Tumor Necrosis Factors (TNF)-α Blockade for Psoriatic Arthritis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||TNF-α Blockade for Psoriatic Arthritis - A Clinical and MRI Study, and the Effects on Cytokine and Cardiovascular Risk Profile|
- Changes in the degree of inflammation as reflected by the MRI score, cytokines and chemokine levels [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
- Changes in the cardiovascular risk factor levels which are directly mediated by TNF-α [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
- Number of patients who can achieve ACR 20 [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
- Correlation of clinical parameter, inflammatory markers and MRI findings [ Time Frame: week 52 ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2006|
|Study Completion Date:||March 2009|
|Primary Completion Date:||March 2009 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Infliximab 5 mg/kg given at day 1, week 2, week 6
Other Name: remicade
Active Comparator: 2
Etanercept 25 mg twice weekly
Other Name: enbrel
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.