Gene Expression in MS Patients Before and During Treatment With Interferon-beta

N/ATerminatedNCT00202384

S. Andrea Hospital600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"

Rome, Italy

Outcomes

Primary Outcomes

Gene Expression in MS Patients

Change in Gene Expression profile in MS Patients at 12 months of IFN beta 1a treatment

Time frame: baseline and 12 months after IFN beta 1a treatment

Data from ClinicalTrials.gov

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