The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial

Phase 4

Completed

Conditions: Relapsing Multiple Sclerosis

Interventions: Other: Blood sampling

Registration Number: NCT01034579

Lead Sponsor: EMD Serono

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 324

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Copaxone® Cohort	Blood sampling	-
Rebif® Cohort	Blood sampling	-

Primary Outcome Measures

Name	Time	Method
Percentage of Responders as Defined by Single Nucleotide Polymorphism (SNP) Markers	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 Outcome Measures

Name	Time	Method
Number of Participants With Confirmed Expanded Disability Status Scale (EDSS) Progression as Defined by SNP2 Marker	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.
Mean Number of Time Constant 2 (T2) Active Lesions Per Subject Per Scan as Defined by SNP5 Marker	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.
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	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.
Change in Brain Volume as Defined by SNP2 Marker	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.