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    Summary
    EudraCT Number:2011-001661-40
    Sponsor's Protocol Code Number:DE038
    Clinical Trial Type:Outside EU/EEA
    Date on which this record was first entered in the EudraCT database:2012-02-07
    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
    H.4 THIRD COUNTRY IN WHICH THE TRIAL WAS FIRST AUTHORISED
    Expand All   Collapse All
    A. Protocol Information
    A.2EudraCT number2011-001661-40
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Juvenile Rheumatiod Arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A multicenter study of the safety, efficacy effects on the body of Humira (adalimumab) in children with polyarticular Juvenile Rheumatoid Arthritis (a form of reheumatoid arthritis in children / young people with unknown cause).
    A.4.1Sponsor's protocol code numberDE038
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00048542
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/141/2011
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbott Laboratories
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAbbott Laboratories
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbott Laboratories
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbott House, Vanwall Business Park, Vanwall
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4XE
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628644475
    B.5.5Fax number+441628644330
    B.5.6E-maileuclinicaltrials@abbott.com
    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 40mg/0.8 ml solution for injection for paediatric use
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Ltd
    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 Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation Yes
    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 CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polyarticular Juvenile Rheumatoid Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10036039
    E.1.2Term Polyarticular juvenile rheumatoid arthritis, chronic or unspecified
    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
    Efficacy - to determine and compare disease flare in non-MTX/adalimumab treated subjects to non-MTX/placebo treated subjects who had previously responded to adalimumab treatment.
    Safety - to contrast the safety profile of adalimumab with placebo in non-MTX treated subjects; to contrast the safety profile of adalimumab with placebo in concomitant MTX-treated subjects; to evaluate the long term safety profile of repeated subcutaneous adminstration of adalimumab in pediatric subjects with polyarticular JRA.
    Pharmacokinetics - to estimate adalimumab population pharmacokinetic parameters in pediatric subjects (at least 4 years old) with polyarticular JRA.
    E.2.2Secondary objectives of the trial
    Efficacy - to determine and compare time to onset of flare and in disease flare in non-MTX/adalimumab treated subjects to non-MTX/placebo treated subjects; to determine continued clinical benefit at the 30%, 50% and 70% improvement response after repeated subcutaneous administration of adalimumab; to compare the safety and efficacy of fixed eow dosing based on body weight to variable eow dosing based on BSA of subjects rolled over into the Fixed Dose Open Label portion of the trial.
    Pharmacokinetics - to characterise adalimumab pk and identify important subject characteristics that will explain pk variability in pediatric subjects with polyarticular JRA; to compare adalimumab pharmacokinetics in children with JRA to adult JRA subjects; to compare the PK of fixed eow dosing based on body weight to variable eow dosing based on BSA of subjects rolled over into the Fixed Dose Open Label portion of the trial whose PK samples will be drawn.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Subjects must have a diagnosis of polyarticular juvenile rheumatoid arthritis (JRA) age 4 to 17 by the American College of Rheumatology (ACR) criteria. Disease onset may have been systemic, polyarticular, or pauciarticular. If the disease was systemic onset, then the subjects must be free of any systemic JRA manifestations for at least 3 months before the time of qualification.
    •At the time of study screening, the subject must have continuing active disease defined as >= 5 swollen joints and >= 3 joints with limitation of motion (LOM). These joints are not mutually exclusive.
    •Subjects may be either naïve to MTX, inadequate responders to MTX, or intolerant to MTX. Intolerance to MTX will be defined by the subject's physician. The MTX must be maintained at a dose of at least 10 mg/m2 body surface area/week for a minimum of 3 months, prior to screening.
    •Duration of disease is not limited, but must have been long enough for a subject to have been given an adequate trial of nonsteroidal anti-inflammatory drugs (NSAIDs).
    E.4Principal exclusion criteria
    •Pregnant or nursing female.
    •Functional class IV by ACR criteria.
    •Laboratory parameters outside limits established in the protocol.
