The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharm
A Multinational, Multicenter, Single Blood Sampling Exploratory Pharmacogenetic Study of the REGARD (the REbif® vs Glatiramer Acetate in Relapsing MS Disease) Trial
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Blood sampling
Results by group
Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers
Day 1 of EMR200136_023 study
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Rebif® Cohort | 63.5 percentage of participants | 135 | |
| Copaxone® Cohort | 63.9 percentage of participants | 149 | |
| Rebif® Cohort | 65.6 percentage of participants | 135 | |
| Copaxone® Cohort | 60.3 percentage of participants | 149 | |
| Rebif® Cohort | 72.7 percentage of participants | 135 | |
| Copaxone® Cohort | 73.3 percentage of participants | 149 | |
| Rebif® Cohort | 61.3 percentage of participants | 135 | |
| Copaxone® Cohort | 64.5 percentage of participants | 149 | |
| Rebif® Cohort | 79.3 percentage of participants | 135 | |
| Copaxone® Cohort | 57.1 percentage of participants | 149 | |
| Rebif® Cohort | 67.7 percentage of participants | 135 | |
| Copaxone® Cohort | 65.3 percentage of participants | 149 | |
| Rebif® Cohort | 60.9 percentage of participants | 135 | |
| Copaxone® Cohort | 56.5 percentage of participants | 149 | |
| Rebif® Cohort | 77.8 percentage of participants | 135 | |
| Copaxone® Cohort | 80.0 percentage of participants | 149 | |
| Rebif® Cohort | 63.0 percentage of participants | 135 | |
| Copaxone® Cohort | 61.0 percentage of participants | 149 | |
| Rebif® Cohort | 67.7 percentage of participants | 135 | |
| Copaxone® Cohort | 65.3 percentage of participants | 149 | |
| Rebif® Cohort | 65.5 percentage of participants | 135 | |
| Copaxone® Cohort | 60.6 percentage of participants | 149 | |
| Rebif® Cohort | 64.8 percentage of participants | 135 | |
| Copaxone® Cohort | 67.2 percentage of participants | 149 | |
| Rebif® Cohort | 65.2 percentage of participants | 135 | |
| Copaxone® Cohort | 56.3 percentage of participants | 149 | |
| Rebif® Cohort | 55.6 percentage of participants | 135 | |
| Copaxone® Cohort | 63.0 percentage of participants | 149 | |
| Rebif® Cohort | 66.7 percentage of participants | 135 | |
| Copaxone® Cohort | 63.1 percentage of participants | 149 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Rebif® Cohort | 158 | 0 (0.0%) | |
| Copaxone® Cohort | 166 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers
Day 1 of EMR200136_023 study
Disability progressionRelapses
Other measures (4)
Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker
Day 1 of EMR200136_023 study
Disability progressionChange in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers
Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
MRI lesionsChange in Brain Volume as Defined by SNP2 Marker
Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study
MRI lesionsBrain volume lossMean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker
Day 1 of EMR200136_023 study
MRI lesions
Who could take part
Relapsing MS · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Feb 2010
Main results due
Nov 2010
Finished
Nov 2010
Results posted
Mar 2014