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    Summary
    EudraCT Number:2010-020743-12
    Sponsor's Protocol Code Number:D4300C00001
    National Competent Authority:Slovakia - SIDC (Slovak)
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-05
    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 ConcernedSlovakia - SIDC (Slovak)
    A.2EudraCT number2010-020743-12
    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 Methotrexate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib
    Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who
    Are Taking Methotrexate But Not Responding. (OSKIRA - 1)
    A.3.2Name or abbreviated title of the trial where available
    OSKIRA - 1
    A.4.1Sponsor's protocol code numberD4300C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01197521
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointInformation Centre
    B.5.6E-mailinformation.center@astrazeneca.com
    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 No
    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 disodium
    D.3.9.1CAS number 914295-16-2
    D.3.9.2Current sponsor codeFosD
    D.3.9.3Other descriptive nameFostamatinib disodium
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E.1.1.1Medical condition in easily understood language
    Rheumatoid arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 (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 methotrexate, compared with placebo plus methotrexate, in patients with active rheumatoid arthritis (RA) by assessment of:
    • The signs and symptoms of RA, as measured by American College of Rheumatology 20% response criteria (ACR20) at Week 24.
    • The prevention of structural joint damage, as measured by change in radiographic modified total Sharp score (mTSS) at Week 24.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study assessed over the 52-week study period are:
    • To further assess the efficacy of fostamatinib 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 fostamatinib using the Health Assessment Questionnaire - Disability Index (HAQ-DI).
    • To evaluate the efficacy of fostamatinib as measured by Disease Activity Score based on a 28 joint count (DAS28) and DAS28 European League Against Rheumatism (EULAR) response criteria.
    • To further assess the efficacy of fostamatinib in the prevention of structural joint damage, as measured by change in the components of modified Total Sharp Score (mTSS).
    • To investigate the effects of fostamatinib on patient reported health outcomes measures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female aged 18 and over
    2) Active Rheumatoid Arthritis (RA) diagnosed after the age of 16
    3) Currently taking Methotrexate
    E.4Principal exclusion criteria
    1) Females who are pregnant or breast feeding
    2) Poorly controlled blood pressure
    3) History of liver problems that have required previous investigation
    4) Certain Inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
    E.5 End points
    E.5.1Primary end point(s)
    There are 2 primary endpoints in this study: the proportion of patients achieving ACR20 at Week 24 and prevention of structural joint damage, as measured by change in radiographic modified total Sharp score mTSS at Week 24. These will be assessed for each dose regimen versus placebo. A hierarchical (fixed sequence) approach will be used within each dosing regimen (ACR20 and then mTSS), and the Hochberg procedure will be used across the 2 dose regimens at the overall 2-sided 5% level.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    − ACR20, ACR50, ACR70, major clinical response, ACR-N, individual
    components of ACR (swollen joint count, tender joint count, patient's
    assessment of pain, patient's global assessment of disease activity,
    physician's global assessment of disease activity, patient's assessment
    of physical function, as measured by the HAQ-DI, C-reactive protein
    [CRP] or erythrocyte sedimentation rate [ESR])
    − HAQ-DI score; HAQ-DI response, individual dimensions of HAQ-DI
    − DAS28 response, DAS28 EULAR response criteria, DAS low disease
    activity, DAS28 remission, clinically important change in DAS28 score
    − mTSS, radiographic erosion score (ES) and joint space narrowing
    (JSN).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary timepoints are : Screening plus week 0 to 6, 12, 24, 28, 36
    and 52.
    For mTSS JSN (Xray) timepoints week 0, 12, 24 and 52.
    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 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 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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA58
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Bulgaria
    Chile
    Estonia
    France
    Germany
    Hungary
    India
    Mexico
    Peru
    Poland
    Russian Federation
    Slovakia
    Ukraine
    United Kingdom
    United States
    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
    As per protocol
    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 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.1.2.1Number of subjects for this age range: 810
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 383
    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)
    Post trial, patients continued treatment will be at the discretion of the investigator and according to local practice. Use of the IMP will be restricted to this study. Patients who complete the treatment period without serious drug-related adverse effects or non responders at Week 12 may be offered Fostamatinib therapy in the long-term
    extension study (Protocol D4300C00005: EUDRACT Number 2010-020892-22)
    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 Decision2010-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-11-26
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