Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
NCT ID: NCT00445770
Last Updated: 2011-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
550 participants
INTERVENTIONAL
2006-07-31
2010-07-31
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
TRIPLE
Study Groups
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1
Etanercept
10 mg twice weekly, subcutaneous injection for 52 weeks
2
Etanercept
25 mg, twice weekly, subcutaneous injection for 52 weeks
3
Methotrexate
up to 8 mg per week, oral dosing for 52 weeks
Interventions
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Etanercept
10 mg twice weekly, subcutaneous injection for 52 weeks
Etanercept
25 mg, twice weekly, subcutaneous injection for 52 weeks
Methotrexate
up to 8 mg per week, oral dosing for 52 weeks
Eligibility Criteria
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Inclusion Criteria
* Must be age 20 to 75 years
* Diagnosed less than or equal to 10 years from time of first visit
Exclusion Criteria
* Patient with other rheumatic diseases or conditions that could predispose the patient to infection
* Pregnant or lactating women
20 Years
75 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
Pfizer Investigational Site
Goshogawara, Aomori, Japan
Pfizer Investigational Site
Asahi, Chiba, Japan
Pfizer Investigational Site
Matsuyama, Ehime, Japan
Pfizer Investigational Site
Fukui-shi, Fukui, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Iizuka, Fukuoka, Japan
Pfizer Investigational Site
Kurume, Fukuoka, Japan
Pfizer Investigational Site
Kurume, Fukuoka, Japan
Pfizer Investigational Site
Munakata, Fukuoka, Japan
Pfizer Investigational Site
Takasaki, Gunma, Japan
Pfizer Investigational Site
Hiroshima, Hiroshima, Japan
Pfizer Investigational Site
Asahikawa, Hokkaido, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Kakogawa, Hyōgo, Japan
Pfizer Investigational Site
Katoh, Hyōgo, Japan
Pfizer Investigational Site
Yūki, Ibaraki, Japan
Pfizer Investigational Site
Komatsu, Ishikawa-ken, Japan
Pfizer Investigational Site
Kagoshima, Kagoshima-ken, Japan
Pfizer Investigational Site
Kagoshima, Kagoshima-ken, Japan
Pfizer Investigational Site
Kawasaki, Kanagawa, Japan
Pfizer Investigational Site
Sagamihara, Kanagawa, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Kumamoto, Kumamoto, Japan
Pfizer Investigational Site
Kumamoto, Kumamoto, Japan
Pfizer Investigational Site
Miyagi, Miyagi, Japan
Pfizer Investigational Site
Sendai, Miyagi, Japan
Pfizer Investigational Site
Hyūga, Miyazaki, Japan
Pfizer Investigational Site
Miyazaki, Miyazaki, Japan
Pfizer Investigational Site
Sasebo, Nagasaki, Japan
Pfizer Investigational Site
Ikoma, Nara, Japan
Pfizer Investigational Site
Kawagoe, Saitama, Japan
Pfizer Investigational Site
Tokorozawa, Saitama, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Ōta-ku, Tokyo, Japan
Pfizer Investigational Site
Sumida-ku, Tokyo, Japan
Pfizer Investigational Site
Toyama, Toyama, Japan
Pfizer Investigational Site
Kato City Fujita Letter Higashiyama, , Japan
Countries
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References
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Takeuchi T, Miyasaka N, Pedersen RD, Sugiyama N, Hirose T. Radiographic and clinical effects of 10 mg and 25 mg twice-weekly etanercept over 52 weeks in Japanese patients with active rheumatoid arthritis. Mod Rheumatol. 2021 Mar;31(2):319-325. doi: 10.1080/14397595.2020.1805142. Epub 2020 Sep 7.
Takeuchi T, Miyasaka N, Pedersen R, Sugiyama N, Hirose T. Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naive patients with active rheumatoid arthritis. Mod Rheumatol. 2020 Mar;30(2):259-268. doi: 10.1080/14397595.2019.1589918. Epub 2019 Mar 29.
Related Links
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Other Identifiers
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B1801002
Identifier Type: -
Identifier Source: secondary_id
0881A1-315
Identifier Type: -
Identifier Source: org_study_id
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