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Trial record 1 of 1 for:    NCT01442194
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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 14, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: other disease-modifying therapy Drug: Fingolimod

Study Design
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Study Type : Observational
Actual Enrollment : 3076 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : August 1, 2011
Actual Primary Completion Date : July 10, 2020
Actual Study Completion Date : July 10, 2020

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Fingolimod
non-interventional
 Drug: Fingolimod
parallel cohort
non-interventional
 Drug: other disease-modifying therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of patients SAEs since study start [ Time Frame: Patients will be followed for an expected average of 5 years ]
  2. PRIMUS activities, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  3. TSQM-9, comparison between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  4. WPAI-GH, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  5. MSIS-29, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
  • 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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442194


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01442194    
Other Study ID Numbers: CFTY720D2403
First Posted: September 28, 2011    Key Record Dates
Last Update Posted: January 14, 2022
Last Verified: December 2021
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple sclerosis
fingolimod
observational study
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Fingolimod Hydrochloride
Sphingosine 1 Phosphate Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs