BARIcitinib Cognitive Emotional and Neural signaTuRE

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT05238896
Phase
PHASE4
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Baricitinib Oral Tablet [Olumiant] — DRUG
    Baricitinib 4 mg/d oral route for 42 days
  • Placebo — DRUG
    Placebo, 4 mg/d, oral route for 7 days, then Baricitinib 4 mg/d oral route for 5 weeks

Study Details

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.

Key Dates

Start date
Jun 27, 2022
Status verified
Nov 2023
Primary completion
Feb 23, 2023
Completion
Mar 31, 2023

Study Design

Enrollment
5 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Patients receiving baricitinib 4mg/day for 7 days, then open label study until day 42 with all patients receiving baricitinib during 5 weeks. 20 patients in this arm will have a MRI at day 0 and day 8
  • Placebo Comparator: Placebo
    Patients receiving placebo 4mg/day for 7 days, then open label study until day 42 with all patients receiving baricitinib during 5 weeks. 20 patients in this arm will have a MRI at day 0 and day 8

Primary Outcome Measure

Percentage of accurate responses in facial emotion recognition task [ Time Frame: Day 1 ]

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