Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis
NCT ID: NCT00650156
Last Updated: 2017-11-20
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
PHASE1
24 participants
INTERVENTIONAL
2007-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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40 mg adalimumab
adalimumab
40 mg single sc dose
80 mg Adalimumab
adalimumab
80 mg single sc dose
Interventions
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adalimumab
40 mg single sc dose
adalimumab
80 mg single sc dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mild RA.
* Body weight less than 100 kg.
Exclusion Criteria
* Joint surgery involving joints to be assessed within this study, within two months prior to the Screening visit.
* Intra-articular, intramuscular or intravenous (IV) administration of corticosteroids within 28 days prior to the Screening visit.
* Prior treatment with any TNF antagonist, including adalimumab.
* Positive tuberculin PPD 5.
* Female subjects who are pregnant or breast-feeding.
* History of HIV or of being immuno-compromised.
* History of malignancy.
* Poorly controlled medical condition.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Abbott
Principal Investigators
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Laura Redden, MD
Role: STUDY_DIRECTOR
Abbott
Locations
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Site Reference ID/Investigator# 7181
Shanghai, , China
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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M10-017
Identifier Type: -
Identifier Source: org_study_id