A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
NCT ID: NCT00713544
Last Updated: 2011-10-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
373 participants
INTERVENTIONAL
2008-07-31
2009-04-30
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
QUADRUPLE
Study Groups
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1
Etanercept
50 mg, subcutaneous injection, weekly
2
20mg
AZD5672
20 mg oral, once daily
3
50mg
AZD5672
50 mg oral, once daily
4
100mg
AZD5672
100 mg oral, once daily
5
150mg
AZD5672
150 mg oral, once daily
6
Placebo
placebo, oral, once daily
Interventions
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AZD5672
20 mg oral, once daily
Etanercept
50 mg, subcutaneous injection, weekly
Placebo
placebo, oral, once daily
AZD5672
50 mg oral, once daily
AZD5672
100 mg oral, once daily
AZD5672
150 mg oral, once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least one of the following: documented history of positive rheumatoid factor (blood test), current presence of positive rheumatoid factor (blood test), baseline radiographic erosion, presence of serum anti-cyclic citrullinated peptide antibodies (bloo
* Be receiving either: Oral (tablets) or subcutaneous (injection) methotrexate for at least 6 months prior to randomisation.
Exclusion Criteria
* Current chronic pain disorders including fibromyalgia and chronic fatigue syndromes.
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Layton
Role: STUDY_DIRECTOR
AstraZeneca
Paul P Tak, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Amsterdam
Locations
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Research Site
Blagoevgrad, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Medellín, Colombia, Colombia
Research Site
Bogotá, , Colombia
Research Site
Bucaramanga, , Colombia
Research Site
Česká Lípa, , Czechia
Research Site
České Budějovice, , Czechia
Research Site
Hlučín, , Czechia
Research Site
Pardubice, , Czechia
Research Site
Prague, , Czechia
Research Site
Praha 11 - Chodov, , Czechia
Research Site
Zlín, , Czechia
Research Site
Békéscsaba, , Hungary
Research Site
Budapest, , Hungary
Research Site
Debrecen, , Hungary
Research Site
Kecskemét, , Hungary
Research Site
Makó, , Hungary
Research Site
Sopron, , Hungary
Research Site
Siena, SI, Italy
Research Site
Valmiera, , Latvia
Research Site
Birkirkara, , Malta
Research Site
Bialystok, , Poland
Research Site
Działdowo, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Sopot, , Poland
Research Site
Szczecin, , Poland
Research Site
Torun, , Poland
Research Site
Warsaw, , Poland
Research Site
Wroclaw, , Poland
Research Site
Brasov, , Romania
Research Site
Bucharest, , Romania
Research Site
Ploieşti, , Romania
Research Site
Saint Petersburg, , Russia
Research Site
Yaroslavl, , Russia
Research Site
Belgrade, , Serbia
Research Site
Niška Banja, , Serbia
Research Site
Banská Bystrica, , Slovakia
Research Site
Bratislava, , Slovakia
Research Site
Piešťany, , Slovakia
Research Site
Pretoria, Gauteng, South Africa
Research Site
Durban, KwaZulu-Natal, South Africa
Research Site
Cape Town, Western Cape, South Africa
Research Site
Donetsk, , Ukraine
Research Site
Ivano-Frankivsk, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Kyiv, , Ukraine
Research Site
Simferopol, , Ukraine
Countries
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References
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Gerlag DM, Hollis S, Layton M, Vencovsky J, Szekanecz Z, Braddock M, Tak PP; ESCAPE Study Group. Preclinical and clinical investigation of a CCR5 antagonist, AZD5672, in patients with rheumatoid arthritis receiving methotrexate. Arthritis Rheum. 2010 Nov;62(11):3154-60. doi: 10.1002/art.27652.
Other Identifiers
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D1710C00009
Identifier Type: -
Identifier Source: org_study_id