Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs

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.

Conditions

• Ankylosing Spondylitis

Interventions

DRUG

Etoricoxib

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.

Sponsors & Collaborators

• Spanish Foundation of Rheumatology

  lead OTHER

Principal Investigators

• Jordi Gratacós, PhD/ MD · Parc Tauli Hospital

• Eduardo Collantes Estevez, PhD/ MD · Reina Sofia Hospital

• Xavier Juanola Roura, PhD/MD · Bellvitge Hospital

• Raimon Sanmartí Sala, PhD/MD · Hospital Clinic i Provincial Barcelona

• Juan Mulero Mendoza, PhD/MD · Puerta de Hierro Hospital

• Estefania Moreno Ruzafa, PhD/MD · San Rafael Hospital

• Luis Francisco Linares Ferrando, PhD/MD · Virgen de la Arrixaca Hospital

• Rubén Queiro Silva, PhD/MD · Asturias Hospital

• Elia Brito Brito, PhD/MD · Ramon y Cajal Hospital

• Carlos Alberto Montilla Morales, PhD/MD · Hospital Clinic of Salamanca

• Maria Cruces Fernández Espartero, PhD/MD · General de Mostoles Hospital

• Pilar Fernández Dapica, PhD/MD · University Hospital 12 de Octubre

• Rosario García de Vicuña, PhD/MD · University Hospital de la Princesa

• Rosa Morlá, PhD/MD · Sant Pau i Santa Tecla Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2013-05-31

Completion

2013-05-31

Countries

• Spain

Study Locations