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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01034644
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-09
• Study First Submitted QC: 2009-12-16
• Study First Posted: 2009-12-17
• Study Start: 2010-03
• Primary Completion: 2010-11
• Study Completion: 2011-01
• Status Verified: 2011-09
• Last Update Submitted: 2014-07-30
• Last Update Posted: 2014-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 290

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers	1 day

Secondary Outcome Measures

Name	Time	Method
Current EDSS score	1 day
Current course of MS: RRMS or SPMS	1 day
Immunogenicity assessment	1 day
Change in EDSS since randomization	1 day

Trial Locations

Locations (1)

Please call/email Central Contact for Recruiting Information in; 🇨🇭 Geneva, Switzerland