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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod | non-interventional |
| |
| parallel cohort | non-interventional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| other disease-modifying therapy | Drug |
| ||
| Fingolimod |
| Measure | Description | Time Frame |
|---|---|---|
| For each of the selected safety outcomes, number of patients with a reported event since study start | Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections | Patients will be followed for an expected average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients SAEs since study start | Patients will be followed for an expected average of 5 years | |
| PRIMUS activities, comparison of mean change between the 2 cohorts | Patients will be followed for an expected average of 5 years |
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Inclusion Criteria:
Fingolimod patients will constitute the fingolimod cohort while patients with the other DMT will constitute the parallel cohort
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35209 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Study Results | View source |
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|
| TSQM-9, comparison between the 2 cohorts | Patients will be followed for an expected average of 5 years |
| WPAI-GH, comparison of mean change between the 2 cohorts | Patients will be followed for an expected average of 5 years |
| MSIS-29, comparison of mean change between the 2 cohorts | Patients will be followed for an expected average of 5 years |
| Birmingham |
| Alabama |
| 35233-0271 |
| United States |
| Novartis Investigative Site | Birmingham | Alabama | 35235 | United States |
| Novartis Investigative Site | Cullman | Alabama | 35058 | United States |
| Novartis Investigative Site | Mobile | Alabama | 36617 | United States |
| Novartis Investigative Site | Phoenix | Arizona | 85013 | United States |
| Novartis Investigative Site | Sottsdale | Arizona | 85258 | United States |
| Novartis Investigative Site | Tucson | Arizona | 85718 | United States |
| Novartis Investigative Site | Bakersfield | California | 93311 | United States |
| Novartis Investigative Site | Banning | California | 92220 | United States |
| Novartis Investigative Site | Burbank | California | 91505 | United States |
| Novartis Investigative Site | Fresno | California | 93710 | United States |
| Novartis Investigative Site | Fullerton | California | 92835 | United States |
| Novartis Investigative Site | Huntington Beach | California | 92649 | United States |
| Novartis Investigative Site | Irvine | California | 92618 | United States |
| Novartis Investigative Site | Loma Linda | California | 92354 | United States |
| Novartis Investigative Site | Los Angeles | California | 90073 | United States |
| Novartis Investigative Site | Newport Beach | California | 92660 | United States |
| Novartis Investigative Site | Oceanside | California | 92056 | United States |
| Novartis Investigative Site | Placentia | California | 92870 | United States |
| Novartis Investigative Site | Pomona | California | 91767 | United States |
| Novartis Investigative Site | Redding | California | 96001 | United States |
| Novartis Investigative Site | Santa Monica | California | 90404 | United States |
| Novartis Investigative Site | Temecula | California | 92591 | United States |
| Novartis Investigative Site | Aurora | Colorado | 80045 | United States |
| Novartis Investigative Site | Basalt | Colorado | 81621 | United States |
| Novartis Investigative Site | Colorado Springs | Colorado | 80907 | United States |
| Novartis Investigative Site | Denver | Colorado | 80210 | United States |
| Novartis Investigative Site | Fort Collins | Colorado | 80524 | United States |
| Novartis Investigative Site | Louisville | Colorado | 80027 | United States |
| Novartis Investigative Site | Parker | Colorado | 80138 | United States |
| Novartis Investigative Site | Fairfield | Connecticut | 06824 | United States |
| Novartis Investigative Site | Hartford | Connecticut | 6112 | United States |
| Novartis Investigative Site | Waterbury | Connecticut | 06708 | United States |
| Novartis Investigative Site | Dover | Delaware | 19901 | United States |
| Novartis Investigative Site | Newark | Delaware | 19713 | United States |
| Novartis Investigative Site | Washington D.C. | District of Columbia | 20007 | United States |
| Novartis Investigative Site | Washington D.C. | District of Columbia | 20037 | United States |
| Novartis Investigative Site | Bradenton | Florida | 34205 | United States |
| Novartis Investigative Site | Clermont | Florida | 34711 | United States |
| Novartis Investigative Site | Delray Beach | Florida | 33445 | United States |
| Novartis Investigative Site | Doral | Florida | 33136 | United States |
| Novartis Investigative Site | Hollywood | Florida | 33021 | United States |
