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OpenTrials
Completed

NCT Number: NCT00510536

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acetaminophen

Drug

dose to be determined by investigator

NSAID

Drug

dose to be determined by investigator

Secondary outcomes

  1. The proportion of subjects who sustain or improve their psoriasis in response to efalizumab.

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Probity Medical Research

Network

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 2, 2007
Registry last updated
Apr 10, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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