Rheumatoid Arthritis
Conditions
Brief summary
Pharmacokinetic and Safety Study with Adalimumab in Chinese Subjects with Mild Rheumatoid Arthritis
Interventions
BIOLOGICALadalimumab
40 mg single sc dose
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pharmacokinetic profile of a single subcutaneous dose of 40 and 80 mg adalimumab | Days 1, 2, 4, 6, 8, 11, 15, 22, & 29 |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event profile | follow up to day 70 after dose |
| VAS assessments | Days 1, 15 and 29 |
| Swollen and Tender Joint counts | Days 1, 15 and 29 |
Countries
China
Outcome results
None listed