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

Sponsor
Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Completed
CT.gov ID
NCT01034644
Collaborator
(none)
290
Enrollment
1
Location
10.1
Duration (Months)
28.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    290 participants
    Time Perspective:
    Retrospective
    Official Title:
    A Multinational, Multicenter, 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
    Study Start Date :
    Mar 1, 2010
    Actual Primary Completion Date :
    Nov 1, 2010
    Actual Study Completion Date :
    Jan 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    PRISMS patients

    This single group includes all the patients from the PRISMS study

    Outcome Measures

    Primary Outcome Measures

    1. The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers [1 day]

    Secondary Outcome Measures

    1. Current course of MS: RRMS or SPMS [1 day]

    2. Current EDSS score [1 day]

    3. Change in EDSS since randomization [1 day]

    4. Immunogenicity assessment [1 day]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Please call/email Central Contact for Recruiting Information in Geneva Switzerland

    Sponsors and Collaborators

    • Merck KGaA, Darmstadt, Germany

    Investigators

    • Study Director: Elisabetta Verdun di Cantogno, MD, Merck Serono S.A., Geneva

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT01034644
    Other Study ID Numbers:
    • EMR200136_022
    First Posted:
    Dec 17, 2009
    Last Update Posted:
    Jul 31, 2014
    Last Verified:
    Sep 1, 2011
    Keywords provided by Merck KGaA, Darmstadt, Germany
    Biomarkers
    Genetic markers
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Jul 31, 2014