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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2009-015019-42
    Sponsor's Protocol Code Number:CNTO148JIA3001
    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:2010-08-20
    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 number2009-015019-42
    A.3Full title of the trial
    A Multicenter, Double Blind, Randomized-Withdrawal Trial of Subcutaneous Golimumab, a Human Anti-TNFα Antibody, in Pediatric Subjects with Active Polyarticular Course Juvenile Idiopathic Arthritis (JIA) Despite Methotrexate Therapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the Safety and Efficacy of CNTO 148 (Golimumab) in Children
    with Juvenile Idiopathic Arthritis (JIA) and Multiple Joint Involvement
    Who Have Poor Response to Methotrexate (GO KIDS)
    A.3.2Name or abbreviated title of the trial where available
    GO KIDS
    A.4.1Sponsor's protocol code numberCNTO148JIA3001
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/84/2010
    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 NV
    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 code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31 71 524 2166
    B.5.5Fax number+31 71 524 2110
    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 Liquid in prefilled syringe
    D.3.2Product code CNTO148
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 antibody
    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) 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 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
    Juvenile Idiopathic Arthritis (JIA)
    E.1.1.1Medical condition in easily understood language
    Juvenile Idiopathic Arthritis (JIA)
    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 16.1
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.2System Organ Class 100000004870
    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 SC administration of golimumab in pediatric subjects (ages 2 to less than 18 years) with JIA manifested by ≥ 5 joints with active arthritis despite methotrexate (MTX) therapy for ≥ 3 months.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate golimumab in pediatric subjects with JIA with respect to:

    1. Safety.
    2. Physical function.
    3. Quality of life.
    4. Disease activity status over time.
    5. Pharmacokinetics and immunogenicity.
    6. Pharmacodynamics.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pediatric subject ages 2 to less than 18 years of age. Age must not be a factor in the ability to continue follow-up with the investigator through the end of the study.
    2. Diagnosis must be made per JIA ILAR diagnostic criteria and the onset of disease must have been before the subject’s 16th birthday Active JIA of one of the subtypes described in the protocol.
    3. Disease duration of at least 6 months before study entry.
    4. Must have ≥ 5 joints with active arthritis as defined by ACR criteria.
    5. Active JIA despite current use of oral, intramuscular or subcutaneous methotrexate.
    6. If using corticosteroids; must be on a stable dose of ≥ 10 mg prednisone equivalent or 0.2 mg/kg/day (whichever is less) for ≥ 4 weeks before first administration of study agent. If currently not using corticosteroids, the subject must have not received corticosteroids for at least 4 weeks before the first dose administration.
    7. If using NSAIDs, must be on a stable dose for ≥ 2 weeks before the first administration of study agent. If not currently using NSAIDs, the subject must not have taken them for at least 2 weeks before the first administration of study agent.
    8. Are considered eligible according to the following TB screening criteria:
    a. Have no history of latent or active TB before screening. An exception is made for subjects who have a history of latent TB and documentation of having completed an adequate treatment regimen for latent TB within 3 years prior to the first administration of study agent under this protocol. Adequate treatment for latent TB is defined according to local country guidelines for immunocompromised patients. If no local guidelines for immunocompromised patients exist, US guidelines must be followed. It is the responsibility of the investigator to verify the adequacy of previous anti-TB treatment and provide appropriate documentation.
    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 before or simultaneously with the first administration of study agent.
    d. Within 6 weeks before the first administration of study agent, have a negative QuantiFERON-TB Gold test result or have a newly identified positive TB screening test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either before or simultaneously with the first administration of study agent.
    e. Have a chest radiograph, taken within 3 months before the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
    9. Medically stable on the basis of physical examination, medical history, and vital signs performed at screening.
    10. Girls of childbearing potential must be:
    a. Incapable of pregnancy,
    b. Abstinent, or
    c. If sexually active, practicing a highly effective method of birth control.
    11. All girls of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening; and a negative urine pregnancy test at each study visit.
    12. Boys must practice abstinence or agree to use a double barrier method of birth control and to not donate sperm during the study and for 6 months after receiving the last dose of study drug.
    13. Willing/able to adhere to the prohibitions and restrictions specified in this protocol.
    14. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study.
    15. Screening laboratory tests must meet the certain criteria (see protocol).
    16. Must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed subjects before enrollment.
    17. A parent or guardian must accompany the subject to each study visit.
    18. The subject and his/her parent must be able to adhere to the study visit schedule, and understand and comply with other protocol requirements.
    19. May have been previously treated with no more than 1 therapeutic agent targeted at reducing TNFα. The first 30 subjects, should not have had been previously treated with any anti-TNF agents.
