A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title: A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

• NCT number: NCT00963313
• Study type: Observational
• Source: Instituto de Investigacion Biomedica de A Coruna
• Status: Completed
• Phase: N/A
• Start date: March 2010
• Completion date: June 2014