A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx

• Conditions: Multiple Sclerosis; MedDRA version: 12.0Level: PTClassification code 10028245Term: Multiple sclerosis

• Registration Number: EUCTR2009-016087-37-GB
• Lead Sponsor: Merck Serono S.A. - Geneva

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-17
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 325

Inclusion Criteria

For inclusion in the trial, all of the following inclusion criteria must be fulfilled:
The subject
1.Was randomized in the REGARD 24735 study
2.Is willing and able to comply with the protocol
3.Has given written informed consent before performing any trial-related activities.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria:
The subject
1.Is unwilling or unable to participate in the trial.
2.Was already included in the initial REGARD PGx-substudy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): The primary endpoint is defined as the proportion of responders in each group defined by SNP markers. A responder is defined as a subject with no MS relapse and no EDSS progression during the 96 weeks (2 years) of treatment of REGARD 24735 trial.;Main Objective: To analyze the association between single nucleotide polymorphisms (SNP) markers and Rebif and Copaxone treatment response. Treatment response is based on EDSS progression and relapse outcomes over the 96 weeks of treatment in the REGARD trial.;Secondary Objective: To analyze the association between genetic markers with responses to treatment for efficacy, safety and immunogenicity parameters.