October 01, 2014
Institutional Review Board, Hospital for Special Surgery
The safety of our participants is our top priority. The trial/study is approved and periodically reviewed by the Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial or research study, the investigator will explain the purpose of the trial/study, its expected benefits, any possible risks or side effects, and what your role will be. If you want to join the trial/study, you must sign informed consent documents. You can leave a trial/study at any time without penalty.
For further information, see Understanding Clinical Trials/Research Studies.
One hundred twenty subjects nationwide will be randomized in a 1:1 ratio to one of the two study treatment arms – continuing MMF treatment for 60 weeks or tapering off MMF within 12 weeks. All subjects will continue on their anti-malarials and may continue the use of their corticosteroids.
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. As disease flares occur, subjects will be brought in for urgent, flare or endpoint visits to document symptoms, collect biological samples, and determine whether primary endpoint has been met.
Enrollment will continue until 120 subjects have been recruited collectively across all 15 participating centers.
Inclusion Criteria (Selected):
• Age 18 - 65 years
• Diagnosis of SLE
• Active SLe at screening visit
• On a stable dose of MMF (1000-3000 mg/day) for at least 12 weeks prior to randomization.
• 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.
• On maintenance hydroxychloroquine or chloroquine at a stable dose for at least 12 weeks prior to randomization.
Exclusion Criteria (Selected):
• A history of life-threatening neuropsychiatric SLE within one calendar year prior to randomization.
• Any of the following laboratory abnormalities at the screening visit:
o Proteinuria as defined by a spot protein/creatinine ratio > 1.0 mg/mg;
o Serum creatinine > 2.0 mg/dL;
o Transaminases > 2.5x the upper limit of normal (ULN);
o Hemoglobin < 9 g/dL, unless the subject has documented hemoglobinopathy;
o White blood count (WBC) < 2000/mm3 (equivalent to < 2 x109/L);
o Neutrophils < 1000/mm3 (equivalent to < 1 x109/L);
o Platelet count < 75,000/mm3 (equivalent to < 75 x 109/L).
• Prednisone > 25 mg/day (or its equivalent) within 24 weeks prior to randomization for lupus activity.
• 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.
• Plasmapheresis or IV immunoglobulin within 12 weeks prior to randomization.
• Cyclophosphamide therapy within 24 weeks prior to randomization.
• Concomitant therapy with belimumab within 24 weeks prior to randomization.
• B cell depleting therapy within two calendar years of randomization.
• Solid organ or stem cell transplantation.
• 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.
• 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.
• 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.
• Non- English speaking
Glendalee Ramón
ramong@hss.edu
212.774.2808
JoAnn Vega
vegaj@hss.edu
212.774.2795