Ignite Creation Date:
2024-05-05 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00432406
Status:
COMPLETED
Last Update Posted:
2009-03-11
First Post:
2007-02-06
Brief Title:
Tumor Necrosis Factors TNF-α Blockade for Psoriatic Arthritis
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
TNF-α Blockade for Psoriatic Arthritis - A Clinical and MRI Study and the Effects on Cytokine and Cardiovascular Risk Profile
Status:
COMPLETED
Status Verified Date:
2009-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None