NCT01034579

The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial

A Multinational, Multicenter, Single Blood Sampling Exploratory Pharmacogenetic Study of the REGARD (the REbif® vs Glatiramer Acetate in Relapsing MS Disease) Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 324 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study, REbif® vs Glatiramer acetate in relapsing multiple sclerosis (MS) disease - pharmacogenetic(s) (REGARD-PGx) is a single blood sampling exploratory pharmacogenetic study of the REGARD trial. The aim of this trial is to provide additional data on the factors influencing interferon (IFN) beta response. This is a Phase 4 trial involving subjects who previously participated in the REGARD trial. To address the trial objectives, a single visit follow-up trial will be performed during which a blood sample will be collected.

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Blood sampling	Subjects who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study will be enrolled in this retrospective cohort study wherein single blood sampling will be performed for pharmacogenetic markers analysis.
OTHER	Blood sampling	Subjects who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study will be enrolled in this retrospective cohort study wherein single blood sampling will be performed for pharmacogenetic markers analysis.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2009-12-17
• Last updated: 2014-03-10
• Results posted: 2014-03-10

Locations

1 site across 1 country: United States