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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01442194
First received: August 21, 2011
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

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 Intervention
Multiple Sclerosis
Drug: Fingolimod
Drug: other disease-modifying therapy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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 ] [ Designated as safety issue: Yes ]
    Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections


Secondary Outcome Measures:
  • Number of patients SAEs since study start [ Time Frame: Patients will be followed for an expected average of 5 years ] [ Designated as safety issue: Yes ]
  • PRIMUS activities, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ] [ Designated as safety issue: No ]
  • TSQM-9, comparison between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ] [ Designated as safety issue: No ]
  • WPAI-GH, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ] [ Designated as safety issue: No ]
  • MSIS-29, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3600
Study Start Date: August 2011
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Fingolimod
non-interventional
Drug: Fingolimod
parallel cohort
non-interventional
Drug: other disease-modifying therapy

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442194

Contacts
Contact: Novartis Pharmaceuticals +1-862-778-8300

  Show 62 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01442194     History of Changes
Other Study ID Numbers: FTY720D2403
Study First Received: August 21, 2011
Last Updated: May 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
Multiple sclerosis
fingolimod
observational study

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Fingolimod
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014