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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:
Information provided by:
Probity Medical Research
ClinicalTrials.gov Identifier:
NCT00510536
First received: August 1, 2007
Last updated: April 8, 2009
Last verified: April 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

MedlinePlus related topics: Psoriasis
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Probity Medical Research
ClinicalTrials.gov Identifier: NCT00510536     History of Changes
Other Study ID Numbers: P07-104
Study First Received: August 1, 2007
Last Updated: April 8, 2009
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Arthralgia
Arthritis
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Skin Diseases, Papulosquamous
Skin Diseases
Acetaminophen
Anti-Inflammatory Agents, Non-Steroidal
 Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 21, 2013