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

Description

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.

Study Start Date

August 2011

Estimated Completion Date

June 2020

Interventions

  • Drug: other disease-modifying therapy
  • Drug: Fingolimod

Specialties

  • Internal Medicine: Clinical Pharmacology,Neurology
  • Neurology: Demyelinating Disorders
  • Pharmacy: Neuro/Psych pharmacology

MeSH Terms

  • Fingolimod
  • Multiple Sclerosis
  • Sclerosis

Study ID

Novartis -- FTY720D2403

Status

Recruiting

Trial ID

NCT01442194

Study Type

Observational

Trial Phase

N/A

Enrollment Quota

3600

Sponsor

Novartis

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

Gender

Both

Ages

N/A

Accepts Healthy Volunteers

No

Study Locations and Contact Information (99)

Study Location Distance Name Phone Email
Island Neurological Associates - Plainview, New York 32.4 miles None None None
Island Neurological Associates - Plainview, New York 32.4 miles None None None
South Shore Neurologic Associates - Patchogue, New York 36.0 miles None None None
South Shore Neurologic Associates - Patchogue, New York 36.0 miles None None None
UMDNJ - Newark, New Jersey 59.2 miles None None None
UMDNJ - Newark, New Jersey 59.2 miles None None None
Springfield Neurology Associates LLC - Springfield, Massachusetts 72.2 miles None None None
Neurological Associates of Albany PC - Albany, New York 103.6 miles None None None
Neurological Associates of Albany PC - Albany, New York 103.6 miles None None None
Fallon Clinic at Worcester Medical Center - Worcester, Massachusetts 105.6 miles None None None
Fallon Clinic at Worcester Medical Center - Worcester, Massachusetts 105.6 miles None None None
Empire Neurology PC - Latham, New York 109.1 miles None None None
Milford Regional Medical Center - Milford, Massachusetts 110.2 miles None None None
Milford Regional Medical Center - Milford, Massachusetts 110.2 miles None None None
University of Pennsylvania Health System - Philadelphia, Pennsylvania 134.5 miles None None None
Caritas St Elizabeths Hospital - Boston, Massachusetts 135.3 miles None None None
Caritas St Elizabeths Hospital - Boston, Massachusetts 135.3 miles None None None
Christiana Care Health Services - Newark, Delaware 168.8 miles None None None
Christiana Care Health Services - Newark, Delaware 168.8 miles None None None
University of Maryland - Baltimore, Maryland 222.5 miles None None None
University of Maryland - Baltimore, Maryland 222.5 miles None None None
Bethesda Neurology LLC - Bethesda, Maryland 255.5 miles None None None
Bethesda Neurology LLC - Bethesda, Maryland 255.5 miles None None None
University of Rochester Medical Center - Rochester, New York 260.4 miles None None None
Westmoreland Neurology - Greensburg, Pennsylvania 336.1 miles None None None
Research Protocol Management Solutions - Pittsburgh, Pennsylvania 361.9 miles None None None
Research Protocol Management Solutions - Pittsburgh, Pennsylvania 361.9 miles None None None
The Neurological Institute PA - Charlotte, North Carolina 585.2 miles None None None
Neurology Specialists Inc - Dayton, Ohio 587.4 miles None None None
Neurology Specialists Inc - Dayton, Ohio 587.4 miles None None None
Associates in Neurology - Lexington, Kentucky 644.1 miles None None None
Associates in Neurology - Lexington, Kentucky 644.1 miles None None None
Norton Healthcare Inc - Louisville, Kentucky 691.3 miles None None None
Neuroscience Institute - Merrillville, Indiana 730.3 miles None None None
Neuroscience Institute - Merrillville, Indiana 730.3 miles None None None
South Suburban Neurology - Flossmoor, Illinois 749.6 miles None None None
Neurostudies - Decatur, Georgia 792.8 miles None None None
Neurostudies - Decatur, Georgia 792.8 miles None None None
University of Florida - Jacksonville, Florida 888.5 miles None None None
Progressive Medical Research - Port Orange, Florida 945.2 miles None None None
Progressive Medical Research - Port Orange, Florida 945.2 miles None None None
Neurology Associates of Ormond Beach - Ormond Beach, Florida 947.8 miles None None None
Neurology Associates of Ormond Beach - Ormond Beach, Florida 947.8 miles None None None
AMO Corporation - Tallahassee, Florida 962.6 miles None None None
Neurology Associates PA - Maitland, Florida 985.2 miles None None None
