Rapamycin vs Methotrexate in Diffuse SSc
A 48-week, Double-blind, Randomized, Parallel Phase I/II Study of Oral Rapamycin Versus Methotrexate in Systemic Sclerosis (Scleroderma)
1 other identifier
interventional
17
1 country
1
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 another group of systemic sclerosis patients receiving methotrexate
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2002
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 14, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2006
CompletedApril 11, 2016
April 1, 2016
3.8 years
October 14, 2005
April 8, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Adverse events
Modified Rodnan Skin thickness score
Secondary Outcomes (11)
Forced vital capacity
Diffusing capacity (DLCO)
Health Assessment Questionnaire-Disability Index
Mahler Dyspnea Index
Medical Outcomes Questionnaire SF-36
- +6 more secondary outcomes
Study Arms (2)
Rapamycin
EXPERIMENTALPatients take oral rapamycin 6 mg daily (and dose adjusted to keep a serum trough level of 5-15 ng/ml) for one year
Methotrexate
ACTIVE COMPARATORMethotrexate 20 mg taken orally weekly for one year
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Severe intractable malabsorption
- Chronic debilitation from any underlying disease
- Off putative disease modifying therapies for one month prior to entry
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Philip Clements, MD
Los Angeles, California, 90095-1670, United States
Related Publications (1)
Su TI, Khanna D, Furst DE, Danovitch G, Burger C, Maranian P, Clements PJ. Rapamycin versus methotrexate in early diffuse systemic sclerosis: results from a randomized, single-blind pilot study. Arthritis Rheum. 2009 Dec;60(12):3821-30. doi: 10.1002/art.24986.
PMID: 19950289RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Philip J Clements, MD, MPH
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MPH
Study Record Dates
First Submitted
October 14, 2005
First Posted
October 18, 2005
Study Start
August 1, 2002
Primary Completion
June 1, 2006
Study Completion
June 1, 2006
Last Updated
April 11, 2016
Record last verified: 2016-04