Status:
TERMINATED
A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Brief Summary
This is an open-label, multicenter and observational study in China, which is designed to record the data of RA \& AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, an...
Detailed Description
The primary objective of this non-interventional study is to evaluate the safety of etanercept in Chinese RA and AS subjects. Total of 600 subjects (300 RA subjects and 300 AS subjects) will be enroll...
Eligibility Criteria
Inclusion
- Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.
- Subject has accepted physician's prescription of etanercept in rheumatology department.
- Subject agreed to be enrolled in the observational study and sign the ICD.
- Subject is≥18 years of age at the time of consent.
- Subject is willing and able to understand and complete questionnaires
Exclusion
- Presence of active or suspected latent infection including HIV, or any underlying disease, including open cutaneous ulcers that could predispose the subject to infections.
- Immunodeficiency syndromes including Felty syndrome or large granular lymphocyte syndrome.
- Active tuberculosis (TB) or a history of TB, or findings consistent with previous exposure to TB on a chest x-ray (CXR). Investigators must follow China's guidelines for appropriate screening and treatment of TB.
- History of hypersensitivity to any of the ingredients in either preparation.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01411215
Start Date
January 1 2011
End Date
January 1 2013
Last Update
March 6 2014
Active Locations (15)
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1
Daping Hospital
Chongqing, Chongqing Municipality, China, 400038
2
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
3
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
4
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510405