Treatment of Mild to Moderate Joint Pain in Patients With Chronic Plaque Psoriasis Receiving Efalizumab

Study Overview
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Brief Summary
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The purpose of this study is to evaluate tolerability and effectiveness of conventional treatment for mild to moderate arthritic or arthralgic symptoms while subjects are being treated with efalizumab for psoriasis.

Detailed Description
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The study objective is to demonstrate that mild to moderate arthritis or arthralgia may be controlled using conventional therapy while being treated with efalizumab, without loss of efficacy.

Official Title
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A Phase 4 Study to Assess the Practical Management of Mild to Moderate Arthritic or Arthralgic Events in Patients With Chronic Plaque Psoriasis Receiving Efalizumab

Conditions
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Arthritis, Arthralgia

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: NSAID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females cannot become pregnant while participating in study. Have a history of plaque psoriasis for at least 6 months. Receiving or about to receive efalizumab for the treatment of chronic plaque psoriasis. Have mild to moderate arthritis or arthralgia occurring while on treatment with efalizumab or untreated mild to moderate arthritis or arthralgia present at the time of initiating treatment with efalizumab. Exclusion Criteria: Previous systemic treatment with biologics other than efalizumab, within 3 months. Treatment with any systemic corticosteroids or intra-articular corticosteroid injection, cyclosporine or methotrexate within 28 days. Any previous treatment with chlorambucil or cyclophosphamide. Have active tuberculosis or are currently receiving treatment or prophylactic therapy for tuberculosis. Have other serious disorders; such as, congestive heart failure, prior or current history of blood dyscrasia, or central nervous system demyelinating disorders. Has a sensitivity, intolerance, or history of gastrointestinal bleeding associated with diclofenac, indomethacin, and/or ibuprofen.

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Acetaminophen|dose to be determined by investigator|
|Drug: NSAID|dose to be determined by investigator|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who sustain or improve their psoriasis in response to efalizumab. |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriasis, arthritis, arthralgia