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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302442
Recruitment Status : Completed
First Posted : October 5, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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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 )

Condition or disease Intervention/treatment
Relapsing-remitting Multiple Sclerosis Other: Non interventional study

Study Design
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Study Type : Observational
Actual Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : August 1, 2017
Actual Study Completion Date : October 1, 2017

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Groups and Cohorts
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Intervention Details:
  • Other: Non interventional study
    Not applicable - Non interventional Study

Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302442


Locations
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France
Nantes University Hospital
Nantes, France, 44093
Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03302442    
Other Study ID Numbers: RC16_0471
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases