Ankylosing Spondylitis Clinical Trial
Official title:
Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis (AS) and Inadequate Response to ≥2 Nonsteroidal Antiinflammatory Drug (NSAID)
The goal of this research is to assess the percentage of non-responders to ≥ 2 NSAIDs
candidates a biological therapy that could adequately respond to treatment with etoricoxib
This study confirm the result of a previous study in a wider similar population. Basing on
previous results, the response rate will be assessed by ASASBIO criteria. The efficacy of
the treatment with etoricoxib 90 mg will be assessed at week 4 in a population of patients
with AS who didn't respond adequately to a previous therapy with ≥ 2 NSAIDs.
Those patients that, based on the ASABIO criteria, achieved a sufficient clinical response
will be followed until week 24 to asses the maintenance of the study drug effects.
Etoricoxib is an oral, selective cyclooxygenase 2 inhibitor approved for the symptomatic
treatment of ankylosing spondylitis (AS) in Spain.
Etoricoxib is a marketed product indicated for the relief of symptomatic osteoarthritis,
rheumatoid arthritis, ankylosing spondylitis, pain and signs of inflammation associated with
acute gouty arthritis. In ankylosing spondylitis,the recommended dose is 90 mg once daily.
Clinical pharmacology studies demonstrate that Etoricoxib induce dose-dependent inhibition
of COX-2 without inhibit COX-1, up to 150 mg daily dose.
Etoricoxib did not inhibit the gastric synthesis of prostaglandin and had no effect on
platelet function. Cyclooxygenase is responsible for the prostaglandin synthesis. Were
identified two different isoforms of cyclooxygenase, COX-1 and COX-2. It has been shown that
COX-2 is the major enzyme responsible for the synthesis of prostanoid mediators involved in
pain, inflammation and fever.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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