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

Arthritis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510536
• Other study ID #: P07-104
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2007
• Last updated: April 8, 2009
• Start date: July 2007
• Est. completion date: October 2008

Study information

• Verified date: April 2009
• Source: Probity Medical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthralgia
• Arthritis
• Psoriasis

Intervention

Drug:
• Acetaminophen
dose to be determined by investigator
• NSAID
dose to be determined by investigator

Locations

Country	Name	City	State
Canada	K. Papp Clinical Research Inc.	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Probity Medical Research

Country where clinical trial is conducted

Canada, 

Outcome

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