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

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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

Tracking Information
First Submitted Date October 2, 2017
First Posted Date October 5, 2017
Last Update Posted Date October 5, 2017
Actual Study Start Date May 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 2, 2017)
Relapse within first year of treatment [ Time Frame: 12 months ]
Proportion of patients experimenting at least one relapse within the first year of treatment
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: October 2, 2017)
  • Occurrence of clinical event at Two years [ Time Frame: 24 months ]
    Proportion of patients with at least one relapse at two years of treatment
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis
Official Title Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis
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 Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Relapsing-remitting Multiple Sclerosis
Intervention Other: Non interventional study
Not applicable - Non interventional Study
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 2, 2017)
3000
Original Actual Enrollment Same as current
Actual Study Completion Date October 1, 2017
Actual Primary Completion Date August 1, 2017   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03302442
Other Study ID Numbers RC16_0471
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor Nantes University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Nantes University Hospital
Verification Date October 2017