A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Phase 2
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Biological: adalimumabBiological: placebo
- Registration Number
- NCT00647491
- Lead Sponsor
- Abbott
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 352
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 80 mg adalimumab 80 mg adalimumab eow Placebo placebo Placebo eow 20 mg adalimumab 20 mg adalimumab eow 40 mg adalimumab 40 mg adalimumab eow
- Primary Outcome Measures
Name Time Method ACR20 Week 24
- Secondary Outcome Measures
Name Time Method ACR70 Weeks 12 and 24 ACR20 Week12 ACR50 Weeks 12 and 24