Multiple SclerosisOFSEPNCT02889965
The French Multiple Sclerosis Registry
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in France. It aims to provide a major epidemiological tool on MS for the scientific community in France and abroad. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Multiple Sclerosis, Neuromyelitis Optica Spectrum Disorders
- How many people
- 54,000 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2011to Dec 2019
- 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All MS and NMOSD patients domiciliated in France
Who may be able to join
- RIS
- CIS
- MS according to McDonald 2010 criteria
- NMOSD and others as per NOMADMUS criteria
- No age limt
- All clinical courses
- Domiciliated in France
- Signed OFSEP informed consent
Who cannot join
- NONE
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer
Bron, 69500
About this study
OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in France. It aims to provide a major epidemiological tool on MS for the scientific community in France and abroad. This tool must help to answer a large number of questions concerning the causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness and safety of therapeutic drugs, the impact of the disease on patients and society, etc.
In December 2015, it has already included more than 54.000 patients. To achieve this goal, OFSEP's objectives are
- To maintain and develop the French cohort of patients suffering from MS or related diseases and syndromes. This means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients.
- To supplement the existing clinical data with standardized and quality biological samples and MRI scans.
- To improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease.
- To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes.
- To ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. This availability is only possible after scientific and regulatory evaluation of the request.
- To provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in France.
- To conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum disorders.
- Keywords
- Multiple sclerosis, Pharmacoepidemiology, Disease modifying drugs, Neuro-myelitis optica
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Radiologically Isolated Syndromes (RIS) | Not described | |
| Clinically Isolated Syndromes (RIS) | Not described | |
| Primary progressive MS (PPMS) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of cases of MS included
Measured: 6 months up to 8 years
number of patients
Measured: 6 months up to 8 years
demographic characteristics
Measured: 6 months up to 8 years
geographical distribution
Measured: 6 months up to 8 years
disease characteristics
Measured: 6 months up to 8 years
simple disease-modifying treatment description
Measured: 6 months up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startJan 2011
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Prospective
- Enrolment
- 54,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sandra VUKUSIC, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889965
- Sponsor's protocol ID
- 69HCL14_0385
- Acronym
- OFSEP
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 7 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Ricigliano VAG, Masmoudi I, Boudot de la Motte M, Manchon E, De Seze J. Cladribine use for multiple sclerosis with autoimmune comorbidities: retrospective analysis of the French MS registry, case series, and therapeutic considerations. Ther Adv Neurol Disord. 2026 Jun 18;19:17562864261458568. doi: 10.1177/17562864261458568. eCollection 2026.
PubMed 42344942Gavoille A, Rollot F, Casey R, Debouverie M, Le Page E, Ciron J, De Seze J, Ruet A, Maillart E, Labauge P, Zephir H, Papeix C, Defer G, Lebrun-Frenay C, Moreau T, Laplaud DA, Berger E, Stankoff B, Clavelou P, Thouvenot E, Heinzlef O, Pelletier J, Al Khedr A, Casez O, Bourre B, Cabre P, Wahab A, Magy L, Camdessanche JP, Maurousset A, Moulin S, Ben NH, Boulos DD, Hankiewicz K, Neau JP, Pottier C, Nifle C, Rabilloud M, Subtil F, Vukusic S; Observatoire Francais de la Sclerose en Plaques (OFSEP) Investigators. Investigating the Long-term Effect of Pregnancy on the Course of Multiple Sclerosis Using Causal Inference. Neurology. 2023 Mar 21;100(12):e1296-e1308. doi: 10.1212/WNL.0000000000206774. Epub 2022 Dec 23.
PubMed 36564207Signori A, Lorscheider J, Vukusic S, Trojano M, Iaffaldano P, Hillert J, Hyde R, Pellegrini F, Magyari M, Koch-Henriksen N, Sorensen PS, Spelman T, van der Walt A, Horakova D, Havrdova E, Girard M, Eichau S, Grand'Maison F, Gerlach O, Terzi M, Ozakbas S, Skibina O, Van Pesch V, Sa MJ, Prevost J, Alroughani R, McCombe PA, Gouider R, Mrabet S, Castillo-Trivino T, Zhu C, de Gans K, Sanchez-Menoyo JL, Yamout B, Khoury S, Sormani MP, Kalincik T, Butzkueven H; Big MS Data Network. Heterogeneity on long-term disability trajectories in patients with secondary progressive MS: a latent class analysis from Big MS Data network. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):23-30. doi: 10.1136/jnnp-2022-329987. Epub 2022 Sep 28.
