Patients with rheumatoid arthritis and indication of baricitinib treatment according to a rheumatologist MedDRA version: 20.0 Level: LLT Classification code 10039076 Term: Rheumatoid arthritis and other inflammatory polyarthropathies System Organ Class: 100000004859
Conditions
Interventions
Trade Name: OLUMIANT 4 mg
Product Name: Baricitinib
Product Code: LY3009104
Pharmaceutical Form: Tablet
INN or Proposed INN: BARICITINIB
CAS Number: 1187594-09
Concentration unit: mg milligram(s)
Conc
Sponsors
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1-Patients aged between 18 and 75 years 2-Diagnosis of RA according to the ACR/EULAR 2010 classification criteria 3-Active rheumatoid arthritis at inclusion (defined by a Disease Activity Score (DAS28) > 3.2) 4-Patient eligible for baricitinib treatment in agreement with European label and French recommendations for RA treatment with dosage of 4mg (patients with 2mg dosage will not be included to ensure patient homogeneity) 5-Informed and signed consent 6-Affiliation to a French social security system (beneficiary or legal) 7-For child-bearing aged women, efficient contraception Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1-Patient under tutorship or guardianship, and incapable to give informed consent 2-Diagnosis of a systemic autoimmune disease other than RA 3-Treatment not allowed: o DMARDS other than Methotrexate or Leflunomide or Hydroxychloroquine or Salazopyrine. o Psychotropic treatments (antidepressive drugs, benzodiazepine, mood stabilizer) during the study or the month prior the study that could change the mood evaluation. 4-Laboratory exclusions: o Total white blood cell count (WBC) less than 3 x 109 cells/L o Absolute lymphocyte count (ALC) less than 0.5 x 109 cells/L o Absolute neutrophil count (ANC) less than 1 x 109 cells/L o Hemoglobin less than 8.0 g/dl o eGFR 5 times upper limit of normal o Any abnormality on screening laboratory tests that, in the opinion of the investigator, could represent a risk when participating in this protocol 5-Any contraindications to baricitinib treatment or to MRI exam 6-Hypersensitivity to the active substance or to any of the excipients 7-History of active tuberculosis without treatment or chronic infectious disease with a need of regular use of antibiotic 8-Active or prior bacterial or viral infection that required treatment with antibiotics within 30 days prior to screening 9-History of lymphoma or leukemia or other malignancy besides non-melanoma skin cancer within 5 years 10-Uncontrolled medical condition or planned major surgery during the study 11-Pregnancy or breast-feeding 12-Claustrophobia 13-Patient unable to understand and follow recommendations or unable to perform self-evaluation 14-Participation in another interventional study or being in the exclusion period at the end of a previous study. 15-Patients with current suicidal intents or behaviours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to detect early cognitive markers of mood-improving effects of the JAK 1/2 inhibitor Baricitinib using a battery of emotional and cognitive tasks (Harmer’s cognitive battery). ;Secondary Objective: - To assess early and late effects on pain sensitization of Baricitinib with clinical (Quantitative Sensory Testing) and MRI evaluation - To assess early modulations of Sg-ACC with functional MRI, which is a surrogate marker of mood and social pain - To assess late effects of Baricitinib on mood symptoms according to the Hamilton depressive rating scale and the Beck depression inventory. - To evaluate the proportion of efficacy related to the expectation of the drug ;Primary end point(s): The primary outcome is the number of accurate responses in facial emotion recognition task at day 1 using Harmer’s cognitive battery (based on Harmer & Cowen evaluation protocol at day 1 (Harmer & Cowen, 2013)). ;Timepoint(s) of evaluation of this end point: Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in RA activity and pain assessment (DAS28 – SDAI – HAQ – Pain VAS – Patient global assessment – Flare RA) between day 0, 8 and 42. - The number of accurate responses in facial emotion recognition task at day 8. - Difference in central and peripheral pain sensitization between day 0, day 8 and day 42 using quantitative sensory testing - Difference in the results of psychometric questionnaire between day 0, day 8 and day 42 using Beck Depression Index and Hamilton scale - Difference in blood-oxygen-level dependent (BOLD) signal activity on MRI in the Sg-ACC between day 0 and day 8 during social exclusion experience - Difference in BOLD signal activity in pain regions between day 0 and 8 - Difference of efficacy between patients with high or low expectations of the drug;Timepoint(s) of evaluation of this end point: Day 8 and Day 42 | — |
Countries
France
Contacts
Public ContactPôle Promotion-DRCI
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS
Outcome results
None listed