Back to resultsTreatment of Mild to Moderate Joint Pain in Patients With Chronic Plaque Psoriasis Receiving Efalizumab
Primary Purpose
Arthritis, Arthralgia
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Acetaminophen
NSAID
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis focused on measuring Psoriasis, arthritis, arthralgia
Eligibility Criteria
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.
Sites / Locations
- K. Papp Clinical Research Inc.
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
The proportion of subjects who sustain or improve their psoriasis in response to efalizumab.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00510536
Brief Title
Treatment of Mild to Moderate Joint Pain in Patients With Chronic Plaque Psoriasis Receiving Efalizumab
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Probity Medical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Arthralgia
Keywords
Psoriasis, arthritis, arthralgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
dose to be determined by investigator
Intervention Type
Drug
Intervention Name(s)
NSAID
Intervention Description
dose to be determined by investigator
Secondary Outcome Measure Information:
Title
The proportion of subjects who sustain or improve their psoriasis in response to efalizumab.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Papp, MD, PhD
Organizational Affiliation
K. Papp Clinical Research Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
K. Papp Clinical Research Inc.
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Treatment of Mild to Moderate Joint Pain in Patients With Chronic Plaque Psoriasis Receiving Efalizumab
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