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

Long-term, Prospective,Multinational, Parallel-cohort Study Monitoring Safety in Patients With MS Newly Started With Fingolimod Once Daily or Treated With Another Approved Disease-modifying Therapy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01442194

Acronym

PASSAGE

Enrollment

3076

Registered

2011-09-28

Start date

2011-08-01

Completion date

2020-07-10

Last updated

2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, fingolimod, observational study

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.

Interventions

DRUGother disease-modifying therapy

DRUGFingolimod

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
WPAI-GH, comparison of mean change 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
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
Number of patients SAEs since study start	Patients will be followed for an expected average of 5 years

Countries

Argentina, Australia, Canada, Chile, Mexico, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026