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    Summary
    EudraCT Number:2010-021141-41
    Sponsor's Protocol Code Number:CH/2008/3061
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-03-30
    Trial results View 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 number2010-021141-41
    A.3Full title of the trial
    Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab in Combination with Methotrexate for the Treatment of Juvenile Idiopathic Arthritis Associated Uveitis.
    A.3.2Name or abbreviated title of the trial where available
    SYCAMORE
    A.4.1Sponsor's protocol code numberCH/2008/3061
    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 SponsorUniversity Hospitals Bristol NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 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 No
    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 nameAdalimumab (40mg)
    D.3.4Pharmaceutical form Solution for injection
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40mg in 0.8mL
    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: 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 No
    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 nameAdalimumab (20mg)
    D.3.4Pharmaceutical form Solution for injection
    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 CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20mg in 0.8mL
    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.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
    D.8.4Route of administration of the placeboSubcutaneous use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    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 Associated Uveitis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10046851
    E.1.2Term Uveitis
    E.1.2System Organ Class 10015919 - Eye 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 compare how effective the use of adalimumab, in combination with methotrexate versus methotrexate alone with regard to controlling disease activity in refractory uveitis associated with juvenile idiopathic arthritis.
    E.2.2Secondary objectives of the trial
    - To evaluate the short term safety and tolerability of adalimumab in combination with methotrexate versus methotrexate alone with regards to complications of treatment, adverse events and laboratory assessments - To determine quality of life and cost effectiveness of adalimumab in combination with methotrexate versus methotrexate alone in patients with severe arthritis associated juvenile idiopathic arthritis - To determine clinical effectiveness of adalimumab in combination with methotrexate versus methotrexate alone with regards to underlying juvenile idiopathic arthritis disease activity - To determine the durability and magnitude of adalimumab efficacy response to sustaining inactive disease and achieve complete clinical remission - To determine the long term safety of adalimumab in combination with methotrexate versus methotrexate alone - To assess the efficacy of treatment with adalimumab to permit concomitant medication reduction, in particular steroids - To assess clinic
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    A participant is eligible for the trial based upon at least one eye fulfilling the eligibility criteria. - Children and young people aged ≥2- ≤18 years fulfilling the ILAR diagnostic criteria for JIA (all subgroups that have uveitis) - At the time of trial screening the participant must have active anterior uveitis, defined as a "sustained grade of cellular infiltrate in anterior chamber of SUN criteria grade ≥1 + or more during the preceding 4 weeks therapy despite MTX and corticosteroid (both systemic and topical therapy) - Failed MTX (min dose of 10mg/ m2) for a minimum of 12 weeks - Disease modifying immunosuppressive drugs, other than MTX, discontinued at least 4 weeks before receiving the first dose of adalimumab. The dose of MTX must be stable for at least 12 weeks prior to the screening visit. - Written informed consent of participant or parent/ legal guardian, and assent where appropriate - Participant and parent/ legal guardian willing and able to comply with protocol requirements - For participants of reproductive potential (males and females), use of a reliable means of contraception throughout their trial participation. Post pubertal females must have a negative serum pregnancy test within 10 days before the first dose of trial drug.
    E.4Principal exclusion criteria
    Uveitis without a diagnosis of JIA Currently on adalimumab or has previously failed on adalimumab. Have been on other biologic agent within previous 5 half-lives of agent (For other biologic agents and their wash out periods, (refer to protocol supplementary document #10) More than 6 topical steroid eye drops per day at randomisation (this dose must have been stable for at least 4 weeks prior to screening visit) For patients on Prednisone or Prednisone equivalent, change of dose within 30 days prior to randomisation For patients on Prednisone or Prednisone equivalent with a dose >0.2mg/kg per day Intra-articular joint injections within four weeks prior to randomisation Any ongoing chronic or active infection (including infective uveitis) or any major episode of infection requiring hospitalisation or treatment with intravenous antibiotics within 30 days or oral antibiotics within 14 days prior to the screening evaluation History of active tuberculosis of less than 6 months treatment or untreated latent TB Participant has history of central nervous system (CNS) neoplasm, active CNS infection, demyelinating disease, or any progressive or degenerative neurological disease Poorly controlled diabetes or persistently poorly controlled severe hypertension (>95th percentile for height / age) as deemed by the treating physician Previous history of malignancy Intraocular surgery within the 3 months prior to screening (cataract/ glaucoma/ vitrectomy) Intra-ocular or peri-ocular corticosteroids within 30 days prior to randomisation. History of ocular herpetic disease Pregnant or nursing female Demonstrations of clinically significant deviations in any of the following laboratory parameters: Platelet count < 100,000/mm3 Total white cell count < 4000 cells/mm3 Neutrophils < 1000 cells/mm3 AST or ALT > 2 x upper limit of normal (ULN) or serum bilirubin > 2x the ULN Glomerular filtration rate (GFR) of < 90 mL/min/1.73m2 [GFR (ml.min/1.73 m2 BSA) = 0.55 x height (cm)/plasma creatinine (mg/dl)] Hematocrit <24% Having been administered a live or attenuated vaccine within three months prior to screening Previous randomisation into the SYCAMORE trial to either arm of the trial. .
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is ‘time to treatment failure’. Treatment failure is defined by ONE or more of the following: 1)Anterior segment inflammatory score grade (SUN criteria) a)Following at least 3 months of therapy: i)2-Step increase in SUN cell activity score (AC Cells) over 2 consecutive readings ii)Sustained non-improvement with entry grade of 3 or greater for 2 consecutive readings iii)Only partial improvement (1 grade) with sustained development of other ocular co-morbidity* iv)Sustained scores as recorded at entry grade measured over 2 consecutive readings (grades 0.5 to 2) still present after 6 months of therapy. v)Worsening of existing (on enrolment) ocular co-morbidity after 3 months 2) Use of Concomitant Medications: At any time, requirement to use concomitant medications in manner out with pre-defined acceptable criteria, or any of the concomitant medications not allowed * Ocular co-morbidities are defined as: i)Disc swelling and/or Cystoid Macular Oedema (CMO) as gauged clinically and where possible by OCT evidence; and/or: ii)Sustained raised intraocular pressure (<25mm Hg) over 1 month not responding to single ocular hypotensive agent, and/or: iii)Sustained hypotony (<6 mm Hg) over 1 month, and/or iv)Development of unexplained reduction in vision (LogMar) of 15 letters (in the event of cataract participants will remain in trial, also if cataract surgery is required. Failure will still remain as described in endpoints above).
    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) 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 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.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned16
    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
    The end of the trial will be considered as the date of the final database lock. However, the trial may be closed prematurely by the Trial Steering Committee (TSC), on the recommendation of the Independent Data and Safety Monitoring Committee. Should the trial be closed prematurely, all active participants (receiving treatment or in follow-up) will be called in for a final follow-up visit and assessments will be undertaken as per schedule.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 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 state154
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 154
    F.4.2.2In the whole clinical trial 154
    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)
    Participants will be followed up for a period of 18 months after their participation in the trial.
    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 Decision2011-05-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-02
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