Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis
Information source: Abbott
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: adalimumab (Biological); adalimumab (Biological)
Phase: Phase 1
Status: Completed
Sponsored by: Abbott Official(s) and/or principal investigator(s): Laura Redden, MD, Study Director, Affiliation: Abbott
Summary
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid
Arthritis
Clinical Details
Official title: A Randomized, Parallel-group, Open-Label, Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis.
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab
Secondary outcome: Adverse event profileVAS assessments Swollen and Tender Joint counts
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Site Reference ID/Investigator# 7181, Shanghai 200001, China
Additional Information
Starting date: June 2007
Last updated: November 11, 2010
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