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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01034644
First received: December 9, 2009
Last updated: September 28, 2011
Last verified: September 2011
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Current course of MS: RRMS or SPMS [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Current EDSS score [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Change in EDSS since randomization [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • Immunogenicity assessment [ Time Frame: 1 day ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01034644     History of Changes
Other Study ID Numbers: EMR200136_022
Study First Received: December 9, 2009
Last Updated: September 28, 2011
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Sweden: Medical Products Agency
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck KGaA:
Biomarkers
Genetic markers

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

ClinicalTrials.gov processed this record on June 17, 2013