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    EudraCT Number:2009-012118-27
    Sponsor's Protocol Code Number:38518168ARA2001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-07-03
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2009-012118-27
    A.3Full title of the trial
    A Phase IIa Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of JNJ-38518168 in Subjects with Active Rheumatoid Arthritis Despite Methotrexate Therapy With Synovial Biopsy Substudy

    Estudio de fase IIa, multicéntrico, aleatorizado, doble ciego, controlado con placebo, con grupos paralelos de JNJ 38518168 en pacientes con artritis reumatoide activa a pesar del tratamiento con metotrexato con un sub-estudio de biopsia sinovial
    A.4.1Sponsor's protocol code number38518168ARA2001
    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 SponsorJanssen-Cilag International NV
    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.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 nameJNJ-38518168 50-mg Over Encapsulated Tablet
    D.3.2Product code GFI 38518168-AEK-B-007
    D.3.4Pharmaceutical form Over encapsulated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeJNJ-38518168
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    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 placeboOver encapsulated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    JNJ-38518168 is being developed for the treatment of Rheumatoid Arthritis.

    JNJ-38518168 se está desarrollando para el tratamiento de la Artritis Reumatoide
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level HLT
    E.1.2Classification code 10039075
    E.1.2Term Rheumatoid arthritis and associated conditions
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the safety, tolerability, and efficacy (in terms of change in DAS28 [using C-Reactive Protein (CRP)] from baseline) of JNJ-38518168 at a dose of 100 mg/day for up to 12 weeks compared to placebo in subjects with active Rheumatoid Arthritis (RA) despite methotrexate (MTX) therapy
    E.2.2Secondary objectives of the trial
    To assess the efficacy of JNJ-38518168 as measured by ACR 20, 50, 70, 90 response rates at Week 12 and other efficacy assessments.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The synovial biopsy substudy will be performed at selected sites in a subset of approximately 18 subjects (JNJ-38518168 100 mg/day [n=12] or placebo [n=6]). Synovial tissue samples collected via biopsy performed during the arthroscopy or ultrasound-guided biopsy of one or more of the inflamed joints. Synovial inflammation will be assessed via immunohistochemistry and digital imaging analysis. RNA and epigenomic profiles will be analyzed in synovial tissues using microarray and other technologies.
    E.3Principal inclusion criteria
    1. Man or woman between 18 and 75 years of age, inclusive.
    2. Have a diagnosis of RA at screening established as positive for either anti-CCP antibody or Rheumatoid Factors (RF) in serum at screening.
    3. Have active RA at screening and at baseline (for joint count only). Active RA is defined for the purpose of this study as persistent disease activity with both of the following criteria:
    a. Serum CRP > upper limit of normal at screening only.
    b. 66/68 Joint Count as follows:
    ? Primary study subjects: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline
    ? Synovial biopsy substudy subjects: at least 4 swollen and 4 tender joints using a 66/68 joint count with a clinically inflamed knee or ankle joint at the time of screening and at baseline.
    4. Have been treated with and tolerated MTX treatment at dosages between 7.5 to 25 mg/wk inclusive, for a minimum of 4 m prior to Screening and must have a stable MTX dose for a min of 4 wks prior to the first study drug dose. In addition, based on the Investigator?s assessment, an adequate supply of MTX as needed throughout the subject?s participation in the study.
    5. If using NSAIDs regularly for RA or other conditions, subjects must have been on a stable dose for at least 2 wks prior to the first dose of study medication. If not using NSAIDs at study initiation, the patient must have been off NSAIDs for at least 2 wks prior to the first dose of study medication.
    6. If using oral corticosteroids (CS), must be on a stable dose of ?10 mg/day of prednisone or an equipotent dose of another oral CS for at least 4 wks prior to the first dose of study medication, and continue with the same dose throughout the study. If not using CS at study initiation, the subject must have not received oral CS for at least 4 wks prior to the first dose of study medication.
    7. Currently treated with folic acid at a minimum dose of 5 mg/wk.
    8. Eligible according to the following TB screening criteria (see protocol for details)
    9. The results of the following laboratory tests performed at the central laboratory must be within the limits specified in the protocol
    10. Except for signs and symptoms of active RA, subjects should be free from any significant health condition on the basis of the physical examination, medical history, laboratory tests, vital signs, 12-lead ECG, and all other assessments performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population at Investigator?s discretion.
    11. Women must be one of the following:
    a. Postmenopausal,
    b. Surgically sterile,
    c. Sexually abstinent, or
    d. If sexually active, be practicing a highly effective method of birth control and must agree to continue to use the same method of contraception throughout the study.
