Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies (PASSAGE)
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ClinicalTrials.gov Identifier: NCT01442194 |
Recruitment Status :
Completed
First Posted : September 28, 2011
Last Update Posted : January 29, 2021
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Tracking Information | ||||
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First Submitted Date | August 21, 2011 | |||
First Posted Date | September 28, 2011 | |||
Last Update Posted Date | January 29, 2021 | |||
Actual Study Start Date | August 1, 2011 | |||
Actual Primary Completion Date | July 10, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
For each of the selected safety outcomes, number of patients with a reported event since study start [ Time Frame: Patients will be followed for an expected average of 5 years ] Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections
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Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies | |||
Official 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 | |||
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 Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients with relapsing forms of MS that have been recently initiated on fingolimod by their treating physician or patients that are treated with other disease-modifying therapies as part of their MS treatment in accordance with the respective local prescribing information and routine clinical practice | |||
Condition | Multiple Sclerosis | |||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
3076 | |||
Original Estimated Enrollment |
6000 | |||
Actual Study Completion Date | July 10, 2020 | |||
Actual Primary Completion Date | July 10, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply |
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Argentina, Australia, Canada, Chile, Mexico, Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01442194 | |||
Other Study ID Numbers | CFTY720D2403 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Novartis ( Novartis Pharmaceuticals ) | |||
Study Sponsor | Novartis Pharmaceuticals | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Novartis | |||
Verification Date | January 2021 |