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.
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.
Study Type
OBSERVATIONAL
Enrollment
160
25mg biweekly or 50mg per week, subcutaneous injection
Daping Hospital
Chongqing, Chongqing Municipality, China
Fujian Provincial Hospital
Fuzhou, Fujian, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
No. 199
Haerbin, Heilongjiang, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China
Jiangsu Province Hospital/Department of Rheumatology
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
...and 5 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: First day of receiving etanercept through 52 weeks
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).
Time frame: 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).
Time frame: 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.
Time frame: 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%.
Time frame: 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.
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Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52