Study Evaluating the Safety of Enbrel (Etanercept)

NCT00683384

Last updated date
Study Location
Metro Manila, , , Philippines
Contact
1-800-718-1021

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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
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.

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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
 (submitted: December 10, 2009)
93
Original Estimated Enrollment
 (submitted: May 22, 2008)
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:

  • 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:

  • Previously discontinued Enbrel therapy due to significant safety concern.
Sex/Gender
Sexes Eligible for Study:All
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
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date October 2010