Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis
Status:
Terminated
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
The treatment of the multisystem autoimmune disease systemic lupus erythematosus (SLE)
remains a challenge, particularly when there is renal involvement (lupus nephritis). For the
last 60 years corticosteroids have been the backbone of the treatment of lupus nephritis but
they are associated with significant toxicity.
Although randomized placebo controlled trials of Rituximab in non-renal lupus and lupus
nephritis did not meet their primary end-points, there is accumulating data that suggests
that B cell depletion with Rituximab may be efficacious in lupus disease refractory to
conventional therapy. Furthermore, our pilot data suggests that the addition of Rituximab to
mycophenolate mofetil (MMF) without oral steroids is at least as effective at inducing a
renal response as the standard of care therapy comprising MMF and high dose oral
corticosteroids.
RITUXILUP is a proof of concept, open labeled, randomized, controlled, multicentre trial that
aims to demonstrate whether the addition of Rituximab to MMF therapy is useful in treating a
new flare of lupus nephritis and whether it has a long lasting steroid-sparing, beneficial
effect with equal efficacy and greater safety than a conventional regimen of MMF and oral
prednisolone. If successful, this trial has the potential to dramatically change the
management of lupus nephritis.
Phase:
Phase 3
Details
Lead Sponsor:
Imperial College London
Collaborators:
Dutch Working Party on Systemic Lupus Erythematosus EULAR Lupus Nephritis Trial Network Study Group Karolinska Institutet Ohio State University