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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00510536

Enrollment

Registered

2007-08-02

Start date

2007-07-31

Completion date

2008-10-31

Last updated

2009-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthralgia, Arthritis

Keywords

Psoriasis, arthritis, arthralgia

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.

Interventions

DRUGAcetaminophen

dose to be determined by investigator

DRUGNSAID

dose to be determined by investigator

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Secondary

Measure	Time frame
The proportion of subjects who sustain or improve their psoriasis in response to efalizumab.	8 weeks

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026