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    Summary
    EudraCT Number:2005-002219-26
    Sponsor's Protocol Code Number:RA1100849
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-08-09
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2005-002219-26
    A.3Full title of the trial
    A randomised, parallel group, placebo-controlled, double blind study to assess the safety and tolerability of SB-681323 at 7.5mg daily dose for 28 days and its effect on the levels of serum C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)
    A.4.1Sponsor's protocol code numberRA1100849
    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 R&D Ltd
    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 Information not present in EudraCT
    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 nameSB-681323 Tablets
    D.3.2Product code SB-681323
    D.3.4Pharmaceutical form 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 codeSB-681323
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,5 and 5
    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.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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboTablet
    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
    Rheumatoid arthritis (RA)
    MedDRA Classification
    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 effect of SB-681323 on the serum levels of C-reactive protein (CRP) in subjects with rheumatoid arthritis (RA)
    E.2.2Secondary objectives of the trial
    • To assess the effect of SB-681323 on Disease Activity Score based on 28 joint count (DAS28)
    • To assess the safety and tolerability of SB-681323 in subjects with rheumatoid arthritis (RA)
    • To assess the effect of SB-681323 on American College of Rheumatology (ACR) 20% response in a core set of rheumatologic assessments (ACR20)
    • To assess the effect of SB-681323 on fatigue in subjects with RA
    • To assess the effect of SB-681323 on relevant biomarkers of inflammation and joint damage
    • To assess pharmacokinetics of SB-681323 in this subject population
    • To explore the potential effects of concomitant medication on the pharmacokinetics of SB-681323
    • To explore the potential correlation between plasma exposure to SB-681323 and disease surrogate (CRP) and clinical endpoints (ACR20 and DAS28)
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. The subject is male or female ≥ 18 years of age.
    2. Subject has a negative pregnancy test (i.e serum beta hCG test) and is of:
    - non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is surgically sterile via hysterectomy or bilateral ligation or who is post-menopausal. For purposes of this study, postmenopausal is defined as one year without menses).
    - child-bearing potential and agrees to commit to one of the protocol-approved methods of contraception, when used consistently and in accordance with both the product label and the instructions of a physician, as indicated below:
    • oral contraceptive (combined or progestin only), and the same oral contraceptive regimen has been used for at least two months prior to study drug administration, and the same method continues throughout the study and through the 2 weeks following the end of the treatment phase of the study
    • progesterone implanted rods (Norplant ) inserted for at least two month prior to the study drug administration (but not beyond the third successive year following insertion) , and is continued throughout the study, and for the 2 weeks following the end of the treatment phase of the study
    • an IUD, inserted by a qualified clinician, with published data showing that the highest expected failure rate is less than 1% per year (not all IUDs meet this criterion) Acceptable IUDs: TCu-380A (Paragard), TCU-380 Slimline (Gyne T Slimline), TCu-220C, MULTILOAD-250 (MLCu-250) and 375, NOVA T and CUNOVAT (Novagard), Levonorgesterol (LNG-20) Intra-uterine System (Mirena/Levonova), and FlexiGard 330/CuFix PP330 (Gynefix). The device must be inserted at least 2 weeks prior to the Screen visit, and remain throughout the study and for the 2 weeks following end of the treatment phase of the study.
    • injectable medroxyprogesterone acetate (e.g., Depo-Provera) and is on a stable dose for 2 months prior to Screen, throughout the study, and 2 weeks following the end of the treatment phase of the study
    • complete abstinence from intercourse for two weeks prior to the study drug administration, throughout the treatment phase, and the follow-up phase
    • double barrier method if comprised of a spermicide with either a condom or diaphragm.
    3. Adult males and females with body weight >/= 50 kg for males and >/= 45 kg for females (Body Mass Index (BMI) within the range 18.5-35.0 kg/m2 inclusive).
    4. The subject has a diagnosis of RA according to the revised 1987 ACR criteria.
    5. The subject has active RA defined as, CRP >/= 15mg/l and a DAS28 score >/= 3.2
    6. The subject must have normal Liver Function Tests (LFTs; i.e. ALT, AST, ALP, GGT and total bilirubin within normal limits) at Screening.
    7. Those subjects who are on oral DMARDs (which may include methotrexate, sulphasalazine, hydroxychloroquine) must be on stable doses for at least eight weeks prior to Screening and continued on stable doses during the screening period. The subject may be using glucocorticoid at doses up to 10mg/day, methotrexate up to 25 mg/week or sulphasalazine up to 3g/day.
    8. Those subjects who are on other oral anti-rheumatic therapies (which may include NSAIDs, COX-2 inhibitors and glucocorticoids) must be on stable dosing regimens for at least 4 weeks prior to Screening and during the screening period.
    9. The subjects on stable doses of methotrexate must also be on stable folate supplements with normal red cell folate levels at screening.
    10. The subject must be capable of giving informed consent and can comply with the study requirements and timetable.
    11. The subject agrees to abstain from alcohol for the duration of the study.
    E.4Principal exclusion criteria
    1. The subject is currently receiving a biological anti-rheumatic therapy or has failed to demonstrate a clinical response to a biological anti-rheumatic therapy, is using glucocorticoid at doses >10mg/day, methotrexate > 25 mg/week or sulphasalazine > 3g/day
    2. The subject has a three month prior history of alcohol use >21 units per week for males and >14 units per week for females or the subject has a positive alcohol screen at the Screening visit
    3. The subject has any history of liver disease
    4. The subject has a positive Hepatitis B surface antigen or Hepatitis C antibody result within 3 months of the start of the study.
    5. Subjects whose DMARDs change at any time during 8 weeks prior to screening or during the screening period..
    6. Subjects whose NSAIDs, COX-2 inhibitors or glucocorticoids change at any time during 4 weeks prior to screening or during the Screening period.
    7. The subject has significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal 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.
    8. The subject has an acute infection.
    9. The subject has a history of active tuberculosis.
    10. The subject has a history of repeated or chronic infections.
    11. The subject has a history of malignancy, except for surgically cured basal cell carcinoma or females with cured cervical carcinoma (> 2 yrs prior).
    12. The subject has a history of HIV or other immunosuppressive disease.
    13. The subject has participated in a clinical trial within the 3 months prior to the study onset for non-biological therapy; or within 6 months of a biological therapy.
    14. The subject has Hb <9 g/dL or platelet count < 100 000/mm3
    15. The subject whose calculated creatinine clearance is less than 50ml/min
    16. The subject has uncontrolled diabetes or psoriasis
    17. The subject is pregnant or lactating
    E.5 End points
    E.5.1Primary end point(s)
    Serum levels of CRP at the end of study (after 28 days of treatment) following repeat dosing with SB-681323 (7.5mg/day) compared with placebo
    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 Information not present in EudraCT
    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.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 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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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 Information not present in EudraCT
    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 2005-08-09. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 82
    F.4.2.2In the whole clinical trial 82
    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)
    Not applicable
    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 Decision2005-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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