Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)

Merck KGaA, Darmstadt, Germany290 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

290

Conditions

Multiple Sclerosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Please call/email Central Contact for Recruiting Information in

Geneva, Switzerland

Outcomes

Primary Outcomes

The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers

Time frame: 1 day

Secondary Outcomes

Current course of MS: RRMS or SPMS

Time frame: 1 day

Current EDSS score

Time frame: 1 day

Change in EDSS since randomization

Time frame: 1 day

Immunogenicity assessment

Time frame: 1 day

Data from ClinicalTrials.gov

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