NCT02883335

Brief Summary

The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started May 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress86%
May 2003Jan 2030

Study Start

First participant enrolled

May 1, 2003

Completed
13.3 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
13.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

26.7 years

First QC Date

August 19, 2016

Last Update Submit

February 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • case occurence of multiple sclerosis

    one year

Secondary Outcomes (1)

  • EDSS score

    30 years

Interventions

Eligibility Criteria

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

Patients suffering from multiple sclerosis in Lorraine

You may qualify if:

  • Having a confirmed multiple sclerosis diagnosis
  • Living in Lorraine (French region)

You may not qualify if:

  • Refusal to be registered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy

Nancy, 54000, France

RECRUITING

Related Publications (4)

  • Brissart H, Morele E, Baumann C, Perf ML, Leininger M, Taillemite L, Dillier C, Pittion S, Spitz E, Debouverie M. Cognitive impairment among different clinical courses of multiple sclerosis. Neurol Res. 2013 Oct;35(8):867-72. doi: 10.1179/1743132813Y.0000000232. Epub 2013 Jun 19.

    PMID: 23816638BACKGROUND
  • Brissart H, Sauvee M, Latarche C, Dillier C, Debouverie M. Integration of cognitive impairment in the expanded disability status scale of 215 patients with multiple sclerosis. Eur Neurol. 2010;64(6):345-50. doi: 10.1159/000322140. Epub 2010 Nov 13.

    PMID: 21071951BACKGROUND
  • El Adssi H, Debouverie M, Guillemin F; LORSEP Group. Estimating the prevalence and incidence of multiple sclerosis in the Lorraine region, France, by the capture-recapture method. Mult Scler. 2012 Sep;18(9):1244-50. doi: 10.1177/1352458512437811. Epub 2012 Feb 21.

  • Becker M, Latarche C, Roman E, Debouverie M, Malaplate-Armand C, Guillemin F. No prognostic value of routine cerebrospinal fluid biomarkers in a population-based cohort of 407 multiple sclerosis patients. BMC Neurol. 2015 May 13;15:79. doi: 10.1186/s12883-015-0330-4.

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Francis Guillemin, MD, PHD

    CHRU Nancy

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis Guillemin, MD, PHD

CONTACT

Jonathan Epstein, MD, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Médecine coordonateur de module

Study Record Dates

First Submitted

August 19, 2016

First Posted

August 30, 2016

Study Start

May 1, 2003

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

open to partnership

Locations