Evaluation of Effectiveness of Two Dosing Regimens of Fostamatinib Compared to Placebo in Patients With Rheumatoid Arthritis (RA) Who Are Taking Methotrexate and Have Had Inadequate Response to Single TNF-alpha Antagonist
NCT ID: NCT01197755
Last Updated: 2014-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
323 participants
INTERVENTIONAL
2010-09-30
2013-02-28
Brief Summary
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Detailed Description
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Full title: Optional Genetic Research
Date: 18 June 2010
Version: 1
Objectives: To collect and store, with appropriate consent ,DNA samples for future exploratory research into genes/genetic variation that may influence response (ie, absorption, distribution, metabolism and excretion, safety, tolerability and efficacy) to fostamatinib disodium and/or methotrexate; and/or susceptibility to, progression of and prognosis of RA
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dosing Regimen A
Oral Treatment
fostamatinib
fostamatinib 100 mg twice daily
Dosing Regimen B
Oral Treatment
fostamatinib
fostamatinib 100 mg twice daily/150 mg once daily
Dosing Regimen C
Oral Treatment
placebo
Placebo twice daily
Interventions
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fostamatinib
fostamatinib 100 mg twice daily
fostamatinib
fostamatinib 100 mg twice daily/150 mg once daily
placebo
Placebo twice daily
Eligibility Criteria
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Inclusion Criteria
* 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 12months prior to study enrolment, presence of serum anti-cyclic citrullinated peptide antibodies (blood test)
Exclusion Criteria
* 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 anakinra or previous treatment with biological agent (other than TNF alpha antagonists including rituximab, abatacept and tocilizumab)
* Severe renal impairment
* Neutropenia
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Neil MacKillop, MD PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Anniston, Alabama, United States
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Huntsville, Alabama, United States
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Tuscaloosa, Alabama, United States
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Mesa, Arizona, United States
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Scottsdale, Arizona, United States
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Hot Springs, Arkansas, United States
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Glendale, California, United States
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La Jolla, California, United States
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Long Beach, California, United States
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Palo Alto, California, United States
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Santa Maria, California, United States
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Torrance, California, United States
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Tustin, California, United States
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Upland, California, United States
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Colorado Springs, Colorado, United States
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Bridgeport, Connecticut, United States
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Trumbull, Connecticut, United States
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Lewes, Delaware, United States
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Brandon, Florida, United States
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Jacksonville, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Venice, Florida, United States
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Zephyrhills, Florida, United States
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Atlanta, Georgia, United States
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Canton, Georgia, United States
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Idaho Falls, Idaho, United States
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Decatur, Illinois, United States
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Cedar Rapids, Iowa, United States
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Bowling Green, Kentucky, United States
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Elizabethtown, Kentucky, United States
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Crofton, Maryland, United States
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Fall River, Massachusetts, United States
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Worcester, Massachusetts, United States
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Lansing, Michigan, United States
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Flowood, Mississippi, United States
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Florissant, Missouri, United States
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Richmond Heights, Missouri, United States
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Las Cruces, New Mexico, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Olean, New York, United States
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Rochester, New York, United States
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Roslyn, New York, United States
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Smithtown, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Greensboro, North Carolina, United States
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Dayton, Ohio, United States
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Mayfield Village, Ohio, United States
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Lake Oswego, Oregon, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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West Reading, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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Hixson, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Tacoma, Washington, United States
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Buenos Aires, Buenos Aires F.D., Argentina
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Córdoba, CRD, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, TUC, Argentina
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Buenos Aires, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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Brussels, Belgium, Belgium
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Ghent, Belgium, Belgium
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Liège, Belgium, Belgium
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Yvoir, , Belgium
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Porto Alegre, Brasil, Brazil
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Goiânia, Goiás, Brazil
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Curitiba, Paraná, Brazil
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São Paulo, São Paulo, Brazil
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St. John's, Newfoundland and Labrador, Canada
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Mississauga, Ontario, Canada
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Toronto, Ontario, Canada
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Pointe-Claire, Quebec, Canada
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Rimouski, Quebec, Canada
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Bruntál, , Czechia
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České Budějovice, , Czechia
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Hlučín, , Czechia
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Ostrava-trebovice, , Czechia
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Prague, , Czechia
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Zlín, , Czechia
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Orléans, , France
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Hamburg, City state of Hamburg, Germany
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Aachen, North Rhine-Westphalia, Germany
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Leipzig, Saxony, Germany
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Erlangen, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Heidelberg, , Germany
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München, , Germany
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Budapest, , Hungary
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Ashkelon, , Israel
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Haifa, , Israel
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Kfar Saba, , Israel
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Ramat Gan, , Israel
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Tel Litwinsky, , Israel
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Iesi, AN, Italy
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Ferrara, FE, Italy
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Chihuahua City, Chihuahua, Mexico
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Obrergon, Sonora, Mexico
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DF, , Mexico
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Monterrey, , Mexico
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Saltillo, , Mexico
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Lisbon, , Portugal
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Porto, , Portugal
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Cape Town, , South Africa
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Pretoria, , South Africa
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Stellenbosch, , South Africa
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Barcelona, , Spain
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Reading, Berkshire, United Kingdom
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Warrington, Cheshire, United Kingdom
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Maidstone, Kent, United Kingdom
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Eastbourne, Sussex, United Kingdom
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Cambridge, , United Kingdom
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Christchurch, , United Kingdom
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Ipswich, , United Kingdom
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London, , United Kingdom
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Metropolitan Borough of Wirral, , United Kingdom
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Nottingham, , United Kingdom
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Westcliff-on-the Sea, , United Kingdom
Countries
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Related Links
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Other Identifiers
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2010-020745-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4300C00003
Identifier Type: -
Identifier Source: org_study_id
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