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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01442194
Recruitment Status : Recruiting
First Posted : September 28, 2011
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date August 21, 2011
First Posted Date September 28, 2011
Last Update Posted Date August 6, 2019
Actual Study Start Date August 1, 2011
Estimated Primary Completion Date December 26, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2011)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01442194 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: September 26, 2011)
  • Number of patients SAEs since study start [ Time Frame: Patients will be followed for an expected average of 5 years ]
  • PRIMUS activities, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  • TSQM-9, comparison between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  • WPAI-GH, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
  • MSIS-29, comparison of mean change between the 2 cohorts [ Time Frame: Patients will be followed for an expected average of 5 years ]
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
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
  • Drug: other disease-modifying therapy
  • Drug: Fingolimod
Study Groups/Cohorts
  • Fingolimod
    non-interventional
    Intervention: Drug: Fingolimod
  • parallel cohort
    non-interventional
    Intervention: Drug: other disease-modifying therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 21, 2018)
3620
Original Estimated Enrollment
 (submitted: September 26, 2011)
6000
Estimated Study Completion Date December 26, 2022
Estimated Primary Completion Date December 26, 2022   (Final data collection date for primary outcome measure)
Eligibility 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

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date August 2019