TERI-PRO
Research type
Research Study
Full title
A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients
IRAS ID
138033
Contact name
David Rog
Contact email
Sponsor organisation
Genzyme Corporation
Eudract number
2013-001439-34
Clinicaltrials.gov Identifier
Research summary
Multiple sclerosis (MS) is a neurological condition which affects around 100,000 people in the UK. The disease most commonly begins in patients between 20 to 40 years of age but can present at even a wider age range. MS is an inflammatory condition that damages the myelin (covering sheath) of the nerve fibres in the spinal cord and brain and leads eventually to nerve fibre damage and neurodegeneration. The clinical presentation is typically of intermittent neurological symptoms/impairment which over time can progress to severe disability.
Relapsing MS is a common form of MS that causes acute attacks of neurological dysfunction and disability. Prognosis is uncertain and there is currently no cure although there are drugs available to help treat or manage many of the symptoms.
The efficacy of teriflunomide has been established in patients with relapsing multiple sclerosis (RMS) in 2 phase 3 studies. Teriflunomide 14 mg demonstrated a favorable benefit/risk ratio for the treatment of RMS patients
to reduce the frequency of relapses and delay the accumulation of physical disability. Teriflunomide has been approved for the treatment of RMS in the US and Australia and has recently been approved for the treatment of Relaspsing Remitting MS in the EU.The purpose of this study is to capture Patient Reported Outcome data and safety information on teriflunomide treatment in patients with Relapsing Multiple Sclerosis according to local labelling - so in the EU this is for patients with Relapsing Remitting MS.
This study will be 50 weeks or 54 weeks (if the accelerated elimination procedure is performed) and will include several interim assessments to allow for a determination to be made of both the potential immediate impact as well as the durability of the patient’s perception of teriflunomide treatment, and also to provide useful information on patient adherence and persistence with teriflunomide therapy.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
14/NW/0017
Date of REC Opinion
17 Feb 2014
REC opinion
Further Information Favourable Opinion