Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis (COMP-RMS)

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 )

Study Overview

• Status: Completed
• Conditions: Relapsing-remitting Multiple Sclerosis
• Intervention / Treatment: Other: Non interventional study

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44093
    • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse within first year of treatment	Proportion of patients experimenting at least one relapse within the first year of treatment	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of clinical event at Two years	Proportion of patients with at least one relapse at two years of treatment	24 months
Progression of disability	Proportion of patients with a progression of disability defined by any increased of EDSS score compared to baseline	12 months and 24 months
Radiological disease activity	Proportion of patients with at least one Gd-enhancing lesion and the proportion of patients with at least one new T2-lesion on MRI scans compared to baseline MRI scan Probablity	12 months and 24 months
Adverse drug reaction	Number and description of adverse reaction. Proportion of patients who had stopped treatment due to AR	12 months and 24 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 2, 2017
• First Submitted That Met QC Criteria: October 2, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 2, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: RC16_0471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No