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CompletedNCT01091675Updated Aug 25, 2015Results posted

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

A Phase 3 interventional study of Etoricoxib in Ankylosing Spondylitis, sponsored by Spanish Foundation of Rheumatology. Completed at 14 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-25.

Sponsored by Spanish Foundation of Rheumatology · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
58
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Ankylosing Spondylitis

Keywords

  • ankylosing spondylitis
  • biologic therapies
  • ASAS
  • ASASBIO
  • etoricoxib
  • NSAIDs
  • COX-2 Inhibitor
  • ARCOXIA 90 mg
  • BASDAI Bath Ankylosing Spondylitis Disease Activity Index
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 58 is below the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Spanish Foundation of Rheumatology is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

    -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
58 participants (actual)

Study arms

  • 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

Interventions

  • DrugEtoricoxib

    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.

    Also known as: Arcoxia

06

What researchers measure

Primary outcomes

  1. the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined

    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.

    Time frame: the ASAS response were evaluated at week 2 and 4 and after 6 months treatment

07

Results

Posted Jun 10, 2015

Participant flow

The study enrolled 58 patients in total, with ankylosing spondylitis, and Inadequate response to ≥2 NSAIDs. Patients who met The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores of 4 or higher and all study criteria participate in the study and were randomized at 14 study sites. The last patient completed in May 2013.

Participant flow — Overall Study
MilestoneEtoricoxib
Started57
Completed23
Not completed34
Withdrew: Adverse event7
Withdrew: Lack of efficacy27

Outcome measures

Primarythe Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined

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.

Time frame:
the ASAS response were evaluated at week 2 and 4 and after 6 months treatment
Reported as:
Number · percentage of participants
the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined
percentage of participantsEtoricoxib
the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined19 (10 to 30)

Adverse events

Collected over from September 23rd 2010 until May 28th 2013. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Etoricoxib—1/57 (1.8%)20/57 (35.1%)
Most frequent serious events
Most frequent serious events
EventEtoricoxib
cavernous hemangiomaVascular disorders1/57
Most frequent other events
Most frequent other events
EventEtoricoxib
arterial hypertensionGeneral disorders7/57
TachycardiaCardiac disorders3/57
headacheNervous system disorders2/57
anxietyGeneral disorders2/57
NervousnessGeneral disorders2/57
coldGeneral disorders2/57
upper respiratory infectionInfections and infestations1/57
weight gainMetabolism and nutrition disorders1/57

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Etoricoxib
<=18 years0
Between 18 and 65 years58
>=65 years0
Age, Continuous
Age, Continuous(years)Etoricoxib
Median44 (23 to 68)
Sex: Female, Male
Sex: Female, Male(Participants)Etoricoxib
Female11
Male47
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Etoricoxib
Hispanic or Latino55
Not Hispanic or Latino3
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Etoricoxib
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American3
White55
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Etoricoxib
Spain58
08

Study locations

14 sites
  • Central Hospital of Asturias
    Oviedo, Asturias 33006, Spain
  • Parc Tauli Hospital
    Sabadell, Barcelona, Spain
  • Sant Rafael Hospital
    Barcelona, 08035, Spain
  • Clinic I Provincial Hospital
    Barcelona, 08036, Spain
  • Bellvitge Hospital
    Barcelona, 08907, Spain
  • Reina Sofia University Hospital
    Cordoba, 14004, Spain
  • Ramon Y Cajal Hospital
    Madrid, 28034, Spain
  • University Hospital 12 Octubre
    Madrid, 28041, Spain
  • Puerta de Hierro Hospital
    Madrid, 28222, Spain
  • Hospital General of Mostoles
    Madrid, 28935, Spain
  • University Hospital de la Princesa
    Madrid, Spain
  • Virgen de la Arrixaca Hospital
    Murcia, 30120, Spain
  • Hospital Clinic of Salamanca
    Salamanca, 37007, Spain
  • Sant Pau i Santa Tecla Hospital
    Tarragona, Spain
09

References and documents

Publications

  • 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. PubMed 15818702 ↗
  • 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. PubMed 18952641 ↗
  • 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. PubMed 12922952 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01091675
Lead sponsor
Spanish Foundation of Rheumatology
Responsible party
Sponsor
First posted
Mar 24, 2010
Start date
Sep 2010
Primary completion
May 2013
Completion
May 2013
Results posted
Jun 10, 2015
Last update
Aug 25, 2015

Study contacts

Jordi Gratacós, PhD/ MD
principal investigator · Parc Tauli Hospital
Eduardo Collantes Estevez, PhD/ MD
principal investigator · Reina Sofia Hospital
Xavier Juanola Roura, PhD/MD
principal investigator · Bellvitge Hospital
Raimon Sanmartí Sala, PhD/MD
principal investigator · Hospital Clinic i Provincial Barcelona
Juan Mulero Mendoza, PhD/MD
principal investigator · Puerta de Hierro Hospital
Estefania Moreno Ruzafa, PhD/MD
principal investigator · San Rafael Hospital
Luis Francisco Linares Ferrando, PhD/MD
principal investigator · Virgen de la Arrixaca Hospital
Rubén Queiro Silva, PhD/MD
principal investigator · Asturias Hospital
Elia Brito Brito, PhD/MD
principal investigator · Ramon y Cajal Hospital
Carlos Alberto Montilla Morales, PhD/MD
principal investigator · Hospital Clinic of Salamanca
Maria Cruces Fernández Espartero, PhD/MD
principal investigator · General de Mostoles Hospital
Pilar Fernández Dapica, PhD/MD
principal investigator · University Hospital 12 de Octubre
Rosario García de Vicuña, PhD/MD
principal investigator · University Hospital de la Princesa
Rosa Morlá, PhD/MD
principal investigator · Sant Pau i Santa Tecla Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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