Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis

• Registration Number: NCT03302442
• Lead Sponsor: Nantes University Hospital

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 )

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-05-01
• Primary Completion: 2017-08-01
• Status Verified: 2017-10
• Study Completion: 2017-10-01
• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Last Update Submitted: 2017-10-02
• Study First Posted: 2017-10-05
• Last Update Posted: 2017-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Relapse within first year of treatment	12 months	Proportion of patients experimenting at least one relapse within the first year of treatment

Secondary Outcome Measures

Name	Time	Method
Occurrence of clinical event at Two years	24 months	Proportion of patients with at least one relapse at two years of treatment
Progression of disability	12 months and 24 months	Proportion of patients with a progression of disability defined by any increased of EDSS score compared to baseline
Radiological disease activity	12 months and 24 months	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
Adverse drug reaction	12 months and 24 months	Number and description of adverse reaction. Proportion of patients who had stopped treatment due to AR

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France