A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis; Ankylosing Spondylitis
Intervention: Enbrel (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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, 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.
Clinical Details
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
Primary outcome: To evaluate the safety of etanercept in real clinical practice in Chinese RA and AS subjects by measuring the number of subjects reporting an event
Secondary outcome: To evaluate the efficacy of etanercept in Chinese RA and AS subjects by comparing Disease Activity Score Using 28-Joint Count (DAS28)To evaluate the efficacy of etanercept in Chinese RA and AS subjects by comparing the Physician Global Assessment (PGA) of Disease Activity on 0-100 mm visual analog scale (VAS) To evaluate the efficacy of etanercept in Chinese RA and AS subjects by comparing the Pain assessment 0-100 mm visual analog scale (VAS) To evaluate the subject's adherence to treatment in real-life by comparing patient's dosage and frequency with label use (25 mg biweekly, or 50 mg weekly) To evaluate the association between subject's age and treatment adherence by comparing grouped adherence
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Baotou Central Hospital, Baotou city, China; Recruiting
Shanghai Changning Guanghua Integrative Medicine Hospital, Beijing 200052, China; Recruiting
Shanghai Jiaotong University Affiliated Third People's Hospital, Shanghai 201900, China; Recruiting
Xinjiang Uygur Autonomous Region People's Hospital, Urumqi 830001, China; Recruiting
Daping Hospital, Chongqing, Chongqing 400038, China; Recruiting
Fujian Provincial Hospital, Fuzhou, Fujian 350001, China; Recruiting
Lanzhou University Second Hospital, Lanzhou, Gansu 730030, China; Recruiting
The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong 510405, China; Recruiting
No. 199, Haerbin, Heilongjiang 150001, China; Recruiting
The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, China; Recruiting
The First Affiliated Hospital of Baotou Medical College, Baotou, Inner Mongolia 014010, China; Recruiting
The Affiliated Hospital of Inner Mongolia Medical College, Hohhot channel, Inner Mongolia 010050, China; Not yet recruiting
Jiangsu Province Hospital/Department of Rheumatology, Nanjing, Jiangsu 210029, China; Recruiting
Affiliated Hospital of Nantong University, Nantong, Jiangsu 226001, China; Recruiting
The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China; Recruiting
Si Chuan Huaxi Hospital/Rheumatology Department, Chengdu, Sichuan 610041, China; Recruiting
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: January 2011
Last updated: January 16, 2013
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