    12. All women must have a negative beta human chorionic gonadotropin pregnancy test at screening and at baseline.
    13. Male subjects must consent to utilize a medically acceptable method of contraception throughout the study and for three months after the last dose of study drug and to not donate sperm during the study and for 3 months after receiving the last dose of study drug.
    14. Willing and able to adhere to all of the procedures, prohibitions and restrictions specified in this protocol.
    15. Before any screening procedure is undertaken, 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.
    16. To participate in the optional pharmacogenomic component of this study, subjects must have signed the informed consent form for pharmacogenomic research indicating willingness to participate in the pharmacogenomic component of the study. Refusal to give consent for this component does not exclude a subject from participation in the clinical study.
    E.4Principal exclusion criteria
    1. Have a diagnosis of RA Functional Class IV according to the ACR criteria which has been ongoing for at least 6 m prior to the first dose of study medication.
    2. Have inflammatory diseases other than RA. At the discretion of the Investigator, certain inflammatory diseases such as Sjogrens Syndromeor Chronic Thyroiditis may be acceptable after discussion with the Medical Monitor.
    3. Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the Investigator?s discretion. RA subjects with chronic co-morbidities will not be excluded if the Investigator has determined that the co-morbid condition is not severe or progressive and is being controlled with stable therapy.
    4. Except for MTX, have been treated with approved or investigational non-biologic DMARDs during the 4 wk or 5 half-lives prior to the first dose of study medication, whichever is longer.
    5. Have received intra-articular, IM, or IV corticosteroids (CS), including adrenocorticotropic hormone, within 4 wk prior to the first dose of study medication, or would be expected to need such therapy during the participation in the study.
    6. Have received any approved or investigational antirheumatic agent targeted at reducing TNF within 3 m or five half lives of the drug prior to the first dose of study medication, whichever is longer.
    7. Have been treated with more than either the total of three biologic antirheumatic agents or the total of five DMARDs that proved ineffective anytime before the screening.
    8. Have been treated with other approved or investigational biologic anti-inflammatory or immunosuppressive agents during the six m or five half-lives of the drug prior to the first dose of study medication, whichever is longer.
    9. Have been treated with Prosorba column apheresis within 3 m prior to the first dose of study medication.
    10. Have been treated with any other investigational drug or medical device within 4 wk or 5 half lives of the drug, whichever is longer prior to the first dose of study medication.
    11. Except for MTX, have been treated with a cytotoxic agent anytime before the first dose of study medication.
    12. Have undergone surgical treatments for RA including synoviectomy and arthroplasty within 3 m prior to the first dose of study medication.
    13. Have undergone arthrocentesis or synovial biopsy within 1 m prior to the first dose of study medication.
    14. Have received drugs that potently inhibit or induce CYP450 3A4 isoform or any drug that potently inhibits or induces the PGP within 2 wk or within 5 half-lives of the drug, whichever is longer, prior to the first dose of study medication.
    15. Have received drugs with a risk of torsades de pointes within 1 wk or within 5 half-lives of the drug, whichever is longer, prior to the first dose of study medication. Use of drugs known to prolong the QT interval should be discussed with the Medical Monitor on a case by case basis.
    16. Have a history of latent or active granulomatous infection, histoplasmosis, or coccidioidomycosis.
    17. Have a QTcF interval >450 msec at screening or baseline , or have a history or current evidence of additional risk factors for torsades de pointes.
    18. Have received, or are expected to receive, any live virus or bacterial vaccines within 1 m prior to the first dose of study medication, during the trial, or within 3 m after the last administration of study medication.
    19. Have a history of an infected joint prosthesis, or have received antibiotics for a suspected infection of a joint prosthesis anytime before the first dose of study medication, if that prosthesis has not been removed or replaced.
    20. Have had an infection which is serious in the opinion of the Investigator, have been hospitalized for an infection, or have been treated with IV antibiotics for an infection within 2 m prior to the first dose of study medication. At the discretion of the Investigator, subjects with mild acute infections at screening or before the first dose of study medication could be considered eligible.
    21. Have a history of, or current evidence of an opportunistic infection.
    22. Are seropositive for HIV, hep B, or hep C. Prior and resolved infection with Hep B or C is permitted with documentation of viral clearance.
    23. Have any known malignancy or a history of malignancy within the previous 5 years.
    24. Have a transplanted organ.
    25. Have a history of or current evidence of substance abuse (drug or alcohol) problem within the previous 2 y.
    26. Have known allergies, hypersensitivity, or intolerance to JNJ-38518168 or its excipients.
    27. Women who are pregnant or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in DAS28 (using CRP) score at Week 12
    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 No
    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 Yes
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned5
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    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 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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 67
    F.4.2.2In the whole clinical trial 90
    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 Decision2009-09-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2010-10-29
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