Multiple SclerosisNCT01281657
Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program
An observational study of Multiple Sclerosis, run by Novartis at 58 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- fingolimod
- How many people
- 64 participants
- Where
- 58 sitesin 2 countries
- Study dates
- Feb 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with relapsing forms of MS who have participated in previous fingolimod trials and now taking commercially available fingolimod as part of routine medical care
Who may be able to join
- Patients who are prescribed fingolimod as part of their routine medical care
- Patients who have participated in a prior fingolimod clinical trials
Who cannot join
- 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
Trial locations and contacts
58 sites in 2 countries.
58 sites in 2 countries
United States42 sites
University of New Mexico Health Science Center
Albuquerque, New Mexico, 87131
University of Maryland
Baltimore, Maryland, 21201
Johns Hopkins MS Center
Baltimore, Maryland, 21287
The Research & Education Inst. of Alta Bates Summit Med. Grp
Berkeley, California, 94705
Caritas St. Elizabeth's Hospital
Boston, Massachusetts, 02135
University of Virginia Health System
Charlottesville, Virginia, 22903
North Central Neurology Associates, PC
Cullman, Alabama, 35058
Mercy Ruan Neurology Clinic Res Ct.
Des Moines, Iowa, 50314
South Suburban Neurology
Flossmoor, Illinois, 60422
Spectrum Health Medical Group, Neurology
Grand Rapids, Michigan, 49525
Sunrise Clinical Research, Inc.
Hollywood, Florida, 33021
University of Texas Medical School
Houston, Texas, 77030
University of Florida
Jacksonville, Florida, 32209
University of Kansas Medical Center
Kansas City, Kansas, 66160
Saint Luke's Hospital
Kansas City, Missouri, 64111
Mid America Neuroscience Institute
Lenexa, Kansas, 66214
Dean Foundation
Madison, Wisconsin, 53715
University of Wisconsin Madison
Madison, Wisconsin, 53792
University of Miami
Miami, Florida, 33136
St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Vanderbilt University
Nashville, Tennessee, 37204
Yale Multiple Sclerosis Center
New Haven, Connecticut, 06510
Mount Sinai School of Medicine
New York, New York, 10029
MS Center of Oklahoma
Oklahoma City, Oklahoma, 73120
Neurologic Associates, LTD
Palos Heights, Illinois, 60463
Neuro-Therapeutics, Inc.
Pasadena, California, 91105
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
Thomas Jerfferson University Hospital
Philadelphia, Pennsylvania, 19107
Island Neurological Associates
Plainview, New York, 11803
Neurological Associates
Pompano Beach, Florida, 33060
Integra Clinical Research
San Antonio, Texas, 78231
University of California San Francisco
San Francisco, California, 94117
Swedish Neuroscience Institute
Seattle, Washington, 98122
Springfield Neurology Associates, LLC
Springfield, Massachusetts, 01104
The MS Center for Innovation in Care
St Louis, Missouri, 63131
SUNY - Stony Brook University
Stony Brook, New York, 11794
Neurology Clinical Research, Inc.
Sunrise, Florida, 33351
AMO Corporation
Tallahassee, Florida, 32308
University of Toledo Health Science Campus
Toledo, Ohio, 43614
Neurological Associates of Tulsa, Inc
Tulsa, Oklahoma, 74137
MS Center of Vero Beach
Vero Beach, Florida, 32960
Georgetown University/Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Canada16 sites
Novartis Investigative Site
Burnaby, British Columbia, V5G 2X6
Novartis Investigative Site
Greenfield Park, Quebec, J4V 2J2
Novartis Investigative Site
Halifax, Nova Scotia, B3H 4K4
Novartis Investigative Site
Kingston, Ontario, K7L 2V7
Novartis Investigative Site
London, Ontario, N6A 5A5
Novartis Investigative Site
Montreal, Quebec, H1T 2M4
Novartis Investigative Site
Montreal, Quebec, H2L 4M1
Novartis Investigative Site
Montreal, Quebec, H3A 2B4
Novartis Investigative Site
Nepean, Ontario, K2G 6E2
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Québec, Quebec, G1J 1Z4
Novartis Investigative Site
Regina, Saskatchewan, S4T 1A5
Novartis Investigative Site
Sherbrooke, Quebec, J1H 5N4
Novartis Investigative Site
Toronto, Ontario, M5B 1W8
Novartis Investigative Site
Vancouver, British Columbia, V6T 2B5
Novartis Investigative Site
Victoria, British Columbia, V8R 1J8
About this study
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
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.
- Conditions
- Multiple Sclerosis
- Being tested
- fingolimod
- Keywords
- Fingolimod, FTY720, Relapsing forms of multiple sclerosis, Multiple sclerosis, MS, Safety, Efficacy
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fingolimodDrug
| Study group | Role | What they receive |
|---|---|---|
| Prescribed fingolimod 0.5 mg/day | Not described Receives: Drug: fingolimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Throughout the entirety of the study up to a maximum of 8 years
Secondary outcomes (1)
Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability
Measured: Throughout the entirety of the study up to a maximum of 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2011 (estimated)
- Study startFeb 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281657
- Sponsor's protocol ID
- CFTY720D2399E1
- Status last verified
- Sep 2012
- First submitted
- 19 Jan 2011
- Last updated
- 6 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01281657
- Acronym / sponsor ID
- CFTY720D2399E1
- Conditions
- Multiple Sclerosis
- Keywords
- Fingolimod, FTY720, Relapsing forms of multiple sclerosis, Multiple sclerosis, MS, Safety, Efficacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 24 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prescribed fingolimod 0.5 mg/day | – | Drug: fingolimod |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with relapsing forms of MS who have participated in previous fingolimod trials and now taking commercially available fingolimod as part of routine medical care
Key inclusion criteria (2 listed)
- Patients who are prescribed fingolimod as part of their routine medical care
- Patients who have participated in a prior fingolimod clinical trials
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fingolimod | Drug | Prescribed fingolimod 0.5 mg/day |
Primary outcome
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
Time frame: Throughout the entirety of the study up to a maximum of 8 years
1 secondary outcome
Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability
Time frame: Throughout the entirety of the study up to a maximum of 8 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
58 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Novartis at 58 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 58 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Throughout the entirety of the study up to a maximum of 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2012.