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

NCT01091675 | Completed Phase 3 Results DMC

• 2 other identifiers: GRE-2009-012009-017309-12
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Ankylosing Spondylitis

Keywords

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

Outcome Measures

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.

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

Study Arms (1)

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.

Drug: Etoricoxib

Interventions

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.

Also known as: Arcoxia

etoricoxib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients ≥ 18 years.
• Patients with diagnosis of AS (based on New York criteria) made ≥ 6 months prior to study start.
• Patient with axial involvement.
• 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.
• Patients who demonstrate a Bath Ankylosing Spondylitis Disease Activity Index score of ≥ 4 (range 0-10).

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Spanish Foundation of Rheumatology: lead

Study Sites (14)

Sant Rafael Hospital

Barcelona, Barcelona, 08035, Spain

Location

Clinic I Provincial Hospital

Barcelona, Barcelona, 08036, Spain

Location

Bellvitge Hospital

Barcelona, Barcelona, 08907, Spain

Location

Parc Tauli Hospital

Sabadell, Barcelona, Spain

Location

Reina Sofia University Hospital

Córdoba, Cordoba, 14004, Spain

Location

Ramon Y Cajal Hospital

Madrid, Madrid, 28034, Spain

Location

University Hospital 12 Octubre

Madrid, Madrid, 28041, Spain

Location

Puerta de Hierro Hospital

Madrid, Madrid, 28222, Spain

Location

Hospital General of Mostoles

Madrid, Madrid, 28935, Spain

Location

Virgen de la Arrixaca Hospital

Murcia, Murcia, 30120, Spain

Location

Central Hospital of Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Hospital Clinic of Salamanca

Salamanca, Salamanca, 37007, Spain

Location

University Hospital de la Princesa

Madrid, Spain

Location

Sant Pau i Santa Tecla Hospital

Tarragona, Spain

Location

Related Publications (5)

• 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.

  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.

  PMID: 15818702 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.

  PMID: 18952641 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.

  PMID: 12922952 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Etoricoxib

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Jordi Gratacós Masmitjá
• Organization: Unidad de Reumatología, Hospital Parc Tauli de Sabadell. Institut Universitari UAB

jgratacosmas@gmail.com

937.23.10.10

Study Officials

• 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

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 24, 2010
• Study Start: September 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: August 25, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-08

Locations

ES (14)