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Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE) — ALE06  

Systemic Lupus Erythematosus Clinical Trial

Official title:
An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE)

Clinical Trial Summary

This trial seeks to describe the effect of withdrawal from mycophenolate mofetil (MMF) on risk of clinically significant disease reactivation in quiescent SLE patients who have been on long-term MMF therapy.

Clinical Trial Description

Participants who have had inactive disease for at least 24 weeks will be enrolled. Half the subjects will continue on MMF and half the subjects will be tapered off their MMF within 12 weeks. All subjects will continue hydroxychloroquine and small doses of prednisone as needed. Subject visits to assess endpoints will occur every 4 weeks from Day 0 through Week 24 and then at Weeks 32, 40, 48, and 60. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01946880
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Terminated
Phase Phase 2
Start date November 20, 2013
Completion date July 3, 2019
View Details
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