Status:
COMPLETED
Post-marketing Observational Study in Subjects With Rheumatoid Arthritis
Lead Sponsor:
Abbott
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational study was to observe and assess the long term use, safety, and effectiveness of adalimumab in a normal clinical setting.
Detailed Description
This was a multicenter, uncontrolled, 5-year observational study of adalimumab in the treatment of patients with rheumatoid arthritis (RA) who had received adalimumab for at least 3 months in NCT00448...
Eligibility Criteria
Inclusion
- Participants with ongoing adalimumab treatment who completed at least Month 3 (Visit 5) of NCT00448383 (Study M02-497) and who had subsequently been prescribed adalimumab according to the Summary of Product Characteristics (SmPC).
- Participants must have been willing to consent to data being collected and provided to Abbott.
Exclusion
- · Participants with contraindications according to the SmPC.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
3435 Patients enrolled
Trial Details
Trial ID
NCT00234884
Start Date
September 1 2003
End Date
July 1 2010
Last Update
September 30 2011
Active Locations (311)
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1
Site Ref # / Investigator 5606
Camperdown, New South Wales, Australia, 2050
2
Site Ref # / Investigator 49504
New Lambton, New South Wales, Australia, 2305
3
Site Ref # / Investigator 49508
Brisbane, Queensland, Australia, 4102
4
Site Ref # / Investigator 49505
Woodville, South Australia, Australia, 5011