A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China
A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China
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 active rheumatoid arthritis (RA) in China.
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 subcutaneously (SC). Adalimumab effectiveness will be assessed based
 on data from clinic visits beginning at Baseline and continuing per standard of care for RA.
 The primary objective is to evaluate the effectiveness of adalimumab in improving patients'
 disease activity measured by Disease Activity Score (DAS28) at Week 12. The maximum
 observation period for each patient is approximately 52 weeks, as long as the patient
 continues to receive adalimumab injections. The study was terminated due to low enrollment.
Inclusion Criteria:

 1. 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.

 2. Patient meets the requirements for treatment with adalimumab per the local product
 label.

 3. 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).

 4. 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 Criteria:

 1. 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.

 2. 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.

 3. Patient who intends to take less than 6 consecutive (every other week) injections of
 adalimumab.

 4. 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.