NCT02889965

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

September 7, 2016

Status Verified

August 1, 2016

Enrollment Period

8.9 years

First QC Date

August 22, 2016

Last Update Submit

September 6, 2016

Conditions

Multiple SclerosisNeuromyelitis Optica Spectrum Disorders

Keywords

Multiple sclerosisPharmacoepidemiologyDisease modifying drugsNeuro-myelitis optica

Outcome Measures

Primary Outcomes (6)

  • Number of cases of MS included

    6 months up to 8 years

  • number of patients

    6 months up to 8 years

  • demographic characteristics

    6 months up to 8 years

  • geographical distribution

    6 months up to 8 years

  • disease characteristics

    6 months up to 8 years

  • simple disease-modifying treatment description

    6 months up to 8 years

Study Arms (3)

Radiologically Isolated Syndromes (RIS)

Clinically Isolated Syndromes (RIS)

Primary progressive MS (PPMS)

Eligibility Criteria

AgeUp to 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All MS and NMOSD patients domiciliated in France

You may qualify if:

  • 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

You may not qualify if:

  • NONE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer

Bron, 69500, France

RECRUITING

Related Publications (2)

  • Gavoille 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.

    PMID: 36564207DERIVED

  • Signori 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.

    PMID: 36171104DERIVED

MeSH Terms

Conditions

Multiple SclerosisNeuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMyelitis, TransverseOptic NeuritisOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Sandra VUKUSIC

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra VUKUSIC

CONTACT

33 4 72 35 73 42sandra.vukusic@chu-lyon.fr

Véronique MILLOT

CONTACT

33 4 72 35 73 42veronique.millot@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 7, 2016

Study Start

January 1, 2011

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

September 7, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)