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    Summary
    EudraCT Number:2010-020744-35
    Sponsor's Protocol Code Number:D4300C000002 (OSKIRA-2)
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-22
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2010-020744-35
    A.3Full title of the trial
    A Phase III, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study of Two Dosing Regimens of Fostamatinib Disodium in Rheumatoid Arthritis Patients with an Inadequate Response to DMARDs. D4300C00002
    A.3.2Name or abbreviated title of the trial where available
    OSKIRA-2
    A.4.1Sponsor's protocol code numberD4300C000002 (OSKIRA-2)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 SponsorASTRAZENECA
    B.1.3.4CountryItaly
    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 nameFostamatinib disodium
    D.3.2Product code FosD
    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 INNFostamatinib
    D.3.9.1CAS number 914295-16-2
    D.3.9.2Current sponsor codeFosD
    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.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 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
    Patients with active Rheumatoid Arthritis despite current treatment with a DMARD.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level PT
    E.1.2Classification code 10039073
    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 evaluate the efficacy of 2 oral dosing regimens of fostamatinib disodium (FosD) (Regimen A - 100 mg twice daily (bid); Regimen B - induction with 100 mg bid for the first 4 weeks, 150 mg once daily (qd) maintenance thereafter) taken in combination with a disease-modifying anti-rheumatic drug (DMARD), compared with placebo plus a DMARD, in patients with active rheumatoid arthritis (RA)
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study assessed over the 52-week study period are: • To assess the efficacy of FosD in the prevention of structural joint damage, as measured by change in radiographic modified Total Sharp Score (mTSS) and the components of mTSS at Week 24 and Week 52. • To further assess the efficacy of FosD measured by ACR20, ACR 50% response criteria (ACR50), ACR 70% response criteria (ACR70), major clinical response, ACR-N and the individual components of the ACR score. • To assess physical function status of patients after administration of FosD using the Health Assessment Questionnaire - Disability Index (HAQ-DI). • To evaluate the efficacy of FosD as measured by Disease Activity Score based on a 28 joint count (DAS28) and DAS28 European League Against Rheumatism (EULAR) response criteria. • To investigate the effects of FosD on patient reported health outcomes measures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    For inclusion in the study subjects should fulfil the following criteria: 1. Provision of informed consent, prior to any study-specific procedures. NB: Patients agreeing to participate in the optional exploratory biomarker and/or exploratory genetic research must provide a separate informed consent. 2. Male or female aged 18 and over with a diagnosis of RA after the age of 16 according to the revised (1987) criteria of the American College of Rheumatology (see Appendix E for criteria). NB: Women of childbearing potential may be included only if using acceptable contraceptive methods (see Appendix H for definitions). All females must have 2 negative pregnancy tests, at least 14 days apart, prior to randomisation. 3. Active RA defined as:  4 swollen joints and 4 tender/painful joints (from 28 joint count) and either:  ESR ≥28 mm/h, or  CRP ≥10 mg/L. 4. At least 1 of the following:  Documented history of positive rheumatoid factor  Current presence of rheumatoid factor  Radiographic erosion within 12 months prior to enrolment  Presence of serum anti-cyclic citrullinated peptide antibodies (anti CCP). 5. Treatment with 1 of the following traditional DMARDs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine. NB: Those patients taking methotrexate should have been treated for at least 6 months prior to randomisation and with a stable dose between 7.5 mg and 25 mg per week for at least 6 weeks prior to randomisation. Those patients taking sulfasalazine should have had a stable dose for at least 6 weeks prior to randomisation. Those patients taking hydroxychloroquine or chloroquine should have had a stable dose for at least 12 weeks prior to randomisation. Patients receiving the lower doses of methotrexate (7.5 mg and 10 mg) should be doing so as a result of a documented history of intolerance to higher doses of methotrexate.
    E.4Principal exclusion criteria
    1. Females who are pregnant or lactating. 2. Any systemic inflammatory conditions (other than RA), connective tissue disease or chronic pain disorders that may interfere with the interpretation of the outcome data. 3. American College of Rheumatology functional Class IV or wheelchair/bed-bound. 4. Uncontrolled or poorly controlled hypertension defined as ≥140 mmHg systolic and/or ≥90 mmHg diastolic at baseline (Visit 2) with or without current anti hypertensive treatment. 5. Absolute neutrophil count (ANC) <1500/mm3 or 1.5 x 109/L. 6. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.2 x upper limit of normal (ULN), or bilirubin >1.2 x ULN. 7. History of liver function abnormality requiring investigation, drug induced liver injury, chronic liver disease, excessive alcohol consumption or chronic alcohol induced disease. 8. Evidence of recent or significant CV disease 9. Evidence of active or recent infection including:  Positive serological test for hepatitis B or hepatitis C (patients may be included if confirmed hepatitis C recombinant immunoblot assay negative or hepatitis C virus RNA negative [qualitative]), or patients with suspected human immunodeficiency virus (HIV).  Treatment with intravenous antibiotics within previous month prior to randomisation, oral antibiotics within 2 weeks prior to randomisation or current evidence of a clinically significant active infection. 10. Evidence of tuberculosis (TB) infection. 11. Patients who have failed to respond to treatment with a TNF- antagonist (including etanercept, certolizumab, adalimumab, infliximab, golimumab) or anakinra. Patients who responded to treatment but where treatment was stopped for other reasons are allowed. Patients who have used anakinra or a TNF- antagonist should have a minimum washout of 8 weeks prior to randomisation. 12. Patients who have previously been treated with other biologic agents including rituximab, abatacept and tocilizumab. 13. Use of any DMARDs other than methotrexate, sulfasalazine, hydroxychloroquine or chloroquine within 28 days prior to Visit 1, eg, leflunomide, azathioprine, cyclosporine, gold, penacillamine, minocycline or doxycycline. Any patient that has received leflunomide within 12 weeks prior to randomisation must have completed a cholestyramine washout prior to study randomisation. 14. Intramuscular, intravenous or intra-articular steroid injection within 6 weeks prior to randomisation. 15. Patients requiring doses of oral steroids >10 mg/day prednisolone (or equivalent). NB: Patients on doses ≤10 mg/day are permitted but should have a stable dose for at least 6 weeks prior to randomisation. 16. Administration of a live vaccine in the 4 weeks prior to randomisation. 17. History of malignancy or neoplastic disease, except successfully treated basal or squamous cell carcinoma of the skin >5 years ago. 18. Severely impaired renal function (estimated glomerular filtration rate ≤30 mL/min according to the Cockcroft-Gault formula). 19. Any other clinically significant disease or disorder, which in the opinion of the investigator (by its nature or by being inadequately controlled) might put the patient at risk due to participation in the study, or may influence the results of the study, or the patient’s ability to participate in the study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint in this study is the proportion of patients achieving ACR20 response at Week 24
    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) 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 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 Yes
    E.8.2.3.1Comparator description
    stesso farmaco, due diversi regimi posologici
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    come da protocollo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    E.8.9.2In all countries concerned by the trial months1
    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) 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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 499
    F.4.2.2In the whole clinical trial 900
    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)
    Ai pazienti che completano il periodo di trattamento o a quelli considerati senza risposta alla settimana 12 verra` offerta la possibilita` di essere trattati con FosD in uno studio di estensione di follow-up a lungo termine
    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 Decision2011-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-01
    P. End of Trial
    P.End of Trial StatusCompleted
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