CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 58 enrolled
Drug / intervention
Etoricoxibdrug
Likely dose
Etoricoxib 90 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01091675
NCT01091675Phase 3Completed

Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis (AS) and Inadequate Response to ≥2 Nonsteroidal Antiinflammatory Drug (NSAID)

Spanish Foundation of Rheumatology·interventional·Posted Mar 24, 2010·Updated Aug 25, 2015

In Brief

A Phase 3 clinical trial evaluating Etoricoxib for Ankylosing Spondylitis. Completed, enrolled 58 participants across 14 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 24, 2010
Enrollment StartSep 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 16.3 years ago

Interventions

Etoricoxibdrug

Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.