PASSAGE: Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01442194
Collaborator
(none)
3,076
238
107.3
12.9
0.1
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
3076 participants
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
Actual Study Start Date
:
Aug 1, 2011
Actual Primary Completion Date
:
Jul 10, 2020
Actual Study Completion Date
:
Jul 10, 2020
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Fingolimod non-interventional |
Drug: Fingolimod
|
| parallel cohort non-interventional |
Drug: other disease-modifying therapy
|
Outcome Measures
Primary Outcome Measures
- For each of the selected safety outcomes, number of patients with a reported event since study start [Patients will be followed for an expected average of 5 years]
Incidence of AEs for bradyarrhythmias, liver toxicity, macular edema, infections
Secondary Outcome Measures
- 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]
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Birmingham | Alabama | United States | 35209 |
| 2 | Novartis Investigative Site | Birmingham | Alabama | United States | 35233-0271 |
| 3 | Novartis Investigative Site | Birmingham | Alabama | United States | 35235 |
| 4 | Novartis Investigative Site | Cullman | Alabama | United States | 35058 |
| 5 | Novartis Investigative Site | Mobile | Alabama | United States | 36617 |
| 6 | Novartis Investigative Site | Phoenix | Arizona | United States | 85013 |
| 7 | Novartis Investigative Site | Sottsdale | Arizona | United States | 85258 |
| 8 | Novartis Investigative Site | Tucson | Arizona | United States | 85718 |
| 9 | Novartis Investigative Site | Bakersfield | California | United States | 93311 |
| 10 | Novartis Investigative Site | Banning | California | United States | 92220 |
| 11 | Novartis Investigative Site | Burbank | California | United States | 91505 |
| 12 | Novartis Investigative Site | Fresno | California | United States | 93710 |
| 13 | Novartis Investigative Site | Fullerton | California | United States | 92835 |
| 14 | Novartis Investigative Site | Huntington Beach | California | United States | 92649 |
| 15 | Novartis Investigative Site | Irvine | California | United States | 92618 |
| 16 | Novartis Investigative Site | Loma Linda | California | United States | 92354 |
| 17 | Novartis Investigative Site | Los Angeles | California | United States | 90073 |
| 18 | Novartis Investigative Site | Newport Beach | California | United States | 92660 |
| 19 | Novartis Investigative Site | Oceanside | California | United States | 92056 |
| 20 | Novartis Investigative Site | Placentia | California | United States | 92870 |
| 21 | Novartis Investigative Site | Pomona | California | United States | 91767 |
| 22 | Novartis Investigative Site | Redding | California | United States | 96001 |
| 23 | Novartis Investigative Site | Santa Monica | California | United States | 90404 |
| 24 | Novartis Investigative Site | Temecula | California | United States | 92591 |
| 25 | Novartis Investigative Site | Aurora | Colorado | United States | 80045 |
| 26 | Novartis Investigative Site | Basalt | Colorado | United States | 81621 |
| 27 | Novartis Investigative Site | Colorado Springs | Colorado | United States | 80907 |
| 28 | Novartis Investigative Site | Denver | Colorado | United States | 80210 |
| 29 | Novartis Investigative Site | Fort Collins | Colorado | United States | 80524 |
| 30 | Novartis Investigative Site | Louisville | Colorado | United States | 80027 |
| 31 | Novartis Investigative Site | Parker | Colorado | United States | 80138 |
| 32 | Novartis Investigative Site | Fairfield | Connecticut | United States | 06824 |
| 33 | Novartis Investigative Site | Hartford | Connecticut | United States | 6112 |
| 34 | Novartis Investigative Site | Waterbury | Connecticut | United States | 06708 |
| 35 | Novartis Investigative Site | Dover | Delaware | United States | 19901 |
| 36 | Novartis Investigative Site | Newark | Delaware | United States | 19713 |
| 37 | Novartis Investigative Site | Washington | District of Columbia | United States | 20007 |
| 38 | Novartis Investigative Site | Washington | District of Columbia | United States | 20037 |
| 39 | Novartis Investigative Site | Bradenton | Florida | United States | 34205 |
