Assessment of the Response to Etoricoxib in Patients With Ankylosing Spondylitis and Inadequate Response to ≥2 NSAIDs
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Intervention: Etoricoxib
Intervention description: 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.
Intervention MeSH terms: Etoricoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ankylosing spondylitis; biologic therapies; ASAS; ASASBIO; etoricoxib; NSAIDs; COX-2 Inhibitor; ARCOXIA 90 mg; BASDAI Bath Ankylosing Spondylitis Disease Activity Index

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.
    

Eligibility criteria:

        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

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