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

• ClinicalTrials.gov Identifier: NCT01442194
• Recruitment Status: Recruiting
• First Posted: September 28, 2011
• Last Update Posted: August 6, 2019
• Sponsor: Novartis Pharmaceuticals
• 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

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

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