Observational study of upadacitinib in ulcerative colitis (PROFUNDUS)
Research type
Research Study
Full title
Prospective real-world study of upadacitinib in ulcerative colitis (PROFUNDUS)
IRAS ID
321991
Contact name
Nicholas Kennedy
Contact email
Sponsor organisation
Abbvie UK
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
4 years, 5 months, 30 days
Research summary
This is a multi-country, prospective, open-label, non-interventional, post-marketing observational study. This study will be conducted in Germany, Australia, Canada, United Arab Emirates, Israel, China, Belgium, Italy, Greece, Argentina, United Kingdom, Portugal, France, Ireland, Qatar and Kuwait.
The study is based on prospective collection of data from patients’ medical records and from patient-reported outcomes (PROs) completed via a mobile application. There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required. The planned study recruitment duration will be approximately 24 months for all participating countries from the global first patient first visit. Each patient will be followed in the study for up to 3 years. The duration of the study overall will be approximately 5 years.
The population for this study is adult patients diagnosed with ulcerative colitis (UC) who receive treatment with a drug called upadacitinib as part of their standard clinical care. It is expected to recruit about 1000 patients in total across different countries from 160 sites. There will be 10 health centres in the UK.
The main purpose of the study is to evaluate how effective upadacitinib is in patients with moderate to severe UC in real-world practice.
REC name
Wales REC 3
REC reference
23/WA/0053
Date of REC Opinion
31 Jan 2023
REC opinion
Favourable Opinion