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
Verified date | April 2009 |
Source | Probity Medical Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | K. Papp Clinical Research Inc. | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
Probity Medical Research |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Secondary | The proportion of subjects who sustain or improve their psoriasis in response to efalizumab. | 8 weeks |
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