NCT02137707

Biologic Basis for Multiple Sclerosis Disease Progression in RRMS Patients Treated With Gilenya

An Investigator-initiated, Multicenter, Phase IV, Open-label Study to Evaluate the Biological Basis for Disease Progression in Relapsing-remitting Multiple Sclerosis Patients Treated in Routine Practice With Gilenya for 2 Years

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 135 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will determine whether in RRMS patients receiving Gilenya there is a link between disease progression and biologic markers.

Detailed description

The biologic basis that determines disease progression in multiple sclerosis (MS) patients remains to be defined. We propose that a long term study of patients where inflammatory activity of the disease is expected to be controlled on treatment, will identify patients into cohorts of those whose disease is deemed to be stable with those patients whose disease has been deemed to progress. Once the two groups have been identified, it will then be possible to assess whether there are differences in biologic markers between the two groups. These markers would then have the potential to be used to monitor disease progression or be predictors for patient response to drug treatment.

Conditions

• Multiple Sclerosis-Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	Gilenya	All patients will receive Gilenya

Timeline

• Start date: 2012-11-01
• Primary completion: 2017-11-01
• Completion: 2018-10-30
• First posted: 2014-05-14
• Last updated: 2018-11-09

Locations

6 sites across 1 country: Canada