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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510536
Recruitment Status : Completed
First Posted : August 2, 2007
Last Update Posted : April 10, 2009
Information provided by:
Probity Medical Research

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.

Condition or disease Intervention/treatment Phase
Arthritis Arthralgia Drug: Acetaminophen Drug: NSAID Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2007
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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

Secondary Outcome Measures :
  1. The proportion of subjects who sustain or improve their psoriasis in response to efalizumab. [ Time Frame: 8 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510536

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Canada, Ontario
K. Papp Clinical Research Inc.
Waterloo, Ontario, Canada, N2J 1C4
Sponsors and Collaborators
Probity Medical Research
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Principal Investigator: Kim Papp, MD, PhD K. Papp Clinical Research Inc.

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Responsible Party: Probity Medical Research Identifier: NCT00510536     History of Changes
Other Study ID Numbers: P07-104
First Posted: August 2, 2007    Key Record Dates
Last Update Posted: April 10, 2009
Last Verified: April 2009
Keywords provided by Probity Medical Research:
Psoriasis, arthritis, arthralgia
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs