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    Summary
    EudraCT Number:2008-006064-11
    Sponsor's Protocol Code Number:CNTO148ART3001
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-10-19
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2008-006064-11
    A.3Full title of the trial
    A Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Golimumab, an Anti-TNFα Monoclonal Antibody, Administered Intravenously, in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Efficacy and Safety Study of intravenous Golimumab in patients with Active Rheumatoid Arthritis (RA) despite treatment with methotrexate, non steroidal pain medications and/or corticosteroids
    A.4.1Sponsor's protocol code numberCNTO148ART3001
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Biologics B.V.
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International N.V.
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31 071 5242166
    B.5.5Fax number31 071 5242110
    B.5.6E-mailClinicalTrialsEU@its.jnj.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 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 CNTO148
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 codeCNTO148
    D.3.9.3Other descriptive nameHuman anti-TNF-alpha monoclonal antibody
    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) 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) No
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Rheumatoid arthritis (RA)
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis (RA)
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    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
    The primary objective of this study is to assess the clinical efficacy of IV administration of golimumab 2 mg/kg + MTX compared with MTX alone in subjects with active RA despite MTX therapy.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:
    • To evaluate safety parameters
    • To evaluate physical function and disability
    • To characterize population pharmacokinetics (PK) and pharmacodynamics (PD) of IV golimumab.
    • Effects of golimumab on structural damage
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible for the study, subjects must meet all of the following criteria:
    1. Are women or men 18 years of age or older.
    2. Have a diagnosis of RA (according to the revised 1987 criteria of the ARA; Arnett et al, 1988) for at least 3 months prior to screening.
    3. Have been treated with and tolerated MTX at a dose of at least 15 mg/week for at least 3 months prior to screening, and have been on a stable MTX dose of ≥ 15 mg/week and ≤ 25 mg/week for at least 4 weeks prior to screening.
    4. Have active RA, as defined by persistent disease activity with at least 6 swollen and 6 tender joints, at the time of screening and at baseline.
    5. CRP ≥ 1.0 mg/dL at screening.
    6. Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF)-positive at screening.
    7. If using NSAIDs or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent.
    8. If using oral corticosteroids, must be on a stable dose equivalent to ≤ 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent. If currently not using corticosteroids, the subject must have not received oral corticosteroids for at least 2 weeks prior to first administration of study agent.
    9. 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 subjects of childbearing potential must test negative for pregnancy.

    10. 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 for 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, have a negative QuantiFERON-TB Gold test result (Appendix A of the protocol), or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. Indeterminate results should be handled as outlined in Section 5.1 of the protocol. A negative tuberculin skin test (see Appendix B of the protocol) is additionally required if the QuantiFERON-TB Gold test is not approved/registered in that country.
    e. Have a chest radiograph (both posterior-anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old, inactive TB.

