a study on Lupus
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.
An Investigator-Initiated, Phase II, Randomized, Withdrawal Study of Mycophenolate Mofetil (MMF) in Patients With Stable, Quiescent Systemic Lupus Erythematosus (SLE)
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.
Systemic Lupus Erythematosus SLE Mycophenolate Mofetil (MMF) Chloroquine diphosphate Prednisone Mycophenolic Acid Mycophenolate mofetil Hydroxychloroquine Chloroquine
Open to people ages 18 years to 70 years
Total duration of stable or decreasing MMF therapy must be at least:
If the subject is on prednisone or other corticosteroid, the following criteria must be met:
Any of the following laboratory abnormalities at the screening visit:
At or within 12 weeks of screening:
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
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If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT01946880.
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