Trial of Rituximab and Mycophenolate Mofetil Without Oral Steroids for Lupus Nephritis

Conditions

• Systemic Lupus Erythematosus, Lupus Nephritis

Eligibility Criteria

Sex

ALL

Age

12 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Oral prednisolone — DRUG
• Rituximab — DRUG
• Mycophenolate mofetil — DRUG
• Methyl prednisolone — DRUG

Study Details

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.

Key Dates

Start date

Apr 30, 2015

Status verified

Jan 2018

Primary completion

Dec 31, 2017

Completion

Dec 31, 2017

Study Design

Enrollment

24 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab
  Rituximab, methyl prednisolone and mycophenolate mofetil
• Active Comparator: Oral prednisolone
  Oral prednisolone, methyl prednisolone and mycophenolate mofetil

Primary Outcome Measure

Complete renal response (CR) at week 52 without the need to prescribe oral steroids within 1 year [ Time Frame: 1 year ]