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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01197521
Registration number
NCT01197521
Ethics application status
Date submitted
8/09/2010
Date registered
9/09/2010
Date last updated
7/04/2014
Titles & IDs
Public title
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.
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Scientific title
(OSKIRA-1): 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
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Secondary ID [1]
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0
2010-020743-12
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Secondary ID [2]
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D4300C00001
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Universal Trial Number (UTN)
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Trial acronym
OSKIRA - 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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0
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Condition category
Condition code
Musculoskeletal
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0
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - fostamatinib
Treatment: Drugs - fostamatinib
Treatment: Drugs - placebo, fostamatinib
Experimental: Dosing Regimen A - Oral Treatment
Experimental: Dosing Regimen B - Oral Treatment
Placebo Comparator: Dosing Regimen C - Oral Treatment
Treatment: Drugs: fostamatinib
fostamatinib 100 mg twice daily
Treatment: Drugs: fostamatinib
fostamatinib 100 mg twice daily/150 mg once daily
Treatment: Drugs: placebo, fostamatinib
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.
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Assessment method [1]
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ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
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Timepoint [1]
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24 weeks
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Primary outcome [2]
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Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.
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Assessment method [2]
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mTSS: modified total Sharp score, a measure of structural progression based upon X-rays. Hand and foot joints are scored for erosions and joint space narrowing and the results summed to give a value between 0 and 448. A higher value represents more serious progression of the disease. After disregarding ineligible records, patients with 2 or more non-missing values have had missing data imputed via linear extrapolation/interpolation methods. Patients with only 1 result have been excluded from the analysis. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, IP=investigational product, PO=orally, QD=once a day.
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Timepoint [2]
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Baseline and 24 weeks
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Secondary outcome [1]
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ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1
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Assessment method [1]
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ACR20: American College of Rheumatology 20% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally.
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Timepoint [1]
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1 week
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Secondary outcome [2]
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Proportion of Patients Achieving ACR50 up to Week 24
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Assessment method [2]
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ACR50: American College of Rheumatology 50% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
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Timepoint [2]
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24 weeks
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Secondary outcome [3]
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Proportion of Patients Achieving ACR70 up to Week 24
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Assessment method [3]
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ACR70: American College of Rheumatology 70% response criteria, based on count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (such as CRP) and the physician and patient's own assessments of disease activity, pain and physical function. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day.
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Timepoint [3]
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24 weeks
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Secondary outcome [4]
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ACRn - Comparison Between Fostamatinib and Placebo at Week 24
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Assessment method [4]
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ACRn: American College of Rheumatology index of RA improvement, based on smallest percentage improvement in the count of swollen joints (out of 28 joints), count of tender joints (out of 28 joints), or in blood test measures of inflammation (such as CRP) or the physician or patient's own assessments of disease activity, pain and physical function. Scores are reported as a percentage improvement on a scale of -100 to +100, with larger values representing a better clinical outcome. BID=twice daily, CI=confidence interval, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, PO=orally, QD=once a day, RA=rheumatoid arthritis. Mean refers to change at Week 24.
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Timepoint [4]
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24 weeks
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Secondary outcome [5]
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Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12
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Assessment method [5]
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DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
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Timepoint [5]
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0
12 weeks
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Secondary outcome [6]
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Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24
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Assessment method [6]
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DAS28-CRP: Disease Activity Score based on a count of swollen and tender joints (out of 28 joints), blood test measures of inflammation (CRP) and the patient's own assessment. Scores can take any positive value with a lower value indicating a better clinical condition. A DAS28-CRP score of <2.6 is indicative of remission of RA symptoms. BID=twice daily, CRP=C-reactive protein, DMARD=Disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
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Timepoint [6]
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24 weeks
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Secondary outcome [7]
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Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24
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Assessment method [7]
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Change in DAS28 was derived for each post baseline scheduled assessment and categorised using the European League Against Rheumatism (EULAR) response criteria. Non-responder imputation has been applied by carrying the baseline observation forward. BID=twice daily, CRP=C-reactive protein, DAS28=Disease Activity Score based on a 28-joint count, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
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Timepoint [7]
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24 weeks
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Secondary outcome [8]
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HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24
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Assessment method [8]
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HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is calculated by summing scores from 8 sub-categories (ie, scores for patient ability in dressing and grooming, rising, eating, walking, hygiene, reach, grip and common daily activities) and dividing by the number of categories completed. The HAQ-DI score takes values between 0 and 3, with higher score indicating greater disability. HAQ-DI response: a reduction from baseline in HAQ-DI greater than or equal to the minimally important difference (0.22). BID=twice daily, DMARD=disease-modifying anti-rheumatic drug, OR=odds ratio, PO=orally, QD=once a day.
