Clinical trial NCT04398732: Study to Evaluate the Efficacy of Enbrel as a Biological Treatment in Moderate to Severe Plaque Psoriasis Patients
Official title: Efficacy of Etanercept in Iraqi Patients With Moderate to Severe Psoriasis: 5 Years Data From Local Registry.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Plaque Psoriasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-05-21
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 registry at the Dermatology Center of Baghdad Teaching Hospital registry.

Brief summary: This study is to evaluate available local data in Iraqi patients with moderate to severe psoriasis on Enbrel treatment with regards to efficacy, treatment regimen adherence and patient characterization (i.e. age, gender, smoking status) using data from the Dermatologists in Baghdad Teaching Hospital registry


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of moderate to severe plaque psoriasis receiving etanercept treatment for a minimum duration of 1 year.
* Age ≥18 years old.
* No history of using a biological treatment, other than etanercept, for treatment of moderate to severe plaque psoriasis or any other reason.

Exclusion Criteria:

* Etanercept use for treatment moderate to severe plaque psoriasis less than 1 year duration.
* Previous use of other biological treatments for any reason

Primary outcomes:
measure: Change From Baseline in Percent Body Surface Area (BSA) at Month 12
timeFrame: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12
timeFrame: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12
timeFrame: Baseline, Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)
Secondary outcomes:
measure: Percent Body Surface Area (BSA) at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment
timeFrame: Baseline, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 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, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 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, Month 4 and Month 12 (from the data retrieved and observed in approximately 2.8 months of this study)
Other outcomes:
measure: Change From Baseline in Percent Body Surface Area (BSA) at Month 4
timeFrame: Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4
timeFrame: Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4
timeFrame: Baseline, Month 4 (from the data retrieved and observed in approximately 2.8 months of this study)
Locations:
city: Baghdad
country: Iraq
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: