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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01411215

Acronym

ENBREL NIS CN

Enrollment

160

Registered

2011-08-08

Start date

2011-01-31

Completion date

2013-01-31

Last updated

2014-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Rheumatoid Arthritis

Keywords

Rheumatoid arthritis, ankylosing spondylitis, observational study

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.

Interventions

DRUGEnbrel

25mg biweekly or 50mg per week, subcutaneous injection

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks	First day of receiving etanercept through 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.
Number of Participants Who Had Any AEs During 52 Weeks	First day of receiving etanercept through 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.
Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks	Informed consent or signed data privacy statement through 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.
Number of Participants Who Had Any SAEs During 52 Weeks	Informed consent or signed data privacy statement through 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.
Number of Participants With AEs Per System Organ Class During 24 Weeks	First day of receiving etanercept through 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.
Number of Participants With AEs Per System Organ Class During 52 Weeks	First day of receiving etanercept through 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.

Secondary

Measure	Time frame	Description
Tender Joint Count (TJC) for RA Participants	Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52	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.
Swollen Joint Count (SJC) for RA Participants	Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52	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.
Physician's Global Assessment of Disease Activity	Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52	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).
Number of RA Participants Had DAS28-4 (ESR) Improvement	Week 2, Week 4, Week 8, Week 12, Week 36, Week 52	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.
Number of RA Participants Had Remission of Disease	Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52	Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) \<2.6.
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])	Baseline (Week 0), Week 2, Week 4, Week 12, Week 52	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.
Participant's Global Assessment (PtGA) of Disease Activity	Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52	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).
VAS Score for Pain	Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52	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.
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%	First day of receiving etanercept up to Week 52	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%.
Evaluate the Association Between Participant's Age and Treatment Adherence Rate	First day of receiving etanercept up to Week 52	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.
Number of Participants With Any Abnormal Laboratory Test Results	Baseline (Week 0) up to Week 52	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).

Countries

China

Participant flow

Participants by arm

Arm	Count
Rheumatoid Arthritis [RA] Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	69
Ankylosing Spondylitis [AS] Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks	90
Total	159

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	1	2
Overall Study	Did not meet entrance criteria	0	1
Overall Study	Lack of Efficacy	2	4
Overall Study	Lost to Follow-up	12	18
Overall Study	Other	12	17
Overall Study	Protocol Violation	3	5
Overall Study	Screen failure	0	1
Overall Study	Study terminated by sponsor	2	15
Overall Study	Withdrawal by Subject	34	21

Baseline characteristics

Characteristic	Rheumatoid Arthritis [RA]	Total	Ankylosing Spondylitis [AS]
Age, Customized >=30 and <40 years	7 Participants	28 Participants	21 Participants
Age, Customized >=40 and <50 years	22 Participants	40 Participants	18 Participants
Age, Customized >=50 years	34 Participants	43 Participants	9 Participants
Age, Customized greater than or equal to (>=) 20 and <30 years	3 Participants	30 Participants	27 Participants
Age, Customized less than (<) 20 years	3 Participants	18 Participants	15 Participants
Sex: Female, Male Female	50 Participants	74 Participants	24 Participants
Sex: Female, Male Male	19 Participants	85 Participants	66 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	8 / 69	9 / 90
serious Total, serious adverse events	0 / 69	0 / 90

Outcome results

Primary

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