Mycophenolate Mofetil in Systemic Sclerosis

Exclusion Criteria

• •Treatment with any investigational agent within 4 weeks of screening or 5 half-lives of the investigational drug (whichever is longer).
• •Ongoing use of high dose steroids (\>10mg/day) or unstable steroid dose in the past 4 weeks.
• •Receipt of a live vaccine within 4 weeks prior to randomization.
• •Previous Treatment with MMF
• •Treatment with immunosuppressive, cytotoxic or anti-fibrotic drug within 4 weeks of screening other than anti-malarial. This includes cyclophosphamide, azathioprine (Immuran), methotrexate or other immunosuppressive or cytotoxic medication.
• •Treatment with cholestyramine within 1 week of trial entry.
• •History of HIV, Hepatitis B and/or Hepatitis C, or evidence of Hepatitis B or C at screening.
• •Moderate to severe hepatic impairment, Child-Pugh Class B or C.
• •History of recurrent significant infection or history of recurrent bacterial infections.
• •Known active bacterial, viral fungal mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
• •Active gastrointestinal bleeding within 4 weeks of study entry or active serious gastrointestinal disease.
• •Pregnancy (a negative serum pregnancy test will be performed for all women of childbearing potential within 14 days of treatment).
• •Concomitant malignancies or previous malignancies within the last five years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
• •A history of phenylketonuria, hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase, Lesch-Nyhan or Kelley-Seegmiller syndrome
• •Allergy to polysorbate 80/Tween
• •Subjects who are breastfeeding
• •Moderately severe renal dysfunction as indicated by Cr \>3.0, dipstick protein \>3+, or patient on dialysis.
• •Hemoglobin: \< 8.5 gm/dL
• •Platelets: \< 100,000/mm
• •AST or ALT \>2.5 x Upper limit of normal unless related to muscle disease.