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

Gene Expression in MS Patients Before and During Treatment With High-dose Interferon Beta: Prospective Study for the Identification of Predicting Factors of Therapeutic Response.

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00202384

Enrollment

600

Registered

2005-09-20

Start date

2004-11-30

Completion date

2011-01-31

Last updated

2018-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis, microarrays

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Italy

Outcome results