ExIST
Research type
Research Study
Full title
Phase II proof of concept study of baricitinib in individuals who are considered at risk of developing inflammatory arthritis: ExIST
IRAS ID
1004563
Contact name
Paul Emery
Contact email
Sponsor organisation
University of Leeds
Eudract number
2017-001248-36
ISRCTN Number
ISRCTN53678960
Research summary
This trial is an open-label randomised control trial (RCT) comparing the effect of the investigational medicinal product Baricitinib versus standard care in a population of individuals at moderate to high risk of developing inflammatory arthritis (IA). Such individuals can be identified by the presence of CCP antibodies in the blood and other clinical features. At present, there are no effective treatments in this pathway until individuals’ develop IA, which is associated with inflammation, swelling, long-term joint pain and disability. Baricitinib may be effective at preventing the development of IA by inhibiting specific enzymes involved in the development of the disease.
The purpose of this trial is therefore to understand if baricitinib can delay the onset of IA in individuals who are deemed to be at-risk of developing IA.
Participants will be primarily recruited from the CCP - Next Generation study, a large existing observational study of individuals considered at risk of developing IA. All participants that consent to ExIST will be withdrawn from the CCP - Next Generation study. Participants that did not participate in the CCP Next Generation study may also be recruited. Eligible individuals will be randomly allocated to receive either a daily 2mg oral dose of baricitinib (Arm A) or to continue with the standard of care treatment (Arm B) for 48 weeks, with a 48 week period of follow-up. This study design (i.e. an RCT) provides the best chance of establishing whether differences observed between the two groups are due to the treatment. To understand whether Baricitinib is effective, clinical measurements, blood tests, and detailed scans will be taken every 12 weeks for the entire study duration (96 weeks) in both Arm A and Arm B, and the proportion of individuals developing IA at 48 and 96 weeks will be compared.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
22/EM/0154
Date of REC Opinion
22 Aug 2022
REC opinion
Further Information Favourable Opinion