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

NCT01411215

Last updated date
Study Location
Daping Hospital
Chongqing, Chongqing, 400038, China
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis, Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Rheumatoid Arthritis, Ankylosing SpondylitisA Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department
NCT01411215
  1. Chongqing, Chongqing
  2. Fuzhou, Fujian
  3. Lanzhou, Gansu
  4. Guangzhou, Guangdong
  5. Haerbin, Heilongjiang
  6. Changsha, Hunan
  7. Baotou, Inner Mongolia
  8. Nanjing, Jiangsu
  9. Nantong, Jiangsu
  10. Taiyuan, Shanxi
  11. Chengdu, Sichuan
  12. Baotou city,
  13. Beijing,
  14. Shanghai,
  15. Urumqi,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department
Official Title A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population outpatient RA and AS patients in China
Condition
  • Rheumatoid Arthritis
  • Ankylosing Spondylitis
Intervention Drug: Enbrel
25mg biweekly or 50mg per week, subcutaneous injection
Other Name: etanercept
Study Groups/Cohorts RA, AS
Rheumatoid arthritis patients Ankylosing spondylitis patients
Intervention: Drug: Enbrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: January 23, 2014)
160
Original Estimated Enrollment
 (submitted: August 4, 2011)
600
Actual Study Completion Date January 2013
Actual Primary Completion Date January 2013   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01411215
Other Study ID Numbers B1801044
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2014