The REbif® vs Glatiramer Acetate in Relapsing Multiple Sclerosis Pharmacogenetics Trial (REGARD-PGx)

Merck KGaA (EMD Serono)

Status and phase: Completed; Phase 4

Conditions: Relapsing Multiple Sclerosis

Treatments: Other: Blood sampling

Study type: Interventional

Funder types: Industry

Identifiers

NCT01034579

EMR200136_023

Details and patient eligibility

About

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.

Enrollment: 324 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

324 participants in 2 patient groups

Rebif® Cohort

Other group

Treatment:

Other: Blood sampling

Copaxone® Cohort

Other group

Treatment:

Other: Blood sampling