Ignite Creation Date:
2024-05-05 @ 9:48 PM
Last Modification Date:
2024-10-26 @ 10:09 AM
Study NCT ID:
NCT00963313
Status:
COMPLETED
Last Update Posted:
2014-09-23
First Post:
2009-08-20
Brief Title:
A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis
Sponsor:
Dr FRANCISCO J BLANCO-GARCIA
Organization:
Instituto de Investigacion Biomedica de A Coruna
Study Overview
Official Title:
A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis
Status:
COMPLETED
Status Verified Date:
2014-09
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:
Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement
Detailed Description:
A recent review from GRAPPA group evaluates therapies for PsA including peripheral and axPsA Analysing particularly the results with present biologic therapies it has been proven that outcome data at 24 weeks show excellent results in the treatment of peripheral forms of PsA with either of the three biologics disposable in the market that is to say infliximab etanercept and adalimumab
However when it comes to analyse data on PsA patients with axPsA there are not results at all The design of clinical trials did not evaluate axial outcomes and therefore there is not a possibility of knowing whether these therapies are useful in axPsA
This is an open label multicenter study designed to evaluate the effectivity of adalimumab 40 mg every 2 weeks during 24 weeks in patients with active axial PsA despite receiving Methotrexate Sulfasalazine Leflunomide or Cyclosporine plus NSAIDs and no more than 10 mg of corticosteroids
However when it comes to analyse data on PsA patients with axPsA there are not results at all The design of clinical trials did not evaluate axial outcomes and therefore there is not a possibility of knowing whether these therapies are useful in axPsA
This is an open label multicenter study designed to evaluate the effectivity of adalimumab 40 mg every 2 weeks during 24 weeks in patients with active axial PsA despite receiving Methotrexate Sulfasalazine Leflunomide or Cyclosporine plus NSAIDs and no more than 10 mg of corticosteroids
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