| 40 | Novartis Investigative Site | Clermont | Florida | United States | 34711 |
| 41 | Novartis Investigative Site | Delray Beach | Florida | United States | 33445 |
| 42 | Novartis Investigative Site | Doral | Florida | United States | 33136 |
| 43 | Novartis Investigative Site | Hollywood | Florida | United States | 33021 |
| 44 | Novartis Investigative Site | Jupiter | Florida | United States | 33458 |
| 45 | Novartis Investigative Site | Maitland | Florida | United States | 32751 |
| 46 | Novartis Investigative Site | Miami | Florida | United States | 33032 |
| 47 | Novartis Investigative Site | Miami | Florida | United States | 33144 |
| 48 | Novartis Investigative Site | Miami | Florida | United States | 33155 |
| 49 | Novartis Investigative Site | Naples | Florida | United States | 34102 |
| 50 | Novartis Investigative Site | Orlando | Florida | United States | 32806 |
| 51 | Novartis Investigative Site | Ormond Beach | Florida | United States | 32174 |
| 52 | Novartis Investigative Site | Panama City | Florida | United States | 32405 |
| 53 | Novartis Investigative Site | Port Charlotte | Florida | United States | 33952 |
| 54 | Novartis Investigative Site | Sarasota | Florida | United States | 34233 |
| 55 | Novartis Investigative Site | Wellington | Florida | United States | 33414 |
| 56 | Novartis Investigative Site | West Palm Beach | Florida | United States | 33407 |
| 57 | Novartis Investigative Site | Weston | Florida | United States | 33331 |
| 58 | Novartis Investigative Site | Atlanta | Georgia | United States | 30309 |
| 59 | Novartis Investigative Site | Atlanta | Georgia | United States | 30327 |
| 60 | Novartis Investigative Site | Augusta | Georgia | United States | 30912 |
| 61 | Novartis Investigative Site | Macon | Georgia | United States | 31210 |
| 62 | Novartis Investigative Site | Suwanee | Georgia | United States | 30024 |
| 63 | Novartis Investigative Site | Arlington Heights | Illinois | United States | 60004 |
| 64 | Novartis Investigative Site | Carbondale | Illinois | United States | 62901 |
| 65 | Novartis Investigative Site | Flossmoor | Illinois | United States | 60422 |
| 66 | Novartis Investigative Site | Marywood | Illinois | United States | 60153 |
| 67 | Novartis Investigative Site | Peoria | Illinois | United States | 61637 |
| 68 | Novartis Investigative Site | Anderson | Indiana | United States | 46011 |
| 69 | Novartis Investigative Site | Indianapolis | Indiana | United States | 46227 |
| 70 | Novartis Investigative Site | Indianapolis | Indiana | United States | 46256 |
| 71 | Novartis Investigative Site | Lafayette | Indiana | United States | 47905 |
| 72 | Novartis Investigative Site | Merrillville | Indiana | United States | 46410 |
| 73 | Novartis Investigative Site | Des Moines | Iowa | United States | 50314-2611 |
| 74 | Novartis Investigative Site | Kansas City | Kansas | United States | 66160 |
| 75 | Novartis Investigative Site | Lenexa | Kansas | United States | 66212 |
| 76 | Novartis Investigative Site | Overland Park | Kansas | United States | 66210 |
| 77 | Novartis Investigative Site | Topeka | Kansas | United States | 66606 |
| 78 | Novartis Investigative Site | Lexington | Kentucky | United States | 40503 |
| 79 | Novartis Investigative Site | Lexington | Kentucky | United States | 40513 |
| 80 | Novartis Investigative Site | Louisville | Kentucky | United States | 40202 |
| 81 | Novartis Investigative Site | Hammond | Louisiana | United States | 70403 |
| 82 | Novartis Investigative Site | Auburn | Maine | United States | 04210 |
| 83 | Novartis Investigative Site | Bangor | Maine | United States | 04401 |
| 84 | Novartis Investigative Site | Baltimore | Maryland | United States | 21201 |
| 85 | Novartis Investigative Site | Baltimore | Maryland | United States | 21209 |
| 86 | Novartis Investigative Site | Baltimore | Maryland | United States | 21212 |
| 87 | Novartis Investigative Site | Bethesda | Maryland | United States | 20814 |
| 88 | Novartis Investigative Site | Charlotte Hall | Maryland | United States | 20622 |
| 89 | Novartis Investigative Site | Hagerstown | Maryland | United States | 21741 |
| 90 | Novartis Investigative Site | Lutherville | Maryland | United States | 21093 |
