A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department (ENBREL NIS CN)

Pfizer

Status: Terminated

Conditions: Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Drug: Enbrel

Study type: Observational

Funder types: Industry

Identifiers

NCT01411215

B1801044

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

160 participants in 1 patient group

RA, AS

Description:

Rheumatoid arthritis patients Ankylosing spondylitis patients

Treatment:

Drug: Enbrel