Status:
COMPLETED
Long Term Open Label Continuation Study
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study was to assess the long-term safety and clinical efficacy following repeated administration of adalimumab in patients with rheumatoid arthritis.
Detailed Description
Study DE020 was a multicenter, open-label continuation study for patients with rheumatoid arthritis who had participated in a prior Phase 1, 2, or 3 adalimumab study in the United States or Canada, ha...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Participant was in a prior D2E7 (adalimumab) study
- Participant was age 18 or older and in good health (Investigator discretion) with a recent stable medical history.
- Exclusion Criteria
- Participant was considered by the investigator, for any reason, to be an unsuitable candidate for the study
- Participant was a female subject who is pregnant or breast-feeding or considering becoming pregnant
- Participant had any ongoing chronic or active infection
Exclusion
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
846 Patients enrolled
Trial Details
Trial ID
NCT00195650
Start Date
July 1 2000
End Date
May 1 2011
Last Update
August 31 2012
Active Locations (92)
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1
Site Reference ID/Investigator# 538
Birmingham, Alabama, United States, 35205
2
Site Reference ID/Investigator# 4111
Birmingham, Alabama, United States, 35294-7201
3
Site Reference ID/Investigator# 4113
Mobile, Alabama, United States, 36608
4
Site Reference ID/Investigator# 408
Anchorage, Alaska, United States, 99508