    •Medical history, medical condition, or previous treatment not allowed by the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint was the number of adalimumab-treated subjects in the non-MTX stratum with disease flare during the Double-Blind Phase compared with the number of placebo-treated subjects in the non-MTX stratum with disease flare during the double-blind phase. Subjects met the criteria for disease flare if they had 1) >= 30% worsening in at least 3 of the 6 Juvenile Rheumatoid Arthritis (JRA) core set criteria and a minimum of 2 active joints, and 2) >= 30% improvement in not more than 1 of the 6 JRA core set criteria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time Frame: Week 16 to Week 48 (32 weeks)
    E.5.2Secondary end point(s)
    •Number of Subjects Meeting Pediatric American College of Rheumatology 30% (PedACR30) Response Criteria at the End of the Open-Label Lead-In Phase
    •Number of Subjects in the MTX Stratum With Disease Flare During the Double-Blind Phase
    •Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the Non-MTX Stratum
    •Time to Onset of Disease Flare During the Double-Blind Phase in Subjects in the MTX Stratum
    •Number of Subjects Meeting PedACR30 Response Criteria at the End of the Double-Blind Phase
    •Number of Subjects Meeting PedACR50 Response Criteria at the End of the Double-Blind Phase
    •Number of Subjects Meeting PedACR70 Response Criteria at the End of the Double-Blind Phase
    •Mean Change From Baseline in Physician's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase
    •Mean Change From Baseline in Parent's/Patient's Global Assessment of Disease Activity at Week 48 of the Double-Blind Phase
    •Mean Change From Baseline in C-Reactive Protein Levels at Week 48 of the Double-Blind Phase
    •Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Body Surface Area Phase
    •Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 56 of the Open-Label Extension Body Surface Area Phase
    •Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 104 of the Open-Label Extension Body Surface Area Phase
    •Number of Subjects Meeting PedACR30/50/70 Response Criteria at Baseline of the Open-Label Extension Fixed Dose Phase [ Time Frame: Baseline ]
    •Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 48 of the Open-Label Extension Fixed Dose Phase
    •Number of Subjects Meeting PedACR30/50/70 Response Criteria at Week 112 of the Open-Label Extension Fixed Dose Phase
    •Number of Subjects Meeting PedACR30/50/70 Response Criteria at the Final Visit (up to 224 Weeks) of the Open-Label Extension Fixed Dose Phase
    E.5.2.1Timepoint(s) of evaluation of this end point
    [ Time Frame: Week 16 ]
    [ Time Frame: Week 16 to Week 48 (32 Weeks) ]
    [ Time Frame: Week 16 to Week 48 (32 weeks) ]
    [ Time Frame: Week 16 to Week 48 (32 weeks)
    [ Time Frame: Week 48 ]
    [ Time Frame: Week 48 ]
    [ Time Frame: Week 48 ]
    [ Time Frame: Baseline and Week 48 ]
    [ Time Frame: Baseline and Week 48 ]
    [ Time Frame: Baseline and Week 48 ]
    [ Time Frame: Open-Label Lead-In Phase Baseline ]
    [ Time Frame: Week 56 ]
    [ Time Frame: Week 104 ]
    [ Time Frame: Baseline ]
    [ Time Frame: Week 48 ]
    [ Time Frame: Week 112 ]
    [ Time Frame: Final Visit (up to 224 weeks of OLE FD phase) ]
    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 Yes
    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 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.8.2.4Number of treatment arms in the trial2
    E.8.3 Will this trial be conducted at a single site globally? No
    E.8.4 Will this trial be conducted at multiple sites globally? Yes
    E.8.6 Trial involving sites outside the EEA
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3Specify the countries outside of the EEA in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    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: 171
    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) 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 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 Yes
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    pediatrics
    F.4 Planned number of subjects to be included
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 171
    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 discontinuation of the study drug, the subject will be treated in accordance with the investigators best clinical judgement.
    G. Investigator Networks to be involved in the Trial
    H.4 Third Country in which the Trial was first authorised
    H.4.1Third Country in which the trial was first authorised:
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