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Understanding Systemic Sclerosis (SSc) and SCOT

SCOT Eligibility Criteria

Subjects with severe SSc and a poor prognosis characterized by extensive skin involvement (modified Rodnan skin score of ≥ 16) and early, internal organ involvement will be recruited to participate in SCOT.

Inclusion Criteria

  • 18 to 65 years of age
  • SSc as defined by the American College of Rheumatology criteria
  • Modified Rodnan skin score (mRSS) ≥ 16 verified on 2 separate occasions ≥ 1 day and < 28 days apart
  • Duration of SSc ≤ 4 years from the onset of first non-Raynaud's symptom
  • 1 of the following:
    • SSc-related pulmonary disease with forced vital capacity (FVC) or hemoglobin-adjusted DLCO < 70% and evidence of alveolitis by high-resolution chest CT scan or broncheoalveolar lavage OR
    • History of SSc-related renal crisis or disease, not active at the time of screening

Exclusion Criteria

  • Pulmonary, cardiac, hepatic, or renal impairment that would limit therapy and compromise survival. Includes, but is not restricted to, any of the following:
    • Severe pulmonary dysfunction: DLCO < 45% or FVC < 45% or pO2 < 70 mm Hg or pCO2 ≥ 45 mm Hg or O2 sat < 92% at rest
    • Significant pulmonary hypertension
    • LVEF < 50% by echo or prior insertion of a pacemaker or cardioverter-defibrillator
    • Estimated CrCl < 40 mL/min and Cr > 2.0 mg/dL or active, untreated SSc renal crisis at time of enrollment
  • Comorbid illnesses with an estimated median life expectancy < 5 years
  • Previous treatment with cyclophosphamide (Cytoxan, CTX) as follows:
    • Prior IV CTX for > 6 months or total cumulative dose > 3 g/m2
    • Prior oral CTX for > 4 months regardless of dose
    • Prior combination of oral and IV doses for > 6 months regardless of dose
  • Steroid therapy > 10 mg/day prednisone or equivalent within 30 days prior to randomization or treatment for concurrent illnesses (e.g., asthma) with the equivalent of prednisone 1 mg/kg/day or its equivalent for > 5 days on > 2 occasions in the previous 12 months or > 1 occasion in prior 6 months

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