|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
18 April 2016 |
|
Main ID: |
NCT00241189 |
|
Date of registration:
|
14/10/2005 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Rapamycin vs Methotrexate in Diffuse SSc
|
|
Scientific title:
|
A 48-week, Double-blind, Randomized, Parallel Phase I/II Study of Oral Rapamycin Versus Methotrexate in Systemic Sclerosis (Scleroderma) |
|
Date of first enrolment:
|
August 2002 |
|
Target sample size:
|
17 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00241189 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Philip J Clements, MD, MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of California, Los Angeles |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Systemic Sclerosis
|
|
Intervention(s)
|
|
Drug: methotrexate
|
|
Drug: rapamycin
|
|
Primary Outcome(s)
|
|
Modified Rodnan Skin thickness score
|
|
Adverse events
|
|
Secondary Outcome(s)
|
|
Physician global (VAS)
|
|
Patient global (VAS)
|
|
Health Assessment Questionnaire-Disability Index
|
|
% responders in FVC (=>10% decrease from baseline)
|
|
% responders in HAQ-DI(=>0.22 units decrease from baseline)
|
|
% responders in skin score (=>35% decrease from baseline)
|
|
Forced vital capacity
|
|
Diffusing capacity (DLCO)
|
|
Mahler Dyspnea Index
|
|
Medical Outcomes Questionnaire SF-36
|
|
Serum rapamycin levels
|
|
Secondary ID(s)
|
|
UCLA IRB Number: 01-10-045
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|