Tumor Necrosis Factors (TNF)-α Blockade for Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title: TNF-α Blockade for Psoriatic Arthritis - A Clinical and MRI Study, and the Effects on Cytokine and Cardiovascular Risk Profile

Status Completed

Clinical Trial Summary

The purpose of this study is:

• To elucidate the immunomodulating properties of anti-TNF-α therapy in patients with psoriatic arthritis (PsA).

• To ascertain whether magnetic resonance imaging (MRI) is a sensitive tool in measuring early response after therapy with anti-TNF-α in the PsA wrist using the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) guidelines for rheumatoid arthritis (RA).

• To assess whether the lipid and other cardiovascular risk profiles would improve after anti-TNF-α therapy in patients with PsA.

Clinical Trial Description

The study was a 12-week, open-label trial of anti-TNF therapy in 20 consecutive patients (Group 1). Another 20 consecutive patients with active disease whom have met the exclusion criteria, or were unwilling to start anti-TNF therapy for fear of toxicity would be recruited as control patients (Group 2). 20 healthy controls were recruited for comparison of the metabolic risk factors (Group 3). Study visits for groups 1 and 2 were conducted at baseline, weeks 2 and 6, and then week 12. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

• NCT number: NCT00432406
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Status: Completed
• Phase: Phase 4
• Start date: May 2006
• Completion date: March 2009