- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01034579
The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial (REGARD-PGx)
A Multinational, Multicenter, Single Blood Sampling Exploratory Pharmacogenetic Study of the REGARD (the REbif® vs Glatiramer Acetate in Relapsing MS Disease) Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Massachusetts
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Rockland, Massachusetts, United States
- Please Contact U.S. Medical Information Located in
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Rebif® Cohort
|
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.
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.
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Other: Copaxone® Cohort
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers
Time Frame: Day 1 of EMR200136_023 study
|
A responder was defined as a participant with no multiple sclerosis (MS) relapse and no Expanded Disability Status Scale (EDSS) progression during 96 weeks in 24735 (NCT00078338).
All responders were categorized on the basis of following six SNP markers: SNP1, SNP2, SNP3, SNP4, SNP5, and SNP6.
Two types of variables were possible for each SNP marker: two-level genotype-based or three-level allele-based association variables.
For the two-level genotype-based SNP markers (SNP2, SNP4, and SNP6), the absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype).
For the three-level allele-based association SNP markers (SNP1, SNP3, and SNP5), the analysis was based on the number of copies of the allele (0, 1 and 2).
Percentage of responders segregated on the basis of SNP marker variable were reported.
|
Day 1 of EMR200136_023 study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker
Time Frame: Day 1 of EMR200136_023 study
|
EDSS assesses disability in 8 functional systems.
An overall score ranging from 0 (normal) to 10 (death due to MS) was calculated.
EDSS progression was defined as increase by at least 1 point if last value of EDSS was equal to 5.5, and by at least 0.5 points if last EDSS was more than 5.5.
SNP2 is two-level genotype-based SNP marker.
The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype).
Number of responders segregated on the basis of SNP2 marker variable were reported.
|
Day 1 of EMR200136_023 study
|
Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers
Time Frame: Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
|
Change in T1 Gd enhancing lesion volume was measured by using magnetic resonance imaging (MRI) scans.
SNP4 is two-level genotype-based SNP marker.
The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype).
SNP3 is a three-level allele-based association SNP markers.
The analysis was based on the number of copies of the allele (0, 1 and 2).
Change in T1 Gd enhancing lesion volume segregated on the basis of SNP3 and SNP4 marker variables were reported.
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Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
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Change in Brain Volume as Defined by SNP2 Marker
Time Frame: Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
|
Change in brain volume was measured as the brain parenchymal fraction using MRI scans.
SNP2 is two-level genotype-based SNP marker.
The absence or presence of the genotype was analyzed as the dichotomous variable as 0 (absence of the genotype) and 1 (presence of the genotype).
Change in brain volume segregated on the basis of SNP2 marker variables were reported.
|
Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
|
Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker
Time Frame: Day 1 of EMR200136_023 study
|
Mean number of T2 active lesions was measured by using MRI scans.
SNP5 is a three-level allele-based association SNP markers.
The analysis was based on the number of copies of the allele (0, 1 and 2).
Mean number of T2 active lesions segregated on the basis of SNP5 marker variables were reported.
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Day 1 of EMR200136_023 study
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Elisabetta Verdun di Cantogno, MD, Merck Serono S.A., Geneva
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR200136_023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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