Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists
NCT00293709
Last updated date
ABOUT THIS STUDY
The purpose of this study is to evaluate the safety profile and the effectiveness of
etanercept under usual care settings in patients with PsA treated by dermatologists.
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, Psoriasis, Papulosquamous Skin Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Clinical diagnosis of Psoriatic Arthritis
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Sepsis or risk for sepsis,
- Acute infection,
- Hypersensitive against Etanercept
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NCT00293709
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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Study Evaluating the Safety and Efficacy of Etanercept in Patients With Psoriatic Arthritis Treated by Dermatologists | |||
| Official Title | Prospective Post Marketing Surveillance To Evaluate The Safety And Efficacy Of Etanercept Under Usual Care Settings In Patients With Psoriatic Arthritis (Psa) Treated By Dermatologists | |||
| Brief Summary | The purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with PsA treated by dermatologists. | |||
| Detailed Description | Non-interventional study: subjects to be selected according to the usual clinical practice of their physician | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | Only patients for whom the decision has already been made to initiate treatment with Enbrel® can be enrolled in this observational trial. These patients must have a proven diagnosis of Psoriatic Arthritis. | |||
| Condition |
| |||
| Intervention | Drug: etanercept
The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. Other Name: Enbrel | |||
| Study Groups/Cohorts | Patients with Psoriatic Arthritis
Intervention: Drug: etanercept | |||
| 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 | 129 | |||
| Original Enrollment | 500 | |||
| Actual Study Completion Date | February 2013 | |||
| Actual Primary Completion Date | February 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 | Germany | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00293709 | |||
| Other Study ID Numbers | 0881A6-102036 B1801126 | |||
| 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 | |||