Pharmacogenetic Trial and Long-term Follow-up of the PRISMS Trial (PRISMS-15)
NCT ID: NCT01034644
Last Updated: 2014-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
290 participants
OBSERVATIONAL
2010-03-31
2011-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RETROSPECTIVE
Study Groups
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PRISMS patients
This single group includes all the patients from the PRISMS study
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Is willing and able to comply with the protocol
* Written informed consent given before any trial-related activities are carried out
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
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Principal Investigators
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Elisabetta Verdun di Cantogno, MD
Role: STUDY_DIRECTOR
Merck Serono S.A., Geneva
Locations
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Please call/email Central Contact for Recruiting Information in
Geneva, , Switzerland
Countries
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References
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Sormani MP, Freedman MS, Aldridge J, Marhardt K, Kappos L, De Stefano N. MAGNIMS score predicts long-term clinical disease activity-free status and confirmed disability progression in patients treated with subcutaneous interferon beta-1a. Mult Scler Relat Disord. 2021 Apr;49:102790. doi: 10.1016/j.msard.2021.102790. Epub 2021 Jan 22.
Other Identifiers
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EMR200136_022
Identifier Type: -
Identifier Source: org_study_id
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