| Novartis Investigative Site | Jupiter | Florida | 33458 | United States |
| Novartis Investigative Site | Maitland | Florida | 32751 | United States |
| Novartis Investigative Site | Miami | Florida | 33032 | United States |
| Novartis Investigative Site | Miami | Florida | 33144 | United States |
| Novartis Investigative Site | Miami | Florida | 33155 | United States |
| Novartis Investigative Site | Naples | Florida | 34102 | United States |
| Novartis Investigative Site | Orlando | Florida | 32806 | United States |
| Novartis Investigative Site | Ormond Beach | Florida | 32174 | United States |
| Novartis Investigative Site | Panama City | Florida | 32405 | United States |
| Novartis Investigative Site | Port Charlotte | Florida | 33952 | United States |
| Novartis Investigative Site | Sarasota | Florida | 34233 | United States |
| Novartis Investigative Site | Wellington | Florida | 33414 | United States |
| Novartis Investigative Site | West Palm Beach | Florida | 33407 | United States |
| Novartis Investigative Site | Weston | Florida | 33331 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30309 | United States |
| Novartis Investigative Site | Atlanta | Georgia | 30327 | United States |
| Novartis Investigative Site | Augusta | Georgia | 30912 | United States |
| Novartis Investigative Site | Macon | Georgia | 31210 | United States |
| Novartis Investigative Site | Suwanee | Georgia | 30024 | United States |
| Novartis Investigative Site | Arlington Heights | Illinois | 60004 | United States |
| Novartis Investigative Site | Carbondale | Illinois | 62901 | United States |
| Novartis Investigative Site | Flossmoor | Illinois | 60422 | United States |
| Novartis Investigative Site | Marywood | Illinois | 60153 | United States |
| Novartis Investigative Site | Peoria | Illinois | 61637 | United States |
| Novartis Investigative Site | Anderson | Indiana | 46011 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46227 | United States |
| Novartis Investigative Site | Indianapolis | Indiana | 46256 | United States |
| Novartis Investigative Site | Lafayette | Indiana | 47905 | United States |
| Novartis Investigative Site | Merrillville | Indiana | 46410 | United States |
| Novartis Investigative Site | Des Moines | Iowa | 50314-2611 | United States |
| Novartis Investigative Site | Kansas City | Kansas | 66160 | United States |
| Novartis Investigative Site | Lenexa | Kansas | 66212 | United States |
| Novartis Investigative Site | Overland Park | Kansas | 66210 | United States |
| Novartis Investigative Site | Topeka | Kansas | 66606 | United States |
| Novartis Investigative Site | Lexington | Kentucky | 40503 | United States |
| Novartis Investigative Site | Lexington | Kentucky | 40513 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40202 | United States |
| Novartis Investigative Site | Hammond | Louisiana | 70403 | United States |
| Novartis Investigative Site | Auburn | Maine | 04210 | United States |
| Novartis Investigative Site | Bangor | Maine | 04401 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21201 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21209 | United States |
| Novartis Investigative Site | Baltimore | Maryland | 21212 | United States |
| Novartis Investigative Site | Bethesda | Maryland | 20814 | United States |
| Novartis Investigative Site | Charlotte Hall | Maryland | 20622 | United States |
| Novartis Investigative Site | Hagerstown | Maryland | 21741 | United States |
| Novartis Investigative Site | Lutherville | Maryland | 21093 | United States |
| Novartis Investigative Site | Waldorf | Maryland | 20603 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02135 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02215 | United States |
| Novartis Investigative Site | Foxborough | Massachusetts | 02035 | United States |
| Novartis Investigative Site | Springfield | Massachusetts | 01104 | United States |
| Novartis Investigative Site | Wellesley | Massachusetts | 02481 | United States |
| Novartis Investigative Site | Worcester | Massachusetts | 01608 | United States |
| Novartis Investigative Site | Caro | Michigan | 48723 | United States |
| Novartis Investigative Site | Detroit | Michigan | 48201 | United States |
| Novartis Investigative Site | Jackson | Michigan | 49201 | United States |
| Novartis Investigative Site | Owosso | Michigan | 48867 | United States |
| Novartis Investigative Site | Rochester Hills | Michigan | 48301 | United States |
| Novartis Investigative Site | Southfield | Michigan | 48034 | United States |
| Novartis Investigative Site | Traverse City | Michigan | 49684-2340 | United States |
| Novartis Investigative Site | Edina | Minnesota | 55435 | United States |
| Novartis Investigative Site | Golden Valley | Minnesota | 55422 | United States |
| Novartis Investigative Site | City of Saint Peters | Missouri | 63303 | United States |
