Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis
NCT02192164
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Adult Trials: 18+ Years
Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator Patients who are scheduled by their dermatologist to initiate treatment with Etanercept
Previous or current treatment with antipsoriatic biologic drugs, such as etanercept,
infliximab, adalimumab, ustekinumab, alefacept, efalizumab Chronic or acute infections
requiring intravenous or oral anti-infectives within 14 days prior to the Baseline visit
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis | |||
| Official Title | Non-interventional Study Of The Effect Of Smoking Status Of The Patient On The Success Of Etanercept Therapy In Psoriasis | |||
| Brief Summary | Pilot observational study to describe the relationship between the smoking status of a psoriatic individual and the success of etanercept therapy in psoriasis treatment | |||
| Detailed Description | non-interventional study There is no sampling | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Other Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Non-Probability Sample | |||
| Study Population | etanercept treated plaque psoriasis patients | |||
| Condition | Plaque Psoriasis | |||
| Intervention | Behavioral: smoking questionnaire
patients fill in a smoking questionnaire about their smoking habits | |||
| Study Groups/Cohorts | Not Provided | |||
| 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 | 126 | |||
| Original Estimated Enrollment | 128 | |||
| Actual Study Completion Date | May 2016 | |||
| Actual Primary Completion Date | May 2016 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria: Clinical diagnosis of chronic plaque type psoriasis for at least 6 months as determined by the subjects medical history, and confirmation of the diagnosis through physical examination by the investigator Patients who are scheduled by their dermatologist to initiate treatment with Etanercept Exclusion Criteria: Previous or current treatment with antipsoriatic biologic drugs, such as etanercept, infliximab, adalimumab, ustekinumab, alefacept, efalizumab Chronic or acute infections requiring intravenous or oral anti-infectives within 14 days prior to the Baseline visit | |||
| Sex/Gender |
| |||
| Ages | 18 Years to 99 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Hungary | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT02192164 | |||
| Other Study ID Numbers | B1801365 | |||
| 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 | April 2017 | |||