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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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.
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
Secondary ID [1] 0 0
2010-020743-12
Secondary ID [2] 0 0
D4300C00001
Universal Trial Number (UTN)
Trial acronym
OSKIRA - 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of Patients With ACR20 at Week 24, Comparison Between Fostamatinib and Placebo.
Timepoint [1] 0 0
24 weeks
Primary outcome [2] 0 0
Change From Baseline to Week 24 in mTSS, Comparison Between Fostamatinib and Placebo.
Timepoint [2] 0 0
Baseline and 24 weeks
Secondary outcome [1] 0 0
ACR20 - Proportion of Patients Achieving ACR20, Comparison Between Fostamatinib and Placebo at Week 1
Timepoint [1] 0 0
1 week
Secondary outcome [2] 0 0
Proportion of Patients Achieving ACR50 up to Week 24
Timepoint [2] 0 0
24 weeks
Secondary outcome [3] 0 0
Proportion of Patients Achieving ACR70 up to Week 24
Timepoint [3] 0 0
24 weeks
Secondary outcome [4] 0 0
ACRn - Comparison Between Fostamatinib and Placebo at Week 24
Timepoint [4] 0 0
24 weeks
Secondary outcome [5] 0 0
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 12
Timepoint [5] 0 0
12 weeks
Secondary outcome [6] 0 0
Proportion of Patients Achieving DAS28-CRP <2.6 at Week 24
Timepoint [6] 0 0
24 weeks
Secondary outcome [7] 0 0
Proportion of Patients Achieving DAS28-CRP EULAR Response at Week 24
Timepoint [7] 0 0
24 weeks
Secondary outcome [8] 0 0
HAQ-DI Response - Comparison of the Change (>=0.22) From Baseline Between Fostamatinib and Placebo at Week 24
Timepoint [8] 0 0
Baseline and 24 weeks
Secondary outcome [9] 0 0
SF-36 - Comparison of the Change in PCS From Baseline Between Fostamatinib and Placebo at Week 24
Timepoint [9] 0 0
Baseline and 24 weeks
Secondary outcome [10] 0 0
SF-36 - Comparison of the Change in MCS From Baseline Between Fostamatinib and Placebo at Week 24
Timepoint [10] 0 0
Baseline and 24 weeks

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2012
Sample size
Target
Accrual to date
Final
923
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Cairns
Recruitment hospital [3] 0 0
Research Site - Southport
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- Cairns
Recruitment postcode(s) [3] 0 0
- Southport
Recruitment outside Australia
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Alabama
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California
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Berkshire
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Poprad
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Zilina
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Ivano-frankivsk
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Zaporyzhzhya
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Cheshire
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Christchurch
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Ipswich
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London
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Westcliff-on-the Sea
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Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01197521
Trial related presentations / publications
Kjelgaard-Petersen CF, Platt A, Braddock M, Jenkins MA, Musa K, Graham E, Gantzel T, Slynn G, Weinblatt ME, Karsdal MA, Thudium CS, Bay-Jensen AC. Translational Biomarkers and Ex Vivo Models of Joint Tissues as a Tool for Drug Development in Rheumatoid Arthritis. Arthritis Rheumatol. 2018 Sep;70(9):1419-1428. doi: 10.1002/art.40527. Epub 2018 Jul 24.
Public notes

Contacts
Principal investigator
Name 0 0
Neil MacKillop, MD PhD
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01197521