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

NCT ID: NCT01411215

Last Updated: 2014-03-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-01-31

Brief Summary

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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

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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

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Rheumatoid Arthritis Ankylosing Spondylitis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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RA, AS

Rheumatoid arthritis patients Ankylosing spondylitis patients

Enbrel

Intervention Type DRUG

25mg biweekly or 50mg per week, subcutaneous injection

Interventions

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Enbrel

25mg biweekly or 50mg per week, subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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etanercept

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Daping Hospital

Chongqing, Chongqing Municipality, China

Site Status

Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status

Lanzhou University Second Hospital

Lanzhou, Gansu, China

Site Status

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Site Status

No. 199

Haerbin, Heilongjiang, China

Site Status

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Site Status

Jiangsu Province Hospital/Department of Rheumatology

Nanjing, Jiangsu, China

Site Status

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Site Status

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status

Si Chuan Huaxi Hospital/Rheumatology Department

Chengdu, Sichuan, China

Site Status

Baotou Central Hospital

Baotou, , China

Site Status

Shanghai Changning Guanghua Integrative Medicine Hospital

Beijing, , China

Site Status

Shanghai Jiaotong University Affiliated Third People's Hospital

Shanghai, , China

Site Status

Xinjiang Uygur Autonomous Region People's Hospital

Ürümqi, , China

Site Status

Countries

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China

Related Links

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Other Identifiers

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B1801044

Identifier Type: -

Identifier Source: org_study_id

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