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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Scleroderma, Diffuse, Scleroderma, Systemic

In brief

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.

Key facts

Study ID

NCT00442611

Run by

Stanford University

People needed

10

Starts

2008-11-01

Expected to finish

2011-06-01

Last updated by the study team

2017-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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\


You may not qualify if…

• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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