A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department (ENBREL NIS CN)

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01411215
First received: May 13, 2011
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Ankylosing Spondylitis
Drug: Enbrel

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks [ Time Frame: First day of receiving etanercept through 24 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: First day of receiving etanercept through 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Informed consent or signed data privacy statement through 24 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Informed consent or signed data privacy statement through 52 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: First day of receiving etanercept through 24 weeks ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: First day of receiving etanercept through 52 weeks ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Physician's Global Assessment of Disease Activity [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 ] [ Designated as safety issue: No ]
    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).

  • Participant's Global Assessment (PtGA) of Disease Activity [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 ] [ Designated as safety issue: No ]
    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% [ Time Frame: First day of receiving etanercept up to Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: First day of receiving etanercept up to Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0) up to Week 52 ] [ Designated as safety issue: Yes ]
    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).

  • Tender Joint Count (TJC) for RA Participants [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 12, Week 52 ] [ Designated as safety issue: No ]
    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.

  • Number of RA Participants Had DAS28-4 (ESR) Improvement [ Time Frame: Week 2, Week 4, Week 8, Week 12, Week 36, Week 52 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52 ] [ Designated as safety issue: No ]
    Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6.


Enrollment: 160
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
RA, AS
Rheumatoid arthritis patients Ankylosing spondylitis patients
Drug: Enbrel
25mg biweekly or 50mg per week, subcutaneous injection
Other Name: etanercept

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

outpatient RA and AS patients in China

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411215

Locations
China, Chongqing
Daping Hospital
Chongqing, Chongqing, China, 400038
China, Fujian
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
China, Gansu
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
China, Guangdong
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510405
China, Heilongjiang
No. 199
Haerbin, Heilongjiang, China, 150001
China, Hunan
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
China, Inner Mongolia
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, China, 014010
China, Jiangsu
Jiangsu Province Hospital/Department of Rheumatology
Nanjing, Jiangsu, China, 210029
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China, 226001
China, Shanxi
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
China, Sichuan
Si Chuan Huaxi Hospital/Rheumatology Department
Chengdu, Sichuan, China, 610041
China
Baotou Central Hospital
Baotou city, China
Shanghai Changning Guanghua Integrative Medicine Hospital
Beijing, China, 200052
Shanghai Jiaotong University Affiliated Third People's Hospital
Shanghai, China, 201900
Xinjiang Uygur Autonomous Region People's Hospital
Urumqi, China, 830001
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01411215     History of Changes
Other Study ID Numbers: B1801044
Study First Received: May 13, 2011
Results First Received: January 23, 2014
Last Updated: January 23, 2014
Health Authority: China: People's hospital

Keywords provided by Pfizer:
Rheumatoid arthritis
ankylosing spondylitis
observational study

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis

ClinicalTrials.gov processed this record on September 22, 2014