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    Summary
    EudraCT Number:2019-000889-38
    Sponsor's Protocol Code Number:2019/MyJIA
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-18
    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 ConcernedNorway - NOMA
    A.2EudraCT number2019-000889-38
    A.3Full title of the trial
    Strategies towards personalised treatment
    in Juvenile Idiopathic Arthritis (JIA):
    An open randomised multicentre blinded-assessor trial assessing the effectiveness of intra-articular glucocorticoid injections in JIA patients starting tumour necrosis factor inhibitor treatment
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Personalised treatment of my juvenile arthritis
    A.3.2Name or abbreviated title of the trial where available
    MyJIA
    A.4.1Sponsor's protocol code number2019/MyJIA
    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 SponsorOslo University Hospital
    B.1.3.4CountryNorway
    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 supportSouthern and Eastern Norway Regional Health Authority
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportOslo university hospital
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportResearch council of Norway
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportNorwegian rhumatism association
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportNorwegian women's public health association
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOslo University Hospital
    B.5.2Functional name of contact pointDepartment of rhuemtology
    B.5.3 Address:
    B.5.3.1Street AddressPostboks 4950 Nydalen
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0424
    B.5.3.4CountryNorway
    B.5.4Telephone number004791502770
    B.5.6E-mailoyvind.molberg@medisin.uio.no
    D. IMP Identification
    D.IMP: 1
    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 Lederspan Triamcinolone hexacetonide (TH) 20mg/ml
    D.2.1.1.2Name of the Marketing Authorisation holderMeda
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarticular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTRIAMCINOLONE HEXACETONIDE
    D.3.9.1CAS number 5611-51-8
    D.3.9.4EV Substance CodeSUB11254MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Juvenile idiopathic arthritis is characterised by inflamed joints and is the most common chronic rheumatic disease in childhood and adolescence that potentially lead to disability due to joint damage. A prerequisite for the JIA diagnosis is the detection of inflammation of one or more joints (arthritis). Arthritis leads to pain, swelling and stiffness of the affected joints, caused by hypertrophy of the synovial lining of the joint and increased synovial fluid. Untreated, disability may follow.
    E.1.1.1Medical condition in easily understood language
    Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease affecting children and adolescents. JIA is characterised by swollen, painful joints leading to disability.
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    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 if concomitant intra-articular (i.a.) glucocorticoid injections of joints with active arthritis in juvenile idiopathic arthritis (JIA) patients starting Tumour Necrosis Factor (TNF) inhibitor (TNFi) treatment increase the proportion of JIA patients reaching sustained, inactive disease, when compared to the control group not receiving joint injections.
    E.2.2Secondary objectives of the trial
    - To compare efficacy of treatment regimens up to 24 weeks.
    - To assess the safety of the intervention and background treatment.
    - To compare the cost effectiveness of the two treatment regimens
    - To evaluate the longitudinal disease burden of JIA over 48 weeks
    - To explore the impact of TNFi concentrations
    - To explore molecular signatures
    - To explore the role of modern imaging techniques
    - To explore composite measures of JIA disease burden as predictor of treatment response.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Type of Participant and Disease Characteristics
    Participants are eligible to be included in the study only if all of the following criteria apply:
    1. 1-18 years of age at the time of signing the informed consent.
    2. Fulfilment of the International League of Associations for Rheumatology (ILAR) classification criteria for non-systemic JIA.
    3. Clinical indication for starting TNFi treatment according to consensus between at least two physicians.
    4. Naïve to TNFi or prior use of one TNFi (stopped at least 3 months before study inclusion and no previous TNFi treatment failure).
    5. Juvenile Disease Activity Score (JADAS) >1 at baseline and at least one joint with active arthritis were joint injection is considered.
    6. Willing to give written consent (participant ≥ 16, guardians if < 16 years of age, both participants and guardians if 16-18) and comply with the requirements of the study protocol.

    Contraceptive use by men or women
    Male participants: No measures necessary.
    Female participants: Contraception Guidance for WOCBP see Appendix 4 (Section 10.4.2).
    Informed Consent
    7. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Medical Conditions
    1. Major comorbidity including significant infectious, neurological, malignant disease, mental disorders or uncontrolled diabetes mellitus.
    Prior/Concomitant Therapy
    2. Used two or more TNFi.
    3. Corticosteroid use (including i.a. injection) less than 4 weeks prior to randomisation.
    Other Exclusions
    4. Presence of hepatitis B surface antigen (HBsAg) at screening.
    5. Positive hepatitis C antibody test result at screening or within 3 months prior to starting study treatment.
    6. Evidence of active or latent tuberculosis (TB) as documented by medical history and examination, chest X-rays (front), and TB testing. The choice of TB tests will be made by the investigator according to local licensing and standard of care.
    7. Having received live vaccines less than two weeks prior to randomisation.
    8. Drug / alcohol abuse which hampers adherence to the study protocol.
    9. Language barriers that hampers adherence to the study protocol.
    10. Pregnancy or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of participants with sustained, inactive disease from week 24 to week 36.
    Inactive disease is defined according the 2011 Wallace criteria:
    No active arthritis†
    Physician global assessment of disease activity score normal (0)
    Erythrocyte sedimentation rate (ESR) within normal range
    Morning stiffness ≤ 15 minutes
    No active uveitis
    No fever, rash, serositis, splenomegaly, or generalized lymphadenopathy attributable to JIA
    In addition, no use of any i.a. or p.o. corticosteroids from week 20 to week 36.

    †Active arthritis according to the ACR definition:
    1) a joint with swelling not due to bony enlargement
    OR, if no swelling is present
    2) limitation of motion accompanied by either pain on motion and/or tenderness.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 24 and week 36
    E.5.2Secondary end point(s)
    • Changes in disease activity measures and measures of treatment response
    • Time to inactive disease, flare rates
    • Changes in patient reported outcomes
    • Proportion of patients reaching inactive disease
    • Costs related to changes in health-related quality of life (QOL)
    • Proportion of patients in disease remission (sustained inactive disease from week 24 to week 48).
    • Change in patient reported outcome measures
    • Patient satisfaction and treatment adherence
    • Longitudinal TNFi drug concentrations, frequency of TNFi drug antibodies compared to measures of disease activity, treatment response and adverse events
    • Comparison of changes in molecular signatures with measures of disease activity, treatment response.
    • US and MRI sensitivity to change during therapy
    • US and MRI sensitivity to detect synovitis
    • US and MRI as predictors of treatment response
    . Clinical characteristics (joint patterns, disease activity, patient satisfaction, adherence, health status), molecular signatures (transcriptional, cellular and genetic), and imaging (US and whole-body MRI) assessed synovitis
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, 6, 12, 24, 36 and 48 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 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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Assessor of primary endpoint is blinded for clinical data
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    The comparator is no use of IMP until week 24.
    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 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
    End of Study Definition
    A participant is considered to have completed the study if he/she has completed all phases of the study including the last visit.
    The end of the study is defined as the date of the last visit of the last participant in the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 202
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 2
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 state202
    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
    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 Decision2020-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-05
    P. End of Trial
    P.End of Trial StatusOngoing
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