Relapsing-remitting Multiple Sclerosis Clinical Trial
— COMP-RMSOfficial title:
Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis
Verified date | October 2017 |
Source | Nantes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 )
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. |
Country | Name | City | State |
---|---|---|---|
France | Nantes University Hospital | Nantes |
Lead Sponsor | Collaborator |
---|---|
Nantes University Hospital |
France,
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 |
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