Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings
NCT00708708
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Adult Trials: 18+ Years
- Subjects with moderate to severe plaque psoriasis on etanercept treatment according to the Summary of Product Characteristics (SmPC), and applicable local guidelines
- Subjects for whom the decision has already been made to initiate treatment with etanercept
- Sepsis or risk of sepsis
- Current or recent infections, including chronic or localized, e.g. tuberculosis (TB)
infection
- Vaccination with live vaccine in last 4 weeks, or expected to require such vaccination
during the course of the study
- Pre-existing or recent onset CNS demyelinating disease.
- Class III or IV congestive heart failure as defined by the New York Heart Association
classification or uncompensated congestive heart failure.
- Previous or ongoing treatment with etanercept
- Participation in other clinical or observational studies.
- Patients with psoriatic arthritis requiring continuous etanercept treatment.
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Observational Study Evaluating Etanercept (Enbrel®) In Subjects With Plaque-Type Psoriasis In Usual Care Settings | |||
| Official Title | A Prospective Non-interventional Study (Nis) Of The Routine Use Of Etanercept In The Long-term Treatment Of Patients With Plaque-type Psoriasis In Everyday Practice: An Efficacy, Safety, And Health Economic Evaluation | |||
| Brief Summary | This prospective observational cohort study will assess the average duration of the drug free interval between etanercept treatment cycles in usual care settings in Germany. | |||
| 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 | Patients with moderate to severe plaque psoriasis | |||
| Condition | Psoriasis | |||
| Intervention | Drug: etanercept (Enbrel®)
The patients will be treated in accordance with the requirements of the labeling of etanercept in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment. | |||
| Study Groups/Cohorts | A
Patients with moderate to severe plaque psoriasis Intervention: Drug: etanercept (Enbrel®) | |||
| Publications * | Luger T, Schopf RE, Schwanke A, Langhammer S, Meng T, Löschmann PA. An observational study to evaluate the long-term outcomes of treatment with etanercept in patients with plaque-type psoriasis. J Eur Acad Dermatol Venereol. 2016 Oct;30(10):1730-1741. doi: 10.1111/jdv.13673. Epub 2016 Jun 14. | |||
* 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 | 926 | |||
| Original Estimated Enrollment | 750 | |||
| Actual Study Completion Date | December 2013 | |||
| Actual Primary Completion Date | December 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 | NCT00708708 | |||
| Other Study ID Numbers | 0881X1-4499 B1801081 ( Other Identifier: Alias Study Number ) | |||
| 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 | July 2015 | |||