Who is sponsoring NCT01235442?

NCT01235442 is sponsored by Amgen.

What drugs are being tested in NCT01235442?

Interventions: 1=Etanercept, 2=Clobetasol propionate foam.

What is the status of NCT01235442?

NCT01235442 is currently COMPLETED.

Last reviewed 2018-07-09 · How we verify

A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis

NCT01235442 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Amgen
Phase	Phase 3
Status	COMPLETED
Enrolment	592
Start date	2010-09
Completion	2011-12

Conditions

Psoriasis

Interventions

1=Etanercept
2=Clobetasol propionate foam

Primary outcomes

PASI 75 at Week 12 — 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.