Study of the Effect of Fostamatinib Twice Daily on Blood Pressure in Patients With Rheumatoid Arthritis
NCT ID: NCT01563978
Last Updated: 2014-05-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
266 participants
INTERVENTIONAL
2012-04-30
2013-01-31
Brief Summary
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The study will last for 57 days.
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Detailed Description
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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
placebo
placebo
Interventions
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fostamatinib
fostamatinib 100 mg twice daily
placebo
placebo
Eligibility Criteria
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Inclusion Criteria
* Active rheumatoid arthritis defined as: ≥4 swollen joints and ≥4 tender/painful joints (from 28 joint count) and either erythrocyte sedimentation rate ≥28 mm/h, or C-reactive protein ≥10 mg/L.
* Currently taking one of the following disease-modifying anti-rheumatic drugs: methotrexate, sulfasalazine, hydroxychloroquine or chloroquine.
* Patients without essential hypertension or with essential hypertension if their blood pressure is controlled (\<140/90 mmHg) with anti-hypertensive medications being stable at least 4 weeks prior to randomisation.
Exclusion Criteria
* Certain inflammatory conditions (other than rheumatoid arthritis), connective tissue diseases or chronic pain disorders
* History of liver problems that have required previous investigations
* Evidence of tuberculosis infection
* Conditions that preclude or render difficult the 24-hour ambulatory blood pressure monitoring technique.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chris O'Brien, MD PhD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Huntsville, Alabama, United States
Research Site
Huntington Beach, California, United States
Research Site
Santa Maria, California, United States
Research Site
Trumbull, Connecticut, United States
Research Site
Boca Raton, Florida, United States
Research Site
Brandon, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Venice, Florida, United States
Research Site
Decatur, Georgia, United States
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South Bend, Indiana, United States
Research Site
Cumberland, Maryland, United States
Research Site
Frederick, Maryland, United States
Research Site
Hagerstown, Maryland, United States
Research Site
Florissant, Missouri, United States
Research Site
Richmond Heights, Missouri, United States
Research Site
Freehold, New Jersey, United States
Research Site
Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
Research Site
Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Lake Oswego, Oregon, United States
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Duncansville, Pennsylvania, United States
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Memphis, Tennessee, 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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Lubbock, Texas, United States
Research Site
Nassau Bay, Texas, United States
Research Site
Tacoma, Washington, United States
Research Site
Sevlievo, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Brno, , Czechia
Research Site
Hlučín, , Czechia
Research Site
Hostivice, , Czechia
Research Site
Kladno, , Czechia
Research Site
Ostrava-Trebovice, , Czechia
Research Site
Prague, , Czechia
Research Site
Aachen, , Germany
Research Site
Halle, , Germany
Research Site
Gdynia, , Poland
Research Site
Grodzisk Mazowiecki, , Poland
Research Site
Kalisz, , Poland
Research Site
Katowice, , Poland
Research Site
Lodz, , Poland
Research Site
Poznan, , Poland
Research Site
Środa Wielkopolska, , Poland
Research Site
Wroclaw, , Poland
Research Site
Bloemfontein, , South Africa
Research Site
Cape Town, , South Africa
Research Site
Durban, , South Africa
Research Site
Kempron Park, , South Africa
Research Site
Donetsk, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Vinnytsia, , Ukraine
Research Site
Zaporizhzhya, , Ukraine
Countries
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Other Identifiers
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2011-006070-73
Identifier Type: -
Identifier Source: secondary_id
D4300C00033
Identifier Type: -
Identifier Source: org_study_id
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