Status:
COMPLETED
A Study of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Lead Sponsor:
Abbott
Collaborating Sponsors:
Eisai Limited
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00647491
Start Date
February 1 2004
End Date
August 1 2005
Last Update
March 31 2008
Active Locations (25)
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1
Aichi, Japan
2
Chiba, Japan
3
Ehime, Japan
4
Fukui, Japan