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

• Conditions: Multiple Sclerosis; MedDRA version: 9.1Level: LLTClassification code 10028245

• Registration Number: EUCTR2009-016087-37-IT
• Lead Sponsor: MERCK SERONO SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-21
• Last Update Posted: 24 April 2012

Recruitment & Eligibility

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

Inclusion Criteria

? Was randomized in the REGARD 24735 study
? Is willing and able to comply with the protocol
? 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

? Is unwilling or unable to participate in the trial
? 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
Main Objective: To analyze the association between single<br>nucleotide polymorphisms (SNP) markers and<br>Rebif and Copaxone treatment response.<br>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.;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.