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    The EU Clinical Trials Register currently displays   35213   clinical trials with a EudraCT protocol, of which   5757   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2009-014567-39
    Sponsor's Protocol Code Number:M10-883
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-10
    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 ConcernedGreece - EOF
    A.2EudraCT number2009-014567-39
    A.3Full title of the trial
    A Multicenter Study of the Efficacy and Safety of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Peripheral Spondyloarthritis
    A.4.1Sponsor's protocol code numberM10-883
    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 40 mg solution for injection in pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    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.3.4Pharmaceutical 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.3.9.1CAS number 331731-18-1
    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
    Peripheral Spondyloarthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level HLT
    E.1.2Classification code 10052775
    E.1.2Term Spondyloarthropathies
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of adalimumab
    40 mg given every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open-label safety and efficacy assessments in subjects with non-AS, non-PsA active peripheral spondyloarthritis who have had an inadequate response to ≥ 2 NSAIDs, or are intolerant to or have a contraindication for NSAIDs.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject is ≥ 18 years of age.
    2. Subject must have had, as defined by the Investigator, an inadequate response to
    ≥ 2 NSAIDs, or are intolerant to or have a contraindication for NSAIDs.
    3. Subjects must have current arthritis (asymmetric or predominantly in the lower
    limbs) or enthesitis (except for enthesitis only along the spine, sacroiliac joints
    and/or chest wall) or dactylitis PLUS:
    ● At least one of the following SpA features
    o Anterior uveitis confirmed by an ophthalmologist (past or present)
    o Crohn's disease or ulcerative colitis diagnosed by a physician (past or
    present)
    o Evidence of preceding infection (acute diarrhea or non-gonococcal
    urethritis or cervicitis 1 month before arthritis)
    o HLA-B27 positivity
    o Sacroiliitis on imaging; based on prior MRI (refer to Section 1.3 for
    definition)
    OR
    ● At least two of the following SpA features:
    o Arthritis (past or present diagnosis), adequately documented and
    identified, or diagnosed by a qualified medical professional
    o Enthesitis (any location, past or present diagnosis), adequately
    documented and identified, or diagnosed by a qualified medical
    professional
    o Dactylitis (past or present diagnosis) adequately documented and
    identified, or diagnosed by a qualified medical professional
    o Inflammatory Back Pain (past or present) (refer to Section 1.3 for
    definition)
    o Family history for SpA (refer to Section 1.3 for definition)
    4. Subjects must have at Screening and Baseline Visit any one of the following:
    ● ≥ 2 tender joints and ≥ 2 swollen joints, (asymmetric or predominantly in the
    lower limbs)
    OR
    ● at least 1 joint with active inflammatory arthritis, not associated with
    dactylitis, plus
    ○ ≥ 2 enthesitis sites (except for enthesitis only along the spine, sacroiliac
    joints and/or chest wall)
    OR
    ○ ≥ 2 digits with dactylitis;
    5. Subject must have had onset of peripheral SpA symptoms ≥ 3 months prior to the
    Baseline Visit.
    6. Subjects must have baseline disease activity as defined by Patient Global
    Assessment of Disease Activity VAS ≥ 40 mm and Patient Global Assessment of
    Pain VAS ≥ 40 mm at Screening and Baseline Visits.
    7. In subjects with concurrent axial SpA symptoms, the peripheral SpA symptoms
    must be the predominant symptoms at study entry based on the Investigator's
    clinical judgment.
    8. If female, subject is either not of childbearing potential, defined as postmenopausal
    for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
    oophorectomy or hysterectomy) or is of childbearing potential and is practicing an
    approved method of birth control throughout the study and for 150 days after last
    dose of study drug.
    Examples of approved methods of birth control include the following:
    ● Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
    ● Oral, parenteral or intravaginal contraceptives for 90 days prior to study drug
    administration;
    ● A vasectomized partner.
