Gene Expression in MS Patients Before and During Treatment With Interferon-beta
Terminated
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT00202384
- Lead Sponsor
- S. Andrea Hospital
- Brief Summary
Clinical and experimental evidences suggest that there is a variability in therapeutic response to immunomodulating therapies in Multiple Sclerosis patients.
Microarrays is a technology that permits to monitor the expression levels of thousands of genes at a time.
The specific aim of this study is to identify predictive factors of therapeutic response in MS patients treated with high-dose Interferon-Beta.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 600
Inclusion Criteria
- diagnosis of relapsing-remitting MS (McDonald criteria)
- age between 18-55
- EDSS less or equal to 5.5
Exclusion Criteria
- use of any other disease modifying drugs
- use of corticosteroids during 3 months before starting protocol
- clinical relapse during 1 month before starting protocol
- serious heart, renal, hepatic or haematological dysfunction defined by laboratory exams
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gene Expression in MS Patients baseline and 12 months after IFN beta 1a treatment Change in Gene Expression profile in MS Patients at 12 months of IFN beta 1a treatment
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"
🇮🇹Rome, Italy