A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)
NCT ID: NCT00520572
Last Updated: 2013-02-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
385 participants
INTERVENTIONAL
2007-08-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Etanercept 50mg, subcutaneous, once weekly
Etanercept
2
50mg oral, once daily
AZD9056
3
100 mg oral, once daily
AZD9056
4
200 mg oral, once daily
AZD9056
5
400mg once, daily
AZD9056
6
oral, once daily
Placebo
Interventions
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AZD9056
Etanercept
Placebo
Eligibility Criteria
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Inclusion Criteria
Be receiving either oral (tablets) or subcutaneous/intramuscular (injection) methotrexate for at least 6 months prior to randomisation.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Edward Keystone, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Zoltan Koroknai, MD, D.E.A.A.
Role: STUDY_CHAIR
Omnicare Clinical Research
Locations
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Research Site
Aventura, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Sarasota, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Petoskey, Michigan, United States
Research Site
Syracuse, New York, United States
Research Site
Portland, Oregon, United States
Research Site
Olympia, Washington, United States
Research Site
Rosario, Santa Fe Province, Argentina
Research Site
Buenos Aires, , Argentina
Research Site
Córdoba, , Argentina
Research Site
Planta Baja San Juan, , Argentina
Research Site
San Miguel de Tucumán, , Argentina
Research Site
Woolloongabba, Queensland, Australia
Research Site
Woodsville, South Australia, Australia
Research Site
Victoria Park, Western Australia, Australia
Research Site
George Town, , Australia
Research Site
Hasselt, , Belgium
Research Site
Winnipeg, Manitoba, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Prague, , Czechia
Research Site
Uherské Hradiště, , Czechia
Research Site
Zlín, , Czechia
Research Site
Bobigny, , France
Research Site
Bordeaux, , France
Research Site
Tours, , France
Research Site
Cd. Juarez, , Mexico
Research Site
Chihuahua City, , Mexico
Research Site
Guadalajara, , Mexico
Research Site
Mexico City, , Mexico
Research Site
Tapachula, , Mexico
Research Site
Tijuana, , Mexico
Research Site
Bialystok, , Poland
Research Site
Elblag, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Sopot, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Brasov, Brașov County, Romania
Research Site
Bucharest, , Romania
Research Site
Cluj-Napoca, , Romania
Research Site
Iași, , Romania
Research Site
Ploieşti, , Romania
Research Site
Sf. Gheorghe, , Romania
Research Site
Saint Petersburg, , Russia
Research Site
Bansky Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Piešťany, , Slovakia
Countries
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References
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Keystone EC, Wang MM, Layton M, Hollis S, McInnes IB; D1520C00001 Study Team. Clinical evaluation of the efficacy of the P2X7 purinergic receptor antagonist AZD9056 on the signs and symptoms of rheumatoid arthritis in patients with active disease despite treatment with methotrexate or sulphasalazine. Ann Rheum Dis. 2012 Oct;71(10):1630-5. doi: 10.1136/annrheumdis-2011-143578.
Other Identifiers
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D1520C00001
Identifier Type: -
Identifier Source: org_study_id
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