N/A N=486

Study To Evaluate The Impact Of Difficult To Treat Sites On Biological Response In Moderate-To-Severe Plaque Psoriasis(PsO).

Plaque Psoriasis

Bottom Line

View on ClinicalTrials.gov: NCT04428411 ↗

Enrolled (actual)

486

Serious AEs

—

Results posted

Oct 2021

Primary outcome: Primary: Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4 — 28.1; 29.21; -6.79; -6.38 Percent BSA — p=0.35

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Enbrel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Pfizer
Primary completion: Aug 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 4	28.1; 29.21; -6.79; -6.38	0.35
PRIMARY Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Month 12	-19.13; -18.93	0.07
PRIMARY Mean Change From Baseline in Percent Body Surface Area (BSA) Score at Last Visit	-23.78; -24.4	0.41
PRIMARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 4	24.6; 24.42; -5.75; -7.56	0.01 sig
PRIMARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Month 12	-15.66; -17.39	0.02 sig
PRIMARY Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Last Visit	-17.49; -19.39	0.09
PRIMARY Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 4	24.68; 21.46; -8.22; -6.22	0.31
PRIMARY Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Month 12	-17.68; -16.16	<0.05 sig
PRIMARY Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Last Visit	-19.79; -18.42	<0.05 sig
SECONDARY Percent Body Surface Area (BSA) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment	27.56; 32.84; 20.06; 31.74; 8.7; 11.1	0.0001 sig
SECONDARY Dermatology Life Quality Index (DLQI) Score at Baseline, Month 4 and Month 12 in Participants Adherent and Not Adherent to Treatment	24.50; 24.94; 16.63; 21.19; 6.6; 11.3	0.0001 sig
SECONDARY Psoriasis Area and Severity Index (PASI) Score at Baseline, Month 4, and Month 12 in Participants Adherent and Not Adherent to Treatment	21.980; 22.458; 14.520; 21.717; 4.8; 9.7	0.0001 sig

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04428411). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.