NCT03302442

Brief Summary

The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 5, 2017

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

3 months

First QC Date

October 2, 2017

Last Update Submit

October 2, 2017

Conditions

Relapsing-remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Relapse within first year of treatment

    Proportion of patients experimenting at least one relapse within the first year of treatment

    12 months

Secondary Outcomes (4)

  • Occurrence of clinical event at Two years

    24 months

  • Progression of disability

    12 months and 24 months

  • Radiological disease activity

    12 months and 24 months

  • Adverse drug reaction

    12 months and 24 months

Interventions

Non interventional studyOTHER

Not applicable - Non interventional Study

Eligibility Criteria

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

RRMS Patients who initiated either DMF or Teriflunomide and with an available MRI scan and EDSS assessment respectively within 12 and 6 months before treatment initiation

You may qualify if:

  • RRMS Patients with an EDSS score ranging between 0 and 5.5, who initiated either DMF or Teriflunomide before 1/01/2016 and with an available MRI scan and EDSS assessment respectively within 12 and 6 months before treatment initiation Patients who had consent to OFSEP registry Naive patient or treated with prior first line treatment : interferon, glatiramer acetate

You may not qualify if:

  • Patient with progressive multiple sclerosis
  • Patients with prior second line Patient with no MRI or EDSS score within the year before DMF or Teriflunomide initiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 5, 2017

Study Start

May 1, 2017

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

October 5, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)