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    The EU Clinical Trials Register currently displays   43925   clinical trials with a EudraCT protocol, of which   7306   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-017938-46
    Sponsor's Protocol Code Number:M11-328
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-07-14
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-017938-46
    A.3Full title of the trial
    A Double-blind, Placebo-controlled, Multicenter Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects with Enthesitis Related Arthritis.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberM11-328
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAbbott GmbH & Co. KG
    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 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 HUMIRA*SC 2SIR+F 40MG 0,8ML+2T
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Enthesitis Related Arthritis (ERA).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10003246
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to evaluate the efficacy and safety of adalimumab given subcutaneously every other week (eow) as compared to placebo in pediatric subjects with Enthesitis Related Arthritis (ERA), and to examine the pharmacokinetics and immunogenicity of adalimumab following SC administration in this subject population.
    E.2.2Secondary objectives of the trial
    N.A.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ages ≥ 6 to < 18 years at Baseline. 2. Diagnosis of Enthesitis Related Arthritis (ERA) as defined by the International League of Associations for Rheumatology (ILAR) prior to subject`s sixteenth birthday. 3. Subjects must have disease activity as defined by the fulfilment of the following conditions: • At least 2 active joints (swelling not due to deformity or joints with limitation of motion plus pain and/or tenderness) AND • Evidence of enthesitis in at least two locations 4. Inadequate response or intolerance to at least one nonsteroidal anti-inflammatory drug (NSAID) and at least one DMARD, either sulfasalazine (SSZ) or methotrexate (MTX). Patients who have a contraindication to SSZ and MTX use may be enrolled in the study. 5. Subject must have an updated immunization schedule according to the Canadian Immunization Guide in Canada, the Mexican Immunization Guide in Mexico, or the Local European Guideline. 6. If female, subjects who are sexually active and are of childbearing potential should be practicing an approved method of birth control throughout the study and for 150 days after study completion. Examples of approved methods of birth control include the following: • Condoms, sponge, foam, jellies, diaphragm or intrauterine device (IUD); • Oral, parenteral or intravaginal contraceptives for 90 days prior to study drug administration; • A vasectomized partner. 7. Parent or legal guardian, as required, has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board/Independent Ethics Committee, after the nature of the study has been explained and the subject`s parent or legal guardian has had the opportunity to ask questions. Subjects will be included in all discussions in order to obtain verbal/and or written assent. 8. Parent or legal guardian must be willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject`s diary. 9. Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and 12-lead electrocardiogram (ECG) performed during Screening. 10. Subject has a negative PPD test (or equivalent) and CXR (PA and lateral view) at Screening. If subject has a positive PPD test (or equivalent), has had a past ulcerative reaction to PPD placement, and/or a CXR consistent with prior TB exposure, subject must initiate and complete a minimum of 2 weeks of anti-TB therapy or have documented completion of a course of anti-TB therapy prior to Baseline. 11. Subjects must be able and willing to self-administer SC injections or have a qualified person available to administer SC injections.
    E.4Principal exclusion criteria
    1. Subjects fulfilling a diagnosis of any ILAR JIA subtype other than ERA. 2. Psoriasis or a history of psoriasis in the patient or first-degree relative. 3. Presence of IgM rheumatoid factor on at least two occasions at least 3 months apart. 4. Presence of systemic JIA. 5. History of inflammatory bowel disease. 6. Previous biologic therapy including anti-TNF therapy with a potential impact on pediatric ERA. 7. Diagnosis of acute inflammatory joint disease not associated with ERA. 8. Known hypersensitivity to adalimumab or its excipients. 9. Subject has received intra-articular joint injection(s) with corticosteroids within 28 days prior to Baseline. 10. Joint surgery within 2 months prior to Baseline. 11. If entering the study on concomitant MTX or SSZ at Screening/Baseline, subject not on stable dose of MTX (≤ 15 mg/m2 with a maximum of 25 mg/ week) or SSZ (≤ 50 mg/kg/day with a maximum of 2 g/day) for 28 days prior to Baseline. 12. Subject on concomitant DMARDs other than MTX or SSZ 28 days prior to Baseline. 13. If entering the study on concomitant prednisone (and/or prednisone equivalents), subjects not on a stable dose (≤ 10 mg/day or 0.2 mg/kg body weight whichever is lower) for 14 days prior to Baseline. 14. If entering the study on concomitant NSAIDs and/or analgesics, subject on opioid analgesics within 14 days prior to Baseline or subject not on stable dose for 14 days prior to Baseline. 15. Subject who has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Baseline. 16. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Baseline or oral anti-infectives within 14 days prior to Baseline. 17. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB. 18. History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the protocol. 19. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. 20. History of clinically significant drug or alcohol abuse in the last 12 months. 21. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease. 22. Positive pregnancy test at Screening or Baseline. 23. Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study. 24. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study. 25. Subject has received any live or live/attenuated vaccines within 90 days prior to screening. 26. Subject with diagnosis and current symptoms of fibromyalgia. 27. Screening laboratory and other analyses show any of the following abnormal results: • ECG – with clinically significant abnormalities; • Aspartate transaminases (AST) or alanine transaminase (ALT) > 1.75 � the upper limit of the reference range; • Total bilirubin ≥ 3 mg/dL; • Serum creatinine > 1.6 mg/dL.
    E.5 End points
    E.5.1Primary end point(s)
    Percent change from Baseline to Week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with limitation of motion plus pain and/or tenderness).
    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 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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicita`
    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 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.8.3 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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) 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    I due genitori o un tutore daranno il consenso per il bambino.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 36
    F.4.2.2In the whole clinical trial 45
    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)
    Alla fine dello studio, ogni soggetto verra` trattato secondo il giudizio clinico dello sperimentatore.
    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 Decision2010-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-30
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