| Novartis Investigative Site | Springfield | Missouri | 65807 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63104 | United States |
| Novartis Investigative Site | St Louis | Missouri | 63128 | United States |
| Novartis Investigative Site | Great Falls | Montana | 59405 | United States |
| Novartis Investigative Site | Hastings | Nebraska | 68901 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68198-2045 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89106 | United States |
| Novartis Investigative Site | Lebanon | New Hampshire | 03756 | United States |
| Novartis Investigative Site | Fair Lawn | New Jersey | 07410 | United States |
| Novartis Investigative Site | Livingston | New Jersey | 07039 | United States |
| Novartis Investigative Site | Somerset | New Jersey | 08873 | United States |
| Novartis Investigative Site | West Long Branch | New Jersey | 07764 | United States |
| Novartis Investigative Site | Albany | New York | 12208 | United States |
| Novartis Investigative Site | Amherst | New York | 14226 | United States |
| Novartis Investigative Site | Brooklyn | New York | 11220 | United States |
| Novartis Investigative Site | Cedarhurst | New York | 11516 | United States |
| Novartis Investigative Site | Johnson City | New York | 13790 | United States |
| Novartis Investigative Site | Kingston | New York | 12401 | United States |
| Novartis Investigative Site | Lake Success | New York | 11042 | United States |
| Novartis Investigative Site | New York | New York | 10003 | United States |
| Novartis Investigative Site | Patchogue | New York | 11772 | United States |
| Novartis Investigative Site | Plainview | New York | 11803 | United States |
| Novartis Investigative Site | Poughkeepsie | New York | 12601 | United States |
| Novartis Investigative Site | Staten Island | New York | 10306 | United States |
| Novartis Investigative Site | Syracuse | New York | 13210 | United States |
| Novartis Investigative Site | The Bronx | New York | 10467 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28805 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28806 | United States |
| Novartis Investigative Site | Chapel Hill | North Carolina | 27599-9500 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28202 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28204 | United States |
| Novartis Investigative Site | Durham | North Carolina | 27710 | United States |
| Novartis Investigative Site | Hickory | North Carolina | 28602 | United States |
| Novartis Investigative Site | Raleigh | North Carolina | 27607 | United States |
| Novartis Investigative Site | Sanford | North Carolina | 27330 | United States |
| Novartis Investigative Site | Wilmington | North Carolina | 28401 | United States |
| Novartis Investigative Site | Bismarck | North Dakota | 58501 | United States |
| Novartis Investigative Site | Bellevue | Ohio | 44811 | United States |
| Novartis Investigative Site | Centerville | Ohio | 45459 | United States |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43210 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43221 | United States |
| Novartis Investigative Site | Dayton | Ohio | 45408 | United States |
| Novartis Investigative Site | Toledo | Ohio | 43614 | United States |
| Novartis Investigative Site | Toledo | Ohio | 43623 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73102 | United States |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73104 | United States |
| Novartis Investigative Site | Portland | Oregon | 97225 | United States |
| Novartis Investigative Site | Springfield | Oregon | 97477 | United States |
| Novartis Investigative Site | Greensburg | Pennsylvania | 15601 | United States |
| Novartis Investigative Site | Meadowbrook | Pennsylvania | 19046 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19107-5098 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19107 | United States |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15243 | United States |
| Novartis Investigative Site | Willow Grove | Pennsylvania | 19090 | United States |
| Novartis Investigative Site | Beaufort | South Carolina | 29902 | United States |
| Novartis Investigative Site | Camden | South Carolina | 29020 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29406 | United States |
| Novartis Investigative Site | Greer | South Carolina | 29650 | United States |
| Novartis Investigative Site | Mt. Pleasant | South Carolina | 29464 | United States |
| Novartis Investigative Site | Old Point Station | South Carolina | 29707 | United States |
| Novartis Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Novartis Investigative Site | Spartanburg | South Carolina | 29307 | United States |
| Novartis Investigative Site | Knoxville | Tennessee | 37922 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37205 | United States |
| Novartis Investigative Site | Nashville | Tennessee | 37212 | United States |
