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    Summary
    EudraCT Number:2009-010643-14
    Sponsor's Protocol Code Number:M10-791
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-06-10
    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 ConcernedGermany - PEI
    A.2EudraCT number2009-010643-14
    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 Axial Spondyloarthritis
    A.4.1Sponsor's protocol code numberM10-791
    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.3.9.3Other descriptive nameABT-Humira
    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
    Active axial spondyloarthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10051265
    E.1.2Term Spondyloarthropathy
    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 active axial spondyloarthritis not fulfilling the modified New York criteria for AS who have had an inadequate response to, or intolerance to one or more NSAIDs 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 an inadequate response to, or intolerance to at least one NSAID or have a contraindication for NSAIDs as defined by the Investigator;
    3. Subject must have chronic back pain (of at least 3 months duration) with onset at age < 45 years;
    4. MRI evidence of active inflammatory lesions of sacroiliac joints (past or present) with definite bone marrow edema/osteitis, suggestive of sacroiliitis associated with SpA PLUS ≥ 1 of the clinical criteria listed below:
    OR
    Positive HLA-B27 PLUS ≥ 2 of the clinical criteria listed below other than HLA-B27 positivity:
    ● Inflammatory back pain defined as the presence at Screening of at least 4 out of the following 5 parameters: 1) age at onset < 40 yrs, 2) insidious onset, 3) improvement with exercise, 4) no improvement with rest, 5) night pain with improvement upon getting up;
    ● Arthritis (past or present);
    ● Heel enthesitis (past or present);
    ● Anterior Uveitis confirmed by an ophthalmologist (past or present);
    ● Dactylitis (past or present);
    ● Crohn's disease or ulcerative colitis (past or present);
    ● Good prior response to NSAIDs – back pain is not present anymore or much better 24 to 48 hours after a full dose of a NSAID;
    ● Family history of SpA;
    ● Positive HLA-B27;
    ● Elevated CRP.
    (See Appendix G of the protocol for definition of SpA features)
    5. Subjects must have baseline disease activity as defined by having a Total Back Pain VAS (Appendix E) score ≥40 mm and BASDAI (Appendix F)≥ 4 at both the Screening and Baseline visits.
    6.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. The results of the serum pregnancy test performed during the Screening Period and urine pregnancy test performed at the Baseline Visit must be negative.
    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.
    7. 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 at Screening;
    ● Subject has a negative PPD test (or equivalent) and CXR (PA and lateral view) at Screening (Section 5.3.1.1). If the subject had a positive PPD test (or equivalent) and/or CXR (PA and/or lateral view) consistent with prior TB exposure, the subject must initiate, be currently receiving or have documented completion of a course of anti-TB therapy (Section 5.3.1).
    8. Inclusion Criteria deleted in Amendment 1.
    9. Subjects must be able and willing to provide written informed consent and comply with the requirements of this study protocol;
    10. 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. Subject fulfilling a diagnosis of ankylosing spondylitis (as defined by the modified New York criteria; at or prior to the Screening Visit;
    2. Subject diagnosed with psoriasis or psoriatic arthritits.
    3. Prior exposure to any biologic therapy with a potential therapeutic impact on SpA, including anti-TNF therapy;
    4. Exclusion Criteria deleted in Amendment 1.
    5. If entering the study on concomitant Disease-Modifying Anti-Rheumatic Drugs (DMARDs), 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;
    6. If entering the study on concomitant oral corticosteroids, subject not on stable dose of prednisone (≤ 10 mg per/day) (or oral corticosteroid equivalents) and/or NSAIDs for at least 14 days prior to the Baseline Visit;
    7. Subject has received cyclosporine or other second line anti-rheumatic therapy, (except MTX, SSZ, hydroxychloroquine or azathioprine) within 28 days prior to the Baseline Visit;
    8. Subject has been treated with intra-articular joint injection(s) or spinal/paraspinal injections(s) of corticosteroids in the preceding 28 days prior to the Baseline Visit;
    9. Subject has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the Baseline Visit;
    10. Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to the Baseline Visit or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to the Baseline Visit;
    11. Subject with extra-articular manifestations (e.g., inflammatory bowel disease, uveitis, etc.) that is not clinically stable for at least 30 days prior to study entry;
    12. Subject has a history of inflammatory arthritis of a different etiology other than axial spondyloarthritis (e.g., rheumatoid arthritis, gout, systemic lupus erythematosus, polyarticular or systemic juvenile idiopathic arthritis).
    13. Known hypersensitivity to the excipients of adalimumab as stated in the label;
    14. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease;
    15. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active TB;
    16. 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;
    17. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix;
    18. Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study;
    19. History of clinically significant drug or alcohol abuse in the last 12 months;
    20. Clinically significant abnormal screening laboratory results as evaluated by the Investigator.
    21. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
    22. 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.
    23. If entering the study on concomitant NSAIDs an/or analgesics, subject on opioid analgesics (other than tramadol) within 14 days prior to Baseline visit or subject not on stable doses of NSAIDs and/or analgesics for 14 days prior to the Baseline Visit.
    24. subject has undergone spinal surgery within 2 months prior to Baseline.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable is the proportion of subjects who have achieved ASAS40 response at the Week 12 Visit.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    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 in the protocol as the date of the last study visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 135
    F.4.2.2In the whole clinical trial 194
    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 Decision2009-06-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-08
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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