| 91 | Novartis Investigative Site | Waldorf | Maryland | United States | 20603 |
| 92 | Novartis Investigative Site | Boston | Massachusetts | United States | 02135 |
| 93 | Novartis Investigative Site | Boston | Massachusetts | United States | 02215 |
| 94 | Novartis Investigative Site | Foxboro | Massachusetts | United States | 02035 |
| 95 | Novartis Investigative Site | Springfield | Massachusetts | United States | 01104 |
| 96 | Novartis Investigative Site | Wellesley | Massachusetts | United States | 02481 |
| 97 | Novartis Investigative Site | Worcester | Massachusetts | United States | 01608 |
| 98 | Novartis Investigative Site | Caro | Michigan | United States | 48723 |
| 99 | Novartis Investigative Site | Detroit | Michigan | United States | 48201 |
| 100 | Novartis Investigative Site | Jackson | Michigan | United States | 49201 |
| 101 | Novartis Investigative Site | Owosso | Michigan | United States | 48867 |
| 102 | Novartis Investigative Site | Rochester Hills | Michigan | United States | 48301 |
| 103 | Novartis Investigative Site | Southfield | Michigan | United States | 48034 |
| 104 | Novartis Investigative Site | Traverse City | Michigan | United States | 49684-2340 |
| 105 | Novartis Investigative Site | Edina | Minnesota | United States | 55435 |
| 106 | Novartis Investigative Site | Golden Valley | Minnesota | United States | 55422 |
| 107 | Novartis Investigative Site | Saint Louis | Missouri | United States | 63104 |
| 108 | Novartis Investigative Site | Saint Louis | Missouri | United States | 63128 |
| 109 | Novartis Investigative Site | Saint Peters | Missouri | United States | 63303 |
| 110 | Novartis Investigative Site | Springfield | Missouri | United States | 65807 |
| 111 | Novartis Investigative Site | Great Falls | Montana | United States | 59405 |
| 112 | Novartis Investigative Site | Hastings | Nebraska | United States | 68901 |
| 113 | Novartis Investigative Site | Omaha | Nebraska | United States | 68198-2045 |
| 114 | Novartis Investigative Site | Las Vegas | Nevada | United States | 89106 |
| 115 | Novartis Investigative Site | Lebanon | New Hampshire | United States | 03756 |
| 116 | Novartis Investigative Site | Fair Lawn | New Jersey | United States | 07410 |
| 117 | Novartis Investigative Site | Livingston | New Jersey | United States | 07039 |
| 118 | Novartis Investigative Site | Somerset | New Jersey | United States | 08873 |
| 119 | Novartis Investigative Site | West Long Branch | New Jersey | United States | 07764 |
| 120 | Novartis Investigative Site | Albany | New York | United States | 12208 |
| 121 | Novartis Investigative Site | Amherst | New York | United States | 14226 |
| 122 | Novartis Investigative Site | Bronx | New York | United States | 10467 |
| 123 | Novartis Investigative Site | Brooklyn | New York | United States | 11220 |
| 124 | Novartis Investigative Site | Cedarhurst | New York | United States | 11516 |
| 125 | Novartis Investigative Site | Johnson City | New York | United States | 13790 |
| 126 | Novartis Investigative Site | Kingston | New York | United States | 12401 |
| 127 | Novartis Investigative Site | Lake Success | New York | United States | 11042 |
| 128 | Novartis Investigative Site | New York | New York | United States | 10003 |
| 129 | Novartis Investigative Site | Patchogue | New York | United States | 11772 |
| 130 | Novartis Investigative Site | Plainview | New York | United States | 11803 |
| 131 | Novartis Investigative Site | Poughkeepsie | New York | United States | 12601 |
| 132 | Novartis Investigative Site | Staten Island | New York | United States | 10306 |
| 133 | Novartis Investigative Site | Syracuse | New York | United States | 13210 |
| 134 | Novartis Investigative Site | Asheville | North Carolina | United States | 28805 |
| 135 | Novartis Investigative Site | Asheville | North Carolina | United States | 28806 |
| 136 | Novartis Investigative Site | Chapel Hill | North Carolina | United States | 27599-9500 |
| 137 | Novartis Investigative Site | Charlotte | North Carolina | United States | 28202 |
| 138 | Novartis Investigative Site | Charlotte | North Carolina | United States | 28204 |
| 139 | Novartis Investigative Site | Durham | North Carolina | United States | 27710 |
