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    Summary
    EudraCT Number:2009-010582-23
    Sponsor's Protocol Code Number:CNTO148ART3002
    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:2009-12-30
    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 ConcernedGreece - EOF
    A.2EudraCT number2009-010582-23
    A.3Full title of the trial
    A Golimumab Phase 3b, Multicenter, Switch Assessment of Subcutaneous and Intravenous Efficacy in Rheumatoid Arthritis Patients Who Have Inadequate Disease Control Despite Treatment with Etanercept (ENBREL) or Adalimumab (HUMIRA)
    A.4.1Sponsor's protocol code numberCNTO148ART3002
    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 SponsorCentocor BV
    B.1.3.4CountryNetherlands
    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 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 nameGolimumab Final Vialed Product (FVP)
    D.3.2Product code CNTO 148
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGolimumab
    D.3.9.2Current sponsor codeCNTO 148
    D.3.9.3Other descriptive nameHuman anti TNF-alpha monoclonal
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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) No
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 nameGolimumab prefilled pen
    D.3.2Product code CNTO 148
    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 INNGolimumab
    D.3.9.2Current sponsor codeCNTO148
    D.3.9.3Other descriptive nameHuman anti TNF-alpha monoclonal
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) No
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 infusion
    D.8.4Route of administration of the placeboIntravenous 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
    Rheumatoid arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the efficacy of golimumab + MTX in reducing signs and symptoms of RA (as assessed by the American College of Rheumatology [ACR] 20) at Week 14 in patients with inadequate disease control despite treatment with etanercept + MTX or adalimumab + MTX.
    E.2.2Secondary objectives of the trial
    The 3 major secondary objectives of this study are to assess the following:
    • The onset of response to golimumab 50 mg SC every 4 weeks + MTX as defined by the proportion of patients who achieve an ACR 20 response within 2 weeks of initiating therapy
    • The persistence of response to golimumab 50 mg SC every 4 weeks + MTX as defined by the proportion of patients who achieve a DAS28 “good” response by Week 16 and maintain this response through Week 52
    • The efficacy of golimumab 2 mg/kg intravenous (IV) therapy + MTX defined by the relative proportions of randomized patients in the golimumab IV group (with a loading dose) and the golimumab SC groups who achieve an ACR 20 response at Week 52 relative to Week 16
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Are women or men 18 years of age or older.
    2. Have inadequate RA disease control (defined as an ESR-based DAS28 ≥ 3.6 and
    ≥ 6 swollen and ≥ 6 tender joints) prior to the first administration of study agent
    despite treatment with:
    − Etanercept at the approved and stable dose of 50 mg SC once weekly or
    25 mg SC injections twice weekly in combination with MTX, or
    − Adalimumab at the approved and stable dose of 40 mg SC injection every
    2 weeks in combination with MTX
    Patients must have received etanercept or adalimumab in combination with MTX for a
    minimum of 3 months prior to the first screening visit (Week –6). The last dose of
    etanercept must be administered no less than 7 days before the first golimumab injection at Week 0, and the last dose of adalimumab must be administered no less than 14 days before the first golimumab injection at Week 0.
    3. Must have received a stable dose of MTX ≥ 7.5 mg/week to ≤ 25 mg/week for at
    least 4 consecutive weeks prior to the first screening visit (Week –6) and must plan
    to maintain that dose throughout the study as described in Section 7.3.1.
    4. If using NSAIDs for RA, must be on a stable dose (not to exceed the normal or
    usual approved prescribing dose) for at least 4 consecutive weeks before the first
    screening visit (Week –6) and must plan to maintain that dose throughout the study
    as described in Section 7.3.4.
    5. If using oral corticosteroids, must be on a stable dose equivalent to ≤ 10 mg of
    prednisone/day for at least 4 consecutive weeks before the first screening visit
    (Week –6) and must plan to maintain that dose throughout the study as described in
    Section 7.3.3. If currently not using corticosteroids, the patient must have not
    received oral corticosteroids for at least 4 weeks before the first screening visit
    (Week –6).
    6. If using hydroxychloroquine and/or sulfasalazine, must have received a stable dose for at least 4 consecutive weeks before the first screening visit (Week –6) and must plan to maintain that dose throughout the study.
    7. Women of childbearing potential or men capable of fathering children must be
    using adequate birth control measures (eg, abstinence, oral contraceptives,
    intrauterine device, barrier method with spermicide, surgical sterilization) during
    the study and for 6 months after receiving the last administration of study agent.
    Female patients of childbearing potential must test negative for pregnancy.
    8. Are considered eligible according to the following TB screening criteria:
    a. Have no history of latent or active TB prior to screening.
    b. Have no signs or symptoms suggestive of active TB upon medical history
    and/or physical examination.
    c. Have had no recent close contact with a person with active TB or, if there has
    been such contact, will be referred to a physician specializing in TB to
    undergo additional evaluation and, if warranted, receive appropriate
    treatment as if having latent TB prior to or simultaneously with the first
    administration of study agent.
    d. Within 6 weeks prior to the first administration of study agent, either have
    negative diagnostic TB test results (see Appendix A), or have a newly
    identified positive diagnostic TB test result (defined as a positive
    QuantiFERON-TB Gold in-tube test) during screening in which active TB
    has been ruled out and for which appropriate treatment (see Section 5.1) has
    been initiated either prior to or simultaneously with the first administration of
    study agent.
    e. In the event of 2 indeterminate QuantiFERON-TB Gold in-tube test results,
    the patient will be treated as if having latent TB prior to or simultaneously
    with the first administration of study agent.
    f. Have a chest radiograph (both posterior-anterior and lateral views), read by a
    qualified radiologist, whose diagnostic assessment is consistent with no evidence of current active TB or old inactive TB, and taken within 12 months of the study or at the screening visit if the patient has received either etanercept or adalimumab continuously throughout this period. Documentation of the chest radiograph should be provided.
