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OpenTrials
Completed

NCT Number: NCT03302442

Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis

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 )

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non interventional study

Other

Not applicable - Non interventional Study

Primary outcomes

  1. Relapse within first year of treatment

    Time frame: 12 months

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

Secondary outcomes

  1. Occurrence of clinical event at Two years

    Time frame: 24 months

    Proportion of patients with at least one relapse at two years of treatment

  2. Progression of disability

    Time frame: 12 months and 24 months

    Proportion of patients with a progression of disability defined by any increased of EDSS score compared to baseline

  3. Radiological disease activity

    Time frame: 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

  4. Adverse drug reaction

    Time frame: 12 months and 24 months

    Number and description of adverse reaction. Proportion of patients who had stopped treatment due to AR

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: COMP-RMS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2017
Registry last updated
Oct 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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