NCT03856619CompletedPhase 4
A Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Sanofi
- Enrollment
- 121
- Locations
- 14
- Primary Endpoint
- Adverse events (AEs)
Study Overview
Brief Summary
Primary Objective:
To describe the safety of teriflunomide in patients with relapsing forms of multiple sclerosis.
Secondary Objective:
To describe the efficacy of teriflunomide in patients with relapsing forms of multiple sclerosis.
Detailed Description
The study duration is one year; post treatment safety follow up visit will be conducted 4 weeks after the patient takes the last dose of teriflunomide
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Aubagio®/Teriflunomide
Experimental
Single dose of Aubagio® to be taken orally, once daily in the morning
Intervention: TERIFLUNOMIDE HMR1726 (Drug)
Outcomes
Primary Outcomes
Adverse events (AEs)
Time Frame: 1 year
Incidence of adverse events
Secondary Outcomes
- Annualized relapse rate(1 year)
- First relapse(1 year)
- Relapse free(1 year)
- Neurological impairment/disability(Baseline to 3 months, 6 months, 9 months and 1 year)
- Drug compliance(1 year)
- Disability progression(1 year)
Investigators
Study Sites (14)
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