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Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE) | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)

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

NCT01946880•National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

Detailed 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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Able and willing to give written informed consent and comply with requirements of the study;
•2. Age 18 - 70 years, inclusive, at randomization;
•3. Diagnosis of SLE, per the American College of Rheumatology (ACR) criteria;
•4. m-SLEDAI score \< 4 at screening visit (SLEDAI score without serologies);
•5. Physician Global Assessment (0-3) score of 1 or less at screening visit;
•6. On a stable dose of MMF (1000-3000 mg/day) for at least 12 weeks prior to randomization;
•7. Total duration of stable or decreasing MMF therapy must be at least:
•* two years for subjects initiating MMF for renal indications (with or without concurrent extra-renal manifestations), or
•* one year for subjects initiating MMF for extra-renal indications.
•8. If the subject is on prednisone or other corticosteroid, the following criteria must be met:
+4 more criteria

Exclusion Criteria

•1. A history of life-threatening neuropsychiatric SLE within 1 calendar year prior to randomization;
•2. Any of the following laboratory abnormalities at the screening visit:
•* Proteinuria as defined by a spot protein/creatinine ratio \> 1.0 mg/mg;
•* Serum creatinine \> 2.0 mg/dL;
•* Transaminases \> 2.5x the upper limit of normal (ULN);
•* Hemoglobin \< 9 g/dL, unless the subject has documented hemoglobinopathy;
•* White blood count (WBC) \< 2000/mm\^3 (equivalent to \< 2 x10\^9/L);
•* Neutrophils \< 1000/mm\^3 (equivalent to \< 1 x10\^9/L); or
•* Platelet count \< 75,000/mm\^3 (equivalent to \< 75 x 10\^9/L).
•3. Prednisone \> 25 mg/day (or its equivalent) within 24 weeks prior to randomization for lupus activity;
+17 more criteria

Locations (19)

Cedars-Sinai Medical Center

Los Angeles, California, United States

UCSD

San Diego, California, United States

UCSF School of Medicine

San Francisco, California, United States

University of Colorado

Denver, Colorado, United States

University of Miami Hospitals and Clinics

Miami, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Key Dates

Start Date

November 20, 2013

Primary Completion Date

July 3, 2019

Completion Date

July 3, 2019

Last Updated

August 17, 2020

Enrollment

102

ACTUAL participants

Conditions

Systemic Lupus ErythematosusSLE

Interventions

Mycophenolate Mofetil

DRUG

Hydroxychloroquine or Chloroquine

DRUG

Prednisone

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)

Inclusion Criteria

Exclusion Criteria

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