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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034644
First Posted: December 17, 2009
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck KGaA
  Purpose

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
Multiple Sclerosis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers [ Time Frame: 1 day ]

Secondary Outcome Measures:
  • Current course of MS: RRMS or SPMS [ Time Frame: 1 day ]
  • Current EDSS score [ Time Frame: 1 day ]
  • Change in EDSS since randomization [ Time Frame: 1 day ]
  • Immunogenicity assessment [ Time Frame: 1 day ]

Biospecimen Retention:   Samples With DNA

Whole blood sampling for:

Genetic markers BAbs/NAbs


Enrollment: 290
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
PRISMS patients
This single group includes all the patients from the PRISMS study

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Group of patients coming from the PRISMS 6789 study
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034644


Locations
Switzerland
Please call/email Central Contact for Recruiting Information in
Geneva, Switzerland
Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Elisabetta Verdun di Cantogno, MD Merck Serono S.A., Geneva
  More Information

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01034644     History of Changes
Other Study ID Numbers: EMR200136_022
First Submitted: December 9, 2009
First Posted: December 17, 2009
Last Update Posted: July 31, 2014
Last Verified: September 2011

Keywords provided by Merck KGaA:
Biomarkers
Genetic markers

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases