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

Information source: EMD Serono
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Relapsing Multiple Sclerosis

Intervention: Blood sampling (Other); Blood sampling (Other)

Phase: Phase 4

Status: Completed

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Elisabetta Verdun di Cantogno, MD, Study Director, Affiliation: Merck Serono S.A., Geneva

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome: Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers

Secondary outcome:

Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker

Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers

Change in Brain Volume as Defined by SNP2 Marker

Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Exclusion Criteria:

- Is unwilling or unable to participate in the study

- Is already included in the initial REGARD 24735 PGx sub-study

Locations and Contacts

Please Contact U.S. Medical Information Located in, Rockland, Massachusetts, United States
Additional Information

Starting date: February 2010
Last updated: January 27, 2014

Page last updated: August 20, 2015

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