Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Fingolimod; Drug: other disease-modifying therapy

• Registration Number: NCT01442194
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this world-wide prospective parallel-cohort study in patients with relapsing forms of MS, either newly treated with fingolimod or receiving another disease-modifying therapy, is to further explore the incidence of selected safety- related outcomes and to further monitor the overall safety profile of fingolimod under conditions of routine medical practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-01
• Study First Submitted: 2011-08-21
• Study First Submitted QC: 2011-09-26
• Study First Posted: 2011-09-28
• Primary Completion: 2020-07-10
• Study Completion: 2020-07-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-28
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3076

Inclusion Criteria

• Patients that as part of their routine clinical care and according to the locally approved label, are either;
• Starting fingolimod at time of study entry.
• Starting another approved DMT or started within maximum 6 months prior to study entry.
• Patients, or a able legal representative of the patient, who are willing to provide written informed consent.

Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort

Exclusion Criteria

• Patients previously or currently treated with a cytotoxic agent (e.g. mitoxantrone, cladribine, alemtuzumab) or natalizumab
• Patients participating simultaneously in another study with inclusion/exclusion criteria more restrictive than the label or an interventional study unless this is a study on fingolimod lasting 1 month maximum

Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fingolimod	Fingolimod	non-interventional
parallel cohort	other disease-modifying therapy	non-interventional

Primary Outcome Measures

Name	Time	Method
For each of the selected safety outcomes, number of patients with a reported event since study start	Patients will be followed for an expected average of 5 years	Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections

Secondary Outcome Measures

Name	Time	Method
PRIMUS activities, comparison of mean change between the 2 cohorts	Patients will be followed for an expected average of 5 years
TSQM-9, comparison between the 2 cohorts	Patients will be followed for an expected average of 5 years
MSIS-29, comparison of mean change between the 2 cohorts	Patients will be followed for an expected average of 5 years
Number of patients SAEs since study start	Patients will be followed for an expected average of 5 years
WPAI-GH, comparison of mean change between the 2 cohorts	Patients will be followed for an expected average of 5 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇵🇷 San Juan, Puerto Rico