Study Evaluating the Efficacy and Safety of Etanercept and Acitretin in Korean Patient With Moderate to Severe Psoriasis

Pfizer

Status and phase

Completed

Phase 4

Conditions

Moderate to Severe Psoriasis

Treatments

Drug: Acitretin

Drug: Etanercept + Acitretin

Drug: Etanercept

Study type

Interventional

Funder types

Industry

Identifiers

NCT00936065

0881A6-4625

B1801065

Details and patient eligibility

About

To compare the efficacy of ETN 50mg twice weekly for 12 weeks followed by reduction to a maintenance dose of 25mg twice weekly at week 24 with that of combination of ETN 25 mg Twice Weekly plus Acitretin 10mg BID at week 24 in subjects with moderate to severe psoriasis.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Active, moderate to severe psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving more than 10% body surface area (BSA) or PASI 10.
In the opinion of the investigator, failure, intolerance, contraindication or not a candidate for the following: Methotrexate (MTX), cyclosporine, and psoralen plus ultraviolet A radiation (PUVA) therapy.
Negative urine pregnancy test before the first dose of study drug in all female patients

Exclusion criteria

Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
Any rheumatologic disease such as rheumatoid arthritis, psoriatic arthritis, gout, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
Prior exposure to TNF inhibitors including ETN. Prior exposure to efalizumab (Raptiva®) and alefacept (Amevive®) is also prohibited.