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

NCT00510536 | Completed Phase 4

• 1 other identifier: P07-104
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthritis; Arthralgia

Keywords

Psoriasis, arthritis, arthralgia

Outcome Measures

Secondary Outcomes (1)

• The proportion of subjects who sustain or improve their psoriasis in response to efalizumab.

  8 weeks

Interventions

Acetaminophen DRUG

dose to be determined by investigator

NSAID DRUG

dose to be determined by investigator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Probity Medical Research: lead

Study Sites (1)

K. Papp Clinical Research Inc.

Waterloo, Ontario, N2J 1C4, Canada

Location

MeSH Terms

Conditions

Arthritis; Arthralgia; Psoriasis

Interventions

Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents

Study Officials

• Kim Papp, MD, PhD

  K. Papp Clinical Research Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: July 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 10, 2009

Record last verified: 2009-04

Locations

CA (1)