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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

Page last updated: February 07, 2013

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