Status:
TERMINATED
A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Arthritis
Rheumatoid
Eligibility:
All Genders
18+ years
Brief Summary
A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely a...
Detailed Description
This post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for RA patients using commercially available adalimumab administered...
Eligibility Criteria
Inclusion
- Male or female patient greater than or equal to 18 years of age with diagnosis of RA (Rheumatoid Arthritis) and no history of chronic arthritis before age 16.
- Patient meets the requirements for treatment with adalimumab per the local product label.
- Patient is naïve to adalimumab, and has not used any other immunomodulatory biologic\* DMARD (Disease Modifying Antirheumatic Drugs) in the past 8 weeks before the Baseline visit (\*rituximab may not have been used in the past 104 weeks before the Baseline visit).
- Patient must be able and willing to provide written authorization (or informed consent where applicable) to disclose and use personal health information and comply with the requirements of this study protocol as well as agree to data being collected by Abbott.
Exclusion
- Patient is currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the Baseline visit.
- Prior clinically active TB (tuberculosis): if patient has had prior clinically active TB, there should be documentation that a full course of appropriate anti-TB therapy was completed or an ongoing full course of appropriate anti-TB therapy has been started before initiation of adalimumab in accordance with the local product label; otherwise, the patient will not be eligible to participate in this study.
- Patient who intends to take less than 6 consecutive (every other week) injections of adalimumab.
- Patients should not be enrolled if they cannot be treated with adalimumab in accordance with the local product label or if the Investigator determines that they should not be enrolled based on his/her clinical judgment.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01464021
Start Date
December 1 2011
End Date
December 1 2012
Last Update
March 6 2014
Active Locations (3)
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1
Site Reference ID/Investigator# 64782
Guangzhou, China, 510080
2
Site Reference ID/Investigator# 65702
Shanghai, China, 200052
3
Site Reference ID/Investigator# 65706
Ürümqi, China, 830001