Pharmacokinetic and Safety Study With Adalimumab in Chinese Subjects With Mild Rheumatoid Arthritis
Phase 1
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: adalimumab
- Registration Number
- NCT00650156
- Lead Sponsor
- AbbVie
- Brief Summary
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 40 mg adalimumab adalimumab - 80 mg Adalimumab adalimumab -
- Primary Outcome Measures
Name Time Method pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab Days 1, 2, 4, 6, 8, 11, 15, 22, & 29
- Secondary Outcome Measures
Name Time Method VAS assessments Days 1, 15 and 29 Swollen and Tender Joint counts Days 1, 15 and 29 Adverse event profile follow up to day 70 after dose
Trial Locations
- Locations (1)
Site Reference ID/Investigator# 7181
🇨🇳Shanghai, China