Study Evaluating Etanercept on Skin and Joint Disease in Psoriatic Arthritis

Study Overview
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Brief Summary
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The purpose of the study was to compare the efficacy of 2 different Etanercept regimens for the treatment of skin and joint manifestations of psoriatic arthritis.

Official Title
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A RANDOMIZED, OPEN-LABEL, TWO-PERIOD STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ETANERCEPT ON SKIN AND JOINT DISEASE IN PSORIASIS SUBJECTS WITH PSORIATIC ARTHRITIS

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: etanercept
* Drug: etanercept
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: 18 years of age or older at time of consent Active Psoriatic Arthritis Clinically stable, plaque psoriasis involving more than 10% of the body surface area Exclusion Criteria: Exclusion Criteria: Evidence of skin conditions other than psoriasis that would interfere with skin examinations. Systemic anti-psoriasis therapy or DMARD within 28 days of study drug initiation Prior exposure to any TNF-inhibitor, including etanercept

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Period 1 (Double Blind): 50mg bi-weekly (BIW) for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW). | Drug: etanercept<br> <br> |
| Active Comparator: B<br>Period 1 (Double Blind): 50mg weekly (QW) with matching placebo for weeks 1-12. Period 2 (Open Label): 50 mg weekly (QW) for weeks 13-24. | Drug: etanercept<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Achieving Clear or Almost Clear on Physician Global Assessment (PGA) of Psoriasis | The PGA of Psoriasis scale ranges from 0 (no psoriasis) to 5 (severe disease). Clear and Almost Clear includes all patients who were scored as a 0 or 1. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients Achieving Psoriatic Arthritis Response Criteria (PsARC) | The PsARC response was defined as improvement in at least 2 of the four criteria: >=30% decrease in swollen joint count, >=30% decrease in tender joint count, >=20% improvement in patient's Global Assessment of Disease Activity (arthritis) using VAS (0-100 mm, 0=excellent and 100= poor), >=20% improvement in physician's Global Assessment of Disease Activity using VAS (VAS: 0-100 mm, 0=no arthritis activity and 100=extremely active arthritis), and at least one of the 2 joint criteria with no deterioration in the other criteria. | 12 and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, Skin Disease, Joint Disease