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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01442194




Registration number
NCT01442194
Ethics application status
Date submitted
21/08/2011
Date registered
28/09/2011
Date last updated
29/01/2021

Titles & IDs
Public title
Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
Scientific title
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
Secondary ID [1] 0 0
CFTY720D2403
Universal Trial Number (UTN)
Trial acronym
PASSAGE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - other disease-modifying therapy
Treatment: Drugs - Fingolimod

Fingolimod - non-interventional

parallel cohort - non-interventional


Treatment: Drugs: other disease-modifying therapy


Treatment: Drugs: Fingolimod


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
For each of the selected safety outcomes, number of patients with a reported event since study start - Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections
Timepoint [1] 0 0
Patients will be followed for an expected average of 5 years
Secondary outcome [1] 0 0
Number of patients SAEs since study start
Timepoint [1] 0 0
Patients will be followed for an expected average of 5 years
Secondary outcome [2] 0 0
PRIMUS activities, comparison of mean change between the 2 cohorts
Timepoint [2] 0 0
Patients will be followed for an expected average of 5 years
Secondary outcome [3] 0 0
TSQM-9, comparison between the 2 cohorts
Timepoint [3] 0 0
Patients will be followed for an expected average of 5 years
Secondary outcome [4] 0 0
WPAI-GH, comparison of mean change between the 2 cohorts
Timepoint [4] 0 0
Patients will be followed for an expected average of 5 years
Secondary outcome [5] 0 0
MSIS-29, comparison of mean change between the 2 cohorts
Timepoint [5] 0 0
Patients will be followed for an expected average of 5 years

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [2] 0 0
Novartis Investigative Site - Box Hill
Recruitment hospital [3] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [4] 0 0
Novartis Investigative Site - Parkville
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
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Delaware
Country [7] 0 0
United States of America
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District of Columbia
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United States of America
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Florida
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Georgia
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United States of America
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Illinois
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United States of America
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Indiana
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Iowa
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United States of America
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Kansas
Country [14] 0 0
United States of America
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Kentucky
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Louisiana
Country [16] 0 0
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Maine
Country [17] 0 0
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Maryland
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Massachusetts
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Michigan
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Minnesota
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Missouri
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Montana
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United States of America
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Nebraska
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United States of America
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Nevada
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New Hampshire
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New Jersey
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Oregon
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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Utah
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United States of America
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Virginia
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Washington
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West Virginia
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Wisconsin
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United States of America
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Wyoming
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Argentina
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Buenos Aires
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Argentina
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Tucuman
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Argentina
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Ciudad Autonoma de Bs As
Country [46] 0 0
Argentina
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Cordoba
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Argentina
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Salta
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Canada
State/province [48] 0 0
Alberta
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Canada
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New Brunswick
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Santiago
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Jalisco
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Mexico
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MEX
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Mexico
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Nuevo León
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Mexico
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Distrito Federal
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Puerto Rico
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Guaynabo
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Puerto Rico
State/province [59] 0 0
San Juan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01442194
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications