A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
NCT ID: NCT00647491
Last Updated: 2008-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
352 participants
INTERVENTIONAL
2004-02-29
2005-08-31
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
QUADRUPLE
Study Groups
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20 mg
20 mg adalimumab eow
adalimumab
20 mg sc eow
40 mg
40 mg adalimumab eow
adalimumab
40 mg sc eow
80 mg
80 mg adalimumab eow
adalimumab
80 mg sc eow
Placebo
Placebo eow
placebo
placebo sc eow
Interventions
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adalimumab
20 mg sc eow
adalimumab
40 mg sc eow
adalimumab
80 mg sc eow
placebo
placebo sc eow
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have failed prior treatment with one or more DMARDs.
* A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration.
* Body weight less than or equal to 100 kg
Exclusion Criteria
* Prior treatment with any TNF antagonist, including adalimumab.
* Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics.
* Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.
20 Years
ALL
No
Sponsors
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Eisai Limited
INDUSTRY
Abbott
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Shigeki Hashimoto, Ph.D.
Role: STUDY_DIRECTOR
Abbott
Locations
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Aichi, , Japan
Chiba, , Japan
Ehime, , Japan
Fukui, , Japan
Fukuoka, , Japan
Gunma, , Japan
Hokkaido, , Japan
Hyōgo, , Japan
Ibaraki, , Japan
Ishikawa, , Japan
Kagoshima, , Japan
Kanagawa, , Japan
Kyoto, , Japan
Miyagi, , Japan
Nagano, , Japan
Nagasaki, , Japan
Niigata, , Japan
Okayama, , Japan
Osaka, , Japan
Saitama, , Japan
Shizuoka, , Japan
Tochigi, , Japan
Tokushima, , Japan
Tokyo, , Japan
Toyama, , Japan
Countries
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References
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Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.
Other Identifiers
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M02-575
Identifier Type: -
Identifier Source: org_study_id