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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2011-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Moderate to Severe Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Group Type ACTIVE_COMPARATOR

Etanercept

Intervention Type DRUG

Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks

Group B

Group Type EXPERIMENTAL

Etanercept + Acitretin

Intervention Type DRUG

Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks

Group C

Group Type ACTIVE_COMPARATOR

Acitretin

Intervention Type DRUG

Acitretin at a dose of 10mg BID for 24 weeks

Interventions

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Etanercept

Etanercept at a dose of 50mg twice weekly for 12 weeks followed by 25mg twice weekly for 12 weeks

Intervention Type DRUG

Etanercept + Acitretin

Combination of etanercept at a dose of 25mg twice weekly and acitretin 10mg BID for 24 weeks

Intervention Type DRUG

Acitretin

Acitretin at a dose of 10mg BID for 24 weeks

Intervention Type DRUG

Other Intervention Names

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Etanercept 50mg followed by 25mg Etancercept 25mg and Acitretin 10mg Acitretin 10mg

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No