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Timepoint [8]
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Baseline and 24 weeks
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Secondary outcome [9]
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SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24
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Assessment method [9]
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SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Physical Component Scores (PCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.
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Timepoint [9]
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Baseline and 24 weeks
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Secondary outcome [10]
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SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24
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Assessment method [10]
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SF-36: 36 item Short Form Health Survey, a measure of health-related QoL. Scores for 8 sub-domains (Physical Functioning, Role-physical, Bodily Pain, General Health, Vitality, Social Function, Role-emotional & Mental Health) are derived & normalised to a scale of 0-100. Mental Component Scores (MCS) are derived by multiplying each of these 8 scores by a constant, summing them & standardising against a population with mean of 50, standard deviation of 10. Higher scores represent a better QoL. Mean changes from baseline score are presented at each visit as increases from baseline (defined as post-baseline minus baseline); larger changes indicate a better clinical condition. ANCOVA=analysis of covariance, BID=twice daily, DMARD=disease modifying antirheumatic drug, PO=orally, QD=once daily, QoL=quality of life.
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Timepoint [10]
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Baseline and 24 weeks
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Eligibility
Key inclusion criteria
- Active rheumatoid arthritis (RA) diagnosed after the age of 16
- Currently taking methotrexate
- 6 or more swollen joints and 6 or more tender/painful joints (from 28 joint count) and
either Erythrocyte Sedimentation Rate (ESR) blood result of 28mm/h or more, or
C-Reactive Protein (CRP) blood result of 10mg/L or more
- At least one of the following: documented history of positive rheumatoid factor (blood
test), current presence of rheumatoid factor (blood test), radiographic erosion within
12 months prior to study enrolment, presence of serum anti-cyclic citrullinated
peptide antibodies (blood test)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Females who are pregnant or breast feeding
- Poorly controlled hypertension
- Liver disease or significant liver function test abnormalities
- Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue
diseases or chronic pain disorders
- Recent or significant cardiovascular disease
- Significant active or recent infection including tuberculosis
- Previous failure to respond to a TNF alpha antagonist, anakinra or previous treatment
with other biological agent
- Severe renal impairment
- Neutropenia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2012
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Sample size
Target
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Accrual to date
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Final
923
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Research Site - Camperdown
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Research Site - Cairns
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Research Site - Southport
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Recruitment postcode(s) [1]
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- Camperdown
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- Cairns
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Recruitment postcode(s) [3]
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- Southport
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Recruitment outside Australia
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Alabama
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Slovakia
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State/province [87]
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Zilina
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Country [88]
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Ukraine
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State/province [88]
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Donetsk
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Country [89]
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Ukraine
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State/province [89]
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Ivano-frankivsk
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Country [90]
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Ukraine
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State/province [90]
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Kharkiv
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Country [91]
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Ukraine
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State/province [91]
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Kiev
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Country [92]
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Ukraine
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State/province [92]
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Kyiv
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Country [93]
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Ukraine
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State/province [93]
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Lviv
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Country [94]
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Ukraine
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State/province [94]
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Odessa
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Country [95]
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Ukraine
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State/province [95]
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Vinnytsya
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Country [96]
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Ukraine
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State/province [96]
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Zaporyzhzhya
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Country [97]
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United Kingdom
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State/province [97]
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Cheshire
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Country [98]
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United Kingdom
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State/province [98]
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Christchurch
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Country [99]
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United Kingdom
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State/province [99]
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Ipswich
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Country [100]
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United Kingdom
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State/province [100]
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London
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Country [101]
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United Kingdom
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State/province [101]
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Westcliff-on-the Sea
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Country [102]
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United Kingdom
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State/province [102]
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Ethics approval
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Summary
Brief summary
The purpose of the study is to evaluate the effectiveness of two dosing regimens of
fostamatinib compared to placebo, in patients with rheumatoid arthritis (RA) who are taking
methotrexate but not responding. The study will last for 1 year.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01197521
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Public notes
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Contacts
Principal investigator
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Neil MacKillop, MD PhD
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Address
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AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01197521
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