BARIcitinib Cognitive Emotional and Neural signaTuRE
Status:
Not yet recruiting
Trial end date:
2024-06-01
Target enrollment:
Participant gender:
Summary
Rheumatoid arthritis (RA) is a frequent and disabling disease, requiring early management to
achieve clinical remission. Recently, baricitinib (jak1-jak2 inhibitor) has been shown to as
an efficient treatment in placebo-controlled trials, and compared to the reference treatment
with TNF inhibitor (adalimumab). Its efficacy has been reported on the inflammatory
parameters, but more importantly on patient-reported outcomes. Baricitinib is thought to have
anti-inflammatory effects, via its inhibition of the JAK pathway. Importantly, it has also
been suggested to affect mood and pain.
Hypotheses: Inhibition of JAK Kinase pathway in patients with RA will improve emotional and
cognitive processing involved in mood disorders and decrease pain sensitization.
The primary objective of this study is to evaluate early emotional impact of the JAK 1/2
inhibitor Baricitinib assessed by a facial emotion recognition task. This precocious effect
on emotion processing is a surrogate marker of clinical imporvement in mood.
Phase 4 study, Double-blind randomized control study with patients receiving placebo or
baricitinib for 7 days, then open label study until day 42 with all patients receiving
baricitinib during 5 weeks.