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    Summary
    EudraCT Number:2009-012055-19
    Sponsor's Protocol Code Number:ZM2009/00035/00
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2009-012055-19
    A.3Full title of the trial
    A randomized, single-blind, placebo-controlled, parallel-group study evaluating the anti-inflammatory activity of GSK315234 in synovial biopsy tissue obtained from subjects with rheumatoid arthritis
    A.4.1Sponsor's protocol code numberZM2009/00035/00
    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 SponsorGlaxoSmithKline Research & Development Limited
    B.1.3.4CountryUnited Kingdom
    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 nameGSK315234 Injection 100mg/mL
    D.3.2Product code GSK315234
    D.3.4Pharmaceutical form Injection*
    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.3.9.2Current sponsor codeGSK315234
    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 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 placeboInjection*
    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
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    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
    1. To assess the change in inflammatory biomarkers in the synovial tissue of subjects with rheumatoid arthritis (RA) on a background of methotrexate after administration of a single, intravenous dose of GSK315234, as compared to placebo
    2. To assess the safety and tolerability of a single, intravenous dose of GSK315234 in subjects with RA on a background of methotrexate, as compared to placebo, under the conditions of this study
    E.2.2Secondary objectives of the trial
    1. To assess the change in bone and synovial parameters (as measured by MRI) in subjects with RA on a background of methotrexate after administration of a single, intravenous dose of GSK315234 or placebo
    2. To assess pharmacodynamic activity (as measured by effects on serum/plasma and urine biomarkers) in subjects with RA on a background of methotrexate after administration of a single, intravenous dose of GSK315234 or placebo
    3. To assess clinical activity (as measured by effects on rheumatological endpoints) in subjects with RA on a background of methotrexate after administration of a single, intravenous dose of GSK315234 or placebo
    4. To assess pharmacokinetic/pharmacodynamic correlations in subjects with RA on a background of methotrexate after administration of a single, intravenous dose of GSK315234
    5. To assess the immunogenicity of GSK315234 in subjects with RA on a background of methotrexate after administration of a single, intravenous dose of GSK315234
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    There is no separate protocol. See main protocol Section 7.10.
    Objectives:
    1. Evaluate the immune response after one month of treatment with GSK315234 (TH1/TH2, TH17, Treg),
    2. Establish the correlation between the immune and the clinical responses
    3. Establish the correlation between the immune response and immunohistological parameters.
    E.3Principal inclusion criteria
    1. Males or females between 18 and 75 years of age, inclusive
    2. Using acceptable contraception to ensure that no pregnancies occur during the course of the study and for at least 12 weeks after receiving the last dose for male subjects and for 32 weeks after receiving the last dose for female subjects (see Section 8.1 of the protocol on contraception for more details)
    3. Body mass index within the range 18.5 - 35 kg/m2 inclusive
    4. Capable of giving informed consent and can comply with the study requirements and timetable
    5. Diagnosis of RA according to the revised 1987 criteria of the ACR
    6. DAS28 disease activity score of greater than 3.2 at screening and prior to dosing
    7. CRP level >0.5 mg/dL at screening and prior to dosing
    8. Inflamed knee or ankle, as shown by clinical examination or ultrasound
    9. Has never received a biological (marketed compounds or experimental treatments) or has been treated with a biological and failed due to lack of efficacy (adequate wash-out is required based on the half-life of the previously administered biological; wash-out time should be discussed with GSK Medical Monitor)
    10. Must have received at least three months of methotrexate (MTX) prior to screening and must be on a stable dose of MTX (up to 25 mg/week) for at least four weeks prior to randomization and be willing to remain on this dose throughout the study
    11. Must be on a stable dose of folate supplements (a minimum of 5 mg/week) for at least four weeks prior to randomization and throughout the course of the study
    12. If sulfasalazine is being taken in addition to MTX, the subject must be on a stable dose for at least four weeks prior to screening and be willing to remain on this dose throughout the study
    13. If hydoxychloroquine or chloroquinine is being taken in addition to MTX, the subject must be on a stable dose for at least three months prior to screening and be willing to remain on this dose throughout the study
    14. If other oral anti-rheumatic therapies are being taken [e.g., non steroidal anti inflammatory drugs (NSAIDs), cyclo-oxygenase type -2 (COX-2) inhibitors, oral glucocorticoids (e.g. prednisolone </=10mg/day)], the subject must be on stable dosing regimens for at least four weeks prior to screening and be willing to remain on this regime throughout the study.
    15. Subjects receiving intramuscular glucocorticoids (e.g., methylprednisolone </=120 mg/month) must be on a stable dosing regimen for at least three months prior to screening and be willing to remain on this regimen throughout the study.
    16. Must have liver function tests including ALT and AST within 1.5 times the ULN and ALP within 3 times ULN at screening. The subject must also have total bilirubin within the ULN at screening.
    17. QTc<450 msec or QTc<480 msec for subjects with Bundle Branch Block based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period
    E.4Principal exclusion criteria
    1. Any clinically relevant abnormality identified on the screening medical assessment, laboratory examination, or ECG (12-lead or Holter); at the discretion of the investigator
    2. Positive Hepatitis B surface antigen or Hepatitis C antibody at screening
    3. History of human immunodeficiency virus or other immunodeficiency disease at screening
    4. A history of elevated liver function tests on more than one occasion (ALT, AST and ALP > 3 times the ULN; total bilirubin > 1.5 times the ULN) in the 6 months prior to screening
    5. Previous exposure or past infection caused by mycobacterium tuberculosis, unless adequately treated (documentation of treatment must be provided to the investigator and reviewed by the investigator and GSK Medical Monitor)
    6. An acute infection
    7. A history of repeated, chronic or opportunistic infections that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial
    8. A history of malignancy, except for adequately treated, non-invasive cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix (an exception would be adequately treated cancer >10 years prior to screening; documentation of treatment must be provided to the investigator and reviewed by the investigator and GSK Medical Monitor)
    9. Calculated creatinine clearance< 50mL/min
    10. Significant cardiac, pulmonary, metabolic, renal, hepatic or GI conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial
    11. Has taken cyclosporine, leflonomide, cyclophosphamide or azathioprine within one month of screening. Subjects who have taken cyclosporine, leflonomide, cyclophophamide or azathioprine in the past must have recovered from all drug related AEs.
    12. Has taken gold salts or d-penicillamine within one month prior to screening. Subjects that have taken gold salts or d-penicillamine in the past must have recovered from all drug related AEs.
    13. Has received intra-articular or intra-muscular glucocorticoids within one month of screening
    14. Has received cell-depleting therapy (e.g., rituximab)
    15. Has received a live vaccine within three months of dosing
    16. Recent history (within six months of screening) of bleeding disorders, anaemia, peptic ulcer disease, haematemesis or GI bleeding
    17. Serum iron AND ferritin below the lower limit of the reference range at screening and prior to dosing
    18. History of B12 or folate deficiency
    19. A history of haematological disease or acquired platelet disorders, including drug-induced thrombocytopaenia, acute idiopathic thrombocytopaenia or von Willebrand’s disease
    20. A known risk of intra-cranial hemorrhage including central nervous system surgery within 12 months prior to screening, arterial vascular malformations, aneurysms, significant closed head trauma within 6 months prior to screening or any other incident the investigator and/or medical monitor considers to be relevant
    21. Hb <10 g/dL and platelet count < 150 x 10 power9 /L
    22. Donation of blood in excess of 500 mL within a 56 day period prior to dosing
    23. An unwillingness of male subjects to abstain from sexual intercourse with pregnant or lactating women; or an unwillingness of the male subject to use a condom with spermicide in addition to having their female partner use another form of contraception [such as an intra-uterine device (IUD), diaphragm, oral contraceptives, injectable progesterone, subdermal implants of levonorgestrel] if the female partner could become pregnant for at least 12 weeks after receiving the last dose of study medication.
    24. An unwillingness of female subject of child bearing potential to use adequate contraception for at least 32 weeks after receiving the last dose of study medication. If necessary, women of non-child bearing potential will be confirmed. Surgical sterility will be defined as females who have had a documented hysterectomy, tubal ligation or bilateral oophorectomy.
    25. History of use of drugs of abuse within 12 months prior to screening
    26. History of regular alcohol consumption exceeding average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). Subjects who regularly consume more than 12 units of alcohol in a 24 hour period will also be excluded.
    27. Positive pregnancy test or lactating at screening or pre-dose
    28. Participation in a trial with any investigational drug within 3 months or 5 half-lives (whichever is longer) before the start of the study and within 4 months if the study drug was new chemical entity. Exposure to more than three new chemical entities in a clinical study setting within 12 months prior to dosing
    E.5 End points
    E.5.1Primary end point(s)
    • Synovial infiltration of sub-lining CD68+ macrophage, expressed as change relative to baseline
    • Spontaneous and elicited adverse events (AEs), vital signs, electrocardiograms (ECGs) and clinical laboratory values
    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 Yes
    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 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) 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 Yes
    E.8.1.4Double blind No
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 the trial will be the last visit of the last subject.
    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 months6
    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 months6
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-03-02. Yes
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 45
    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)
    Subjects will return to standard of care treatment for their condition.
    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 Decision2010-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-01-22
    P. End of Trial
    P.End of Trial StatusCompleted
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