PubMed 36171104
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The French Multiple Sclerosis Registry
- ClinicalTrials.gov ID
- NCT02889965
- Acronym / sponsor ID
- OFSEP / 69HCL14_0385
- Keywords
- Multiple sclerosis, Pharmacoepidemiology, Disease modifying drugs, Neuro-myelitis optica
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54,000 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Sep 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.
OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in France. It aims to provide a major epidemiological tool on MS for the scientific community in France and abroad. This tool must help to answer a large number of questions concerning the causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness and safety of therapeutic drugs, the impact of the disease on patients and society, etc.
In December 2015, it has already included more than 54.000 patients. To achieve this goal, OFSEP's objectives are
- To maintain and develop the French cohort of patients suffering from MS or related diseases and syndromes. This means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients.
- To supplement the existing clinical data with standardized and quality biological samples and MRI scans.
- To improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease.
- To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes.
- To ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. This availability is only possible after scientific and regulatory evaluation of the request.
- To provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in France.
- To conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radiologically Isolated Syndromes (RIS) | – | – |
| Clinically Isolated Syndromes (RIS) | – | – |
| Primary progressive MS (PPMS) | – | – |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All MS and NMOSD patients domiciliated in France
Key inclusion criteria (8 listed)
- RIS
- CIS
- MS according to McDonald 2010 criteria
- NMOSD and others as per NOMADMUS criteria
- No age limt
Key exclusion criteria (2 listed)
- NONE
- -
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
Number of cases of MS included
Time frame: 6 months up to 8 years
number of patients
Time frame: 6 months up to 8 years
demographic characteristics
Time frame: 6 months up to 8 years
geographical distribution
Time frame: 6 months up to 8 years
disease characteristics
Time frame: 6 months up to 8 years
simple disease-modifying treatment description
Time frame: 6 months up to 8 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2016.
- Derived from this study: PubMed 42344942Ricigliano VAG, Masmoudi I, Boudot de la Motte M, Manchon E, De Seze J. Cladribine use for multiple sclerosis with autoimmune comorbidities: retrospective analysis of the French MS registry, case series, and therapeutic considerations. Ther Adv Neurol Disord. 2026 Jun 18;19:17562864261458568. doi: 10.1177/17562864261458568. eCollection 2026.
- Derived from this study: PubMed 36564207Gavoille A, Rollot F, Casey R, Debouverie M, Le Page E, Ciron J, De Seze J, Ruet A, Maillart E, Labauge P, Zephir H, Papeix C, Defer G, Lebrun-Frenay C, Moreau T, Laplaud DA, Berger E, Stankoff B, Clavelou P, Thouvenot E, Heinzlef O, Pelletier J, Al Khedr A, Casez O, Bourre B, Cabre P, Wahab A, Magy L, Camdessanche JP, Maurousset A, Moulin S, Ben NH, Boulos DD, Hankiewicz K, Neau JP, Pottier C, Nifle C, Rabilloud M, Subtil F, Vukusic S; Observatoire Francais de la Sclerose en Plaques (OFSEP) Investigators. Investigating the Long-term Effect of Pregnancy on the Course of Multiple Sclerosis Using Causal Inference. Neurology. 2023 Mar 21;100(12):e1296-e1308. doi: 10.1212/WNL.0000000000206774. Epub 2022 Dec 23.
- Derived from this study: PubMed 36171104Signori A, Lorscheider J, Vukusic S, Trojano M, Iaffaldano P, Hillert J, Hyde R, Pellegrini F, Magyari M, Koch-Henriksen N, Sorensen PS, Spelman T, van der Walt A, Horakova D, Havrdova E, Girard M, Eichau S, Grand'Maison F, Gerlach O, Terzi M, Ozakbas S, Skibina O, Van Pesch V, Sa MJ, Prevost J, Alroughani R, McCombe PA, Gouider R, Mrabet S, Castillo-Trivino T, Zhu C, de Gans K, Sanchez-Menoyo JL, Yamout B, Khoury S, Sormani MP, Kalincik T, Butzkueven H; Big MS Data Network. Heterogeneity on long-term disability trajectories in patients with secondary progressive MS: a latent class analysis from Big MS Data network. J Neurol Neurosurg Psychiatry. 2023 Jan;94(1):23-30. doi: 10.1136/jnnp-2022-329987. Epub 2022 Sep 28.
- Individual participant dataSharing planned: No
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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.
Sandra VUKUSIC principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorders, run by Hospices Civils de Lyon at 1 site in France.
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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandra VUKUSIC (33 4 72 35 73 42, sandra.vukusic@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases of MS included (time frame: 6 months up to 8 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02889965, which also lists 3 linked publications.
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 7 Sep 2016; AzTrials last refreshed its copy on 28 Oct 2026.