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    Summary
    EudraCT Number:2004-000482-35
    Sponsor's Protocol Code Number:ARA102198
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-02-08
    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 ConcernedUK - MHRA
    A.2EudraCT number2004-000482-35
    A.3Full title of the trial
    A randomised, double-blind, placebo-controlled, parallel group study to investigate the anti-inflammatory and metabolic effects of rosiglitazone XR, 8mg once daily, in subjects with rheumatoid arthritis.
    A.3.2Name or abbreviated title of the trial where available
    HM2004/00255/00
    A.4.1Sponsor's protocol code numberARA102198
    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 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 nameRosiglitazone Extended Release Tablets
    D.3.2Product code BRL-049653
    D.3.4Pharmaceutical form Film-coated 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.3.8INN - Proposed INNRosiglitazone
    D.3.9.1CAS number 0155141-29-0
    D.3.9.3Other descriptive nameRosiglitazone maleate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    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 placeboFilm-coated 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
    Rheumatoid Arthritis
    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 anti-inflammatory efficacy of rosiglitazone XR 8 mg administered once daily for a period of 6 months to subjects with rheumatoid arthritis who demonstrate active disease despite disease-modifying antirheumatic drug (DMARD) therapy.
    E.2.2Secondary objectives of the trial
    - To assess the effect of once daily rosiglitazone XR 8 mg on biochemical markers of inflammation.
    - To assess the metabolic effects of once daily rosiglitazone XR 8 mg in subjects with rheumatoid arthritis.
    - To assess the safety and tolerability of once daily rosiglitazone XR 8 mg in subjects with rheumatoid arthritis.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    A subject will be eligible for inclusion in this study only if all of the following criteria apply:
    1. Subjects over 18 years old at the time of screening.
    2. Females must be post-menopausal (i.e., > 6 months without a menstrual period), surgically sterile, or using acceptable contraceptive measures (oral contraceptive, Norplant, Depo-Provera, an IUD, a diaphragm with spermicide or condoms). Women of childbearing potential must use an acceptable contraceptive measure for at least one month prior to screening and for 30 days after completing the study.
    3. Subjects with a diagnosis of RA according to the revised 1987 criteria of the American College of Rheumatology [Arnett et al., 1988].
    4. The subject must have at least six swollen joints plus two out of the following criteria: i) six tender joints, ii) early morning stiffness > 30 minutes, and iii) Erythrocyte sedimentation rate (ESR) > 28 mm/h.
    5. The subject must be receiving a stable dose of DMARD therapy, which may include MTX, sulfasalazine, hydroxychloroquine, D-penicillamine, azathioprine, cyclosporin A, gold or a combination of these, for at least the past 2 months prior to screening, which may not be changed during the course of this study.
    6. The subject must be willing and able to give written informed consent prior to any protocol specific procedures being performed, willing to participate for the full duration of the study, and able to understand and follow instructions related to study procedures.
    E.4Principal exclusion criteria
    A subject will not be eligible for inclusion in this study if any of the following criteria apply:
    1. Women who are lactating, pregnant, or planning to become pregnant during the conduct of or within 3 months of finishing the study.
    2. Systolic blood pressure (SBP) >165 mmHg or diastolic blood pressure (DBP) >95 mmHg while receiving optimal antihypertensive therapy.
    3. Any clinically significant abnormality identified on the screening physical exam, laboratory tests, or ECG, which in the judgement of the Investigator makes the subject unsuitable for inclusion in the study.
    4. The subject has a prior history of alcohol abuse or consumes >3 units per day for males and >2 units per day for females (one unit is equivalent to a 285 mL glass of full strength beer or 425 mL schooner of light beer or 1 (30 mL) measure of spirits or one (100 mL) glass of wine).
    5. The subject has a history of liver disease or has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels >2.5 times upper limit of normal and total bilirubin levels greater than 1.5 times the upper limit of normal (unless associated with predominantly indirect bilirubin or Gilbert’s syndrome) at screening
    6. The subject is using glucocorticoid at doses >10 mg/day currently or within the last 3 months or may be expected to do so during the course of the study.
    7. The subject’s dose of NSAIDs, COX-2 inhibitors or glucocorticoids has changed at any time during the past 2 weeks prior to screening or may be expected to change during the course of the study.
    8. The subject’s dose or treatment with a statin has changed at any time during the past 3 months prior to screening or may be expected to change during the course of the study.
    9. The subject has a history of renal disease or has serum creatinine greater than 150 micromol/L. Subjects receiving methotrexate as DMARD therapy should be monitored for renal toxicity as per the standard of care for methotrexate therapy.
    10. The subject has diabetes mellitus that requires medication or hyperglycaemia with a HbA1c of >7%.
    11. History of new cardiovascular event within the last 6 months (i.e., intervention, percutaneous coronary intervention, vascular surgery, acute coronary syndrome [non Q-wave myocardial infarction, Q-wave myocardial infarction, unstable angina) or significant arrhythmia; or major intervention (e.g., cardiac surgery or angiography plus stenting) scheduled.
    12. Concurrent or past medical history of congestive heart failure or pulmonary oedema.
    13. Presence of severe peripheral oedema or a medically serious fluid-related event.
    14. The subject has significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or immunological conditions that, in the opinion of the Investigator and/or GSK medical monitor, places the patient at an unacceptable risk as a participant in this trial.
    15. The subject has a history of malignancy in the last 5 years, except for surgically cured basal cell carcinoma (>2 years prior to first dosing).
    16. The subject has a history of human immunodeficiency virus (HIV), or chronic hepatitis B or positive C serology.
    17. The patient has a history of drug abuse.
    18. The subject has participated in a clinical trial within the 3 months before the start of the study for non-biological therapy; or within 6 months of a biological therapy.
    19. Subject is on a biological therapy or has received biological therapy within 6 months prior to screening.
    20. The subject has donated blood in excess of 500 mL within 56 days prior to dosing.
    21. The subject is at risk of non-compliance in following directions or adhering to study restrictions.
    22. The subject has a history of drug or other allergy, which, in the opinion of the physician responsible, contraindicates their participation.
    23. The subject has anaemia defined by haemoglobin concentration <11 g/dL for males or <10 g/dL for females.

    E.5 End points
    E.5.1Primary end point(s)
    Disease activity scores (DAS) based on 28 joint count (DAS28) after 6 months of treatment.
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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 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 No
    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
    The study will be deemed to have completed when the last randomised patient completes the last protocol specified visit , i.e. the safety follow-up visit, 2-4 weeks after receiving the last dose of study medication.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months16
    E.8.9.1In the Member State concerned days
    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 2005-02-08. 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 state66
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 96
    F.4.2.2In the whole clinical trial 96
    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)
    Enrolled patients will continue to receive stable doses of their regular anti-rheumatic therapy throughout the study so patients' routine standard of care will not be compromised at the end of the trial. There is no open-label extension or compassionate use programme planned for subjects following completion of this trial. Rosiglitazone (Avandia) is a registered product in the UK and is indicated for the treatment of type II diabetes mellitus.
    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 Decision2004-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-12-08
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