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

Rheumatoid Arthritis Clinical Trial

— ENBREL NIS CN  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01411215
• Other study ID #: B1801044
• Status: Terminated
• Phase: N/A
• First received: May 13, 2011
• Last updated: January 23, 2014
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: People's hospital
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Enbrel
25mg biweekly or 50mg per week, subcutaneous injection

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Baotou Medical College	Baotou	Inner Mongolia
China	Baotou Central Hospital	Baotou city
China	Shanghai Changning Guanghua Integrative Medicine Hospital	Beijing
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Si Chuan Huaxi Hospital/Rheumatology Department	Chengdu	Sichuan
China	Daping Hospital	Chongqing	Chongqing
China	Fujian Provincial Hospital	Fuzhou	Fujian
China	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong
China	No. 199	Haerbin	Heilongjiang
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Jiangsu Province Hospital/Department of Rheumatology	Nanjing	Jiangsu
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu
China	Shanghai Jiaotong University Affiliated Third People's Hospital	Shanghai
China	The Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Xinjiang Uygur Autonomous Region People's Hospital	Urumqi

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	First day of receiving etanercept through 24 weeks	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

External Links

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