Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis

Study Identifier
M10-017
CT.gov Identifier
NCT00650156
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Rheumatoid Arthritis
    • Study Drug
  • adalimumab
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Male or Female ages 18 years and older. * Mild RA. * Body weight less than 100 kg.
    Exclusion Criteria:
    * Wheelchair-bound or bedridden. * 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.

    Protocol Summary

    Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 7181
    Shanghai, China, 200001
    Status
    Not applicable