| 140 | Novartis Investigative Site | Hickory | North Carolina | United States | 28602 |
| 141 | Novartis Investigative Site | Raleigh | North Carolina | United States | 27607 |
| 142 | Novartis Investigative Site | Sanford | North Carolina | United States | 27330 |
| 143 | Novartis Investigative Site | Wilmington | North Carolina | United States | 28401 |
| 144 | Novartis Investigative Site | Bismarck | North Dakota | United States | 58501 |
| 145 | Novartis Investigative Site | Bellevue | Ohio | United States | 44811 |
| 146 | Novartis Investigative Site | Centerville | Ohio | United States | 45459 |
| 147 | Novartis Investigative Site | Cincinnati | Ohio | United States | 45219 |
| 148 | Novartis Investigative Site | Columbus | Ohio | United States | 43210 |
| 149 | Novartis Investigative Site | Columbus | Ohio | United States | 43221 |
| 150 | Novartis Investigative Site | Dayton | Ohio | United States | 45408 |
| 151 | Novartis Investigative Site | Toledo | Ohio | United States | 43614 |
| 152 | Novartis Investigative Site | Toledo | Ohio | United States | 43623 |
| 153 | Novartis Investigative Site | Oklahoma City | Oklahoma | United States | 73102 |
| 154 | Novartis Investigative Site | Oklahoma City | Oklahoma | United States | 73104 |
| 155 | Novartis Investigative Site | Portland | Oregon | United States | 97225 |
| 156 | Novartis Investigative Site | Springfield | Oregon | United States | 97477 |
| 157 | Novartis Investigative Site | Greensburg | Pennsylvania | United States | 15601 |
| 158 | Novartis Investigative Site | Meadowbrook | Pennsylvania | United States | 19046 |
| 159 | Novartis Investigative Site | Philadelphia | Pennsylvania | United States | 19107-5098 |
| 160 | Novartis Investigative Site | Philadelphia | Pennsylvania | United States | 19107 |
| 161 | Novartis Investigative Site | Pittsburgh | Pennsylvania | United States | 15243 |
| 162 | Novartis Investigative Site | Willow Grove | Pennsylvania | United States | 19090 |
| 163 | Novartis Investigative Site | Beaufort | South Carolina | United States | 29902 |
| 164 | Novartis Investigative Site | Camden | South Carolina | United States | 29020 |
| 165 | Novartis Investigative Site | Charleston | South Carolina | United States | 29406 |
| 166 | Novartis Investigative Site | Greer | South Carolina | United States | 29650 |
| 167 | Novartis Investigative Site | Indian Land | South Carolina | United States | 29707 |
| 168 | Novartis Investigative Site | Mount Pleasant | South Carolina | United States | 29464 |
| 169 | Novartis Investigative Site | Spartanburg | South Carolina | United States | 29303 |
| 170 | Novartis Investigative Site | Spartanburg | South Carolina | United States | 29307 |
| 171 | Novartis Investigative Site | Knoxville | Tennessee | United States | 37922 |
| 172 | Novartis Investigative Site | Nashville | Tennessee | United States | 37205 |
| 173 | Novartis Investigative Site | Nashville | Tennessee | United States | 37212 |
| 174 | Novartis Investigative Site | Brownwood | Texas | United States | 76801 |
| 175 | Novartis Investigative Site | Dallas | Texas | United States | 75214 |
| 176 | Novartis Investigative Site | Dallas | Texas | United States | 75390 |
| 177 | Novartis Investigative Site | Houston | Texas | United States | 77005 |
| 178 | Novartis Investigative Site | Houston | Texas | United States | 77025 |
| 179 | Novartis Investigative Site | Kingwood | Texas | United States | 77339 |
| 180 | Novartis Investigative Site | Mansfield | Texas | United States | 76063 |
| 181 | Novartis Investigative Site | San Antonio | Texas | United States | 78229 |
| 182 | Novartis Investigative Site | Stafford | Texas | United States | 77477 |
| 183 | Novartis Investigative Site | Sugar Land | Texas | United States | 77479 |
| 184 | Novartis Investigative Site | Provo | Utah | United States | 84604 |
| 185 | Novartis Investigative Site | Salt Lake City | Utah | United States | 84103 |
| 186 | Novartis Investigative Site | Salt Lake City | Utah | United States | 84132 |
| 187 | Novartis Investigative Site | Alexandria | Virginia | United States | 22310 |
| 188 | Novartis Investigative Site | Arlington | Virginia | United States | 22205 |
