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    Summary
    EudraCT Number:2020-005773-27
    Sponsor's Protocol Code Number:APHP190353
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-005773-27
    A.3Full title of the trial
    BARIcitinib Cognitive Emotional and Neural signaTuRE
    BARICENTRE
    BARIcitinib signaTuRE Cognitive, Emotionnelle et Neuronale
    BARICENTRE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BARIcitinib Cognitive Emotional and Neural signaTuRE
    BARICENTRE
    BARIcitinib signaTuRE Cognitive, Emotionnelle et Neuronale
    BARICENTRE
    A.3.2Name or abbreviated title of the trial where available
    BARICENTRE
    A.4.1Sponsor's protocol code numberAPHP190353
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportDGOS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS
    B.5.2Functional name of contact pointPôle Promotion-DRCI
    B.5.3 Address:
    B.5.3.1Street AddressDRCI - Hôpital St Louis, 1 av Claude Vellefaux
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75010
    B.5.3.4CountryFrance
    B.5.4Telephone number+33140 27 57 27
    B.5.5Fax number+331 44 84 17 01
    B.5.6E-mailcarla.vandenabele@aphp.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OLUMIANT 4 mg
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBaricitinib
    D.3.2Product code LY3009104
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.1CAS number 1187594-09
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name OLUMIANT 4mg
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBaricitinib
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBARICITINIB
    D.3.9.1CAS number 1187594-09
    D.3.9.4EV Substance CodeSUB180983
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with rheumatoid arthritis and indication of baricitinib treatment according to a rheumatologist
    Patients atteints de polyarthrite rhumatoïde et indication d'un traitement par baricitinib selon un rhumatologue
    E.1.1.1Medical condition in easily understood language
    Patients with rheumatoid arthritis and indication of baricitinib treatment according to a rheumatologist
    Patients atteints de polyarthrite rhumatoïde et indication d'un traitement par baricitinib selon un rhumatologue
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10039076
    E.1.2Term Rheumatoid arthritis and other inflammatory polyarthropathies
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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).
    L'objectif principal de cette étude est de détecter les premiers marqueurs cognitifs - émotionnels précoces des effets d'amélioration de l'humeur du baricitinib, inhibiteur de JAK 1/2, en utilisant une batterie de tests émotionnels et cognitifs (batterie cognitive de Harmer).
    E.2.2Secondary objectives of the trial
    - 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
    - Évaluer les effets précoces et tardifs sur la sensibilisation à la douleur du Baricitinib à l'aide d'une évaluation clinique (Tests Quantitatifs Sensoriels) et d'une IRM cérébrale
    - évaluer les modulations précoces de la portion sub-génuale du cortex cingulaire antérieur à l'aide de l'IRM fonctionnelle, qui est un marqueur indirect précoce de l'humeur et de la douleur sociale
    - Évaluer les effets tardifs du Baricitinib sur les symptômes de l'humeur selon l'échelle d'évaluation de la dépression de Hamilton et l'inventaire de la dépression de Beck.
    - Évaluer la proportion d'efficacité liée à l'attente du médicament
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    1-Patients âgés de 18 à 75 ans
    2-Diagnostic de PR selon les critères de classification ACR/EULAR 2010
    3-Polyarthrite rhumatoïde active à l'inclusion (définie par un score d'activité de la maladie (DAS28) > 3,2)
    4-Patient éligible au traitement par Baricitinib en accord avec les recommandations européennes et les recommandations françaises pour le traitement de la PR avec un dosage de 4mg (les patients avec un dosage de 2mg ne seront pas inclus pour assurer l'homogénéité des patient)
    5-Consentement éclairé et signé
    6-Affiliation à un régime de sécurité sociale français (bénéficiaire ou légal)
    7-Pour les femmes en âge de procréer, une contraception efficace
    E.4Principal 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 < 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
    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
    1-Patient sous tutelle ou curatelle, et incapable de donner un consentement éclairé
    2-Diagnostic d'une maladie auto-immune systémique autre que la PR
    3-Traitements non autorisés :
    o DMARDS autres que Méthotrexate ou Léflunomide ou Hydroxychloroquine ou Salazopyrine.
    o Les traitements psychotropes (antidépresseurs, benzodiazépine, stabilisateur d'humeur) pendant l'étude ou le mois précédant l'étude qui pourraient modifier l'évaluation de l'humeur.
    4-Exclusion des laboratoires :
    o Leucopénie inférieure à 3 x 109 cellules/L
    o Lymphopénie inférieure à 0,5 x 109 cellules/L
    o Neutropénie inférieure à 1 x 109 cellules/L
    o Hémoglobine inférieure à 8,0 g/dl
    o eGFR < 60 mL/min/1,73 m² sur la base de la créatinine sérique la plus récente (méthode Cockroft-Gault)
    o ALT ou AST > 5 fois la limite supérieure de la normale
    o Toute anomalie sur les tests de laboratoire de dépistage qui, de l'avis de l'investigateur, pourrait représenter un risque lors de la participation au présent protocole
    5-Toute contre-indication au traitement par Baricitinib ou IRM sans produit de contraste
    6-Hypersensibilité à la substance active ou à l'un des excipients
    7-Antécédents de tuberculose active sans traitement ou de maladie infectieuse chronique nécessitant un usage régulier d'antibiotiques
    8-Infection bactérienne virale active ou antérieure qui a nécessité un traitement antibiotique dans les 30 jours précédant le dépistage
    9-Antécédents de lymphome ou de leucémie ou d'une autre forme de malignité en plus d'un cancer de la peau non mélanique dans les 5 ans
    10-Condition médicale non contrôlée ou intervention chirurgicale majeure prévue pendant l'étude
    11- Grossesse ou allaitement
    12- Claustrophobie
    13-Patient incapable de comprendre et de suivre les recommandations ou incapable de procéder à une auto-évaluation
    14-Participation à une autre étude interventionnelle ou le fait d'être dans la période d'exclusion à la fin d'une étude précédente.
    15-Les patients ayant des intentions ou des comportements suicidaires actuels
    E.5 End points
    E.5.1Primary 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)).
    Le critère d’évaluation principal est le nombre de réponses précises dans la tâche de reconnaissance des émotions faciales au jour 1 en utilisant la batterie cognitive de Harmer (basée sur le protocole d'évaluation de Harmer & Cowen au jour 1 (Harmer & Cowen, 2013)).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1
    Jour 1
    E.5.2Secondary 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
    - Différence dans l'activité de la PR et l'évaluation de la douleur (DAS28 - SDAI - HAQ - Douleur VAS - Évaluation globale du patient - Éruption de la PR) entre les jours 0, 8 et 42.
    - Le nombre de réponses précises dans la tâche de reconnaissance des émotions faciales au jour 8.
    - Différence de sensibilisation à la douleur centrale et périphérique entre le jour 0, le jour 8 et le jour 42 à l'aide de tests sensoriels quantitatifs
    - Différence des résultats du questionnaire psychométrique entre le jour 0, le jour 8 et le jour 42 en utilisant l'indice de dépression de Beck et l'échelle de Hamilton
    - Différence dans l'activité du signal dépendant du niveau d'oxygène dans le sang (BOLD) sur l'IRM dans la portion sub-génuale du cortex cingulaire antérieur entre le jour 0 et le jour 8 pendant l'expérience d'exclusion sociale
    - Différence d'activité du signal BOLD dans les régions douloureuses entre le jour 0 et le jour 8
    - Différence d'efficacité entre les patients ayant des attentes élevées ou faibles à l'égard du médicament
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 8 and Day 42
    Jour 8 et Jour 42
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last Visit of the Last Subject
    Dernière visite du dernier patient inclus
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 68
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-02-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-09
    P. End of Trial
    P.End of Trial StatusCompleted
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