Rheumatoid Arthritis Clinical Trial
Verified date | March 2008 |
Source | Abbott |
Contact | n/a |
Is FDA regulated | No |
Health authority | Japan: Ministry of Health, Labor and Welfare |
Study type | Interventional |
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
Status | Completed |
Enrollment | 352 |
Est. completion date | August 2005 |
Est. primary completion date | June 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Abbott | Eisai Limited |
Japan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ACR20 | Week 24 | No | |
Secondary | ACR20 | Week12 | No | |
Secondary | ACR50 | Weeks 12 and 24 | No | |
Secondary | ACR70 | Weeks 12 and 24 | No |
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