Clinical trial NCT01411215: A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department
Official title: A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Keywords: Rheumatoid arthritis
ankylosing spondylitis
observational study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatient RA and AS patients in China

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks
timeFrame: First day of receiving etanercept through 24 weeks
measure: Number of Participants Who Had Any AEs During 52 Weeks
timeFrame: First day of receiving etanercept through 52 weeks
measure: Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks
timeFrame: Informed consent or signed data privacy statement through 24 weeks
measure: Number of Participants Who Had Any SAEs During 52 Weeks
timeFrame: Informed consent or signed data privacy statement through 52 weeks
measure: Number of Participants With AEs Per System Organ Class During 24 Weeks
timeFrame: First day of receiving etanercept through 24 weeks
measure: Number of Participants With AEs Per System Organ Class During 52 Weeks
timeFrame: First day of receiving etanercept through 52 weeks
Secondary outcomes:
measure: Physician's Global Assessment of Disease Activity
timeFrame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
measure: Participant's Global Assessment (PtGA) of Disease Activity
timeFrame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
measure: VAS Score for Pain
timeFrame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
measure: 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%
timeFrame: First day of receiving etanercept up to Week 52
measure: Evaluate the Association Between Participant's Age and Treatment Adherence Rate
timeFrame: First day of receiving etanercept up to Week 52
measure: Number of Participants With Any Abnormal Laboratory Test Results
timeFrame: Baseline (Week 0) up to Week 52
measure: Tender Joint Count (TJC) for RA Participants
timeFrame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
measure: Swollen Joint Count (SJC) for RA Participants
timeFrame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
measure: Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
timeFrame: Baseline (Week 0), Week 2, Week 4, Week 12, Week 52
measure: Number of RA Participants Had DAS28-4 (ESR) Improvement
timeFrame: Week 2, Week 4, Week 8, Week 12, Week 36, Week 52
measure: Number of RA Participants Had Remission of Disease
timeFrame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Daping Hospital
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
city: Lanzhou
country: China
facility: Lanzhou University Second Hospital
state: Gansu
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
city: Haerbin
country: China
facility: No. 199
state: Heilongjiang
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Baotou
country: China
facility: The First Affiliated Hospital of Baotou Medical College
state: Inner Mongolia
city: Nanjing
country: China
facility: Jiangsu Province Hospital/Department of Rheumatology
state: Jiangsu
city: Nantong
country: China
facility: Affiliated Hospital of Nantong University
state: Jiangsu
city: Taiyuan
country: China
facility: The Second Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: Si Chuan Huaxi Hospital/Rheumatology Department
state: Sichuan
city: Baotou city
country: China
facility: Baotou Central Hospital
city: Beijing
country: China
facility: Shanghai Changning Guanghua Integrative Medicine Hospital
city: Shanghai
country: China
facility: Shanghai Jiaotong University Affiliated Third People's Hospital
city: Urumqi
country: China
facility: Xinjiang Uygur Autonomous Region People's Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: