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

Completed

• Conditions: MS; 10007951

• Registration Number: NL-OMON34629
• Lead Sponsor: Merck Serono the Netherlands - a division of Merck B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

Randomized patients from the REGARD 24735 study

Exclusion Criteria

Patient who where already included in the initial REGARD PGx sub-study

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To analyze the association between single nucleotide polymorphisms (SNP)<br /><br>markers and Rebif and Copaxone treatment response.<br /><br>Treatment response is based on EDSS progression and relapse outcomes over the<br /><br>96 weeks of treatment in the REGARD trial.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To analyze the association between genetic markers with responses to treatment<br /><br>for efficacy, safety and immunogenicity parameters.</p><br>