Status:
COMPLETED
A Study of Adalimumab in Japanese Subjects With Rheumatoid Arthritis
Lead Sponsor:
Abbott
Collaborating Sponsors:
Eisai Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
To evaluate the potential of adalimumab to inhibit radiographic progression in joint destruction compared with placebo in adult Japanese subjects with recent onset of rheumatoid arthritis.
Detailed Description
This was a Phase 3 multicenter, randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the inhibition of radiographic progression by adalimumab compared with placebo i...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Rheumatoid arthritis based on the American College of Rheumatology criteria
- Methotrexate or leflunomide naïve
- Disease duration less than or equal to 2 years from diagnosis
- Exclusion Criteria
- History of acute inflammatory joint disease of different origin from rheumatoid arthritis, cancer, lymphoma, leukemia or lymphoproliferative disease, active TB, HIV
- Previously received anti-TNF therapy anti-IL-6 receptor antibody, CTLA4-Ig, anti-CD20 antibody, cyclophosphamide, cyclosporine, azathioprine, or tacrolimus
- Joint surgery involving joints to be assessed within 8 weeks prior to Screening
Exclusion
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
334 Patients enrolled
Trial Details
Trial ID
NCT00870467
Start Date
March 1 2009
End Date
August 1 2011
Last Update
August 7 2012
Active Locations (88)
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1
Site Reference ID/Investigator# 46861
Anjo, Japan
2
Site Reference ID/Investigator# 46919
Aomori, Japan
3
Site Reference ID/Investigator# 46805
Chiba, Japan
4
Site Reference ID/Investigator# 46806
Chiba, Japan