    20. If previously treated with anti-TNF agent, must have previously:
    a. Received at least an 8-week dosage regimen (including a dose at Week 8) of etanercept, adalimumab, or certolizumab pegol or
    b. Received at least a 14-week dosage regimen (including a dose at Week 14) of infliximab
    c. This inclusion criterion ONLY applies to subjects enrolled after the interim analysis of the first 30 subjects has been completed.
    E.4Principal exclusion criteria
    1. Have known allergies, hypersensitivity, or intolerance to golimumab or other immunoglobulins or its excipients.
    2. Are pregnant or breast-feeding, or planning a pregnancy or fathering a child within 6 months after the last study agent administration.
    3. Have a past history of macrophage activation syndrome (MAS).
    4. Have received an investigational drug or used an investigational medical device within 3 months or 5 half lives, before the planned start of treatment or are currently enrolled in an investigational study.
    5. Have initiated DMARDS and/or immunosuppressive therapy within 4 weeks prior to study initiation.
    6. Have other inflammatory disease that might confound the evaluation of benefit from golimumab therapy.
    7. Are incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for age-appropriate self care.
    8. Have been treated with intra-articular, intramuscular or intravenous corticosteroids during the 4 weeks before first study agent administration.
    9. Have been treated with any therapeutic agent targeted at reducing IL-12 or IL-23.
    10. Have been treated with natalizumab, efalizumab, or therapeutic agents that deplete B or T cells during the 12 months before first study agent administration, or have evidence at screening of persistent depletion of the targeted lymphocyte after receiving any of these agents.
    11. Have been treated with alefacept or abatacept within 3 months before first study agent administration.
    13. Have been treated with leflunomide within 4 weeks before first study agent administration, or have received leflunomide from 4 to 12 weeks before first study agent administration and have not undergone a drug elimination procedure.
    14. Have been treated with cytotoxic agents.
    15. Have received or are expected to receive any live viral or bacterial vaccinations from 3 months before first study agent administration and up to 3 months after the last study agent administration.
    16. Have a history of latent or active granulomatous infection.
    17. Have had a Bacille Calmette-Guérin (BCG) vaccination within 12 months of screening.
    18. If applicable, have a chest radiograph within 3 months before the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB.
    19. Have had a nontuberculous mycobacterial infection or opportunistic infection.
    20. Have current side effects related to MTX which would preclude treatment with MTX.
    21. Have a history of an infected joint prosthesis or have received antibiotics for a suspected infection of a joint prosthesis unless that prosthesis has been removed or replaced.
    22. Have or have had a serious infection, or have been hospitalized or received IV antibiotics for an infection during the 2 months before first study agent administration.
    23. Have a history of or ongoing chronic or recurrent infectious disease.
    24. Have a known history of infection with HIV.
    25. Have a known history of hepatitis C infection.
    26. Have a known history of demyelinating diseases such as multiple sclerosis.
    27. 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.
    28. Have a known malignancy or have a history of malignancy.
    29. Have or have had a substance abuse (drug or alcohol) problem.
    30. Are unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
    31. Have history (current or past) of uveitis.
    32. Have a history of or concomitant diagnosis of CHF.
    33. Have a history of severe progressive or uncontrolled liver or renal insufficiency; or significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances.
    34. Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
    35. Are employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
    36. Have received IL-1ra (anakinra) within 4 weeks of the first study agent administration.
    37. Have received infliximab, etanercept, adalimumab, certolizumab pegol within 6 weeks of the first dose of study agent.
    38. Subjects must undergo screening for hepatitis B virus (HBV). At a minimum, this includes testing for HBsAg (HBV surface antigen), anti-HBs (HBV surface antibody), and anti-HBc total (HBV core antibody total), for outcome criteria see protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of patients with American College of Rheumatology (ACR) 30 response at week 16 who will not experience a flare of disease between Week 16 and Week 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 16 through Week 48
    E.5.2Secondary end point(s)
    1. The proportion of patients with American College of Rheumatology (ACR) 30 response at week 16 who will also achieve ACR 30 response at Week 48.
    2. The proportion of patients with American College of Rheumatology (ACR) 30 response at week 16 who will have inactive disease at Week 48.
    3. The proportion of patients with American College of Rheumatology (ACR) 30 response at week 16 who will achieve clinical remission while on medication for Juvenile Idiopathic Arthritis (JIA) at Week 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 16 through Week 48
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Withdrawal
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    Austria
    Netherlands
    Argentina
    Brazil
    Finland
    Germany
    Lithuania
    Mexico
    Peru
    Poland
    Russian Federation
    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 Patient Last Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months11
    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 months11
    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.1.1Number of subjects for this age range: 170
    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.1.1.5.1Number of subjects for this age range: 85
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 85
    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
    Pediatric subject ages 2 to less than 18 years of age. Age must not be a factor in the
    ability to continue follow-up with the investigator through the end of the study.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 170
    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)
    Treatment will be continued for the study subject until Golimumab will be commercially available.
    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 Decision2011-01-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-05-27
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