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    Summary
    EudraCT Number:2018-002655-14
    Sponsor's Protocol Code Number:29BRC18.0144
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-09-06
    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 number2018-002655-14
    A.3Full title of the trial
    BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    BAriCitinib Healing Effect in earLy pOlymyalgia Rheumatica (BACHELOR study)
    A.3.2Name or abbreviated title of the trial where available
    BACHELOR
    A.4.1Sponsor's protocol code number29BRC18.0144
    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 SponsorCHRU BREST
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 baricitinib
    D.2.1.1.2Name of the Marketing Authorisation holderLILLY
    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 nameOLUMIANT
    D.3.4Pharmaceutical form Tablet
    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 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.3.11.13.1Other medicinal product typeBaricitinib represents a selective inhibitor of the Janus kinase (JAK) family of protein tyrosine kinases with selectivity for JAK1 and JAK2, and less selectivity for JAK3, or tyrosine kinase 2
    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
    polymyalgia rheumatica
    E.1.1.1Medical condition in easily understood language
    Inflammatory disease in the elderly
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10036099
    E.1.2Term Polymyalgia rheumatica
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the ability of baricitinib in comparison to placebo to obtain a disease activity [PMR-AS(CRP)] lower or equal to 10 without oral GCs (prednisone or prednisolone) at week 12 in early PMR patients.
    E.2.2Secondary objectives of the trial
    To evaluate in both arm:
    - Ability of baricitinib (4 mg by day for 12 weeks and then 2 mg for 12 weeks) to treat PMR without any dosage of steroids
    - Safety profile of baricitinib in PMR
    - PMR-AS(CRP) in baricitinib arm versus placebo
    - PMR-AS using ESR, imputed CRP, and without CRP
    - Cost of baricitinib arm in comparison to placebo and GCs
    - Cumulative dose of GCs in baricitinib arm versus placebo
    - Evaluation of synovitis and tenosynovitis in shoulders and hips using ultrasound in mode B and Doppler
    - Proportion of patients with PMR-AS ≤ 1.5 (remission) or PMR-AS > 1.5 (non-remission) at each visit
    - Proportion of patients with PMR-AS ≤7 (inactive) 7 < PMR-AS ≤17 (low activity) and PMR-AS > 17 (high activity) at each visit
    - Patients with PMR-AS <10 (recommanded treatment), 10≤ PMR-AS ≤20 (stable treatment) and PMR-AS > 20 (indication for therapeutic change) at each visit
    - Biological markers and cells subpopulations
    -quality of life
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - At least 50 years of age
    - Fulfilling ACR/EULAR criteria for PMR
    - Disease duration ≤6 months
    - No oral or parenteral steroid since ≥ 2 weeks prior to randomization
    - PMR-AS >17
    - Absence of connective tissue diseases or vasculitis
    E.4Principal exclusion criteria
    - Clinical symptoms of giant cell arteritis
    - Uncontrolled high blood pressure or cardiovascular disease
    - Clinical evidence of significant unstable or uncontrolled acute or chronic diseases not due to PMR
    - Planned major surgical procedure during the study.
    - History of malignant neoplasm within the last 5 years (or 3 years in case of cervical carcinoma, basal cell or squamous epithelial skin cancer resected with no evidence of recurrence or metastatic disease).
    - Current active uncontrolled infection
    - Detailed exclusion criteria related to prior or concomitant therapy, general safety and laboratory data are reported in the protocol
    E.5 End points
    E.5.1Primary end point(s)
    at week 12, is a PMR-AS (CRP) ≤10 (no flare) without steroids.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    In both arms
    - PMR-AS(CRP) at inclusion, week 2, 4, 8, 12, 16, 20 24, 28, 36 (i.e. at each visit)
    - PMR-AS using ESR, imputed CRP and PMR-AS without CRP at each visit
    - Proportion of patients with PMR-AS ≤ 1.5 (remission) or PMR-AS > 1.5 (non-remission) at each visit
    - Proportion of patients with PMR-AS ≤7 (inactive) 7 < PMR-AS ≤17 (low activity) and PMR-AS > 17 (high activity) at each visit
    - Patients with PMR-AS <10 (recommended treatment decrease), 10≤ PMR-AS ≤20 (stable treatment) and PMR-AS > 20 (indication for therapeutic change) at each visit
    - Adverse events following SOC classification
    - Cost of baricitinib
    - Cumulative dose of GCs at W24 and W36- Percentage of patients free of GCs and dose of GCs at W12, W20, W24 and W36
    - Ultrasound Scoring of synovitis and tenosynovitis (mode B and Doppler) at inclusion and W12 and W24
    - Level of biological markers and cell subpopulations in baricitinib and placebo arms: cytokines, immune cells, CRP at inclusion, W12, W24
    - Quality of life (SF-36, HAQ-DI, EQ5D) at inclusion, W12, 24 and 36
    E.5.2.1Timepoint(s) of evaluation of this end point
    36 weeks
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned4
    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 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
    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 months22
    E.8.9.1In the Member State concerned days
    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: 34
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 34
    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 state34
    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 Decision2019-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-20
    P. End of Trial
    P.End of Trial StatusOngoing
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