Status:
COMPLETED
A Drug Use Investigation of ENBREL for Post-marketing Surveillance (PMS) for RA and PsA
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
4+ years
Brief Summary
The objective of this investigation is to identify the following problems and questions with respect to the safety and efficacy of Enbrel during the post-marketing period as required by Korea Food and...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Rheumatoid Arthritis
- Adults: Treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirhematic drugs (DMARDs), including MTX, has been inadequate
- Children: Treatment of active polyarticular-course chronic active rheumatoid arthritis in children aged 4 to 17 years who have had an inadequate response to, or whom have proved intolerant of, MTX
- Psoriatic Arthritis
- \- Active and progressive psoriatic arthritis (PsA) in adults who do not respond adequately to previous DMARDs
- Exclusion Criteria
- Patients to whom Enbrel is contraindicated as per the local labeling
- Patients with known hypersensitivity to Enbrel or any component of the product
- Patients with sepsis or risk of sepsis
- Patients with active infections including chronic or localized infections such as tuberculosis. (Treatment of Enbrel should not be initiated.)
Exclusion
Key Trial Info
Start Date :
May 1 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
1014 Patients enrolled
Trial Details
Trial ID
NCT00195403
Start Date
May 1 2004
End Date
February 1 2008
Last Update
August 15 2013
Active Locations (4)
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1
Kyunggi-do, South Korea, 463-712
2
Seoul, South Korea, 120-752
3
Seoul, South Korea, 133-792
4
Seoul, South Korea, 137-807