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

NCT01034579 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2014-03-10

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Elisabetta Verdun di Cantogno, MD · Merck Serono S.A., Geneva

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01034579 on ClinicalTrials.gov