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.
NCT ID: NCT01197521
Last Updated: 2014-04-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
923 participants
INTERVENTIONAL
2010-09-30
2012-11-30
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, fostamatinib
Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
Interventions
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fostamatinib
fostamatinib 100 mg twice daily
fostamatinib
fostamatinib 100 mg twice daily/150 mg once daily
placebo, fostamatinib
Placebo for 24 weeks followed by fostamatinib 100 mg 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 12 months 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 a TNF alpha antagonist, anakinra or previous treatment with other biological agent
* 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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Tucson, Arizona, United States
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Huntington Beach, California, United States
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Long Beach, California, United States
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Santa Maria, California, United States
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Santa Monica, California, United States
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Colorado Springs, Colorado, United States
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Bridgeport, Connecticut, United States
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Lewes, Delaware, United States
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Daytona Beach, Florida, United States
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Ocala, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Idaho Falls, Idaho, United States
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Springfield, Illinois, United States
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Wichita, Kansas, United States
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Bowling Green, Kentucky, 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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St Louis, Missouri, United States
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Kalispell, Montana, United States
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Albuquerque, 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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Asheville, North Carolina, United States
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Greensboro, North Carolina, United States
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Perrysburg, Ohio, United States
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Lake Oswego, Oregon, United States
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Erie, Pennsylvania, United States
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Waxford, Pennsylvania, United States
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Charleston, South Carolina, United States
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Hixson, Tennessee, United States
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Memphis, Tennessee, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
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Reading, Berkshire, Argentina
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Buenos Aires, Buenos Aires F.D., Argentina
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Ciudad Autonoma Bs As, CBA, Argentina
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Córdoba, CRD, Argentina
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San Juan, San Juan Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de Tucumán, TUC, Argentina
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Caba, , Argentina
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Quilmes, , Argentina
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Camperdown, New South Wales, Australia
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Cairns, Queensland, Australia
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Southport, Queensland, Australia
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Brussels, , Belgium
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Yvoir, , Belgium
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Vitória, Espírito Santo, Brazil
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Curitiba, Paraná, Brazil
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Recife, Pernambuco, Brazil
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São Paulo, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Plovdiv, , Bulgaria
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Sevlievo, , Bulgaria
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Sofia, , Bulgaria
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Veliko Tarnovo, , Bulgaria
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Osorno, Los Lagos Region, Chile
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Santiago, , Chile
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Orléans, , France
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Paris, , France
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Balatonfüred, , Hungary
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Makó, , Hungary
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Sopron, , Hungary
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Szentes, , Hungary
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Zalaegerszeg-pozva, , Hungary
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Secunderabad, Andhra Pradesh, India
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Visakhapatnam, Andhra Pradesh, India
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Ahmedabad, Gujarat, India
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Bangalore, Karnataka, India
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Mangalore, Karnataka, India
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Udupi, Karnataka, India
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Nagpur, Maharshtra, India
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Lucknow, Uttar Pradesh, India
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Hyderabad, , India
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Kolkata, , India
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Chihuahua City, Chihuahua, Mexico
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Saltillo, Coahuila, Mexico
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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San Luis Potosi, Mexico, Mexico
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Monterrey, Nuevo León, Mexico
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Obrergon, Sonora, Mexico
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Mexicali, , Mexico
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Arequipa, Arequipa, Peru
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Lima, Lima Province, Peru
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Pueblo Libre, Lima region, Peru
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Bytom, , Poland
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Chełm Śląski, , Poland
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Grodzisk Mazowiecki, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Żyrardów, , Poland
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Bratislava, Slovakia, Slovakia
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Žilina, Slovakia, Slovakia
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Poprad, , Slovakia
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Rimavská Sobota, , Slovakia
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Vinnytsia, , Ukraine
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Zaporyzhzhya, , Ukraine
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Warrington, Cheshire, United Kingdom
Research Site
Christchurch, , United Kingdom
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Ipswich, , United Kingdom
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London, , United Kingdom
Research Site
Metropolitan Borough of Wirral, , United Kingdom
Research Site
Westcliff-on-the Sea, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2010-020743-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D4300C00001
Identifier Type: -
Identifier Source: org_study_id
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