Safety of Etoricoxib (MK-0663) in Patients With Spondyloarthropathy (SpA)/Ankylosing Spondylitis (AS) in Sweden (EP07013.013.11.082)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The study is intended to provide additional post-marketing safety data regarding the use of etoricoxib for the indication of ankylosing spondylitis.
| Condition | Intervention |
|---|---|
|
Spondylarthropathies; Spondylitis, Ankylosing |
Drug: etoricoxib Drug: Other COX-2 inhibitor Drug: nsNSAIDs |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Retrospective |
| Official Title: | Safety Data on Etoricoxib From Swedish Registries of Spondyloarthropathy/Ankylosing Spondylitis Patients |
- Number of patients with Characteristics of inflammatory SPA/AS [ Time Frame: Over a 12 year period (2001-2013) ] [ Designated as safety issue: No ]
- Number of patients who used etoricoxib [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ] [ Designated as safety issue: Yes ]
- Number of patients who used other COX-2 inhibitors [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ] [ Designated as safety issue: Yes ]
- Number of patients who used nsNSAIDs [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ] [ Designated as safety issue: Yes ]
- Number of clinical outcomes of special interest [ Time Frame: Up to 7 1/2 years (Q3 2005 - 2013) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 16671 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Patients with SpA/AS and etoricoxib treatment |
Drug: etoricoxib
Patients with SpA/AS who took etoricoxib
Other Name: MK-0663; Arcoxia
|
| Patients with SpA/AS and other COX-2 inhibitor treatment |
Drug: Other COX-2 inhibitor
Patients with SpA/AS who took other COX-2 inhibitors
|
| Patients with SpA/AS and nsNSAIDs treatment |
Drug: nsNSAIDs
Patients with SpA/AS who took nsNSAIDs
|
Detailed Description:
The specific project objectives are to:
1) Describe the characteristics of Swedish patients with inflammatory SpA/AS ; 2) Describe the use of etoricoxib and other cyclooxygenase-2 (COX-2 inhibitors)/non-selective nonsteroidal anti-inflammatory drugs (nsNSAIDs) in Swedish patients with SpA/AS; and 3) Estimate and compare the rates of clinical outcomes of special interest (gastrointestinal, renovascular, cardiovascular and cerebrovascular) with use of etoricoxib and other COX-2 inhibitors/nsNSAIDs in Swedish patients with SpA/AS. Comparisons of clinical outcomes among the drugs of interest will be made by descriptive comparison of the point estimates for the incidence rates and their associated 95% confidence intervals (CIs), using both clinical and epidemiological judgment and in light of the limitations of this observational study. No formal statistical significance testing will be performed for purposes of such comparisons.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Out-patients in Sweden with SpA/AS who took etoricoxib, other COX-2 inhibitors, or nsNSAIDs from 2001-2010.
Inclusion Criteria:
- Participant attended an out-patient clinic 2001-2010.
- Participant is registered with an International Classification of diseases (ICD, Version 10)-code corresponding to SpA/AS and AS.
Exclusion Criteria:
Not applicable.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT01327638 History of Changes |
| Other Study ID Numbers: | 0663-159, EP07013.013.11.082 |
| Study First Received: | March 11, 2011 |
| Last Updated: | March 7, 2013 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Spondylitis Spondylitis, Ankylosing Spondylarthropathies Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Ankylosis Joint Diseases Arthritis Etoricoxib Cyclooxygenase 2 Inhibitors |
Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Therapeutic Uses Central Nervous System Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013