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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
The disease, disorder, syndrome, illness, or injury that is being studied.
Psoriatic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Previously discontinued Enbrel therapy due to significant safety concern.
NEED INFO?
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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 | |||