Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns

Study Overview
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Brief Summary
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The most common pain-relievers used by patients with rheumatic disorders are called non-steroidal anti-inflammatory drugs (NSAIDs). These drugs are effective and well documented, but they can cause ulcers and gastrointestinal side effects. Vimovo™ is a tablet containing naproxen (NSAID) and a gastroprotective agent called esomeprazole. Patients with rheumatic disorders, who are at risk for developing gastrointestinal side effects, and where lower doses of naproxen or other NSAID treatment is not considered sufficient, could use this tablet. The regulatory authorities in many European countries have approved the use of Vimovo™, but they would like to understand how various factors influence the doctors' decision to prescribe the tablet and what is characterizing the patients receiving it. The aim of the study is to answer these questions.

Detailed Description
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European study in patients with osteoarthritis, rheumatoid arthritis, or ankylosing spondylitis at gastrointestinal risk: A retrospective, non-interventional study of Vimovo™ prescribing patterns

Official Title
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European Study in Patients With Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis at Gastrointestinal Risk: A Retrospective, Non-interventional Study of Vimovo™ Prescribing Patterns

Conditions
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Rheumatoid Arthritis, Osteoarthritis, Ankylosing Spondylitis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Risk for developing gastrointestinal ulcer Already prescribed Vimovo Exclusion Criteria: Participation in any interventional drug study at the time Vimovo™ was prescribed Patients started on Vimovo during the first 3 months after country-specific launch date Patients started on Vimovo after the study site is initiated (in order to avoid influence on prescribing decision and recruitment)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences |  | baseline | 
| Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences |  | baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vimovo™ treated patients and prescribing patterns, Risk of gastrointestinal side effects