Multiple SclerosisGilenyaNCT02799199
Fingolimod Real World Experience: the French Grand-Est Cohort
An observational study of Multiple Sclerosis, run by CHU de Reims.
Trial summary
Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at least 6 months in the east of France from January 2011 to December 2014. Background: The Grand-Est is a geographical region in France with a high prevalence of multiple sclerosis (more than 10000 patients registered in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 1,014 participants
- Where
- No sites listed yet
- Study dates
- Sep 2014to Oct 2015
- 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 treated with fingolimod for at least 6 months
Who may be able to join
- Patients with MS treated with Gilenya because of the disease
Who cannot join
- contraindications of Gilenya treatment or receiving Gilenya after the 31st of March 2014
About this study
Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at least 6 months in the east of France from January 2011 to December 2014.
Background: The Grand-Est is a geographical region in France with a high prevalence of multiple sclerosis (more than 10000 patients registered in the European Database for Multiple Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014 patients have been treated for at least 6 months with Fingolimod, the first oral therapy for patient with very active relapsing-remitting MS.
Methods: Features of patients followed up in the Grand-Est region and treated with fingolimod in the 6 university hospitals, general hospitals and private neurologists were reviewed in a retrospective study after identification of the clinical files reported in the EDMUS database.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
the course of the disease by magnetic resonance imaging (MRI)
Measured: assessed between January 2012 and September 2014, up to a total of 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startSep 2014
- Primary completionOct 2015
- Study completionOct 2015
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.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,014 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02799199
- Sponsor's protocol ID
- PO14105
- Acronym
- Gilenya
- Status last verified
- Jun 2016
- First submitted
- 27 May 2016
- Last updated
- 14 Jun 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fingolimod Real World Experience: the French Grand-Est Cohort
- ClinicalTrials.gov ID
- NCT02799199
- Acronym / sponsor ID
- Gilenya / PO14105
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,014 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 14 Jun 2016 (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.
Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at least 6 months in the east of France from January 2011 to December 2014.
Background: The Grand-Est is a geographical region in France with a high prevalence of multiple sclerosis (more than 10000 patients registered in the European Database for Multiple Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014 patients have been treated for at least 6 months with Fingolimod, the first oral therapy for patient with very active relapsing-remitting MS.
Methods: Features of patients followed up in the Grand-Est region and treated with fingolimod in the 6 university hospitals, general hospitals and private neurologists were reviewed in a retrospective study after identification of the clinical files reported in the EDMUS database.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with fingolimod for at least 6 months
Key inclusion criteria (1 listed)
- Patients with MS treated with Gilenya because of the disease
Key exclusion criteria (1 listed)
- contraindications of Gilenya treatment or receiving Gilenya after the 31st of March 2014
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the course of the disease by magnetic resonance imaging (MRI)
Time frame: assessed between January 2012 and September 2014, up to a total of 32 months
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 14 Jun 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by CHU de Reims.
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 1 inclusion and 1 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 14 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
the course of the disease by magnetic resonance imaging (MRI) (time frame: assessed between January 2012 and September 2014, up to a total of 32 months). 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 14 Jun 2016.