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

NCT ID: NCT01034644

Last Updated: 2014-07-31

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-01-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Study Time Perspective

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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Switzerland

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.

Reference Type DERIVED
PMID: 33571946 (View on PubMed)

Other Identifiers

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EMR200136_022

Identifier Type: -

Identifier Source: org_study_id

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