    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 a 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 the 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, the subject must initiate, or have documented completion of a course
    of anti-TB therapy; (Section 5.3.1).
    11. Subjects must be able and willing to provide written informed consent and comply
    with the requirements of this study protocol.
    12. 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. History of a diagnosis of psoriasis or psoriatic arthritis.
    2. Subject fulfilling a diagnosis of ankylosing spondylitis (as defined by the modified
    New York criteria; Appendix C) at or prior to the Screening Visit.
    3. Presence of back pain ≥ 20 mm on a Total Back Pain VAS at Screening or
    Baseline.
    4. Subject with extra-articular manifestation (e.g., inflammatory bowel disease,
    uveitis, etc.) that is not clinically stable for at least 28 days prior to baseline.
    5. Medical history of inflammatory arthritis of a different etiology other than
    peripheral spondyloarthritis (e.g., rheumatoid arthritis, systemic lupus
    erythematosus, gout, or any arthritis with onset prior to age 16 years such as JIA).
    6. Prior exposure to any biologic therapy with a potential therapeutic impact on SpA,
    including anti-TNF therapy.
    7. Subject has received cyclosporine or other second line anti-rheumatic therapy
    (except MTX, SSZ, azathioprine or hydroxychloroquine) within 28 days prior to
    the Baseline Visit.
    8. If entering the study on concomitant DMARDs at Screening/Baseline, subject not
    on stable dose of MTX (≤ 25 mg per week) and/or SSZ (≤ 3 g per day) and/or
    hydroxychloroquine (≤ 400 mg per day) for 28 days prior to the Baseline Visit.
    9. If entering the study on concomitant azathioprine, subject not on stable dose
    (≤ 150 mg/day) for 28 days prior to the Baseline Visit or on azathioprine and
    another concomitant immunosuppressive drug at study entry.
    10. If entering the study on concomitant NSAIDs and/or analgesics, subject on opioid
    analgesics (other than tramadol) or subject not on stable doses for 14 days prior to
    baseline.
    11. Treatment with intra-articular joint injection(s) of corticosteroids in the preceding
    28 days prior to the Baseline Visit.
    12. Treatment 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 the
    Baseline Visit.
    13. Infection(s) requiring treatment with intravenous (IV) anti-infectives within
    30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to
    the Baseline Visit.
    14. Known hypersensitivity to the excipients of adalimumab as stated in the label
    (Table 3).
    15. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS
    demyelinating disease;
    16. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,
    human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
    chronic recurring infections or active TB.
    17. 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.
    18. 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.
    19. Positive pregnancy test at Screening or Baseline.
    20. Female subjects who are breast-feeding or considering becoming pregnant during
    the study.
    21. History of clinically significant drug or alcohol abuse in the last 12 months.
    22. Clinically significant abnormal screening laboratory results as evaluated by the
    Investigator.
    23. Positive rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP)
    antibody at Screening.
    24. Subject is considered by the Investigator, for any reason, to be an unsuitable
    candidate for the study.
    25. If entering the study on concomitant oral corticosteroids, subject not on stable dose
    of prednisone (≤ 10 mg per/day), or oral corticosteroid equivalents, for at least
    14 days prior to the Baseline Visit.
    26. Subject with diagnosis and current symptoms of fibromyalgia.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of patients achieving the following
    composite response at Week 12:
    ● ≥ 40% improvement (minimum 20 mm absolute improvement) from Baseline
    in Patient Global Assessment of Disease Activity; and
    ● ≥ 40% improvement (minimum 20 mm absolute improvement) from Baseline
    in Patient Global Assessment of Pain; and
    ● ≥ 40% improvement from Baseline in at least 1 of the following 3 criteria:
    o Swollen Joint Count (76 joints) and Tender Joint Count (78 joints)
    o Enthesitis Count
    o Dactylitis Count
    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) 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    The end-of-study is defined as the date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is longer.
    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 years3
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 154
    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 Decision2010-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-07-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-12
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