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    Summary
    EudraCT Number:2019-000412-29
    Sponsor's Protocol Code Number:17-23987
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-03-25
    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 ConcernedUK - MHRA
    A.2EudraCT number2019-000412-29
    A.3Full title of the trial
    Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST)
    A.3.2Name or abbreviated title of the trial where available
    ADJUST
    A.4.1Sponsor's protocol code number17-23987
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03816397
    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 SponsorF.I. Proctor Foundation, University of California San Francisco
    B.1.3.4CountryUnited States
    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 supportNational Eye Institute, National Institutes of Health
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.I. Proctor Foundation, University of California San Francisco
    B.5.2Functional name of contact pointCaleb Ebert
    B.5.3 Address:
    B.5.3.1Street Address513 Parnassus Avenue
    B.5.3.2Town/ citySan Francisco, CA
    B.5.3.3Post code94143
    B.5.3.4CountryUnited States
    B.5.4Telephone number14154766687
    B.5.6E-mailCaleb.Ebert@ucsf.edu
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Deutschland GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameHumira
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAdalimumab
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40/0.8
    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) Yes
    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 placeboSolution for injection in pre-filled syringe
    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
    juvenile-idiopathic arthritis
    paediatric uveitis
    E.1.1.1Medical condition in easily understood language
    Inflammation of the joints and eyes
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10022557
    E.1.2Term Intermediate uveitis
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10033687
    E.1.2Term Panuveitis
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036370
    E.1.2Term Posterior uveitis
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10066681
    E.1.2Term Acute uveitis
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10059176
    E.1.2Term Juvenile idiopathic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    In patients with controlled JIA-associated uveitis, to compare rate of recurrence and time to recurrence of ocular inflammation in patients randomized to discontinue adalimumab compared to those who continue treatment. As a primary outcome, time to recurrence of ocular inflammation will be compared between the two treatment groups. Patients randomized to continue adalimumab will continue at their pre-randomization dose of no greater than 20 mg (if patient weighs < 30 kg) or 40 mg biweekly (if patient weighs ≥30 kg), administered subcutaneously. Patients stopping treatment will receive a volume-matched placebo injection biweekly. Secondary outcomes will include proportion of patients with ocular and arthritic flares, incidence of adverse events (AEs), best-corrected visual acuity (BCVA), treatment adherence, and quality of life among others.
    E.2.2Secondary objectives of the trial
    To determine predictors of recurrence in JIA-associated uveitis. Erythrocyte Sedimentation Rate (ESR), C-reactive Protein (CRP), anti-drug antibodies (ADA) to adalimumab, and serum MRP 8/14 (calprotectin) levels will be measured in patients in order to identify factors predictive of uveitis recurrence. Additional clinical characteristics, including age at diagnosis of arthritis, arthritis subtype, duration of uveitis inactivity prior to stopping, length of adalimumab treatment prior to stopping, and age at randomization will be assessed as potential predictors of uveitis recurrence.

    To determine if stopping adalimumab leads to overall less control of inflammation at the 6 and 12-month visits, even if patients restart adalimumab after a uveitis recurrence. Patients randomized to stop treatment will have the option to restart treatment if they experience a treatment failure. Regardless of treatment course, we will assess clinical outcomes, such as recurrence of ocular inflammation, visu
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Stated willingness to comply with all study procedures and availability for the duration of the study period
    History of JIA diagnosed prior to 16 years of age
    2 year of age or older
    Formal diagnosis of JIA-associated uveitis with no other suspected etiology
    ≥12 consecutive months of controlled ocular inflammation (≤0.5+ AC cell, ≤0.5+ vitreous haze, and no active retinal/choroidal lesions in either eye or macular edema)
    ≥ 12 consecutive months of controlled arthritis verified by a pediatric rheumatologist (see definition of controlled arthritis in Table 2)
    ≥12 consecutive months with adalimumab or a biosimilar
    ≥180 days on a stable dose of adalimumab or a biosimilar; must be a biweekly dose of no greater than 20 mg (if< 30kg) or 40 mg (if ≥30kg)
    If on a biosimilar of adalimumab, ≥90 days on biosimilar
    If on concomitant injectable or oral methotrexate or mycophenolate mofetil, dose must be ≤25 mg weekly for methotrexate or ≤3 g daily for mycophenolate mofetil and stable for ≥90 days
    If on topical corticosteroids, dose must be ≤2 drops prednisolone acetate 1% or equivalent per day and stable for ≥90 days
    Willingness to limit consumption of alcohol during the study period
    Agreement to avoid live attenuated vaccinations
    Agreement to use effective contraception or abstinence for ≥28 days prior to screening and throughout study period (for patients of reproductive age)
    E.4Principal exclusion criteria
    Intraocular surgery in the past 90 days or planned surgery in the next 180 days
    Severe cataract or opacity preventing view to the posterior pole in both eyes
    Acute or recurrent anterior uveitis characterized by redness and symptoms, including but not limited to: floaters, light sensitivity, pain
    Chronic hypotony (< 5 mmHg for ≥90 days) in either eye
    Treatment with oral corticosteroids or intraocular corticosteroid injections within the last 12 months
    Acute anterior uveitis characterized by redness and symptoms, including but not limited to floaters, pain, and light sensitivity
    Pregnancy or lactation (a pregnancy test will be conducted at baseline and all follow-up visits for females of reproductive age)
    Prior safety or tolerability issues with adalimumab
    History of cancer, tuberculosis, or hepatitis B
    Other medical condition expected to dictate treatment course during the study
    Any of the following abnormal lab values within 28 days prior to enrollment: leukocyte count < 2500, platelet count ≤75000, hemoglobin< 9.0, AST (SGOT) or ALT (SGPT) ≥ 2 times the upper limit of normal range, creatinine ≥1.5
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome is time to treatment failure (i.e., recurrence of ocular inflammation).
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    E.5.2Secondary end point(s)
    proportion of patients with treatment failure (i.e., recurrence of ocular inflammation)

    proportion of patients with corticosteroid-sparing control of ocular inflammation
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 and 12 months

    12 months
    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 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 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 concerned6
    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 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
    Australia
    United States
    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 years4
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    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: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 55
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 58
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state59
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 59
    F.4.2.2In the whole clinical trial 118
    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)
    Following the conclusion of the trial, participants, along with guidance from the investigator, will pursue the best medical approach for continued care and treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-15
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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