Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs
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|ClinicalTrials.gov Identifier: NCT01091675|
Recruitment Status : Completed
First Posted : March 24, 2010
Results First Posted : June 10, 2015
Last Update Posted : August 25, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Ankylosing Spondylitis||Drug: Etoricoxib||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis (AS) and Inadequate Response to ≥2 Nonsteroidal Antiinflammatory Drug (NSAID)|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.
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.
Other Name: Arcoxia
- the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined [ Time Frame: the ASAS response were evaluated at week 2 and 4 and after 6 months treatment ]
BASDAI Bath Ankylosing Spondylitis Disease Activity Index, is the gold standard for measuring and evaluating disease activity in Ankylosing Spondylitis consists of a one through 10 scale which is used to answer 6 questions pertaining to the 5 major symptoms of AS.
BASDAI has been used to assess the efficacy of the treatment. Possible Patients were considerate respond to ASABIO criteria when presented a change of 2 in the BASDAI score range.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091675
|Central Hospital of Asturias|
|Oviedo, Asturias, Spain, 33006|
|Parc Tauli Hospital|
|Sabadell, Barcelona, Spain|
|Sant Rafael Hospital|
|Barcelona, Spain, 08035|
|Clinic I Provincial Hospital|
|Barcelona, Spain, 08036|
|Barcelona, Spain, 08907|
|Reina Sofia University Hospital|
|Cordoba, Spain, 14004|
|Ramon Y Cajal Hospital|
|Madrid, Spain, 28034|
|University Hospital 12 Octubre|
|Madrid, Spain, 28041|
|Puerta de Hierro Hospital|
|Madrid, Spain, 28222|
|Hospital General of Mostoles|
|Madrid, Spain, 28935|
|University Hospital de la Princesa|
|Virgen de la Arrixaca Hospital|
|Murcia, Spain, 30120|
|Hospital Clinic of Salamanca|
|Salamanca, Spain, 37007|
|Sant Pau i Santa Tecla Hospital|
|Principal Investigator:||Jordi Gratacós, PhD/ MD||Parc Tauli Hospital|
|Principal Investigator:||Eduardo Collantes Estevez, PhD/ MD||Reina Sofia Hospital|
|Principal Investigator:||Xavier Juanola Roura, PhD/MD||Bellvitge Hospital|
|Principal Investigator:||Raimon Sanmartí Sala, PhD/MD||Hospital Clinic i Provincial Barcelona|
|Principal Investigator:||Juan Mulero Mendoza, PhD/MD||Puerta de Hierro Hospital|
|Principal Investigator:||Estefania Moreno Ruzafa, PhD/MD||San Rafael Hospital|
|Principal Investigator:||Luis Francisco Linares Ferrando, PhD/MD||Virgen de la Arrixaca Hospital|
|Principal Investigator:||Rubén Queiro Silva, PhD/MD||Asturias Hospital|
|Principal Investigator:||Elia Brito Brito, PhD/MD||Ramon y Cajal Hospital|
|Principal Investigator:||Carlos Alberto Montilla Morales, PhD/MD||Hospital Clinic of Salamanca|
|Principal Investigator:||Maria Cruces Fernández Espartero, PhD/MD||General de Mostoles Hospital|
|Principal Investigator:||Pilar Fernández Dapica, PhD/MD||University Hospital 12 de Octubre|
|Principal Investigator:||Rosario García de Vicuña, PhD/MD||University Hospital de la Princesa|
|Principal Investigator:||Rosa Morlá, PhD/MD||Sant Pau i Santa Tecla Hospital|