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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00510536
First Posted: August 2, 2007
Last Update Posted: April 10, 2009
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.
Information provided by:
Probity Medical Research
  Purpose
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 Intervention Phase
Arthritis Arthralgia Drug: Acetaminophen Drug: NSAID Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Probity Medical Research:

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

Estimated Enrollment: 50
Study Start Date: July 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Acetaminophen
    dose to be determined by investigator
    Drug: NSAID
    dose to be determined by investigator
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00510536


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

Responsible Party: Probity Medical Research
ClinicalTrials.gov Identifier: NCT00510536     History of Changes
Other Study ID Numbers: P07-104
First Submitted: August 1, 2007
First Posted: August 2, 2007
Last Update Posted: April 10, 2009
Last Verified: April 2009

Keywords provided by Probity Medical Research:
Psoriasis, arthritis, arthralgia

Additional relevant MeSH terms:
Arthritis
Psoriasis
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics