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The Rebif vs Glatiramer Actetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial (REGARD-PGx)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01034579
First received: December 16, 2009
Last updated: August 23, 2011
Last verified: August 2011
History of Changes
  Purpose

This study, REGARD-PGx is a single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Actetate in Relapsing MS Disease) trial.

The aim of this trial is to provide additional data on the factors influencing IFN beta response.

This is a Phase IV 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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Multinational, Multicenter, Single Blood Sampling Exploratory Pharmacogenetic Study of the REGARD (the REbif vs Glatiramer Actetate in Relapsing MS Disease) Trial

Resource links provided by NLM:

Drug Information available for: Glatiramer
U.S. FDA Resources

Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Proportion of responders in each group defined by SNP (Single Nucleotide Polymorphism) markers. A responder is defined as a subject with no MS relapse and no EDSS progression during the 96 weeks (2 years) of treatment of REGARD 24735. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment response data from REGARD will be used to analyze the association of genetic markers with efficacy parameters. [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Whole blood sampling for genetic markers analysis


Enrollment: 324
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
REGARD patients
This single group includes all patients from the REGARD study 24735

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Group of subjects coming from the REGARD study (24735)

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.
  • Was already included in the initial REGARD PGx-substudy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034579

Locations
United States, Massachusetts
Please call Central Contact for Recruiting Information in
Rockland, Massachusetts, United States
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Elisabetta Verdun di Cantogno, MD Merck Serono S.A., Geneva
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01034579     History of Changes
Other Study ID Numbers: EMR200136_023
Study First Received: December 16, 2009
Last Updated: August 23, 2011
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Ireland: Irish Medicines Board
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Russia: Ministry of Health of the Russian Federation

Keywords provided by EMD Serono:
Biomarkers
Genetic markers

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013