Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis

Relapsing-remitting Multiple Sclerosis Clinical Trial

— COMP-RMS  

Official title:

Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302442
• Other study ID #: RC16_0471
• Status: Completed
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 2, 2017
• Start date: May 1, 2017
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 )

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3000
• Est. completion date: October 1, 2017
• Est. primary completion date: August 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-remitting Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Non interventional study
Not applicable - Non interventional Study

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relapse within first year of treatment	Proportion of patients experimenting at least one relapse within the first year of treatment	12 months
Secondary	Occurrence of clinical event at Two years	Proportion of patients with at least one relapse at two years of treatment	24 months
Secondary	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
Secondary	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
Secondary	Adverse drug reaction	Number and description of adverse reaction. Proportion of patients who had stopped treatment due to AR	12 months and 24 months