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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/NCT01242514
Registration number
NCT01242514
Ethics application status
Date submitted
10/11/2010
Date registered
17/11/2010
Date last updated
4/04/2014
Titles & IDs
Public title
Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)
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Scientific title
(OSKIRA-X): A Long-term Extension Study to Assess the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Rheumatoid Arthritis
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Secondary ID [1]
0
0
2010-020892-22
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Secondary ID [2]
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0
D4300C00005
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Universal Trial Number (UTN)
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Trial acronym
OSKIRA-X
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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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0
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Osteoarthritis
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Inflammatory and Immune System
0
0
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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 - Fostamatinib
Experimental: A - Oral treatment
Experimental: B - Oral treatment
Experimental: C - Oral treatment
Treatment: Drugs: Fostamatinib
Fostamatinib 100mg twice daily
Treatment: Drugs: Fostamatinib
Fostamatinib 150mg once daily
Treatment: Drugs: Fostamatinib
Fostamatinib 100mg once daily
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Intervention code [1]
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0
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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Percentage of Patients Who Had at Least 1 Adverse Event in Any Category
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Assessment method [1]
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AE = adverse event, bid = twice daily, IP = investigational product, qd = once daily, SAE = serious adverse event
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Timepoint [1]
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Entry in extension to end of study (variable duration; maximum 109 weeks)
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Secondary outcome [1]
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Mean DAS28-CRP Score
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Assessment method [1]
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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. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, CRP = C-reactive protein, qd = once daily
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Timepoint [1]
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Weeks 0, 12, 24, 36 and 52
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Secondary outcome [2]
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Mean mTSS Score
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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 488. A higher value represents more serious progression of the disease. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, N/A = not applicable, qd = once daily
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Timepoint [2]
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Weeks 0 and 52
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Secondary outcome [3]
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Mean HAQ-DI Score
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Assessment method [3]
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HAQ-DI: Health Assessment Questionnaire - Disability Index, a measure of physical function. The HAQ-DI score is then calculated by summing the category 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 a higher score indicating greater disability. Number of participants are those with data at entry to this study (Week 0). As no imputation was applied, the numbers at subsequent visits are lower. bid = twice daily, qd = once daily
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Timepoint [3]
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Weeks 0, 12, 24, 36 and 52
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Eligibility
Key inclusion criteria
- Patients who have successfully completed a qualifying study (D4300C00001, D4300C00002,
D4300C00003 or D4300C00004) with fostamatinib
- Patients who have participated in a qualifying study and who have been classified as
non-responders due to pre-defined lack of efficacy at Week 12 (D4300C00001,
D4300C00002, D4300C00003).
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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
- Premature withdrawal from the qualifying study (D4300C00001, D4300C00002, D4300C00003
and D4300C00004)
- Females who are pregnant or breast feeding
- Poorly controlled hypertension
- Significant liver function test abnormalities or physical symptoms of hepatotoxicity
- Significant infection
- Gastrointestinal intolerance
- Cancer
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Terminated
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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
1/01/2011
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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
1/01/2015
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Actual
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Sample size
Target
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Accrual to date
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Final
1917
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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 - Southport
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Research Site - Cairns
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Recruitment postcode(s) [1]
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- Camperdown
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- Southport
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- Cairns
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0
Mexico
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0
NL
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Country [135]
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Mexico
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SON
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Country [136]
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Mexico
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State/province [136]
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Chihuahua
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Country [137]
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Mexico
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San Luis Potosi
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Country [138]
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Peru
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State/province [138]
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Lima
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Country [139]
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Peru
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Arequipa
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Country [140]
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Poland
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Bytom
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Country [141]
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Poland
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Chelm Slaski
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Country [142]
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Poland
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Grodzisk Mazowiecki
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Poland
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State/province [143]
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Kalisz
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Country [144]
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Poland
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Katowice
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Poland
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Krakow
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Country [146]
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Poland
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Lodz
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Country [147]
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Poland
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Warszawa
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Country [148]
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Poland
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Wroclaw
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Country [149]
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Poland
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Zyrardow
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Country [150]
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Portugal
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Aveiro
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Country [151]
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Country [154]
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Romania
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Prahova
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Romania
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Braila
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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Russian Federation
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Petrozavodsk
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Country [159]
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Russian Federation
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Ryazan
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Country [160]
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Russian Federation
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Sankt-peterburg
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Russian Federation
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Voronezh
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Country [162]
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Russian Federation
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Yaroslavl
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Country [163]
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Serbia
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Belgrade
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Country [164]
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Serbia
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Kragujevac
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Country [165]
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Serbia
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Niska Banja
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Country [166]
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Serbia
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State/province [166]
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Novi Sad
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Country [167]
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Slovakia
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State/province [167]
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Bratislava
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Country [168]
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Slovakia
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State/province [168]
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Poprad
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Country [169]
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Slovakia
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Rimavska Sobota
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Country [170]
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Slovakia
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Ruzomberok
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Country [171]
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Slovakia
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State/province [171]
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Trnava
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Country [172]
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Slovakia
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State/province [172]
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Zilina
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Country [173]
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South Africa
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Cape Town
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Country [174]
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South Africa
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State/province [174]
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E Cape
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Country [175]
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South Africa
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State/province [175]
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Gauteng
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Country [176]
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South Africa
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State/province [176]
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Kwazulu Natal
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Country [177]
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South Africa
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State/province [177]
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Western Cape
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Country [178]
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South Africa
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State/province [178]
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Stellenbosch
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Country [179]
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Spain
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State/province [179]
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Extremadura
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Country [180]
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Spain
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State/province [180]
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Barcelona
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Country [181]
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Ukraine
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State/province [181]
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Donetsk
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Country [182]
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Ukraine
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State/province [182]
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Ivano-frankivsk
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Country [183]
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Ukraine
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State/province [183]
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Kharkiv
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Country [184]
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Ukraine
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State/province [184]
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Kyiv
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Country [185]
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Ukraine
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State/province [185]
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Lugansk
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Country [186]
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Ukraine
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State/province [186]
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Lutsk
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Country [187]
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Ukraine
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State/province [187]
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Lviv
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Country [188]
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Ukraine
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State/province [188]
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Odessa
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Country [189]
0
0
Ukraine
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State/province [189]
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Simferopol
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Country [190]
0
0
Ukraine
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State/province [190]
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0
Vinnytsia
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Country [191]
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0
Ukraine
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State/province [191]
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Vinnytsya
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Country [192]
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Ukraine
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State/province [192]
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Zaporizhzhya
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Country [193]
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Ukraine
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State/province [193]
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Zaporyzhzhya
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Country [194]
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United Kingdom
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State/province [194]
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Berkshire
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Country [195]
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United Kingdom
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State/province [195]
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Cheshire
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Country [196]
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United Kingdom
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State/province [196]
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Greater London
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Country [197]
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United Kingdom
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State/province [197]
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Kent
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Country [198]
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United Kingdom
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State/province [198]
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Sussex
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Country [199]
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United Kingdom
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State/province [199]
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West Midlands
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Country [200]
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United Kingdom
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Basingstoke
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Country [201]
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United Kingdom
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Cambridge
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Country [202]
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United Kingdom
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Christchurch
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Country [203]
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United Kingdom
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Ipswich
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Country [204]
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United Kingdom
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Nottingham
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Country [205]
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United Kingdom
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Stoke on Trent
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Country [206]
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United Kingdom
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Westcliff-on-the Sea
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Country [207]
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United Kingdom
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State/province [207]
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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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Address
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Ethics approval
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Summary
Brief summary
The purpose of this study is to evaluate the long term safety and tolerability of
fostamatinib in patients with rheumatoid arthritis (RA).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01242514
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Chris O'Brien, MD PhD
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Address
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0
AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01242514
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