Rheumatoid Arthritis
Conditions
Brief summary
The primary objective of this study is to evaluate the safety, efficacy and pharmacokinetics of three doses of adalimumab in adult Japanese subjects with RA
Interventions
BIOLOGICALadalimumab
20 mg sc eow
BIOLOGICALplacebo
placebo sc eow
Sponsors
Eisai Limited
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Meet ACR criteria for diagnosis of active RA and have at both screening and baseline visits \>10 swollen joints, \>12 tender joints. * Subjects must have failed prior treatment with one or more DMARDs. * A negative (serum) pregnancy test for all female subjects of child-bearing potential at screening and a negative (urine) pregnancy test prior to study drug administration. * Body weight less than or equal to 100 kg
Exclusion criteria
* A history of, or current, acute inflammatory joint disease of different origin from RA. * Prior treatment with any TNF antagonist, including adalimumab. * Any ongoing chronic or active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics. * Unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke or any poorly controlled medical condition.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR20 | Week 24 |
Secondary
| Measure | Time frame |
|---|---|
| ACR20 | Week12 |
| ACR50 | Weeks 12 and 24 |
| ACR70 | Weeks 12 and 24 |
Countries
Japan
Outcome results
None listed