Clinical trial NCT04428411: Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO).
Official title: The Impact of Difficult to Treat Sites on Biological Treatment Response in Patients With Moderate-to-Severe Plaque Psoriasis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-06-11
Enrollment: 486
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients data from the local Dermatology Center of the Baghdad Teaching Hospital

Brief summary: This study is to evaluate available local data in Iraq patients with moderate-to-severe plaque psoriasis on Enbrel treatment with regards to efficacy, treatment for PsO who have difficult to treat sites at presentation.


Eligibility criteria: Inclusion Criteria:

* Moderate-to-severe plaque psoriasis patients whom have been receiving etanercept for at least 1 year duration.
* Have difficult to treat sites at presentation.
* Age ≥18 years.
* No history of using other biological treatments, other than etanercept for the treatment of moderate-to-severe PsO.

Exclusion Criteria:

* Etanercept use for treatment of moderate-to-severe PsO less than 1 year duration.
* Previous use of another biological treatment for treatment of moderate-to-severe PsO.

Primary outcomes:
measure: Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4
timeFrame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12
timeFrame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit
timeFrame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4
timeFrame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12
timeFrame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit
timeFrame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4
timeFrame: Baseline (pre-treatment), Month 4 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12
timeFrame: Baseline (pre-treatment), Month 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit
timeFrame: Baseline (pre-treatment), Last Visit (any time after 12 months till maximum of approximately 5 years) (from the data retrieved and observed in approximately 1.8 months of this study)
Secondary outcomes:
measure: Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment
timeFrame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment
timeFrame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
measure: Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment
timeFrame: Baseline (pre-treatment), Month 4, 12 (post-treatment) (from the data retrieved and observed in approximately 1.8 months of this study)
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: