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    Summary
    EudraCT Number:2020-004345-37
    Sponsor's Protocol Code Number:CHUBX2019/56
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-02-11
    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 number2020-004345-37
    A.3Full title of the trial
    Combination of baricitinib and adalimumab vs. baricitinib alone in patients with rheumatoid arthritis: a randomized placebo-controlled phase-III trial
    Efficacité et tolerance de la combinaison baricitinib /adalimumab vs. baricitinib seul dans le traitement de la polyarthrite rhumatoïde : essai clinique randomisé versus placebo de phase III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combination of baricitinib and adalimumab vs. baricitinib alone in patients with rheumatoid arthritis
    Efficacité et tolerance de la combinaison baricitinib /adalimumab vs. baricitinib seul dans le traitement de la polyarthrite rhumatoïde
    A.3.2Name or abbreviated title of the trial where available
    CRI-RA
    CRI-RA
    A.4.1Sponsor's protocol code numberCHUBX2019/56
    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 SponsorCHU de Bordeaux
    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 supportMinistère de la Santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de BORDEAUX
    B.5.2Functional name of contact pointLaetitia LACAZE-BUZY
    B.5.3 Address:
    B.5.3.1Street Address12, rue Dubernat
    B.5.3.2Town/ cityTalence
    B.5.3.3Post code33404
    B.5.3.4CountryFrance
    B.5.4Telephone number33557821134
    B.5.5Fax number33559794926
    B.5.6E-maillaetitia.lacaze-buzy@chu-bordeaux.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 4mg
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 IMRALDI 40mg
    D.2.1.1.2Name of the Marketing Authorisation holderSamsung Bioepis
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Prednisone
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 namePrednisone
    D.3.4Pharmaceutical form Cachet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboInjection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    rheumatoid arthritis (RA)
    polyarthrite rhumatoïde (PR)
    E.1.1.1Medical condition in easily understood language
    rheumatoid arthritis (RA)
    polyarthrite rhumatoïde (PR)
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the clinical efficacy at 24 weeks of the combination strategy of adalimumab (40 mg every two weeks) with baricitinib (4mg daily) versus baricitinib alone (4mg daily) in patients with refractory RA.
    Evaluer l’efficacité clinique à 24 semaines de la combinaison adalimumab (40 mg toutes les 2 semaines) avec le baricitinib (4mg/j) vs. baricitinib en monothérapie (4mg/j) chez des patients avec une PR réfractaire.
    E.2.2Secondary objectives of the trial
    - To assess the safety of the combination of baricitinib and adalimumab versus baricitinib alone, comparing the clinical and biological safety profiles through 24 weeks of follow-up.
    - To assess the clinical efficacy of the combination of baricitinib and adalimumab versus baricitinib alone:
    - To assess drug retention rates at weeks 4, 12 and 24 in each treatment group;
    - To assess the proportion of patients who decrease the glucocorticosteroid dose ≤ 5 mg per day, sustained from week 12 to week 24, among patients with a baseline dose > 5 mg per day, in each treatment group.
    - To assess patient-reported outcomes (HAQ, FACIT, RAID) at week 24 in each treatment group.
    - To assess the maintenance of clinical efficacy at week 52 in each treatment group.
    - Évaluer la tolérance de la combinaison adalimumab/baricitinib vs. baricitinib en monothérapie, en comparant les profils biologiques cliniques sur 24 semaines de suivi.
    - Évaluer l’efficacité clinique de la combinaison adalimumab/baricitinib vs. baricitinib en monothérapie
    - Evaluer le maintien thérapeutique à la semaine 4, 12 et 24 dans chaque groupe de traitement.
    - Evaluer la proportion de patients qui présentent une décroissance des corticoïdes avec une dose journalière ≤ 5 mg, entre la semaine 12 et 24, parmi les patients avec une dose > 5mg par jour à l’inclusion, dans chaque groupe de traitement.
    - Evaluer l’impact sur la qualité de vie (HAQ, FACIT, RAID) à la semaine 24 dans chaque groupe de traitement.
    - Evaluer le maintien de l’efficacité clinique à la semaine 52 dans chaque groupe de traitement.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female;
    - Age between 18 and 75 years-old;
    - Adult patient with a diagnosis of RA as defined by the ACR/EULAR 2010 criteria for the classification of RA;
    - Patient who presents an inadequate response to one to four bDMARDs or tsDMARDs for at least 12 weeks prior to study entry at a dose that is considered acceptable to assess clinical response adequately;
    - Patient affected by active RA (DAS28-ESR > 3.2) eligible to receive a bDMARD or tsDMARD according to the French Society of Rheumatology guidelines;
    - Patient treated by prednisone dosage ≤ 10mg per day. The corticosteroids dosage will be decreased to 7,5 mg/day at the beginning of the study (W0);
    - Person affiliated with or beneficiary of the French social security scheme;
    - Free, informed and written consent signed by the participant and the investigator (on the day of inclusion at the latest and before any examination required by the research project).
    - Patient adulte âgé entre 18 et 75 ans ;
    - Patient présentant un diagnostic de PR défini selon les critères ACR/EULAR 2010 ;
    - Patient présentant une réponse inadéquate à un ou plusieurs bDMARDS (maximum de 4 antécédents de traitements bDMARDs) depuis au moins 12 semaines avant l’inclusion dans l’étude, à une dose considérée comme acceptable pour évaluer la pertinence de la réponse clinique ;
    - Patient atteint d’une PR active (DAS28-VS > 3.2) éligible pour recevoir un bDMARD ou un tsDMARD selon les recommandations de la société française de rhumatologie ;
    - Patient traité par une dose de prednisone ≤ 10mg par jour. La posologie des corticoïdes sera diminuée pour atteindre 7,5 mg/jour au démarrage de l’étude (W0);
    - Personne affiliée à ou bénéficiaire d’un régime de sécurité sociale ;
    - Consentement libre, éclairé et écrit signé par le participant et l’investigateur (au plus tard le jour de l'inclusion et avant tout examen requis par la recherche).
    E.4Principal exclusion criteria
    - Patient previously treated with baricitinib or adalimumab for RA;
    - Patient affected by another form of inflammatory arthritis with the exception of secondary Sjögren syndrome;
    - Patient who presents contraindications to the study treatments;
    - Patient who is currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or has been receiving an unstable dosing regimen of corticosteroids within 4 weeks of study entry;
    - Patient who is currently receiving more than 1 concomitant csDMARD (MTX, leflunomide, hydroxychloroquine or sulfasalazine) at the time of study entry;
    - Patient who is currently receiving or has received csDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX (up to 25 mg/week), leflunomide (up to 20 mg/day), hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 4 weeks prior to study entry.
    - Patient who has received any parenteral corticosteroid administered by intramuscular or intravenous injection within 4 weeks prior to study entry, or is anticipated to require parenteral injection of corticosteroids during the study;
    - Patient who had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 4 weeks prior to study entry. Joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization cannot be counted in the TJC and SJC for entry or enrollment purposes;
    - Patient with haemoglobin less than 80 g/L, absolute lymphocyte count lower than 0.5×109/L, absolute neutrophil count less than 1×109/L, or platelet count less than 100×109/L; clearance creatinine less than 60 mL/min; total bilirubin more than 1,5 times the upper limit of normal (ULN) at screening, aspartate aminotransferase, or alanine amino-transferase more than 2 times the upper limit of normal (ULN) at screening.
    - Patient with co-administration with OAT3 inhibitors with a strong inhibition potential (such as probenecid);
    - Patient who has a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data;
    - Patient who has a history of VTE (DVT/PE) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE). Prior DVT with PE where events overlapped in time (i.e., with PE considered resulting from DVT) is not considered recurrent DVT/PE for the purpose of this criterion;
    - Patient who has been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination). Investigators should review the vaccination status of their patients and follow the local guidelines for adult vaccination with nonlive vaccines intended to prevent infectious disease prior to entering patients into the study;
    - Patient with an active cancer;
    - Patient with malignancy or history of malignancy in the past 5 years, with the exception of adequately treated or excised non-metastatic basal-cell or squamous-cell cancer of the skin or cervical carcinoma in situ;
    - Patient who has a current or recent (<30 days prior to study entry) clinically serious viral, bacterial, fungal, or parasitic infection;
    - Patient who is immunocompromised and, in the opinion of the investigator, is at an unacceptable risk for participating in the study;
    - Patient with a history of active HBV, HCV or HIV;
    - Patient who had household contact with a person with active tuberculosis (TB) and did not receive appropriate and documented prophylaxis for TB;
    - Patient who has evidence of active TB or has previously had evidence of active TB and did not receive appropriate and documented treatment;
    - Patient who has evidence of latent TB (as documented by a positive PPD, no clinical symptoms consistent with active TB, and a normal chest x-ray at screening) unless patient completes at least 3 weeks of appropriate treatment prior to study entry and agrees to complete the remainder of treatment while in the trial
    - Patient who had any major surgery within 8 weeks prior to study entry or will require major surgery during the study that, in the opinion of the investigator, would pose an unacceptable risk to the patient;
    - Pregnant or breastfeeding woman, or woman who refuses to use an effective contraception during the study course;
    - Patient governed by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
    - Patient traité précédemment par baricitinib ou adalimumab pour sa PR;
    - Patient atteint d’un autre rhumatisme inflammatoire chronique, à l’exception d’un syndrome de Sjögren secondaire ;
    - Patient présentant une contre-indication aux traitements à l’étude;
    - Patient traité précédemment par tout autre biologique qu’un anti-TNF;
    - Patient qui reçoit actuellement des corticoïdes à des doses > 10 mg de prednisone par jour (ou équivalent) ou qui a reçu un schéma posologique instable de corticostéroïdes dans les 4 semaines précédant son entrée dans l’étude ;
    - Patient recevant plus d’un traitement csDMARD concomitant (MTX, leflunomide, hydroxychloroquine ou sulfasalazine) à l’inclusion dans l’étude ;
    - Patient recevant ou ayant reçu un csDMARDs (tels que sels d’or, cyclosporine, azathioprine, ou tout autre autre immunosuppresseur) autre que le MTX (dose maximale de 25 mg/semaine), le leflunomide (dose maximale de 20 mg/jour), l’hydroxychloroquine (dose maximale de 400 mg/jour), ou la sulfasalazine (dose maximale de 3000 mg/jour) dans les 4 semaines précédant son entrée dans l’étude.
    - Patient ayant reçu une administration parentérale de corticostéroïdes par injection intramusculaire ou intraveineuse dans les 4 semaines précédant son entrée dans l'étude, ou qui doit en recevoir une pendant l'étude;
    - Patient ayant reçu une injection de corticostéroïdes intra-articulaires ou d'acide hyaluronique dans 3 articulations ou plus dans les 4 semaines précédant l'entrée dans l'étude. Les articulations ayant reçu des injections de corticostéroïdes intra-articulaires ou d'acide hyaluronique dans les 2 semaines précédant l'entrée dans l'étude ou dans les 6 semaines précédant la randomisation prévue ne peuvent pas être comptées dans le nombre d’articulations douloureuses et gonflées pour l'entrée dans l’étude ;
    - Patient présentant une hémoglobine inférieure à 80 g/L, une numération lymphocytaire absolue inférieure à 0,5×109/L, une numération absolue des neutrophiles inférieure à 1×109/L ou une numération plaquettaire inférieure à 100×109/L ; une clairance de la créatinine inférieure à 60 ml/min ; une bilirubine totale supérieure à 1,5 fois la limite supérieure de la normale (LSN) au moment du screening, des ASAT ou ALAT à 2 fois la limite supérieure de la normale (LSN) au moment du screening ;
    - Patient avec un traitement concomitant par inhibiteur de l’OAT3 (tel que le probenecid);
    - Patient ayant des antécédents ou présentant des troubles cardiovasculaires, respiratoires, hépatiques, gastro-intestinaux, endocriniens, hématologiques, neurologiques ou neuropsychiatriques ou toute autre maladie grave et/ou instable qui, de l'avis de l'investigateur, pourrait constituer un risque lors de la prise du produit de recherche ou pourrait interférer avec l'interprétation des données;
    - Patient qui a été exposé à un vaccin vivant dans les 12 semaines précédant la randomisation prévue ou qui devrait avoir besoin de recevoir un vaccin vivant au cours de l'étude (à l'exception de la vaccination contre l'herpès zoster). Les investigateurs doivent examiner le statut vaccinal de leurs patients et suivre les directives locales pour la vaccination des adultes avec des vaccins non vivants destinés à prévenir les maladies infectieuses avant d’inclure les patients dans l'étude ;
    - Patient présentant un cancer actif;
    - Patient présentant un cancer ou des antécédents de cancer au cours des 5 dernières années, à l'exception d'un cancer basocellulaire ou squameux non métastatique de la peau ou d'un carcinome du col de l'utérus in situ, traité ou excisé de manière adéquate;
    - Patient atteint d'une infection virale, bactérienne, fongique ou parasitaire actuelle ou récente (<30 jours avant l'entrée dans l'étude) cliniquement grave;
    - Patient immunodéprimé qui, de l'avis de l'investigateur, présente un risque inacceptable de participer à l'étude;
    - Patient ayant des antécédents VHB, VHC ou VIH;
    - Patient ayant eu des contacts rapprochés avec une personne atteinte de tuberculose active, et n'ayant pas reçu de prophylaxie appropriée et documentée contre la tuberculose;
    - Patient présentant des signes de tuberculose active ou ayant déjà présenté des signes de tuberculose active, et n'ayant pas reçu de traitement approprié et documenté;
    - Patient présentant des signes de tuberculose latente documentés, sauf si le patient suit un traitement approprié pendant au moins trois semaines avant son entrée dans l'étude et accepte de suivre le reste du traitement pendant l'essai ;
    - Patient ayant subi une intervention chirurgicale majeure dans les 8 semaines précédant son entrée dans l'étude ou qui devra subir une intervention chirurgicale majeure au cours de l'étude qui, de l'avis de l'investigateur, présenterait un risque inacceptable pour le patient;
    - Femme enceinte ou qui allaite, ou femme qui refuse d'utiliser une contraception efficace pendant la durée de l’étude ;
    - Patient couvert par les articles L 1121-5 à L 1121-8.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients who achieve an ACR 50 response at week 24 in each treatment group (COMBI group (adalimumab + baricitinib) vs. MONO group (baricitinib conventional therapy)).
    Proportion de patients qui atteignent une réponse ACR50 à la semaine 24 dans chaque groupe de traitement (groupe COMBI (adalimumab + baricitinib) vs. Groupe MONO (baricitinib)).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 months of treatment
    Après 6 mois de traitement
    E.5.2Secondary end point(s)
    - Proportion of AEs and SAEs in each treatment group;
    - Proportion of patients who achieve an ACR20 response and an ACR70 response at weeks 4, 12 and 24 in each treatment group;
    - Proportion of patients who achieve an ACR50 response at weeks 4 and 12 in each treatment group
    - Proportion of patients who present a EULAR response at weeks 4, 12 and 24, according to DAS28-ESR, in each treatment group;
    - Proportion of patients who achieve remission or low disease activity at weeks 4, 12 and 24, according to DAS28-ESR, in each treatment group;
    - Quantitative change in DAS28-ESR, DAS28-CRP, sDAI and cDAI scores between baseline and each visit (until week 24 included) for each treatment group of treatment;
    - Drug retention rates at weeks 4, 12 and 24 in each treatment group;
    - Proportion of patients who decrease the glucocorticosteroid dose ≤ 5 mg per day, sustained from week 12 to week 24, among patients with a baseline dose > 5 mg per day, in each treatment group;
    - Quantitative change in patient-reported outcomes (HAQ, FACIT, RAID) between baseline, weeks 4, 12 and 24 visit in each treatment group;
    - Proportion of participants maintaining an ACR50 response, remission or low disease activity at week 52 in each treatment group.
    - Quantitative change in DAS28-ESR, DAS28-CRP, sDAI and cDAI scores between weeks 24 and 52 in each treatment group.
    - Proportion d’EIs et d’EIGs dans chaque groupe de traitement;
    - Proportion de patients qui atteignent une réponse ACR20 et ACR70 à la semaine 4, 12 et 24 dans chaque groupe de traitement ;
    - Proportion de patients qui atteignent une réponse ACR50 à al semaine 4 et à la semaine 12 dans chaque groupe de traitement ;
    - Proportion de patients qui atteignent une réponse EULAR à la semaine 4, 12 et 24, évaluée selon le DAS28-VS, dans chaque groupe de traitement ;
    - Proportion de patients qui atteignent la rémission ou un faible niveau d’activité à la semaine 4, 12 et 24, évaluée selon le DAS28-VS, dans chaque groupe de traitement ;
    - Variation des scores DAS28-VS, DAS28-CRP, sDAI et cDAI entre la visite W0 et chaque visite de suivi (jusqu’à la semaine 24 inclus) dans chaque groupe de traitement;
    - Proportion de patients qui diminue leur dose de glucocorticosteroïdes ≤ 5 m/jour, entre la semaine 12 et la semaine 24, parmi les patients avec une dose > 5mg par jour à l’inclusion, dans chaque groupe de traitement.
    - Taux de maintien thérapeutique à la semaine 4, 12 et 24 dans chaque groupe de traitement ;
    - Variations dans les scores de qualité de vie (HAQ, FACIT, RAID) entre la visite W0 et la semaine 4, 12 et 24 dans chaque groupe de traitement ;
    - Proportion de patients qui maintiennent une réponse ACR50, la rémission ou un faible niveau d’activité à la semaine 52 dans chaque groupe de traitement ;
    - Variations des scores DAS28-VS, DAS28-CRP, sDAI et cDAI entre la semaine 24 et la semaine 52 dans chaque groupe de traitement.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 12 months of inclusion
    A 12 mois de l'inclusion
    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 Yes
    E.6.4Safety Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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 concerned19
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA1
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Monaco
    France
    E.8.7Trial has a data monitoring committee Yes
    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
    LVLS
    Dernière visite du dernier patient (DVDP)
    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 months42
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months42
    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: 140
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state178
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Aucune
    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 Decision2021-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-04-06
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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