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

Multiple Sclerosis Clinical Trial

— PRISMS-15  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01034644
• Other study ID #: EMR200136_022
• Status: Completed
• Phase: N/A
• First received: December 9, 2009
• Last updated: July 30, 2014
• Start date: March 2010
• Est. completion date: January 2011

Study information

• Verified date: September 2011
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaFinland: Finnish Medicines AgencyGermany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Sweden: Medical Products AgencySwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: January 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Switzerland	Please call/email Central Contact for Recruiting Information in	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of responders by group as defined by SNP (Single Nucleotide Polymorphism) markers		1 day	No
Secondary	Current course of MS: RRMS or SPMS		1 day	No
Secondary	Current EDSS score		1 day	No
Secondary	Change in EDSS since randomization		1 day	No
Secondary	Immunogenicity assessment		1 day	No