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

April 17, 2018 updated by: Giovanni Ristori, S. Andrea Hospital

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.

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 Overview

Status

Terminated

Conditions

Multiple Sclerosis

Study Type

Observational

Enrollment (Actual)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Italy
- - Rome, Italy, 00100
    - Azienda Ospedaliera S. Andrea, II Facoltà di Medicina e Chirurgia, Università di Roma "La Sapienza"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatient MS centres

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gene Expression in MS Patients Time Frame: 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	baseline and 12 months after IFN beta 1a treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S. Andrea Hospital

Investigators

Study Director: Marco Salvetti, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria