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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-017309-12 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| etoricoxib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Etoricoxib | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | the ASAS response were evaluated at week 2 and 4 and after 6 months treatment |
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Inclusion Criteria:
Exclusion Criteria:
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.
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.
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.
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.
Pregnancy, lactation or waiting to conceive a child
Patient with history of disorders, treatments or laboratory abnormality that can interfere with the study results and study participation.
Patient cannot comply with the study procedures, study calendar. Patient with plan of moving.
Patients awaiting the legal assessment of the degree of disability or the permanent work disability
Patients unable to respond to questionnaires (difficulty understanding and / or reading of questionnaires)
Any other warning that, in the investigator opinion, could discourage the inclusion of the patient in the study.
Patient to be treated with other drug which can modulate the pain perception
Patients with AS associated disease (inflammatory bowel disease, psoriasis).
Patients with active peripheral articular involvement defined by presence of peripheral arthritis.
Patient with predominant enthesitis or an enthesis that, according to investigator's opinion, can confound the correct evaluation.
Presence of extra-articular manifestations.
Patients with fibromyalgia or other rheumatic disorders that could confound the evaluation of efficacy
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.
Patients with AS who received active treatment with etoricoxib
Hypersensitivity to the active substance or to any of the excipients
Active peptic ulceration or active gastro-intestinal bleeding
Patients with severe renal failure (creatinine clearance rate < 30 ml/min)
Congestive heart failure (NYHA II-IV)
Established ischaemic heart disease or cerebrovascular disease
Patients with severe hepatic dysfunction (serum albumin <25 g/l or Child-Pugh score ≥10).
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
Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sant Rafael Hospital | Barcelona | Barcelona | 08035 | Spain | ||
| Clinic I Provincial Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Estévez, E. Collantes, and A. Escudero Contreras. | ||
| Background | Sociedad Española de reumatología: estudio EPISER. Prevalencia de las enfermedades reumáticas en la población española. Reumatología. Madrid, Merck, Sharp & Dohme, 2001. | ||
| 15818702 | Background | 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. | |
| 18952641 |
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From a total of 58 patients recruited 1 did not met the exclusion criteria, so 57 patients start the first phase. 4 patients abandoned the study due to hypertension. 53 patients completed the first phase. 27 did not proceed to phase 2 due to lack of efficacy and 3 patients were withdraw due to hypertension. 23 patients complete the study period.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| 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 | Principal Investigator |
| Barcelona |
| Barcelona |
| 08036 |
| Spain |
| Bellvitge Hospital | Barcelona | Barcelona | 08907 | Spain |
| Parc Tauli Hospital | Sabadell | Barcelona | Spain |
| Reina Sofia University Hospital | Córdoba | Cordoba | 14004 | Spain |
| Ramon Y Cajal Hospital | Madrid | Madrid | 28034 | Spain |
| University Hospital 12 Octubre | Madrid | Madrid | 28041 | Spain |
| Puerta de Hierro Hospital | Madrid | Madrid | 28222 | Spain |
| Hospital General of Mostoles | Madrid | Madrid | 28935 | Spain |
| Virgen de la Arrixaca Hospital | Murcia | Murcia | 30120 | Spain |
| Central Hospital of Asturias | Oviedo | Principality of Asturias | 33006 | Spain |
| Hospital Clinic of Salamanca | Salamanca | Salamanca | 37007 | Spain |
| University Hospital de la Princesa | Madrid | Spain |
| Sant Pau i Santa Tecla Hospital | Tarragona | Spain |
| Background |
| 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. |
| 12922952 | Background | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | From a total of 58 patients recruited one did not met the exclusion criteria so 57 patients were included in the study. | Median | Full Range | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Patients with physician-diagnosed Ankylosing Spondylitis at 6 months before study start | Posted | Number | 95% Confidence Interval | percentage of participants | the ASAS response were evaluated at week 2 and 4 and after 6 months treatment |
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from September 23rd 2010 until May 28th 2013
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: 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. | 1 | 57 | 20 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cavernous hemangioma | Vascular disorders | Systematic Assessment | The investigator evaluated this serious adverse event SAE, as possibly related to the study drug, The patient already suffered from cavernoma pedunculi left quadrigeminy but was unknown until symptoms appearance. Was withdrawn from the study. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arterial hypertension | General disorders | Systematic Assessment | 7 patients were withdrew from the study due to hypertension. 1 case certainly related to the study drug. 3 patients demonstrate seriousness grade 1, and grade 2 in 4 patients |
| |
| Tachycardia | Cardiac disorders | Systematic Assessment |
| ||
| headache | Nervous system disorders | Systematic Assessment |
| ||
| anxiety | General disorders | Systematic Assessment |
| ||
| Nervousness | General disorders | Systematic Assessment |
| ||
| cold | General disorders | Systematic Assessment |
| ||
| upper respiratory infection | Infections and infestations | Systematic Assessment |
| ||
| weight gain | Metabolism and nutrition disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jordi Gratacós Masmitjá | Unidad de Reumatología, Hospital Parc Tauli de Sabadell. Institut Universitari UAB | 937.23.10.10 | jgratacosmas@gmail.com |
| ID | Term |
|---|---|
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |
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| ID | Term |
|---|---|
| D000077613 | Etoricoxib |
| ID | Term |
|---|---|
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|