Medpedia

• Systemic Sclerosis
• Scleroderma

Inclusion Criteria:
-  Diagnosis of diffuse systemic sclerosis
-  Duration of disease 18 months or less
-  Modified Rodnan Skin Score in a range as identified by the study protocol
-  Evidence of worsening disease activity
-  Ability to attend follow-up assessments for a minimum of 9 months
-  Agree to delay elective surgery during the trial and up to 9 months after final
infusion
-  Agree to delay reproduction during the trial and up to 9 months after final infusion
Exclusion Criteria:
-  Women who are pregnant or lactating
-  Clinical evidence of other definable connective tissue or autoimmune disease
-  Severe kidney, heart, lung, or gastrointestinal disease
-  Treatment with protocol-specified immunosuppressants within 4 weeks of starting the
clinical study
-  Treatment with systemic corticosteroids in a dose greater than 10 mg/day of
prednisone or equivalent (inhaled steroids at standard doses are allowed)
-  Current treatment by photopheresis

• Drug: Human Anti-Transforming Growth Factor Beta-1 Monoclonal Antibody

• University of Texas - Houston Medical School
  Houston, Texas, 77030, United States
  Completed
• UMDNJ Scleroderma Program
  New Brunswick, New Jersey, 08903, United States
  Completed
• Boston Medical Center
  Boston, Massachusetts, 02118, United States
  Completed
• UCLA—Department of Medicine, Division of Rheumatology
  Los Angeles, California, 90095, United States
  Completed

• Genzyme
  Lead Sponsor
• United States: Food and Drug Administration