| Novartis Investigative Site | Brownwood | Texas | 76801 | United States |
| Novartis Investigative Site | Dallas | Texas | 75214 | United States |
| Novartis Investigative Site | Dallas | Texas | 75390 | United States |
| Novartis Investigative Site | Houston | Texas | 77005 | United States |
| Novartis Investigative Site | Houston | Texas | 77025 | United States |
| Novartis Investigative Site | Kingwood | Texas | 77339 | United States |
| Novartis Investigative Site | Mansfield | Texas | 76063 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Stafford | Texas | 77477 | United States |
| Novartis Investigative Site | Sugar Land | Texas | 77479 | United States |
| Novartis Investigative Site | Provo | Utah | 84604 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84103 | United States |
| Novartis Investigative Site | Salt Lake City | Utah | 84132 | United States |
| Novartis Investigative Site | Alexandria | Virginia | 22310 | United States |
| Novartis Investigative Site | Arlington | Virginia | 22205 | United States |
| Novartis Investigative Site | Charlottesville | Virginia | 22911 | United States |
| Novartis Investigative Site | McLean | Virginia | 22101 | United States |
| Novartis Investigative Site | Newport News | Virginia | 23601 | United States |
| Novartis Investigative Site | Norfolk | Virginia | 23507 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23228 | United States |
| Novartis Investigative Site | Richmond | Virginia | 23924 | United States |
| Novartis Investigative Site | Vienna | Virginia | 22182 | United States |
| Novartis Investigative Site | Winchester | Virginia | 22601 | United States |
| Novartis Investigative Site | Richland | Washington | 99352 | United States |
| Novartis Investigative Site | Spokane | Washington | 99208 | United States |
| Novartis Investigative Site | Tacoma | Washington | 98405 | United States |
| Novartis Investigative Site | Wenatchee | Washington | 98801 | United States |
| Novartis Investigative Site | Beckley | West Virginia | 25801 | United States |
| Novartis Investigative Site | Huntington | West Virginia | 25701 | United States |
| Novartis Investigative Site | Green Bay | Wisconsin | 54311 | United States |
| Novartis Investigative Site | Milwaukee | Wisconsin | 53211 | United States |
| Novartis Investigative Site | Monroe | Wisconsin | 53566 | United States |
| Novartis Investigative Site | Neenah | Wisconsin | 54956 | United States |
| Novartis Investigative Site | Wisconsin Rapids | Wisconsin | 54495 | United States |
| Novartis Investigative Site | Casper | Wyoming | 82601 | United States |
| Novartis Investigative Site | Jenin | Buenos Aires | 6000 | Argentina |
| Novartis Investigative Site | San Miguel de Tucumán | Tucumán Province | T4000DPB | Argentina |
| Novartis Investigative Site | Buenos Aires | 1061 | Argentina |
| Novartis Investigative Site | Ciudad Autonoma de Bs As | Argentina |
| Novartis Investigative Site | Córdoba | X5004CDT | Argentina |
| Novartis Investigative Site | Salta | A4400BKZ | Argentina |
| Novartis Investigative Site | Kogarah | New South Wales | 2217 | Australia |
| Novartis Investigative Site | Box Hill | Victoria | 3128 | Australia |
| Novartis Investigative Site | Melbourne | Victoria | 3004 | Australia |
| Novartis Investigative Site | Parkville | Victoria | 3050 | Australia |
| Novartis Investigative Site | Edmonton | Alberta | T6G 2G3 | Canada |
| Novartis Investigative Site | Saint John | New Brunswick | E2L 4L2 | Canada |
| Novartis Investigative Site | Halifax | Nova Scotia | B3H 4K4 | Canada |
| Novartis Investigative Site | Guelph | Ontario | N1H 4J4 | Canada |
| Novartis Investigative Site | Kingston | Ontario | K7L 2V7 | Canada |
| Novartis Investigative Site | Ottawa | Ontario | K1H 8L6 | Canada |
| Novartis Investigative Site | Saint Catharine's | Ontario | L2R 2P7 | Canada |
| Novartis Investigative Site | Chicoutimi | Quebec | G7H 5H6 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H1T 2M4 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2L 4M1 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3A 2B4 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H3T 1E2 | Canada |
| Novartis Investigative Site | Trois-Rivières | Quebec | G8Z 3R9 | Canada |
| Novartis Investigative Site | Santiago | PISO 1 | Chile |
| Novartis Investigative Site | Guadalajara | Jalisco | 44130 | Mexico |
| Novartis Investigative Site | Monterrey | Nuevo León | 64710 | Mexico |
| Novartis Investigative Site | Culiacan | State of Mexico | 80020 | Mexico |
| Novartis Investigative Site | Distrito Federal | 10700 | Mexico |
| Novartis Investigative Site | Guaynabo | 00968 | Puerto Rico |
| Novartis Investigative Site | San Juan | 00935 | Puerto Rico |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D011409 | Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |
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