Multiple Sclerosis
Conditions
Keywords
Biomarkers, Genetic markers
Brief summary
This study, PRISMS-15 is a single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial. The aim of this trial is to provide additional data on the driving factors of IFN beta response and the long-term outcomes of Rebif® treatment. This is a Phase IV trial involving subjects who previously participated in the PRISMS trial. To address the trial objectives, a single visit will be performed, at least 3 months after the onset of the last relapse.
Interventions
None listed
Sponsors
Merck KGaA, Darmstadt, Germany
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Was randomized in the PRISMS study * Is willing and able to comply with the protocol * Written informed consent given before any trial-related activities are carried out
Exclusion criteria
* Is unwilling or unable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers | 1 day |
Secondary
| Measure | Time frame |
|---|---|
| Current course of MS: RRMS or SPMS | 1 day |
| Current EDSS score | 1 day |
| Change in EDSS since randomization | 1 day |
| Immunogenicity assessment | 1 day |
Countries
Switzerland
Outcome results
None listed