A prospective, open-label, multicenter, single-arm observational registry to describe adherence in relapsing remitting multiple sclerosis patients being prescribed teriflunomide (Aubagio®) in Belgium in routine clinical practice. (AUBADHE)

Study identification

• EU PAS number:
  EUPAS27536
• Study ID:
  48859
• Official title and acronym:
  A prospective, open-label, multicenter, single-arm observational registry to describe adherence in relapsing remitting multiple sclerosis patients being prescribed teriflunomide (Aubagio®) in Belgium in routine clinical practice. (AUBADHE)
• DARWIN EU® study:
  No
• Study countries:
  Belgium
• Study description:
  Product observational registry to describe adherence in terms of persistence and continuation rate during the first 18 months in patients who take Aubagio® in a real life setting, and  To describe adherence in terms of initiation and implementation  To describe the reasons for treatment discontinuation  To describe the drivers of adherence  To assess the evolution of fatigue, depression and cognition in patients taking Aubagio® and their impact on adherence The study is non-interventional. Patients will be prescribed Aubagio® according to local label and reimbursement criteria, independently from the decision to include the patient in the registry. Patients fulfilling the study criteria will be asked to participate in this study. Duration of treatment: the registry observation period will last until the termination of the treatment or maximum 18 months, whichever comes first. Patients will continue on medication as long as this treatment is considered appropriate for this patient independently from the registry. Data will be collected at inclusion (baseline visit), after 3 months and every 6 months after inclusion (according to general clinical practice) or as planned according to clinical practice. An additional checkpoint for adherence (phone call) will be planned 2 weeks after inclusion.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 17 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:01/03/2017

Actual:17/01/2019

Study start date

Planned:28/08/2018

Actual:17/01/2019

Data analysis start date

Planned:30/03/2021

Date of interim report, if expected

Planned:30/03/2021

Date of final study report

Planned:12/01/2022

Actual:02/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi Belgium

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

TERIFL08913 - AUBADHE