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

July 30, 2014 updated by: Merck KGaA, Darmstadt, Germany

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

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 Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland
        • Please call/email Central Contact for Recruiting Information in

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Group of patients coming from the PRISMS 6789 study

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
PRISMS patients
This single group includes all the patients from the PRISMS study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers
Time Frame: 1 day
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Current course of MS: RRMS or SPMS
Time Frame: 1 day
1 day
Current EDSS score
Time Frame: 1 day
1 day
Change in EDSS since randomization
Time Frame: 1 day
1 day
Immunogenicity assessment
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 16, 2009

First Posted (Estimate)

December 17, 2009

Study Record Updates

Last Update Posted (Estimate)

July 31, 2014

Last Update Submitted That Met QC Criteria

July 30, 2014

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR200136_022

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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