Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)



Status:Active, not recruiting
Conditions:Lupus
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 70
Updated:5/18/2018
Start Date:November 2013
End Date:October 1, 2020

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

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.

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.

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:

- the dose may not exceed 10 mg/day (or its equivalent) for the 12 weeks prior to
randomization; however, temporary (up to 4 total days) increases, not to exceed
20mg/day, are permitted;

- the dose must be held stable for the four weeks prior to randomization (no
temporary increases within 4 weeks of randomization are permitted).

9. If the subject has a history of B cell depleting therapy within the past 3 years,
presence of CD19 positive cells must be documented within 12 weeks prior to screening;

10. On maintenance HCQ or chloroquine at a stable dose for at least 12 weeks prior to
randomization.

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;

4. Concomitant immunosuppressants including but not limited to azathioprine,
methotrexate, 6-mercaptopurine, leflunomide, calcineurin inhibitors, anti-tumor
necrosis factor agents within 12 weeks prior to randomization;

5. Plasmapheresis or IV immunoglobulin within 12 weeks prior to randomization;

6. Cyclophosphamide therapy within 24 weeks prior to randomization;

7. Concomitant therapy with belimumab within 24 weeks prior to randomization;

8. B cell depleting therapy within two calendar years of randomization;

9. Experimental therapy within the 24 weeks, or five half-lives of the agent, whichever
is longer, prior to randomization;

10. Solid organ or stem cell transplantation;

11. Identified definitive diagnosis of another autoimmune disease that may require
immunosuppression for treatment, including but not limited to: rheumatoid arthritis,
scleroderma, primary Sjogren's syndrome, primary vasculitis, psoriasis, multiple
sclerosis, ankylosing spondylitis, and inflammatory bowel disease.

12. Chronic infections including, but not limited to, human immunodeficiency virus (HIV),
active tuberculosis (TB), currently receiving therapy)), hepatitis B or hepatitis C,
or latent systemic fungal infection;

13. At or within 12 weeks of screening:

- a history of or current positive purified protein derivative (PPD) (> 5 mm
induration regardless of prior Bacillus Calmette-Guérin (BCG) vaccine
administration) or positive QuantiFERON unless documentation exists of completion
of at least one month of prophylaxis for latent TB or completed treatment for
active TB; or

- an indeterminate QuantiFERON® unless followed by a subsequent negative PPD or
negative QuantiFERON.

14. History of malignancy within the last five years, except for resected basal or
squamous cell carcinoma, treated cervical dysplasia, or treated in situ cervical
cancer Grade I;

15. Pregnant or lactating, or intention to pursue pregnancy within three months after the
completion of the study;

16. Unable or unwilling to use reliable methods of contraception, as outlined in the
Mycophenolate REMS (e.g., Risk Evaluation and Mitigation Strategy), from four weeks
prior to randomization to 6 weeks after completion of the study. This criterion
applies to females of reproductive potential. (Reference: Mycophenolate REMS, Program
Resources and Educational Materials, Information for Patients, What are my birth
control options? Access the link at:
(https://www.mycophenolaterems.com/PatientOverview.aspx).

17. Drug or alcohol abuse within one calendar year of randomization;

18. Other medical or psychiatric conditions that the investigator feels would place the
subject at special risk by participation in this protocol.
We found this trial at
19
sites
281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Brad H. Rovin, MD
Phone: 614-293-5081
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: Sung Sam Lim, MD, MPH
Phone: 404-616-3359
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Elena Massarotti, MD
Phone: 617-525-6497
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Kichul Ko, MD
Phone: 773-702-8741
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
Principal Investigator: Vikas Majithia, MD
Phone: 601-984-4653
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Jackson, MS
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Daniel Wallace, MD
Phone: 310-360-9197
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: R. John Looney, MD
Phone: 585-275-7167
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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San Diego, California 92103
Principal Investigator: Kenneth Kalunian, MD
Phone: 858-246-2386
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: W. J. McCune, MD
Phone: 734-615-7884
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Ann Arbor, MI
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Diane Kamen, MD
Phone: 843-792-8613
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Denver, Colorado 80210
Principal Investigator: Chris Striebich, MD
Phone: 303-724-7518
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Megan EB Clowse, MD, MPH
Phone: 919-681-5871
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Hershey, Pennsylvania 17033
Principal Investigator: Nancy Olsen, MD
Phone: 717-531-0003
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Manhasset, New York 11030
Principal Investigator: Cynthia Aranow, MD
Phone: 516-562-2401
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Miami, Florida 33136
Principal Investigator: Gabriel Contreras, MD, MPH
Phone: 305-243-4691
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New York, New York 10021
Principal Investigator: Doruk Erkan, MD
Phone: 212-774-2795
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Amit Saxena, MD
Phone: 646-501-7387
New York University Langone Medical Center NYU NYU Langone Medical Center, a world-class, patient-centered, integrated,...
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Oklahoma City, Oklahoma 73104
Principal Investigator: Eliza Chakravarty, MD
Phone: 405-271-8001
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San Francisco, California 94143
Principal Investigator: Maria Dall'Era, MD
Phone: 415-502-5108
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