Study identification

EU PAS number

EUPAS27883

Study ID

27884

Official title and acronym

A prospective, observational, UK study to describe patient reported quality of life in relapsing remitting multiple sclerosis patients treated with Aubagio® (teriflunomide) 14 mg in a routine clinical practice. (TeriQoL)

DARWIN EU® study

No

Study countries

United Kingdom

Study description

This is a 2 year prospective, multicentre observational UK Study to describe HRQoL and other PROs in RRMS patients treated with Aubagio® (teriflunomide) 14 mg in a routine clinical practice. The study will be conducted at approximately 20 sites in the UK and will collect data on the current status, characteristics, and management of patients who are starting treatment with Aubagio® as part of their routine medical care. The decision to treat with Aubagio® must be made prior to and independently from the proposal to enrol the patient on this study. All patients must be prescribed Aubagio® in accordance with the UK SmPC.This is an observational study with no experimental intervention. Enrolled patients will receive treatment and evaluations for their MS as determined by their treating physicians in accordance with the local standard of care. Visits will be scheduled by the treating HCP according to patient-specific needs and local clinical practice. Administration of Aubagio® and monitoring of patients according to the SmPC and safety reporting will be the sole responsibility of the treating neurologist. Patients will be followed with laboratory monitoring in a regular healthcare setting in line with locally approved label requirements and the Risk Management Plan (RMP) for Aubagio®.For purposes of this study, 6 visits are expected: study baseline (Visit 1), with follow up visits at months 3 (if part of clinical setting), 6, 12, 18 and 24. Patients will be expected to complete up to 7 questionnaires (see section 2.2) at different time points. Completing all of the questionnaires takes approximately 45 minutes. Questionnaires will be completed by the patient at the site during study visits or within 7 days before study visits (for visits V3-V6). Each questionnaire can be completed on a different day. Patient-reported outcomes, clinical outcomes and safety findings during routine clinical practice will be recorded for the entire cohort .

Study status

Ongoing
Research institutions and networks

Institutions

Contact details

Timothy Harrower

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable