Clinical trial NCT00111449: Evaluating the Safety of Etanercept 50 mg Twice Weekly in Subjects With Psoriasis
Official title: A Phase 3 Multicenter Study to Assess the Efficacy and Safety of Etanercept 50 mg Twice Weekly in Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis, adults
skin, Phase 3
clinical trial, Amgen
etanercept, Enbrel®
moderate, severe
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-05-23
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of etanercept 50 mg twice weekly compared to placebo over 12 weeks on the psoriasis area and severity index (PASI) in subjects with psoriasis. This study will also evaluate the safety and tolerability of etanercept 50 mg twice weekly; determine the effect of etanercept 50 mg twice weekly on patient reported outcomes (PRO); and characterize the pharmacokinetics (PK) profile of etanercept 50 mg twice weekly.


Eligibility criteria: Inclusion Criteria: - Active, but clinically stable, plaque psoriasis involving greater than or equal to 10% of the body surface area - A minimum PASI score of 10 obtained during the screening period Exclusion Criteria: - Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit - Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of an investigational product on psoriasis

Primary outcomes:
measure: Achievement of 75% or greater improvement from baseline in the Psoriasis Area and Severity Index (PASI) after 12 weeks of double-blind treatment.
Secondary outcomes:
measure: Dermatology Live Quality Index (DLQI) response at week 12
measure: Subject's assessment of itching and improvements from baseline in joint pain (visual analog scale [VAS]) at week 12
measure: Psoriasis pain (VAS) at week 12
measure: Functional Assessment of Chronic Illness Therapy (FACIT) fatigue scale at week 12
measure: PASI 50, 75 and 90 response and improvement from baseline in PASI score during long-term therapy
measure: Static physician's global assessment of psoriasis (sPGA) from baseline during long-term therapy
measure: Adverse events, infections injection site reactions during long-term therapy
measure: Serious adverse events and infections during long-term therapy
measure: Clinical laboratory values, vital signs and antibodies to etanercept during long-term therapy
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Krishnan R, Cella D, Leonardi C, Papp K, Gottlieb AB, Dunn M, Chiou CF, Patel V, Jahreis A. Effects of etanercept therapy on fatigue and symptoms of depression in subjects treated for moderate to severe plaque psoriasis for up to 96 weeks. Br J Dermatol. 2007 Dec;157(6):1275-7. doi: 10.1111/j.1365-2133.2007.08205.x. Epub 2007 Oct 4. No abstract available.
citation: Tyring S, Gottlieb A, Papp K, Gordon K, Leonardi C, Wang A, Lalla D, Woolley M, Jahreis A, Zitnik R, Cella D, Krishnan R. Etanercept and clinical outcomes, fatigue, and depression in psoriasis: double-blind placebo-controlled randomised phase III trial. Lancet. 2006 Jan 7;367(9504):29-35. doi: 10.1016/S0140-6736(05)67763-X.
citation: Tyring S, Gordon KB, Poulin Y, Langley RG, Gottlieb AB, Dunn M, Jahreis A. Long-term safety and efficacy of 50 mg of etanercept twice weekly in patients with psoriasis. Arch Dermatol. 2007 Jun;143(6):719-26. doi: 10.1001/archderm.143.6.719.
citation: Papp K, Poulin Y, Vieira A, Shelton J, Poulin-Costello M. Disease characteristics in patients with and without psoriatic arthritis treated with etanercept. J Eur Acad Dermatol Venereol. 2014 May;28(5):581-9. doi: 10.1111/jdv.12138. Epub 2013 Mar 7.