NCT01411215

A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department

A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 160 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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. 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.

Conditions

• Rheumatoid Arthritis
• Ankylosing Spondylitis

Interventions

Type	Name	Description
DRUG	Enbrel	25mg biweekly or 50mg per week, subcutaneous injection

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-08-08
• Last updated: 2014-03-06
• Results posted: 2014-03-06

Locations

15 sites across 1 country: China