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

Phase 4

Completed

• Conditions: Arthritis; Arthralgia

• Registration Number: NCT00510536
• Lead Sponsor: Probity Medical Research

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-01
• Study First Submitted QC: 2007-08-01
• Study First Posted: 2007-08-02
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-04
• Last Update Submitted: 2009-04-08
• Last Update Posted: 2009-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

K. Papp Clinical Research Inc.; 🇨🇦 Waterloo, Ontario, Canada