Study Evaluating Etanercept for the Treatment of Moderate to Severe Psoriasis (PRISTINE)

Pfizer

Status and phase: Completed; Phase 4

Conditions: Psoriasis; Plaque Psoriasis

Treatments: Drug: Etanercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00663052

0881A6-4425

B1801013

Details and patient eligibility

About

The purpose of this study is to compare the safety and efficacy of different doses of etanercept for the treatment of moderate to severe psoriasis.

Enrollment: 273 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older at time of consent.
• Active, moderate to severe chronic plaque psoriasis defined by the following criteria: Clinically stable, plaque psoriasis involving greater than or equal to 10% body surface area (BSA) or PASI greater than or equal to 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.

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.
• Rheumatologic disease such as rheumatoid arthritis, systemic lupus erythematous, systemic vasculitis, scleroderma and polymyositis, or associated syndromes.
• Active or recent (within 2 years) tuberculosis (TB) infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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273 participants in 2 patient groups

Group A

Experimental group

Description:

A

Treatment:

Drug: Etanercept

Drug: Etanercept

Group B

Experimental group

Description:

B

Treatment:

Drug: Etanercept

Drug: Etanercept