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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis; Ankylosing Spondylitis

Intervention: Enbrel (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer


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:

Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks

Number of Participants Who Had Any AEs During 52 Weeks

Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks

Number of Participants Who Had Any SAEs During 52 Weeks

Number of Participants With AEs Per System Organ Class During 24 Weeks

Number of Participants With AEs Per System Organ Class During 52 Weeks

Secondary outcome:

Physician's Global Assessment of Disease Activity

Participant's Global Assessment (PtGA) of Disease Activity

VAS Score for Pain

Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%

Evaluate the Association Between Participant's Age and Treatment Adherence Rate

Number of Participants With Any Abnormal Laboratory Test Results

Tender Joint Count (TJC) for RA Participants

Swollen Joint Count (SJC) for RA Participants

Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])

Number of RA Participants Had DAS28-4 (ESR) Improvement

Number of RA Participants Had Remission of Disease

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.

- Subject has accepted physician's prescription of etanercept in rheumatology


- 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


- 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

Baotou Central Hospital, Baotou city, China

Shanghai Changning Guanghua Integrative Medicine Hospital, Beijing 200052, China

Shanghai Jiaotong University Affiliated Third People's Hospital, Shanghai 201900, China

Xinjiang Uygur Autonomous Region People's Hospital, Urumqi 830001, China

Daping Hospital, Chongqing, Chongqing 400038, China

Fujian Provincial Hospital, Fuzhou, Fujian 350001, China

Lanzhou University Second Hospital, Lanzhou, Gansu 730030, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, Guangdong 510405, China

No. 199, Haerbin, Heilongjiang 150001, China

The Second Xiangya Hospital of Central South University, Changsha, Hunan 410011, China

The First Affiliated Hospital of Baotou Medical College, Baotou, Inner Mongolia 014010, China

Jiangsu Province Hospital/Department of Rheumatology, Nanjing, Jiangsu 210029, China

Affiliated Hospital of Nantong University, Nantong, Jiangsu 226001, China

The Second Hospital of Shanxi Medical University, Taiyuan, Shanxi 030001, China

Si Chuan Huaxi Hospital/Rheumatology Department, Chengdu, Sichuan 610041, China

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: January 2011
Last updated: January 23, 2014

Page last updated: August 20, 2015

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