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OpenTrials
Completed

NCT Number: NCT01442194

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Jenin, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

other disease-modifying therapy

Drug

Fingolimod

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: PASSAGE

Important dates

Study start
2011
Primary completion
2020
Study completion
2020
First posted
Sep 28, 2011
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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