TERI-QoL
Research type
Research Study
Full title
A prospective, observational, UK study to describe the patient reported quality of life in relapsing remitting multiple sclerosis patients treated with Aubagio (teriflunomide) 14mg in a routine clinical practice,
IRAS ID
233643
Contact name
Timothy Harrower
Contact email
Sponsor organisation
Genzyme, a Sanofi Company
Duration of Study in the UK
4 years, 0 months, 2 days
Research summary
This is a prospective observational study. The purpose of this study is to evaluate the health related quality of life and outcomes in adult patients with relapsing remitting multiple sclerosis (RRMS) following treatment with Aubagio®. This study will collect information for a period of 2 years following the patients first month of treatment of Aubagio®.
Enrolled patients will receive treatment and evaluations for their Multiple Sclerosis as determined by their treating physicians in accordance with local standard of care. Visits will be scheduled by the treating healthcare provider (HCP) according to patient specific needs and local clinical practice. Aubagio® will be prescribed to the patient independent to their participation in the study.
There will be 6 study visits for participating patients. Data collection will be at baseline and at months 3, 6, 18 and 24/end of study (EOS). The patient’s baseline visit will be conducted up to 4 weeks after the decision to treat the patient with Aubagio®, with other visits as schedules by the health care provider, depending on local clinical practice.After patient consent, demographics, information about the patient’s disease, related treatment history and information will be collected. To assess the patient’s quality of life the patients will be required to complete 8 questionnaires, taking approximately 1 hour to complete. The questionnaires will assess the patient’s level of fatigue, anxiety and depression, cognition, sexual dysfunction, treatment satisfaction and work/daily activity. This data will be collected at baseline, 6 months, 12 months, 18 months and 24 months / EOS. Number of scheduled and unscheduled HCP encounters, treatment adherence, number of emergency visits and safety information will be collected at baseline, month 3, month 6, month 12, month 18 and month 24 / EOS.
The study duration is expected to be approximately 3 years in duration, including a 1 year enrolment period.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0312
Date of REC Opinion
11 May 2018
REC opinion
Further Information Favourable Opinion