Clinical trial NCT00111436: Evaluating the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Official title: An Open-Label, Long-Term Extension Study to Assess the Safety of Etanercept in the Treatment of Psoriasis in Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis
Keywords: Psoriasis, adults, skin
Phase 3, clinical trial
Amgen, etanercept
Enbrel®, moderate
severe, extension
Lead sponsor: Amgen
Sponsor class: INDUSTRY
Collaborators: name: Immunex Corporation
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-05-23
Enrollment: 912
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of long-term administration of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. This study will also evaluate the maintenance of the efficacy of etanercept in adults with psoriasis who have participated in previous etanercept psoriasis studies. All subjects enrolled in this study will receive 50 mg once weekly or twice weekly (if qualified after week 12) by subcutaneous injections for at least 48 weeks and up to 72 weeks.


Eligibility criteria: Inclusion Criteria:

- Subjects who were randomized and received at least one dose of investigational product in Study 20021639 or 20021642 (provided that they meet all inclusion/exclusion criteria of this protocol)

Exclusion Criteria:

* Active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit
* Pregnant or breast-feeding females
* Evidence of skin conditions at the time of the screening visit (e.g., eczema) that would interfere with evaluations of the effect of the investigational product on psoriasis

Primary outcomes:
measure: Subject incidence of adverse events, including infectious episodes
timeFrame: 72 weeks
measure: Changes from baseline in laboratory values
timeFrame: 72 weeks
Secondary outcomes:
measure: Improvement in Psoriasis Area and Severity Index (PASI) Score in this study relative to baseline in the original study
timeFrame: 72 weeks
measure: Proportion of subjects who achieve 0 or 1 (clear or almost clear) in the Physician Global Assessment of psoriasis
timeFrame: 72 weeks
measure: Patient Global Assessment of psoriasis
timeFrame: 72 weeks
measure: Percent improvement from baseline in the Dermatology Life Quality Index (DLQI) scores
timeFrame: 72 weeks
measure: Changes from baseline in SF-36 Health Survey scores
timeFrame: 72 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Elewski B, Leonardi C, Gottlieb AB, Strober BE, Simiens MA, Dunn M, Jahreis A. Comparison of clinical and pharmacokinetic profiles of etanercept 25 mg twice weekly and 50 mg once weekly in patients with psoriasis. Br J Dermatol. 2007 Jan;156(1):138-42. doi: 10.1111/j.1365-2133.2006.07585.x.
citation: Leonardi C, Strober B, Gottlieb AB, Elewski BE, Ortonne JP, van de Kerkhof P, Chiou CF, Dunn M, Jahreis A. Long-term safety and efficacy of etanercept in patients with psoriasis: an open-label study. J Drugs Dermatol. 2010 Aug;9(8):928-37.