BARIcitinib Cognitive Emotional and Neural signaTuRE

NCT05238896 | Terminated Phase 4

• 2 other identifiers: APHP1903532020-005773-27
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Active rheumatoid arthritis; Baricitinib treatment; Mood-improving effects; MRI

Outcome Measures

Primary Outcomes (1)

• Percentage of accurate responses in facial emotion recognition task

  Percentage of accurate responses in facial emotion recognition task using Harmer's cognitive battery (based on Harmer \& Cowen evaluation protocol)

  Day 1

Secondary Outcomes (11)

• DIfference in disease activity

  Day 0, 8 and 42

• Difference in function improvement

  Day 0, 8 and 42

• Difference in pain

  Day 0, 8 and 42

• Difference in patient global assessment of the disease

  Day 0, 8 and 42

• Number of accurate responses in facial emotion recognition task

  Day 8

Study Arms (2)

Baricitinib

EXPERIMENTAL

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

Drug: Baricitinib Oral Tablet [Olumiant]

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Baricitinib Oral Tablet [Olumiant] DRUG

Baricitinib 4 mg/d oral route for 42 days

Also known as: Baricitinib

Baricitinib

Placebo DRUG

Placebo, 4 mg/d, oral route for 7 days, then Baricitinib 4 mg/d oral route for 5 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged between 18 and 75 years
• Diagnosis of RA according to the ACR/EULAR 2010 classification criteria
• 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)
• Informed and signed consent
• Affiliation to a french social security system (beneficiary or legal)
• For child-bearing aged women, efficient contraception

You may not qualify if:

• Patient under tutorship or guardianship, and incapable to give informed consent
• Diagnosis of a systemic autoimmune disease other than RA
• Treatment not allowed:
• DMARDS other than Methotrexate or Leflunomide or Hydroxychloroquine or Salazopyrine.
• Psychotropic treatments (antidepressive drugs, benzodiazepine, mood stabilizer) during the study or the month prior the study that could change the mood evaluation.
• Any contraindications to baricitinib treatment or to Non-contrast MRI exam
• Hypersensitivity to the active substance or to any of the excipients
• History of active tuberculosis without treatment or chronic infectious diseasewith a need of regular use of antibiotic
• Active or prior bacterial or viral infection that required treatment with antibiotics within 30 days prior to screening
• History of lymphoma or leukemia or other malignancy besides non-melanoma skin cancer within 5 years
• Uncontrolled medical condition or planned major surgery during the study
• Pregnancy or breast-feeding
• Claustrophobia
• Patient unable to understand and follow recommendations or unable to perform self-evaluation

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

CHU Pitié Salpêtrière

Paris, 75013, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Bruno FAUTREL, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Florian BAILLY, MD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: February 14, 2022
• Study Start: June 27, 2022
• Primary Completion: February 23, 2023
• Study Completion: March 31, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodological sound proposal.

Locations

FR (1)