The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial
NCT ID: NCT01034579
Last Updated: 2014-03-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
324 participants
INTERVENTIONAL
2010-02-28
2010-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
NONE
Study Groups
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Rebif® Cohort
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.
Copaxone® Cohort
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* Is willing and able to comply with the protocol
* Has given written informed consent before performing any trial-related activities
Exclusion Criteria
* Is already included in the initial REGARD 24735 PGx sub-study
18 Years
ALL
No
Sponsors
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EMD Serono
INDUSTRY
Responsible Party
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Principal Investigators
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Elisabetta Verdun di Cantogno, MD
Role: STUDY_DIRECTOR
Merck Serono S.A., Geneva
Locations
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Please Contact U.S. Medical Information Located in
Rockland, Massachusetts, United States
Countries
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Other Identifiers
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EMR200136_023
Identifier Type: -
Identifier Source: org_study_id
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