Upadacitinib effectiveness in moderate rheumatoid arthritis patients
Research type
Research Study
Full title
Real world clinical and patient-reported outcomes of patients with moderate rheumatoid arthritis initiating upadacitinib in the United Kingdom: A prospective observational cohort study (ENDEAVOUR).
IRAS ID
287680
Contact name
James Galloway
Contact email
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
This is a multi-centre, observational prospective study that will be conducted across 12-15 secondary and tertiary care centres in the UK.
Rheumatoid arthritis (RA) is characterised by chronic inflammation, pain and stiffness of the joints. Upadacitinib is a new treatment licensed for use in adult patients with moderately-to-severely active RA. The overall aim of this study is to understand the population of patients who receive treatment with upadacitinib for moderate RA and to evaluate the real world clinical and patient-reported outcomes.
The study is based on retrospective and prospective collection of data from patients medical notes. The retrospective data will be patient medical history and baseline data.
Prospective data will be collected by trained site personnel for the 6 month period from the date the patient takes their first dose of upadacitinib and will be in line with routine clinic follow up appointments at 3 and 6 months.
Data collected will relate to patients characteristics, upadacitinib treatment, concomitant medication, disease characteristics and clinical outcomes.
Patient-reported outcome (PRO) questionnaires will be collected using a mobile app or online portal. Patients will complete these questionnaires daily, once weekly, or once fortnightly (depending on the questionnaire). One further questionnaire will be completed at clinic visits in paper format.
There will be no changes to patient management for the study and no requirements for additional testing, investigations or visits except completing questionnaires.
The population for this study is adult patients diagnosed with American College of Rheumatology (ACR) or EULAR confirmed diagnosis of RA with moderately active disease, who were prescribed upadacitinib in line with the marketing authorisation.
The study is expected to enrol 150 patients who meet the criteria.REC name
London - Bromley Research Ethics Committee
REC reference
20/PR/0476
Date of REC Opinion
12 Oct 2020
REC opinion
Further Information Favourable Opinion