A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Systemic sclerosis (scleroderma) is an autoimmune connective tissue disease that involves the skin and other internal organs for which there are few effective treatment options. We hypothesize that treatment with abatacept, a new therapy recently approved for the treatment of rheumatoid arthritis, may reduce the progression of skin thickening and fibrosis in people with scleroderma.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Bristol-Myers Squibb
• Treatments: Abatacept

Criteria

Inclusion Criteria:

• Diagnosis of diffuse systemic sclerosis

• age 18 years or older

• Adequate renal, pulmonary, and cardiovascular function

• Willingness to use effective contraception for the duration of the study if subject is of childbearing potential

Exclusion Criteria:

• Other connective tissues diseases or overlap syndromes including MCTD, SLE, RA, eosinophilic fasciitis, and limited systemic sclerosis or morphea

• Use of disease modifying agents including methotrexate, cyclosporine,azathioprine, mycophenolate mofetil, minocycline, doxycycline, minocycline, thalidomide, penicillamine, tamoxifen, colchicine, or investigational agent within 90 days of screening visit

• HIV, Hepatitis B or Hepatitis C infection

• use of prednisone greater than 10mg daily for 28 days prior to screening visit

• women who are breastfeeding or pregnant