Neurology Associates PA - Maitland, Florida 985.2 miles None None None
MS Center of Vero Beach - Vero Beach, Florida 1,024.4 miles None None None
MS Center of Vero Beach - Vero Beach, Florida 1,024.4 miles None None None
Brandenton Neurology Inc - Bradenton, Florida 1,031.9 miles None None None
Brandenton Neurology Inc - Bradenton, Florida 1,031.9 miles None None None
Minneapolis Clinic of Neurology - Edina, Minnesota 1,045.3 miles None None None
Minneapolis Clinic of Neurology - Edina, Minnesota 1,045.3 miles None None None
Mercy Ruan Neurology Clinic Res Ct - Des Moines, Iowa 1,056.7 miles None None None
Suncoast Neuroscience Associates Inc - St. Petersburg, Florida 1,073.1 miles None None None
Suncoast Neuroscience Associates Inc - St. Petersburg, Florida 1,073.1 miles None None None
Roskamp Institute - Sarasota, Florida 1,092.4 miles None None None
Roskamp Institute - Sarasota, Florida 1,092.4 miles None None None
StJohns Research Institute Inc - Springfield, Missouri 1,106.9 miles None None None
StJohns Research Institute Inc - Springfield, Missouri 1,106.9 miles None None None
Neurological Associates - Pompano Beach, Florida 1,110.3 miles None None None
Neurological Associates - Pompano Beach, Florida 1,110.3 miles None None None
Sunrise Clinical Research Inc - Hollywood, Florida 1,125.0 miles None None None
Cleveland Clinic Florida - Weston, Florida 1,126.5 miles None None None
Saint Lukes Hospital - Kansas City, Missouri 1,137.2 miles None None None
Saint Lukes Hospital - Kansas City, Missouri 1,137.2 miles None None None
Mid America Neuroscience Institute - Lenexa, Kansas 1,144.4 miles None None None
Cotton ONeil Clinical Research Institute - Topeka, Kansas 1,195.6 miles None None None
Cotton ONeil Clinical Research Institute - Topeka, Kansas 1,195.6 miles None None None
Precise Clinical Research - Topeka, Kansas 1,196.6 miles None None None
Precise Clinical Research - Topeka, Kansas 1,196.6 miles None None None
Texoma Neurology Associates - Sherman, Texas 1,383.4 miles None None None
Texoma Neurology Associates - Sherman, Texas 1,383.4 miles None None None
University of Texas Southwestern - Dallas, Texas 1,414.8 miles None None None
University of Texas Southwestern - Dallas, Texas 1,414.8 miles None None None
Baylor Research Institute - Dallas, Texas 1,420.1 miles None None None
Baylor Research Institute - Dallas, Texas 1,420.1 miles None None None
Central Texas Neurology Consultants PA - Round Rock, Texas 1,552.9 miles None None None
Innovative Clinical Trials Bexar Diagnostic Medicine Assoc - San Antonio, Texas 1,635.9 miles None None None
Colorado Neurological Institute - Englewood, Colorado 1,666.4 miles None None None
Benefis Physician Associates - Great Falls, Montana 1,911.9 miles None None None
Swedish Neuroscience Institute - Seattle, Washington 2,425.4 miles None None None
Pacific Medical Centers - Seattle, Washington 2,425.5 miles None None None
Pacific Medical Centers - Seattle, Washington 2,425.5 miles None None None
MultiCare Research Institute - Tacoma, Washington 2,436.7 miles None None None
MultiCare Research Institute - Tacoma, Washington 2,436.7 miles None None None
Viking Clinical Research Center - Temecula, California 2,445.3 miles None None None
Viking Clinical Research Center - Temecula, California 2,445.3 miles None None None
Providence Multiple Sclerosis Center - Portland, Oregon 2,471.9 miles None None None
Providence Multiple Sclerosis Center - Portland, Oregon 2,471.9 miles None None None
Fullerton Neurology and Headache Center - Fullerton, California 2,476.1 miles None None None
Multiple Sclerosis Center of California Research - Newport Beach, California 2,485.6 miles None None None
Multiple Sclerosis Center of California Research - Newport Beach, California 2,485.6 miles None None None
Victoria Walton MD - Fresno, California 2,491.0 miles None None None
Victoria Walton MD - Fresno, California 2,491.0 miles None None None
The Corvallis Clinic PC - Corvallis, Oregon 2,508.9 miles None None None
Sutter Institute for Medical Research - Sacramento, California 2,536.1 miles None None None
Sutter Institute for Medical Research - Sacramento, California 2,536.1 miles None None None
University of California San Francisco - San Francisco, California 2,605.3 miles None None None
Leo Maher MD - Honolulu, Hawaii 5,002.7 miles None None None

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