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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01034644

EMR200136_022

Details and patient eligibility

About

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.

Enrollment: 290 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

290 participants in 1 patient group

PRISMS patients

Description:

This single group includes all the patients from the PRISMS study