    9. Have a screening laboratory test result as follows:
    a. Hemoglobin ≥ 8.5 g/dL (International System of Units [SI]: ≥ 85 g/L) or ≥ 5.3 mmol/L.
    b. White blood cell (WBC) count ≥ 3.5 × 103 cells/μL (SI: ≥ 3.5 × 109 cells/L).
    c. Neutrophils ≥ 1.5 × 103 cells/μL (SI: ≥ 1.5 × 109 cells/L).
    d. Platelets ≥ 100 × 103 cells/μL (SI: ≥ 100 × 109 cells/L).
    e. Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal (ULN) for the central laboratory conducting the test.
    f. Serum creatinine not exceeding 1.5 mg/dL (SI: ≤ 133 μmol/L).
    10. Are willing and able to adhere to the study visit schedule and other protocol
    requirements.
    11. Are capable of providing informed consent, which must be obtained prior to any
    study-related procedures.
    E.4Principal exclusion criteria
    1. Have a history of latent or active granulomatous infection, including TB,
    histoplasmosis, or coccidioidomycosis, prior to the first screening visit (Week –6)
    or during the Screening Period, or are frequently in contact with individuals who
    carry active TB infection.
    2. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
    3. Have a chest radiograph within 3 months prior to the first administration of study
    agent that shows an abnormality suggestive of a malignancy or current active
    infection, including TB, histoplasmosis, or coccidioidomycosis.
    4. Have had a nontuberculous mycobacterial infection or opportunistic infection (eg,
    cytomegalovirus, Pneumocystis, aspergillosis, cryptomycosis) within 6 months
    prior to the first screening visit (Week –6) or during the Screening Period.
    5. Have inflammatory diseases other than RA, including but not limited to psoriatic
    arthritis, ankylosing spondylitis, systemic lupus erythematosus, primary Sjogren’s
    or Lyme disease, which might confound the evaluation of the benefit of golimumab
    therapy.
    6. Have been treated with DMARDs/systemic immunosuppressive agents (eg,
    leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the
    4 weeks prior to the first administration of study agent. Patients may have received
    MTX, sulfasalazine, or hydroxychloroquine.
    7. Have received intra-articular, intramuscular or IV corticosteroids, including
    adrenocorticotropic hormone, during the 4 weeks prior to the first administration of
    study agent.
    8. Have demonstrated a discernible improvement in disease activity as demonstrated
    by an ESR-based DAS28 response and as defined by the EULAR criteria between
    Week –6 (screening) and prior to the first golimumab injection at Week 0.
    9. Have a known hypersensitivity to human immunoglobulin proteins or other
    components of golimumab.
    10. Have had a clinically serious adverse reaction to a biologic anti-TNFα agent.
    11. Have received infliximab, golimumab, or certolizumab prior to the first
    administration of the study agent.
    12. Have received natalizumab, rituximab, or efalizumab prior to the first
    administration of the study agent.
    13. Have received anakinra during the 4 weeks prior to the first administration of study agent.
    14. Have received alefacept within the 3 months prior to the first administration of the study agent.
    15. Have used cytotoxic agents, including chlorambucil, cyclophosphamide, nitrogen
    mustard, or other alkylating agents.
    16. Have received any investigational anti-TNFα agent including but not limited to
    lenercept or onercept.
    17. Have been treated with the investigational agents ocrelizumab, ofatumumab, or
    janus kinase 3 inhibitor (CP-690550) at any time, or any other investigational drug
    within 5 half-lives of that drug prior to the first administration of study agent.
    18. Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of the study agent.
    19. Have received, or are expected to receive, any live virus or bacterial vaccination
    within 3 months prior to the first administration of study agent, during the trial, or
    within 6 months after the last administration of study agent.
    20. Have a history of an infected joint prosthesis, or have received antibiotics for a
    suspected infection of a joint prosthesis, if that prosthesis has not been removed or
    replaced.
    21. Have had a serious infection (eg, hepatitis, pneumonia, or pyelonephritis), have
    been hospitalized for an infection, or have been treated with IV antibiotics for an
    infection within 2 months prior to the first administration of study agent. Less
    serious infections (eg, acute upper respiratory tract infection, simple urinary tract
    infection [UTI]) need not be considered exclusionary at the discretion of the
    investigator.
    22. Have a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to: chronic renal infection; chronic chest infection (eg, bronchiectasis);
    sinusitis; recurrent UTI (eg, recurrent pyelonephritis, chronic nonremitting cystitis);
    an open, draining, or infected skin wound; or an ulcer.
    23. Are known to be infected with human immunodeficiency virus (HIV), hepatitis B,
    or hepatitis C.
    24. Have a history of known demyelinating diseases such as multiple sclerosis or optic neuritis.
    25. Have current signs or symptoms of severe, progressive, or uncontrolled renal,
    hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic,
    psychiatric, or cerebral disease.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is the proportion of patients who achieve an ACR 20 response at Week 14.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    First part open, second part double blind
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 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 study is defined as the last follow-up assessment (or visit) for the last patient after his or her last study agent administration.
    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 months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months4
    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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 400
    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)
    This information has been provided in the protocol.
    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 Decision2010-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-06-15
    P. End of Trial
    P.End of Trial StatusCompleted
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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