Phase 4
Completed N=324
The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial
Source: ClinicalTrials.gov NCT01034579 ↗Enrolled (actual)
324
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers — 63.5; 63.9; 65.6; 60.3 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers |
63.5; 63.9; 65.6; 60.3; 72.7; 73.3 | — |
| SECONDARY Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker |
16; 16; 3; 0 | — |
| SECONDARY Change in Time Constant 1 Gadolinium (T1 Gd) Enhancing Lesion Volume as Defined by SNP3 and SNP4 Markers |
-524.23; -203.71; -106.97; -61.95; -26.50; -22.80 | — |
| SECONDARY Change in Brain Volume as Defined by SNP2 Marker |
-1.51; -1.10; -0.57; -0.48 | — |
| SECONDARY Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker |
0.72; 1.05; 0.53; 0.55; 0.30; 0.18 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01034579). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.