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 MarkerChange 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
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