A Multinational, Multicenter, Single Blood Sampling Exploratory Pharmacogenetic Study of the REGARD (the REbif® vs Glatiramer Acetate in Relapsing MS Disease) Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- EMD Serono
- Enrollment
- 324
- Locations
- 1
- Primary Endpoint
- Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Rebif® Cohort
Intervention: Blood sampling (Other)
Copaxone® Cohort
Intervention: Blood sampling (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change 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)
- Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker(Day 1 of EMR200136_023 study)
- Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker(Day 1 of EMR200136_023 study)
- Change in Brain Volume as Defined by SNP2 Marker(Baseline (Day 1 of 24735 [NCT00078338] study) and Day 1 of EMR200136_023 study)