The objective of this surveillance is to determine the following items in all patients receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:Infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions.
· Patients with rheumatoid arthritis [only those refractory to the previous treatment]
· Patients with rheumatoid arthritis [only those refractory to the previous treatment]
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan | |||
| Official Title | Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan | |||
| Brief Summary | The objective of this surveillance is to determine the following items in all patients receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:Infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions. | |||
| Detailed Description | Not Provided | |||
| Study Type | Observational | |||
| Study Design | Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Not Provided | |||
| Study Population | Not Provided | |||
| Condition | Rheumatoid Arthritis | |||
| Intervention | Drug: Enbrel (etanercept) | |||
| Study Groups/Cohorts | Not Provided | |||
| Publications * | Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, Takeuchi T, Tanaka Y, Yamanaka H, Fujii K, Freundlich B, Suzukawa M. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009 May;36(5):898-906. doi: 10.3899/jrheum.080791. Epub 2009 Mar 30. | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Enrollment | Not Provided | |||
| Original Enrollment | Not Provided | |||
| Actual Study Completion Date | October 2007 | |||
| Actual Primary Completion Date | October 2007 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria · Patients with rheumatoid arthritis [only those refractory to the previous treatment] | |||
| Sex/Gender |
| |||
| Ages | 11 Years to 90 Years (Child, Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Not Provided | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00503503 | |||
| Other Study ID Numbers | 0881Y1-4460 | |||
| Has Data Monitoring Committee | Not Provided | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
| Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | December 2007 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
