A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department
Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis; Ankylosing Spondylitis
Intervention: Enbrel (Drug)
Sponsored by: Pfizer
Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
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, and evaluate the safety and efficacy of the treatment. All eligible
subjects agreed to be recruited in the study and can withdraw anytime if they choose so.
Patients with RA or AS are typically managed by rheumatologists. As this study seeks to
record the data of RA & AS patient in etanercept and evaluate the safety and efficacy of the
treatment, patients will be recruited from Rheumatic department. Rheumatologist will be
asked to build up the database for RA & AS patient surveillance prospectively in outpatient
dept, which benefits for the patient treatment outcomes evaluation and clinical management.
Official title: A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department
Study design: Observational Model: Case Control, Time Perspective: Prospective
Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks
Number of Participants Who Had Any AEs During 52 Weeks
Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks
Number of Participants Who Had Any SAEs During 52 Weeks
Number of Participants With AEs Per System Organ Class During 24 Weeks
Number of Participants With AEs Per System Organ Class During 52 Weeks
Physician's Global Assessment of Disease Activity
Participant's Global Assessment (PtGA) of Disease Activity
VAS Score for Pain
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%
Evaluate the Association Between Participant's Age and Treatment Adherence Rate
Number of Participants With Any Abnormal Laboratory Test Results
Tender Joint Count (TJC) for RA Participants
Swollen Joint Count (SJC) for RA Participants
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Number of RA Participants Had DAS28-4 (ESR) Improvement
Number of RA Participants Had Remission of Disease
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 enrolled in the study. If the true rate of an adverse event is no less
than 0. 5%, with sample size of 600 subjects, this study will have 95% probability to detect
at least one occurrence of the adverse event. The study prematurely discontinued on January
15, 2013 due to slow enrollment and low adherence of etanercept. It should be noted that
safety concerns have not been seen in this study and have not factored into this decision.
Minimum age: 18 Years.
Maximum age: N/A.
- Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.
- Subject has accepted physician's prescription of etanercept in rheumatology
- 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
- Presence of active or suspected latent infection including HIV, or any underlying
disease, including open cutaneous ulcers that could predispose the subject to
- Immunodeficiency syndromes including Felty syndrome or large granular lymphocyte
- 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.
Locations and Contacts
Baotou Central Hospital, Baotou city, China
Shanghai Changning Guanghua Integrative Medicine Hospital, Beijing 200052, China
Shanghai Jiaotong University Affiliated Third People's Hospital, Shanghai 201900, China
Xinjiang Uygur Autonomous Region People's Hospital, Urumqi 830001, China
Daping Hospital, Chongqing, Chongqing 400038, China
Fujian Provincial Hospital, Fuzhou, Fujian 350001, China
Lanzhou University Second Hospital, Lanzhou, Gansu 730030, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong 510405, China
No. 199, Haerbin, Heilongjiang 150001, China
The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, China
The First Affiliated Hospital of Baotou Medical College, Baotou, Inner Mongolia 014010, China
Jiangsu Province Hospital/Department of Rheumatology, Nanjing, Jiangsu 210029, China
Affiliated Hospital of Nantong University, Nantong, Jiangsu 226001, China
The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China
Si Chuan Huaxi Hospital/Rheumatology Department, Chengdu, Sichuan 610041, China
To obtain contact information for a study center near you, click here.
Starting date: January 2011
Last updated: January 23, 2014