Rapamycin vs Methotrexate in Diffuse SSc

• Status: Completed
• Trial end date: 2006-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a study to determine the safety of the immunosuppressive rapamycin in patients with systemic sclerosis with diffuse cutaneous scleroderma. The effects (both good and bad) are being compared to another group of systemic sclerosis patients receiving methotrexate

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

Details

• Lead Sponsor: University of California, Los Angeles
• Treatments: Everolimus; Methotrexate; Sirolimus

Criteria

Inclusion Criteria:

• Satisfy American College of Rheumatology classification criteria for systemic sclerosis

• Have skin thickening proximal to the elbows and/or knees (diffuse scleroderma)

• Cutaneous involvement for less than 5 years from the onset of the first non-Raynaud's manifestation

Exclusion Criteria:

• Severe intractable malabsorption

• Chronic debilitation from any underlying disease

• Off putative disease modifying therapies for one month prior to entry