Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT01281657
Collaborator
(none)
64
58
17
1.1
0.1
Study Details
Study Description
Brief Summary
The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Observational
Actual Enrollment
:
64 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program
Study Start Date
:
Feb 1, 2011
Actual Primary Completion Date
:
Jul 1, 2012
Actual Study Completion Date
:
Jul 1, 2012
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Prescribed fingolimod 0.5 mg/day
|
Drug: fingolimod
|
Outcome Measures
Primary Outcome Measures
- Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice [Throughout the entirety of the study up to a maximum of 8 years]
Secondary Outcome Measures
- Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability [Throughout the entirety of the study up to a maximum of 8 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients who are prescribed fingolimod as part of their routine medical care
-
Patients who have participated in a prior fingolimod clinical trials
Exclusion Criteria:
-
Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label
-
Any patient who has prematurely discontinued from the previous fingolimod trial
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North Central Neurology Associates, PC | Cullman | Alabama | United States | 35058 |
| 2 | The Research & Education Inst. of Alta Bates Summit Med. Grp | Berkeley | California | United States | 94705 |
| 3 | Neuro-Therapeutics, Inc. | Pasadena | California | United States | 91105 |
| 4 | University of California San Francisco | San Francisco | California | United States | 94117 |
| 5 | Yale Multiple Sclerosis Center | New Haven | Connecticut | United States | 06510 |
| 6 | Georgetown University/Lombardi Cancer Center | Washington | District of Columbia | United States | 20007 |
| 7 | Sunrise Clinical Research, Inc. | Hollywood | Florida | United States | 33021 |
| 8 | University of Florida | Jacksonville | Florida | United States | 32209 |
| 9 | University of Miami | Miami | Florida | United States | 33136 |
| 10 | Neurological Associates | Pompano Beach | Florida | United States | 33060 |
| 11 | Neurology Clinical Research, Inc. | Sunrise | Florida | United States | 33351 |
| 12 | AMO Corporation | Tallahassee | Florida | United States | 32308 |
| 13 | MS Center of Vero Beach | Vero Beach | Florida | United States | 32960 |
| 14 | South Suburban Neurology | Flossmoor | Illinois | United States | 60422 |
| 15 | Neurologic Associates, LTD | Palos Heights | Illinois | United States | 60463 |
| 16 | Mercy Ruan Neurology Clinic Res Ct. | Des Moines | Iowa | United States | 50314 |
| 17 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
| 18 | Mid America Neuroscience Institute | Lenexa | Kansas | United States | 66214 |
| 19 | University of Maryland | Baltimore | Maryland | United States | 21201 |
| 20 | Johns Hopkins MS Center | Baltimore | Maryland | United States | 21287 |
| 21 | Caritas St. Elizabeth's Hospital | Boston | Massachusetts | United States | 02135 |
| 22 | Springfield Neurology Associates, LLC | Springfield | Massachusetts | United States | 01104 |
| 23 | Spectrum Health Medical Group, Neurology | Grand Rapids | Michigan | United States | 49525 |
| 24 | Saint Luke's Hospital | Kansas City | Missouri | United States | 64111 |
| 25 | The MS Center for Innovation in Care | St. Louis | Missouri | United States | 63131 |
| 26 | University of New Mexico Health Science Center | Albuquerque | New Mexico | United States | 87131 |
| 27 | Mount Sinai School of Medicine | New York | New York | United States | 10029 |
| 28 | Island Neurological Associates | Plainview | New York | United States | 11803 |
| 29 | SUNY - Stony Brook University | Stony Brook | New York | United States | 11794 |
| 30 | University of Toledo Health Science Campus | Toledo | Ohio | United States | 43614 |
| 31 | MS Center of Oklahoma | Oklahoma City | Oklahoma | United States | 73120 |
| 32 | Neurological Associates of Tulsa, Inc | Tulsa | Oklahoma | United States | 74137 |
| 33 | University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States | 19104 |
| 34 | Thomas Jerfferson University Hospital | Philadelphia | Pennsylvania | United States | 19107 |
| 35 | Vanderbilt University | Nashville | Tennessee | United States | 37204 |
| 36 | University of Texas Medical School | Houston | Texas | United States | 77030 |
| 37 | Integra Clinical Research | San Antonio | Texas | United States | 78231 |
| 38 | University of Virginia Health System | Charlottesville | Virginia | United States | 22903 |
| 39 | Swedish Neuroscience Institute | Seattle | Washington | United States | 98122 |
| 40 | Dean Foundation | Madison | Wisconsin | United States | 53715 |
| 41 | University of Wisconsin Madison | Madison | Wisconsin | United States | 53792 |
| 42 | St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 43 | Novartis Investigative Site | Burnaby | British Columbia | Canada | V5G 2X6 |
| 44 | Novartis Investigative Site | Vancouver | British Columbia | Canada | V6T 2B5 |
| 45 | Novartis Investigative Site | Victoria | British Columbia | Canada | V8R 1J8 |
| 46 | Novartis Investigative Site | Halifax | Nova Scotia | Canada | B3H 4K4 |
| 47 | Novartis Investigative Site | Kingston | Ontario | Canada | K7L 2V7 |
| 48 | Novartis Investigative Site | London | Ontario | Canada | N6A 5A5 |
| 49 | Novartis Investigative Site | Nepean | Ontario | Canada | K2G 6E2 |
| 50 | Novartis Investigative Site | Ottawa | Ontario | Canada | K1H 8L6 |
| 51 | Novartis Investigative Site | Toronto | Ontario | Canada | M5B 1W8 |
| 52 | Novartis Investigative Site | Greenfield Park | Quebec | Canada | J4V 2J2 |
| 53 | Novartis Investigative Site | Montreal | Quebec | Canada | H1T 2M4 |
| 54 | Novartis Investigative Site | Montreal | Quebec | Canada | H2L 4M1 |
| 55 | Novartis Investigative Site | Montreal | Quebec | Canada | H3A 2B4 |
| 56 | Novartis Investigative Site | Sherbrooke | Quebec | Canada | J1H 5N4 |
| 57 | Novartis Investigative Site | Regina | Saskatchewan | Canada | S4T 1A5 |
| 58 | Novartis Investigative Site | Quebec | Canada | G1J 1Z4 |
Sponsors and Collaborators
- Novartis
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT01281657
Other Study ID Numbers:
- CFTY720D2399E1
First Posted:
Jan 24, 2011
Last Update Posted:
Sep 6, 2012
Last Verified:
Sep 1, 2012
Keywords provided by Novartis
Additional relevant MeSH terms: