Randomized MMF Withdrawal in Systemic Lupus Erythematosus (SLE)

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.