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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01091675
Recruitment Status : Completed
First Posted : March 24, 2010
Results First Posted : June 10, 2015
Last Update Posted : August 25, 2015
Information provided by (Responsible Party):
Spanish Foundation of Rheumatology

Brief 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.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: Etoricoxib Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

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.
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.
Other Name: Arcoxia

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Patients ≥ 18 years.
  2. Patients with diagnosis of AS (based on New York criteria) made ≥ 6 months prior to study start.
  3. Patient with axial involvement.
  4. 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.
  5. Patients who demonstrate a Bath Ankylosing Spondylitis Disease Activity Index score of ≥ 4 (range 0-10).

Exclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Pregnancy, lactation or waiting to conceive a child
  6. Patient with history of disorders, treatments or laboratory abnormality that can interfere with the study results and study participation.
  7. Patient cannot comply with the study procedures, study calendar. Patient with plan of moving.
  8. Patients awaiting the legal assessment of the degree of disability or the permanent work disability
  9. Patients unable to respond to questionnaires (difficulty understanding and / or reading of questionnaires)
  10. Any other warning that, in the investigator opinion, could discourage the inclusion of the patient in the study.
  11. Patient to be treated with other drug which can modulate the pain perception
  12. Patients with AS associated disease (inflammatory bowel disease, psoriasis).
  13. Patients with active peripheral articular involvement defined by presence of peripheral arthritis.
  14. Patient with predominant enthesitis or an enthesis that, according to investigator's opinion, can confound the correct evaluation.
  15. Presence of extra-articular manifestations.
  16. Patients with fibromyalgia or other rheumatic disorders that could confound the evaluation of efficacy
  17. 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.
  18. Patients with AS who received active treatment with etoricoxib
  19. Hypersensitivity to the active substance or to any of the excipients
  20. Active peptic ulceration or active gastro-intestinal bleeding
  21. Patients with severe renal failure (creatinine clearance rate < 30 ml/min)
  22. Congestive heart failure (NYHA II-IV)
  23. Established ischaemic heart disease or cerebrovascular disease
  24. Patients with severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
  25. 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
  26. Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01091675

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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
Bellvitge Hospital
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
Madrid, Spain
Virgen de la Arrixaca Hospital
Murcia, Spain, 30120
Hospital Clinic of Salamanca
Salamanca, Spain, 37007
Sant Pau i Santa Tecla Hospital
Tarragona, Spain
Sponsors and Collaborators
Spanish Foundation of Rheumatology
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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
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Responsible Party: Spanish Foundation of Rheumatology Identifier: NCT01091675    
Other Study ID Numbers: GRE-2009-01
2009-017309-12 ( EudraCT Number )
First Posted: March 24, 2010    Key Record Dates
Results First Posted: June 10, 2015
Last Update Posted: August 25, 2015
Last Verified: August 2015
Keywords provided by Spanish Foundation of Rheumatology:
ankylosing spondylitis
biologic therapies
COX-2 Inhibitor
BASDAI Bath Ankylosing Spondylitis Disease Activity Index
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Bone Diseases, Infectious
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Joint Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action