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

Study Overview
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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.

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

Conditions
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Rheumatoid Arthritis, Ankylosing Spondylitis

Intervention / Treatment
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* Drug: Enbrel


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA, AS<br>Rheumatoid arthritis patients Ankylosing spondylitis patients | Drug: Enbrel<br>* 25mg biweekly or 50mg per week, subcutaneous injection<br>* Other names: etanercept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | First day of receiving etanercept through 24 weeks | 
| Number of Participants Who Had Any AEs During 52 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. | First day of receiving etanercept through 52 weeks | 
| Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks | An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Informed consent or signed data privacy statement through 24 weeks | 
| Number of Participants Who Had Any SAEs During 52 Weeks | An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Informed consent or signed data privacy statement through 52 weeks | 
| Number of Participants With AEs Per System Organ Class During 24 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category. | First day of receiving etanercept through 24 weeks | 
| Number of Participants With AEs Per System Organ Class During 52 Weeks | An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category. | First day of receiving etanercept through 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Global Assessment of Disease Activity | Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant's disease according to the participant's clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active). | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | 
| Participant's Global Assessment (PtGA) of Disease Activity | Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active). | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | 
| VAS Score for Pain | Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain. | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | 
| 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% | Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%. | First day of receiving etanercept up to Week 52 | 
| Evaluate the Association Between Participant's Age and Treatment Adherence Rate | Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above. | First day of receiving etanercept up to Week 52 | 
| Number of Participants With Any Abnormal Laboratory Test Results | Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN). | Baseline (Week 0) up to Week 52 | 
| Tender Joint Count (TJC) for RA Participants | TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed. | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | 
| Swollen Joint Count (SJC) for RA Participants | SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed. | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 | 
| Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) | DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity. | Baseline (Week 0), Week 2, Week 4, Week 12, Week 52 | 
| Number of RA Participants Had DAS28-4 (ESR) Improvement | Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2. | Week 2, Week 4, Week 8, Week 12, Week 36, Week 52 | 
| Number of RA Participants Had Remission of Disease | Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6. | Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid arthritis, ankylosing spondylitis, observational study