Status:
COMPLETED
Rapamycin vs Methotrexate in Diffuse SSc
Lead Sponsor:
University of California, Los Angeles
Conditions:
Systemic Sclerosis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Systemic sclerosis (SSc) is a disorder characterized by overproduction and deposition of collagen in the skin and visceral organs, abnormalities of the microcirculation, and autoimmunity. Patients who...
Eligibility Criteria
Inclusion
- 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
- Severe intractable malabsorption
- Chronic debilitation from any underlying disease
- Off putative disease modifying therapies for one month prior to entry
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00241189
Start Date
August 1 2002
End Date
June 1 2006
Last Update
April 11 2016
Active Locations (1)
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1
Philip Clements, MD
Los Angeles, California, United States, 90095-1670