A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department
NCT01411215
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Adult Trials: 18+ Years
- 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
- 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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| 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 |
| |||
| 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 | 160 | |||
| Original Estimated Enrollment | 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:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2014 | |||