- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01091675
Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs
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.
Study Overview
Detailed Description
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
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08907
- Bellvitge Hospital
-
Barcelona, Spain, 08035
- Sant Rafael Hospital
-
Barcelona, Spain, 08036
- Clinic i Provincial Hospital
-
Cordoba, Spain, 14004
- Reina Sofia University Hospital
-
Madrid, Spain, 28034
- Ramón y Cajal Hospital
-
Madrid, Spain, 28041
- University Hospital 12 Octubre
-
Madrid, Spain, 28222
- Puerta De Hierro Hospital
-
Madrid, Spain, 28935
- Hospital General of Mostoles
-
Madrid, Spain
- University Hospital de La Princesa
-
Murcia, Spain, 30120
- Virgen de la Arrixaca Hospital
-
Salamanca, Spain, 37007
- Hospital Clinic of Salamanca
-
Tarragona, Spain
- Sant Pau i Santa Tecla Hospital
-
-
Asturias
-
Oviedo, Asturias, Spain, 33006
- Central Hospital of Asturias
-
-
Barcelona
-
Sabadell, Barcelona, Spain
- Parc Tauli Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients ≥ 18 years.
- Patients with diagnosis of AS (based on New York criteria) made ≥ 6 months prior to study start.
- Patient with axial involvement.
- Patients who have been treated with ≥ 2 documented NSAID with proven anti-inflammatory potency during at least 3 months at maximal recommended or tolerated doses prior the visit 1.
- Patients who demonstrate a Bath Ankylosing Spondylitis Disease Activity Index score of ≥ 4 (range 0-10).
Exclusion Criteria:
- Patient that according to the investigator opinion is legally unable (i.e. mentally incapable person), with psychiatric disorder precedent, active psychosis or emotional problems at the moment to be enrolled in the study.
- Patient who is participating in a clinical study with a drug or experimental device or it was done within 4 weeks prior to the inform consent signature.
- Patient with a recent history (since last 5 years) of abuse or dependence to opiates, tranquilizer or drugs at the inform consent signature moment. Patient with a recent history (since last 5 years) of alcoholism or drug addiction.
- Patient with a history of neoplastic disease or malignant neoplasia ≤ 5 years prior to the inform consent signature, except basal cell or squamous cell cancer skin adequately treated or uterine cancer insitu without recurrence prior to study entry according to the investigator opinion. Patients with history of leukemia, lymphoma, malignant melanoma or myeloproliferative disease cannot participate at the study.
- Pregnancy, lactation or waiting to conceive a child
- Patient with history of disorders, treatments or laboratory abnormality that can interfere with the study results and study participation.
- Patient cannot comply with the study procedures, study calendar. Patient with plan of moving.
- Patients awaiting the legal assessment of the degree of disability or the permanent work disability
- Patients unable to respond to questionnaires (difficulty understanding and / or reading of questionnaires)
- Any other warning that, in the investigator opinion, could discourage the inclusion of the patient in the study.
- Patient to be treated with other drug which can modulate the pain perception
- Patients with AS associated disease (inflammatory bowel disease, psoriasis).
- Patients with active peripheral articular involvement defined by presence of peripheral arthritis.
- Patient with predominant enthesitis or an enthesis that, according to investigator's opinion, can confound the correct evaluation.
- Presence of extra-articular manifestations.
- Patients with fibromyalgia or other rheumatic disorders that could confound the evaluation of efficacy
- Patients with AS who received biologic therapy. Note: The use of approved nonstudy antirheumatic therapy at a stable dose(methotrexate, sulfasalazine) for 3 months prior to the study start will be allowed.
- Patients with AS who received active treatment with etoricoxib
- Hypersensitivity to the active substance or to any of the excipients
- Active peptic ulceration or active gastro-intestinal bleeding
- Patients with severe renal failure (creatinine clearance rate < 30 ml/min)
- Congestive heart failure (NYHA II-IV)
- Established ischaemic heart disease or cerebrovascular disease
- Patients with severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
- Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, or allergic-type reactions after taking acetylsalicylic acid or NSAIDs including cyclooxygenase-2 inhibitors
Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: etoricoxib
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
the ASAS response were evaluated at week 2 and 4 and after 6 months treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jordi Gratacós, PhD/ MD, Parc Tauli Hospital
- Principal Investigator: Eduardo Collantes Estevez, PhD/ MD, Reina Sofía 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, Ramón 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
Publications and helpful links
General Publications
- Braun J, Pham T, Sieper J, Davis J, van der Linden S, Dougados M, van der Heijde D; ASAS Working Group. International ASAS consensus statement for the use of anti-tumour necrosis factor agents in patients with ankylosing spondylitis. Ann Rheum Dis. 2003 Sep;62(9):817-24. doi: 10.1136/ard.62.9.817.
- Estévez, E. Collantes, and A. Escudero Contreras.
- Sociedad Española de reumatología: estudio EPISER. Prevalencia de las enfermedades reumáticas en la población española. Reumatología. Madrid, Merck, Sharp & Dohme, 2001.
- van der Heijde D, Baraf HS, Ramos-Remus C, Calin A, Weaver AL, Schiff M, James M, Markind JE, Reicin AS, Melian A, Dougados M. Evaluation of the efficacy of etoricoxib in ankylosing spondylitis: results of a fifty-two-week, randomized, controlled study. Arthritis Rheum. 2005 Apr;52(4):1205-15. doi: 10.1002/art.20985.
- Jarrett SJ, Sivera F, Cawkwell LS, Marzo-Ortega H, McGonagle D, Hensor E, Coates L, O'Connor PJ, Fraser A, Conaghan PG, Emery P. MRI and clinical findings in patients with ankylosing spondylitis eligible for anti-tumour necrosis factor therapy after a short course of etoricoxib. Ann Rheum Dis. 2009 Sep;68(9):1466-9. doi: 10.1136/ard.2008.092213. Epub 2008 Oct 24. Erratum In: Ann Rheum Dis. 2011 Aug;70(8):1519.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Spondylitis
- Spondylarthritis
- Spondylitis, Ankylosing
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Etoricoxib
Other Study ID Numbers
- GRE-2009-01
- 2009-017309-12 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ankylosing Spondylitis
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina
-
AbbVieBoehringer IngelheimCompletedAnkylosing Spondylitis (AS)
-
Sun Yat-sen UniversityUnknownEarly Ankylosing Spondylitis
-
Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRecruitingAnkylosing Spondylitis (AS)China
-
Chinese University of Hong KongCompletedAnkylosing Spondylitis(AS)China
-
AbbVieCompletedAnkylosing Spondylitis (AS)United States, Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, United Kingdom
-
AbbVieCompletedAnkylosing Spondylitis (AS)Taiwan
-
Jiangsu vcare pharmaceutical technology co., LTDRecruitingActive Ankylosing SpondylitisChina
-
Tianjin Hemay Pharmaceutical Co., LtdCompletedActive Ankylosing SpondylitisChina
-
Assiut UniversityUnknownActive Sacroiliitis in Ankylosing Spondylitis
Clinical Trials on Etoricoxib
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Organon and CoCompleted
-
Radboud University Medical CenterCompletedOssification, HeterotopicNetherlands
-
Organon and CoCompleted
-
Clinica Virgen MilagrosaMerck Sharp & Dohme LLCTerminatedSoft Tissue Injuries of the Shoulder | Tenosynovitis and Bursitis Affecting the ShoulderPeru
-
University of Erlangen-Nürnberg Medical SchoolMerck Sharp & Dohme LLC; Rush University Medical Center; HELIOS Kliniken GmbHTerminatedPain | Postoperative Pain | Osteoarthritis, HipGermany
-
Núcleo de Estudos em Esportes e Ortopedia, BrazilMerck Sharp & Dohme LLCUnknownSprains and Strains | ContusionsBrazil
-
Organon and CoCompletedAcute Pain Following a Total Abdominal Hysterectomy