study
Full title
RITUXILUP - An open label randomised multicentre controlled trial of RITUXImab and mycophenolate mofetil (MMF) without oral steroids for the treatment of LUPus nephritis
IRAS ID
143800
Contact name
Liz Lightstone
Contact email
Sponsor organisation
Imperial College London
Eudract number
2012-004893-25
ISRCTN Number
ISRCTN84054592
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
The treatment of the multi-system autoimmune disease systemic lupus erythematosus (SLE) remains a challenge, particularly when there is kidney involvement (lupus nephritis). Steroids were introduced as a treatment for lupus nephritis in 1952 and have remained the cornerstone of all treatment regimens since despite being associated with significant toxicity both in the short and long term. In recent years several trials have demonstrated a degree of efficacy of certain agents when used with steroids. However, despite the many problems associated with steroids there has not been a consistent attempt to demonstrate whether other combinations of treatments may be just as good (“non-inferior”) as steroids plus a second agent and with fewer adverse effects. This study is a proof of concept, open label, randomised, controlled, multi-centre clinical trial which builds on published pilot data. The trial aims to evaluate whether the combination of Rituximab, an antibody that depletes B cells (a subset of the body’s white blood cells) plus mycophenolate mofetil (MMF) is non-inferior to the standard of care combination of MMF plus oral steroids in inducing complete remission of lupus nephritis, and safer with regard to serious adverse events. The study will include patients aged 12-75 years. The study has been developed by the principal investigators - all clinical experts in the management of lupus and lupus nephritis- together with the Imperial College Clinical Trials Unit (IC CTU), with input from patients and LUPUS UK. We aim to recruit the required number of patients within 2 years and follow them up for a minimum of 2 years. If the trial demonstrates non-inferiority of the Rituximab-based, oral steroid free regimen, it would change the fundamental landscape for patients with lupus nephritis as for the first time in 60 years they could be spared the burden of long term steroids.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
14/EM/0121
Date of REC Opinion
7 May 2014
REC opinion
Further Information Favourable Opinion