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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01235442
Other study ID # 20080470
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 2010
Est. completion date December 2011

Study information

Verified date August 2015
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.


Recruitment information / eligibility

Status Completed
Enrollment 592
Est. completion date December 2011
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Subject has had stable moderate to severe plaque psoriasis for at least 6 months

- Subject has involved BSA = 10% and PASI = 10 at screening and at baseline.

- Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator

Exclusion Criteria:

- Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.

- Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis.

- Subject diagnosed with medication-induced or medication exacerbated psoriasis

- Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection

- Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol.

- Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids.

- Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies

- Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose

- Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept

- Subject has ever used efalizumab (Raptiva®).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
1=Etanercept
50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.
2=Clobetasol propionate foam
0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Amgen Wyeth is now a wholly owned subsidiary of Pfizer

References & Publications (1)

Lebwohl MG, Kircik L, Callis Duffin K, Pariser D, Hooper M, Wenkert D, Thompson EH, Yang J, Kricorian G, Koo J. A randomized study to evaluate the efficacy and safety of adding topical therapy to etanercept in patients with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2013 Sep;69(3):385-92. doi: 10.1016/j.jaad.2013.03.031. Epub 2013 May 1. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary PASI 75 at Week 12 The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline. Week 12
Secondary sPGA (0,1) at Week 12 The percentage of participants achieving sPGA 0 or 1 at week 12. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. Week 12
Secondary PASI 90 at Week 12 The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 90 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 90% reduction in the PASI score from Baseline. Week 12
Secondary Patient Satisfaction at Week 12 Patient assessment of treatment satisfaction status at week 12. It is a measure of a participant's level of satisfaction with the medication's control of psoriasis, ranging from "very satisfied" to "very dissatisfied." Week 12
Secondary Percent PASI Improvement From Baseline at Week 12 The percentage of the improvement in PASI score at week 12 from baseline. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. Week 12
Secondary PASI 75 at Week 24 The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 24. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline. Week 24
Secondary sPGA (0,1) at Week 24 The percentage of participants achieving sPGA 0 or 1 at week 24. Static physician global assessment of psoriasis (sPGA) is a physician's global assessment of the participant's psoriasis based on severity of induration, scaling, and erythema. The sPGA of psoriasis comprises a 6-point scale ranging from 0 (clear) to 5 with increasing severity. Week 24
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