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

August 12, 2015 updated by: Spanish Foundation of Rheumatology

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

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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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Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Arcoxia

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 23, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 12, 2015

Last Verified

August 1, 2015

More Information

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.

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