Status:
COMPLETED
Drug Outcome Survey for Biological Treatments in Rheumatoid Arthritis: an Observational Study (Dose)
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Brief Summary
The primary purpose of this observational study is to describe and define the current daily practice of management of anti-TNF-agents in Rheumatoid Arthritis (RA) patients. Data will be collected only...
Eligibility Criteria
Inclusion
- Eighteen years of age or older
- Diagnosis of RA in accordance with ARA 1987 classification has satisfied at least 4 of the following 7 criteria:
- Morning stiffness in and around the joints lasting at least 1 hour;
- Arthritis of 3 or more joint areas;
- Arthritis of hand joints;
- Symmetric arthritis. simultaneous involvement of the same joint areas on both sides of the body;
- Rheumatoid nodules;
- Serum Rheumatoid Factor (RF)
- Radiographic changes. Criteria 1 through 4 must have been present for at least 6 weeks.
- Patients refractory or without complete response to DMARDs according to the Italian Guidelines for the clinical practice established by Italian Society of Rheumatology
- Patients naive to anti-TNF drugs
- Outpatients
Exclusion
- Patients involved in controlled or interventional trials in the 12 previous months
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00794118
Start Date
June 1 2008
End Date
April 1 2011
Last Update
July 1 2019
Active Locations (1)
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1
Pfizer Investigational Site
Roma, Italy, 00161