Multiple Sclerosis MedDRA version: 12.0 Level: PT Classification code 10028245 Term: Multiple sclerosis
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Merck Serono SA – Geneva
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the trial, all of the following inclusion criteria must be fulfilled: 1. Was randomized in the PRISMS study 2. Is willing and able to comply with the protocol 3. Written informed consent given before any trial-related activities are carried out Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are not eligible for this trial if they fulfill any of the following exclusion criteria: 1. Is unwilling or unable to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To analyze the association between single nucleotide polymorphism (SNP) markers and treatment response. Treatment response is based on the Expanded Disability Status Scale (EDSS) progression and relapse outcomes over the first 2 years of treatment in the PRISMS trial. ;Secondary Objective: Secondary objectives: - To assess disease evolution in subjects over the long term (15-16 years after initial randomization). - To assess long term immunogenicity of IFN-beta-1a. Tertiary objectives: - To analyze the association between genetic markers and outcome over 2, 4, 7-8 years and 15-16 years after the initial randomization for efficacy parameters - To analyze the association between genetic markers and outcome over 2, 4, 6 and 7-8 years after initial randomization for safety parameters - To explore the association between genetic biomarkers and other possible prognostic indicators. ;Primary end point(s): The primary endpoint is defined as the proportion of responders by group as defined by SNP markers. A responder is defined as a subject with no MS relapse and no EDSS progression during the first 24 months of treatment of PRISMS 6789. The efficacy data to be used for the primary endpoint will be: • Data at month 24 of PRISMS 6789 (year 2) from the groups of subjects initially randomized to Rebif® or placebo • Data at month 48 of PRISMS 6789 (year 4) from the group of subjects initially randomized to placebo who were re-randomized to Rebif® at month 24 of PRISMS 6789 (year 2). | — |
Countries
Belgium, Finland, Germany, Sweden, United Kingdom
Outcome results
None listed