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

NCT01773616 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-02-01

No results posted yet for this study

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.

Conditions

  • Systemic Lupus Erythematosus, Lupus Nephritis

Interventions

DRUG

Oral prednisolone

DRUG

Rituximab

DRUG

Mycophenolate mofetil

DRUG

Methyl prednisolone

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • Ohio State University

    collaborator OTHER

  • Dutch Working Party on Systemic Lupus Erythematosus

    collaborator UNKNOWN

  • EULAR Lupus Nephritis Trial Network Study Group

    collaborator UNKNOWN

  • Imperial College London

    lead OTHER

Principal Investigators

  • Liz Lightstone, Dr · Imperial College London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01773616 on ClinicalTrials.gov