Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
(PASSAGE Trial)
Recruiting in Palo Alto (17 mi)
+207 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Novartis Pharmaceuticals
No Placebo Group
Breakthrough Therapy
Trial Summary
What is the purpose of this trial?
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.
Eligibility Criteria
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.
See 2 more
Treatment Details
Interventions
- Fingolimod (Immunomodulator)
- Other disease-modifying therapy (Immunomodulator)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: parallel cohortExperimental Treatment1 Intervention
non-interventional
Group II: FingolimodExperimental Treatment1 Intervention
non-interventional
Fingolimod is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Gilenya for:
- Relapsing forms of multiple sclerosis
🇺🇸 Approved in United States as Gilenya for:
- Relapsing forms of multiple sclerosis
🇨🇦 Approved in Canada as Gilenya for:
- Relapsing forms of multiple sclerosis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novartis Investigative SiteRedding, CA
Novartis Investigative SiteHollywood, FL
Novartis Investigative SiteOrlando, FL
Novartis Investigative SiteKansas City, KS
More Trial Locations
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Who Is Running the Clinical Trial?
Novartis PharmaceuticalsLead Sponsor