Last updated date
ABOUT THIS STUDY
The purpose of this study is to collect post-marketing information on the safety of Enbrel in
Filipino patients.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Psoriatic Arthritis
Sex
Females and Males
Age
0 +
Inclusion Criteria
Show details
- All patients from the study center who received or will receive at least one dose of Enbrel according to the approved product indication.
Exclusion Criteria
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- Previously discontinued Enbrel therapy due to significant safety concern.
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Study Evaluating the Safety of Enbrel (Etanercept) | |||
Official Title | A Prospective, Observational Study to Monitor Safety in Patients Who Were Administered With Etanercept (Enbrel) 25 mg by Subcutaneous Injection | |||
Brief Summary | The purpose of this study is to collect post-marketing information on the safety of Enbrel in Filipino patients. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Primary Care | |||
Condition | Arthritis, Psoriatic | |||
Intervention | Drug: Etanercept (Enbrel) | |||
Study Groups/Cohorts | 1
Intervention: Drug: Etanercept (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 | Completed | |||
Actual Enrollment | 93 | |||
Original Estimated Enrollment | 99 | |||
Actual Study Completion Date | October 2009 | |||
Actual Primary Completion Date | October 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Philippines | |||
Removed Location Countries | United States | |||
Administrative Information | ||||
NCT Number | NCT00683384 | |||
Other Study ID Numbers | 0881A-102300 | |||
Has Data Monitoring Committee | No | |||
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 | October 2010 |