    11. Have 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. WBCs ≥ 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 ALT and AST levels not exceeding 1.5 times the ULN for the central laboratory conducting the test.
    f. Serum creatinine not exceeding 1.5 mg/dL (SI: ≤ 133 µmol/L).
    12. Are willing and able to adhere to the study visit schedule and other protocol requirements.
    13. Are capable of providing informed consent, which must be obtained prior to any study-related procedures.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria may not be enrolled in the study:
    1. Have other inflammatory diseases, including but not limited to PsA, AS, systemic lupus erythematosus, or Lyme disease, that might confound the evaluation of the benefit of golimumab therapy.
    2. Have been treated with DMARDs (other than MTX)/systemic immunosuppressives (eg, D-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to first administration of study agent.
    3. Have received intra-articular, IM, or IV corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to first administration of study agent.
    4. Have a known hypersensitivity to human Ig proteins or other components of golimumab.
    5. Have ever received any commercial or investigational anti-TNF therapy such as but not exclusively infliximab, golimumab, adalimumab, certolizumab pegol, or etanercept.
    6. Have received rituximab or efalizumab or abatacept.
    7. Have received natalizumab or other agents that target alpha-4-integrin.
    8. Have received anakinra during the 4 weeks prior to first administration of study agent.
    9. Have received alefacept within the 3 months prior to the first administration of the study agent.
    10. Have used cytotoxic agents, including but not limited to chlorambucil, cyclophosphamide, nitrogen mustard, or other alkylating agents.
    11. Have been treated with any investigational drug, within 5 half-lives of that drug prior to the first administration of study agent.
    12. Are pregnant, nursing, or planning a pregnancy or fathering a child within 6 months after receiving the last administration of study agent.
    13. Have a history of latent or active granulomatous infection, including histoplasmosis, or coccidioidomycosis prior to screening. Refer to inclusion criteria # 10 for information regarding eligibility with a history of latent TB.
    14. Have had a bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
    15. 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.
    16. Have had a nontuberculous mycobacterial infection or opportunistic infection (eg, cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening. 17. 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 study, or within 6 months after the last administration of study agent.
    18. 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.
    19. 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 first administration of study agent. Less serious infections (eg, acute upper respiratory tract infection, simple UTI) need not be considered exclusionary at the discretion of the investigator.
    20. Have a history of, or ongoing, chronic or recurrent (> 3 identical infections/12 months) infectious disease, including but not limited to, chronic renal infection, chronic chest infection (eg, bronchiectasis), sinusitis, recurrent UTI (eg, recurrent pyelonephritis, chronic non remitting cystitis), an open, draining, or infected skin wound, or an ulcer.
    21. Are known by history to be infected with HIV, hepatitis B, or hepatitis C.
    22. Have a history of known demyelinating diseases such as multiple sclerosis or optic neuritis.
    23. Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, GI, endocrine, pulmonary, cardiac, neurologic, psychiatric, or cerebral disease.
    24. Have a history of, or concurrent, CHF, including medically controlled, asymptomatic CHF.
    25. Have a history of lymphoproliferative disease, including lymphoma, or signs suggestive of possible lymphoproliferative disease such as lymphadenopathy of unusual size or location, or clinically significant splenomegaly.
    26. Have any known malignancy or have a history of malignancy within the previous 5 years (with the exception of a nonmelanoma skin cancer that has been treated with no evidence of recurrence).
    27. Have a transplanted organ (with the exception of a corneal transplant performed > 3 months prior to first study agent administration).
    28. Have or have had a substance abuse (drug or alcohol) problem within the previous 3 years.
    29. Are unwilling or unable to undergo multiple venipunctures because of poor tolerability or lack of easy access.
    30. Are participating in another study with an investigational agent or procedure.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects with an ACR 20 response at Week 14. To address the primary objective, the proportion of subjects between the IV golimumab 2 mg/kg + MTX and IV placebo + MTX groups will be compared using a 2-sided (α = 0.05) Cochran Mantel Haenszel test, stratified by CRP level at screening (< 1.5 mg/dL or ≥ 1.5mg/dL).

    In this primary efficacy analysis, data from all randomized subjects will be analyzed according to their assigned treatment group. A last observation carried forward (LOCF) procedure will be used to impute the missing ACR components if the subject has data for at least 1 ACR component at Week 14. If a subject has no data for any ACR component at Week 14, the subject will be considered to not have achieved an ACR 20 response. In addition, subjects who meet any one of the following treatment failure rules will be considered to not have achieved the primary endpoint:
    • Increase in a subject’s MTX above baseline for RA.
    • Initiate treatment with DMARDs/systemic immunosuppressives and/or biologics for RA prior to Week 14.
    • Initiate treatment with oral corticosteroids for RA, increase the dose of oral corticosteroids for RA above the baseline dose, or receive IV or IM administration of corticosteroids for RA prior to Week 14.
    • Discontinue study agent infusions due to an unsatisfactory therapeutic effect prior to Week 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 14
    E.5.2Secondary end point(s)
    The following major secondary analyses will be performed if the primary endpoint is statistically different between Group I and Group II. These analyses will be performed in sequential order only if the previous analyses are statistically significant
    1. The proportion of subjects with moderate or good DAS 28 scores (using CRP) at Week 14 will be summarized and compared between treatment groups.
    2. Change from baseline in HAQ at Week 14 will be summarized and compared between treatment groups.
    3. The proportion of subjects with ACR 50 improvement at Week 24 will be summarized and compared between treatment groups.
    4. Change from baseline in vdH-S score at Week 24 will be summarized and compared between treatment groups.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 14 and 24
    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 Yes
    E.6.13.1Other scope of the trial description
    Serum samples will be collected for analysis of anemia markers
    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 Yes
    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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Argentina
    Australia
    Colombia
    Hungary
    Korea, Republic of
    Lithuania
    Malaysia
    Mexico
    New Zealand
    Poland
    Russian Federation
    Ukraine
    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
    Last visit of the last patient as given in the protocol at week 112.
    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.1.2.1Number of subjects for this age range: 474
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 564
    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)
    After completion of their participation in the trial subjects will be eligible to initiate or re-initiate rheumatology treatment with all other commercially available drugs, including DMDS and anti TNF agents (also subcutaneous golimumab)
    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 Decision2009-12-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-08
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