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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

August 21, 2011
May 28, 2014
August 2011
June 2020   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01442194 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
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

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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

Multiple Sclerosis
  • Drug: Fingolimod
  • Drug: other disease-modifying therapy
  • Fingolimod
    non-interventional
    Intervention: Drug: Fingolimod
  • parallel cohort
    non-interventional
    Intervention: Drug: other disease-modifying therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3600
June 2020
June 2020   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact: Novartis Pharmaceuticals +1-862-778-8300
United States,   Puerto Rico
 
NCT01442194
FTY720D2403
Not Provided
Novartis
Novartis
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP