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
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.
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.
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 →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.
Exclusion Criteria:
Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
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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.
Also known as: Arcoxia
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
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.
| Milestone | Etoricoxib |
|---|---|
| Started | 57 |
| Completed | 23 |
| Not completed | 34 |
| Withdrew: Adverse event | 7 |
| Withdrew: Lack of efficacy | 27 |
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.
| percentage of participants | Etoricoxib |
|---|---|
| the Percentage of Patients Fulfilling the Assessment Study (ASAS) Response Criteria Were Determined | 19 (10 to 30) |
Collected over from September 23rd 2010 until May 28th 2013. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Etoricoxib | — | 1/57 (1.8%) | 20/57 (35.1%) |
| Event | Etoricoxib |
|---|---|
| cavernous hemangiomaVascular disorders | 1/57 |
| Event | Etoricoxib |
|---|---|
| arterial hypertensionGeneral disorders | 7/57 |
| TachycardiaCardiac disorders | 3/57 |
| headacheNervous system disorders | 2/57 |
| anxietyGeneral disorders | 2/57 |
| NervousnessGeneral disorders | 2/57 |
| coldGeneral disorders | 2/57 |
| upper respiratory infectionInfections and infestations | 1/57 |
| weight gainMetabolism and nutrition disorders | 1/57 |
| Age, Categorical(Participants) | Etoricoxib |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 58 |
| >=65 years | 0 |
| Age, Continuous(years) | Etoricoxib |
|---|---|
| Median | 44 (23 to 68) |
| Sex: Female, Male(Participants) | Etoricoxib |
|---|---|
| Female | 11 |
| Male | 47 |
| Ethnicity (NIH/OMB)(Participants) | Etoricoxib |
|---|---|
| Hispanic or Latino | 55 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Etoricoxib |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 55 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Etoricoxib |
|---|---|
| Spain | 58 |
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Spanish Foundation of Rheumatology