| 189 | Novartis Investigative Site | Charlottesville | Virginia | United States | 22911 |
| 190 | Novartis Investigative Site | McLean | Virginia | United States | 22101 |
| 191 | Novartis Investigative Site | Newport News | Virginia | United States | 23601 |
| 192 | Novartis Investigative Site | Norfolk | Virginia | United States | 23507 |
| 193 | Novartis Investigative Site | Richmond | Virginia | United States | 23228 |
| 194 | Novartis Investigative Site | Richmond | Virginia | United States | 23924 |
| 195 | Novartis Investigative Site | Vienna | Virginia | United States | 22182 |
| 196 | Novartis Investigative Site | Winchester | Virginia | United States | 22601 |
| 197 | Novartis Investigative Site | Richland | Washington | United States | 99352 |
| 198 | Novartis Investigative Site | Spokane | Washington | United States | 99208 |
| 199 | Novartis Investigative Site | Tacoma | Washington | United States | 98405 |
| 200 | Novartis Investigative Site | Wenatchee | Washington | United States | 98801 |
| 201 | Novartis Investigative Site | Beckley | West Virginia | United States | 25801 |
| 202 | Novartis Investigative Site | Huntington | West Virginia | United States | 25701 |
| 203 | Novartis Investigative Site | Green Bay | Wisconsin | United States | 54311 |
| 204 | Novartis Investigative Site | Milwaukee | Wisconsin | United States | 53211 |
| 205 | Novartis Investigative Site | Monroe | Wisconsin | United States | 53566 |
| 206 | Novartis Investigative Site | Neenah | Wisconsin | United States | 54956 |
| 207 | Novartis Investigative Site | Wisconsin Rapids | Wisconsin | United States | 54495 |
| 208 | Novartis Investigative Site | Casper | Wyoming | United States | 82601 |
| 209 | Novartis Investigative Site | Jenin | Buenos Aires | Argentina | 6000 |
| 210 | Novartis Investigative Site | San Miguel de Tucuman | Tucuman | Argentina | T4000DPB |
| 211 | Novartis Investigative Site | Buenos Aires | Argentina | 1061 | |
| 212 | Novartis Investigative Site | Ciudad Autonoma de Bs As | Argentina | ||
| 213 | Novartis Investigative Site | Cordoba | Argentina | X5004CDT | |
| 214 | Novartis Investigative Site | Salta | Argentina | A4400BKZ | |
| 215 | Novartis Investigative Site | Kogarah | New South Wales | Australia | 2217 |
| 216 | Novartis Investigative Site | Box Hill | Victoria | Australia | 3128 |
| 217 | Novartis Investigative Site | Melbourne | Victoria | Australia | 3004 |
| 218 | Novartis Investigative Site | Parkville | Victoria | Australia | 3050 |
| 219 | Novartis Investigative Site | Edmonton | Alberta | Canada | T6G 2G3 |
| 220 | Novartis Investigative Site | Saint John | New Brunswick | Canada | E2L 4L2 |
| 221 | Novartis Investigative Site | Halifax | Nova Scotia | Canada | B3H 4K4 |
| 222 | Novartis Investigative Site | Guelph | Ontario | Canada | N1H 4J4 |
| 223 | Novartis Investigative Site | Kingston | Ontario | Canada | K7L 2V7 |
| 224 | Novartis Investigative Site | Ottawa | Ontario | Canada | K1H 8L6 |
| 225 | Novartis Investigative Site | St. Catharine's | Ontario | Canada | L2R 2P7 |
| 226 | Novartis Investigative Site | Chicoutimi | Quebec | Canada | G7H 5H6 |
| 227 | Novartis Investigative Site | Montreal | Quebec | Canada | H1T 2M4 |
| 228 | Novartis Investigative Site | Montreal | Quebec | Canada | H2L 4M1 |
| 229 | Novartis Investigative Site | Montreal | Quebec | Canada | H3A 2B4 |
| 230 | Novartis Investigative Site | Montreal | Quebec | Canada | H3T 1E2 |
| 231 | Novartis Investigative Site | Trois Rivieres | Quebec | Canada | G8Z 3R9 |
| 232 | Novartis Investigative Site | Santiago | Chile | PISO 1 | |
| 233 | Novartis Investigative Site | Guadalajara | Jalisco | Mexico | 44130 |
| 234 | Novartis Investigative Site | Culiacan | MEX | Mexico | 80020 |
| 235 | Novartis Investigative Site | Monterrey | Nuevo León | Mexico | 64710 |
| 236 | Novartis Investigative Site | Distrito Federal | Mexico | 10700 | |
| 237 | Novartis Investigative Site | Guaynabo | Puerto Rico | 00968 | |
| 238 | Novartis Investigative Site | San Juan | Puerto Rico | 00935 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01442194
Other Study ID Numbers:
- CFTY720D2403
First Posted:
Sep 28, 2011
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms: