Rheumatoid ArthritisPhase 4BARICENTRENCT05238896
BARIcitinib Cognitive Emotional and Neural signaTuRE
A Phase 4 study testing Baricitinib Oral Tablet [Olumiant] in people with Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Baricitinib Oral Tablet [Olumiant]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jun 2022to 31 Mar 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 18 and 75 years
- Diagnosis of RA according to the ACR/EULAR 2010 classification criteria
- Active rheumatoid arthritis at inclusion (defined by a Disease Activity Score (DAS28) > 3.2)
- 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
Who cannot join
- 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.
- 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 < 60 mL/min/1.73 m² based on the most recent serum creatinine (Cockroft-Gault method) o ALT or AST > 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
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- 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
- Participation in another interventional study or being in the exclusion period at the end of a previous study.
- Patients with current suicidal intents or behaviors, Past or present depression or anxiety will be neither a criterion for inclusion nor a criterion for non-inclusion but will be collected in case report form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BARIcitinib Cognitive Emotional and Neural signaTuRE (BARICENTRE)
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.
Read more
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.
Read the detailed description
Rheumatoid arthritis (RA) is a frequent and disabling disease, requiring early management to achieve clinical remission. Recently, baricitinib (jak1-jak2 inhibitor) has demonstrated its efficacy compared to placebo, 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. Inhibition of JAK pathway could have anti-inflammatory activity but also direct action on 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 Harmer's cognitive and emotional battery, This emotional aspect is a surrogate marker of future mood impact.
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).
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. At baseline (day 0), RA activity, mood symptoms, the number of accurate responses in facial emotion recognition task (Harmer's cognitive battery), clinical pain sensitization, will be assessed.3 follow-up research visits will be conducted at day 1, 8 and 42 (final visit) at the Pitié Salpêtrière hospital.The first intake of the Investigational medicinal product (IMP) (baricitinib or placebo) is at day 1. At day 1, the number of accurate responses in facial emotion recognition task and RA activity will be evaluated (2 to 4 hours after intake of baricitinib). At day 8 and 42, RA activity and flares, mood symptoms, the number of accurate responses in facial emotion recognition task (Harmer's cognitive battery), clinical pain sensitization, will be assessed. In each group (placebo vs Baricitinib), 20 patients will underwent a non-contrast MRI at day 0 and 8 (with evaluation of mood modification using BOLD signal during the different experimental conditions of the Cyberball task with comparison to baseline condition, and pain evaluation using fMRI-based neurological pain signature provided by Wager et al.) During the follow-up until day 42, patients will conduct questionnaires (day 15 and 29) at home about RA activity, pain (Patient pain VAS, Patient global assessment of the disease, Flare RA questionnaire) and psychometric questionnaire (Hospital Anxiety and Depression Scale)
- Conditions
- Rheumatoid Arthritis
- Being tested
- Baricitinib Oral Tablet [Olumiant], Placebo
- Keywords
- Active rheumatoid arthritis, Baricitinib treatment, Mood-improving effects, MRI
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baricitinib Oral Tablet [Olumiant]Drug
Also called Baricitinib
Baricitinib 4 mg/d oral route for 42 days
PlaceboDrug
Placebo, 4 mg/d, oral route for 7 days, then Baricitinib 4 mg/d oral route for 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Day 1
Secondary outcomes (11)
DIfference in disease activity
DIfference in disease activity on DAS28 (disease activity score on 28 joints) - SDAI (Simplified Disease Activity Score)
Measured: Day 0, 8 and 42
Difference in function improvement
Difference in function improvement on HAQ (health assessment questionnaire)
Measured: Day 0, 8 and 42
Difference in pain
Difference in pain using Visual Analogic Scale (VAS) for pain
Measured: Day 0, 8 and 42
Difference in patient global assessment of the disease
Difference in VAS for patient global assessment of the disease
Measured: Day 0, 8 and 42
Number of accurate responses in facial emotion recognition task
The number of accurate responses in facial emotion recognition task using Harmer's cognitive battery (based on Harmer \& Cowen evaluation protocol)
Measured: Day 8
Difference in central and peripheral pain sensitization
Difference in central and peripheral pain sensitization using quantitative sensory testing
Measured: Day 0, 8 and 42
Difference in the results of psychometric questionnaire
Difference in the results of psychometric questionnaire using Hospital Anxiety and Depression Scale
Measured: Day 0, 8 and 42
Difference in blood-oxygen-level dependent (BOLD) signal activity in regions of interest (ROI) such as the subgenual anterior cingulate cortex (Sg-ACC) during a cyberball task
Main effect of group on social exclusion-related brain responses (e.g. actiavtion of the Sg_ACC ROI)
Measured: day 0 and day 8
Difference in BOLD signal activity in pain-encoding brain regions
Main effect of group in pain-related brain responses
Measured: day 0 and day 8
Differences in mood and pain assessments between patients with high or low expectations of the drug
Main effect of group on accurate responses during the facial emotion recognition task and pain assessment variables
Measured: Day 1,8 and 42
Difference in BOLD signal activity in reward-learning related brain regions
Main effect of group reward-learning related brain responses (e.g. activation of the ventral striatum or vmPFC ROIs)
Measured: day 0 and day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2022
- Study start27 Jun 2022
- Primary completion23 Feb 2023
- Study completion31 Mar 2023
Why it stopped: Difficulties of inclusion in the study following expiry of the experimental treatment. The time required to supply the study treatment is too long to obtain conclusive results at the end of the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno FAUTREL, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisFlorian BAILLY, MD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05238896
- Sponsor's protocol ID
- APHP190353
- Other IDs
- 2020-005773-27
- Acronym
- BARICENTRE
- Status last verified
- Nov 2023
- First submitted
- 4 Jan 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BARIcitinib Cognitive Emotional and Neural signaTuRE (BARICENTRE)
- ClinicalTrials.gov ID
- NCT05238896
- Acronym / sponsor ID
- BARICENTRE / APHP190353
- Conditions
- Rheumatoid Arthritis
- Keywords
- Active rheumatoid arthritis, Baricitinib treatment, Mood-improving effects, MRI
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties of inclusion in the study following expiry of the experimental treatment. The time required to supply the study treatment is too long to obtain conclusive results at the end of the study.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 27 Jun 2022 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rheumatoid arthritis (RA) is a frequent and disabling disease, requiring early management to achieve clinical remission. Recently, baricitinib (jak1-jak2 inhibitor) has demonstrated its efficacy compared to placebo, 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. Inhibition of JAK pathway could have anti-inflammatory activity but also direct action on 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 Harmer's cognitive and emotional battery, This emotional aspect is a surrogate marker of future mood impact.
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).
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. At baseline (day 0), RA activity, mood symptoms, the number of accurate responses in facial emotion recognition task (Harmer's cognitive battery), clinical pain sensitization, will be assessed.3 follow-up research visits will be conducted at day 1, 8 and 42 (final visit) at the Pitié Salpêtrière hospital.The first intake of the Investigational medicinal product (IMP) (baricitinib or placebo) is at day 1. At day 1, the number of accurate responses in facial emotion recognition task and RA activity will be evaluated (2 to 4 hours after intake of baricitinib). At day 8 and 42, RA activity and flares, mood symptoms, the number of accurate responses in facial emotion recognition task (Harmer's cognitive battery), clinical pain sensitization, will be assessed. In each group (placebo vs Baricitinib), 20 patients will underwent a non-contrast MRI at day 0 and 8 (with evaluation of mood modification using BOLD signal during the different experimental conditions of the Cyberball task with comparison to baseline condition, and pain evaluation using fMRI-based neurological pain signature provided by Wager et al.) During the follow-up until day 42, patients will conduct questionnaires (day 15 and 29) at home about RA activity, pain (Patient pain VAS, Patient global assessment of the disease, Flare RA questionnaire) and psychometric questionnaire (Hospital Anxiety and Depression Scale)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: Baricitinib Oral Tablet [Olumiant]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 | Placebo comparator | Drug: PlaceboPatients 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients aged between 18 and 75 years
- Diagnosis of RA according to the ACR/EULAR 2010 classification criteria
- Active rheumatoid arthritis at inclusion (defined by a Disease Activity Score (DAS28) > 3.2)
- 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
Key exclusion criteria (17 listed)
- Patient under tutorship or guardianship, and incapable to give informed consent
- Diagnosis of a systemic autoimmune disease other than RA
- Treatment not allowed:
- 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 < 60 mL/min/1.73 m² based on the most recent serum creatinine (Cockroft-Gault method) o ALT or AST > 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
- Any contraindications to baricitinib treatment or to Non-contrast MRI exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baricitinib Oral Tablet [Olumiant]Also: BaricitinibBaricitinib 4 mg/d oral route for 42 days | Drug | Baricitinib |
| PlaceboPlacebo, 4 mg/d, oral route for 7 days, then Baricitinib 4 mg/d oral route for 5 weeks | Drug | Placebo |
Primary outcome
Percentage of accurate responses in facial emotion recognition task
Time frame: Day 1
Percentage of accurate responses in facial emotion recognition task using Harmer's cognitive battery (based on Harmer \& Cowen evaluation protocol)
11 secondary outcomes
DIfference in disease activity
Time frame: Day 0, 8 and 42
Difference in function improvement
Time frame: Day 0, 8 and 42
Difference in pain
Time frame: Day 0, 8 and 42
Difference in patient global assessment of the disease
Time frame: Day 0, 8 and 42
Number of accurate responses in facial emotion recognition task
Time frame: Day 8
Difference in central and peripheral pain sensitization
Time frame: Day 0, 8 and 42
Difference in the results of psychometric questionnaire
Time frame: Day 0, 8 and 42
Difference in blood-oxygen-level dependent (BOLD) signal activity in regions of interest (ROI) such as the subgenual anterior cingulate cortex (Sg-ACC) during a cyberball task
Time frame: day 0 and day 8
Difference in BOLD signal activity in pain-encoding brain regions
Time frame: day 0 and day 8
Differences in mood and pain assessments between patients with high or low expectations of the drug
Time frame: Day 1,8 and 42
Difference in BOLD signal activity in reward-learning related brain regions
Time frame: day 0 and day 8
Results and safety
The study was stopped early (reason given: Difficulties of inclusion in the study following expiry of the experimental treatment. The time required to supply the study treatment is too long to obtain conclusive results at the end of the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients. Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno FAUTREL, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Florian BAILLY, MD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Baricitinib Oral Tablet [Olumiant] in people with Rheumatoid Arthritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulties of inclusion in the study following expiry of the experimental treatment. The time required to supply the study treatment is too long to obtain conclusive results at the end of the study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of accurate responses in facial emotion recognition task (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.