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

  Hide Study Locations
Locations
United States, California
Victoria Walton, MD Recruiting
Fresno, California, United States, 93720
Fullerton Neurology and Headache Center Recruiting
Fullerton, California, United States, 92835
Multiple Sclerosis Center of California & Research Recruiting
Newport Beach, California, United States, 92663
Sutter Institute for Medical Research Recruiting
Sacramento, California, United States, 95816
University of California San Francisco Recruiting
San Francisco, California, United States, 94117
Viking Clinical Research Center Recruiting
Temecula, California, United States, 92591
United States, Colorado
Colorado Neurological Institute Recruiting
Englewood, Colorado, United States, 80113
United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19713
United States, Florida
Brandenton Neurology, Inc. Recruiting
Bradenton, Florida, United States, 32405
Sunrise Clinical Research, Inc. Recruiting
Hollywood, Florida, United States, 33021
University of Florida Recruiting
Jacksonville, Florida, United States, 32209
Neurology Associates, PA Recruiting
Maitland, Florida, United States, 32751
Neurology Associates of Ormond Beach Recruiting
Ormond Beach, Florida, United States, 32124
Neurological Associates Recruiting
Pompano Beach, Florida, United States, 33060
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Roskamp Institute Recruiting
Sarasota, Florida, United States, 34243
Suncoast Neuroscience Associates, Inc Recruiting
St. Petersburg, Florida, United States, 33713
AMO Corporation Recruiting
Tallahassee, Florida, United States, 32308
MS Center of Vero Beach Recruiting
Vero Beach, Florida, United States, 32960
Cleveland Clinic Florida Recruiting
Weston, Florida, United States, 33331
United States, Georgia
Neurostudies Recruiting
Decatur, Georgia, United States, 30033
United States, Hawaii
Leo Maher, MD Recruiting
Honolulu, Hawaii, United States, 96813
United States, Illinois
South Suburban Neurology Recruiting
Flossmoor, Illinois, United States, 60422
United States, Indiana
Neuroscience Institute Recruiting
Merrillville, Indiana, United States, 46410
United States, Iowa
Mercy Ruan Neurology Clinic Res Ct. Recruiting
Des Moines, Iowa, United States, 50314
United States, Kansas
Mid America Neuroscience Institute Recruiting
Lenexa, Kansas, United States, 66214
Cotton O'Neil Clinical Research Institute Recruiting
Topeka, Kansas, United States, 66606
Precise Clinical Research Recruiting
Topeka, Kansas, United States, 66604
United States, Kentucky
Associates in Neurology Recruiting
Lexington, Kentucky, United States, 40513
Norton Healthcare, Inc. Recruiting
Louisville, Kentucky, United States, 40207
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Bethesda Neurology, LLC Recruiting
Bethesda, Maryland, United States, 20814
United States, Massachusetts
Caritas St. Elizabeth's Hospital Recruiting
Boston, Massachusetts, United States, 02135
Milford Regional Medical Center Recruiting
Milford, Massachusetts, United States, 01757
Springfield Neurology Associates, LLC Recruiting
Springfield, Massachusetts, United States, 01104
Fallon Clinic at Worcester Medical Center Recruiting
Worcester, Massachusetts, United States, 01605
United States, Minnesota
Minneapolis Clinic of Neurology Recruiting
Edina, Minnesota, United States, 55435
United States, Missouri
Saint Luke's Hospital Recruiting
Kansas City, Missouri, United States, 64111
St.John's Research Institute, Inc Recruiting
Springfield, Missouri, United States, 65804
United States, Montana
Benefis Physician Associates Recruiting
Great Falls, Montana, United States, 59405
United States, New Jersey
UMDNJ Recruiting
Newark, New Jersey, United States, 07101
United States, New York
Neurological Associates of Albany, PC Recruiting
Albany, New York, United States, 12208
Empire Neurology, PC Recruiting
Latham, New York, United States, 12110
South Shore Neurologic Associates Recruiting
Patchogue, New York, United States, 11772
Island Neurological Associates Recruiting
Plainview, New York, United States, 11803
University of Rochester Medical Center Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
The Neurological Institute, PA Recruiting
Charlotte, North Carolina, United States, 28204
United States, Ohio
Neurology Specialists, Inc. Recruiting
Dayton, Ohio, United States, 45417
United States, Oregon
The Corvallis Clinic, P.C. Recruiting
Corvallis, Oregon, United States, 97330
Providence Multiple Sclerosis Center Recruiting
Portland, Oregon, United States, 97225
United States, Pennsylvania
Westmoreland Neurology Recruiting
Greensburg, Pennsylvania, United States, 15601
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Research Protocol Management Solutions Recruiting
Pittsburgh, Pennsylvania, United States, 15243
United States, Texas
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75390
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75246
Central Texas Neurology Consultants, P.A. Recruiting
Round Rock, Texas, United States, 78681
Innovative Clinical Trials, Bexar Diagnostic Medicine Assoc. Recruiting
San Antonio, Texas, United States, 78229
Texoma Neurology Associates Recruiting
Sherman, Texas, United States, 75092
United States, Washington
Pacific Medical Centers Recruiting
Seattle, Washington, United States, 98144
Swedish Neuroscience Institute Recruiting
Seattle, Washington, United States, 98122
MultiCare Research Institute Recruiting
Tacoma, Washington, United States, 98405
Puerto Rico
Caribbean Center for Clinical Research, Inc. Recruiting
Guaynabo, Puerto Rico, 00969
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 23, 2014