Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns
CHARACTERIZE
European Study in Patients With Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis at Gastrointestinal Risk: A Retrospective, Non-interventional Study of Vimovo™ Prescribing Patterns
1 other identifier
observational
2,000
8 countries
96
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2012
Typical duration for all trials
96 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 10, 2012
CompletedFirst Posted
Study publicly available on registry
January 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedMarch 10, 2015
March 1, 2015
2.2 years
January 10, 2012
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (1)
1
Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis
Eligibility Criteria
Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis (AS), and with gastrointestinal (GI) risk factors. The patients will be asked to participate by their treating doctors at GP centres, specialist centres or hospitals across Europe.
You may qualify if:
- Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Risk for developing gastrointestinal ulcer Already prescribed Vimovo
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (96)
Research Site
Aalst, Belgium
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Dilbeek, Belgium
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Erembodegem, Belgium
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Genk, Belgium
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Halen, Belgium
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Heers, Belgium
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Huy, Belgium
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Langemark, Belgium
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Lasne, Belgium
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Lembeke, Belgium
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Melsele, Belgium
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Morkhoven, Belgium
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Olen, Belgium
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Sart-lez-Spa, Belgium
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Sint-Lievens-Houtem, Belgium
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Tessenderlo, Belgium
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Wambeek, Belgium
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Wingene, Belgium
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Zonhoven, Belgium
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Helsinki, Finland
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Hyvinkää, Finland
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Vantaa, Finland
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Bad Brückenau, Germany
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Blankenhain, Germany
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Deggingen, Germany
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Freiberg, Germany
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Gersthofen, Germany
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Hagen, Germany
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Lienen, Germany
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Löhne, Germany
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München, Germany
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Stockach, Germany
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's-Hertogenbosch, Netherlands
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Andijk, Netherlands
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Beek en Donk, Netherlands
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Dordrecht, Netherlands
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Eersel, Netherlands
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Heesch, Netherlands
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Hoogwoud, Netherlands
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Midwoud, Netherlands
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Nijverdal, Netherlands
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Ravenstein, Netherlands
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Sint Geertruid, Netherlands
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Spijkernisse, Netherlands
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Vlodrop, Netherlands
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Bøverbru, Norway
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Eidsvoll, Norway
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Kirkenær, Norway
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Kråkerøy, Norway
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Oslo, Norway
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Røa, Norway
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Skarnes, Norway
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Sola, Norway
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Stavanger, Norway
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Strømmen, Norway
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Svelvik, Norway
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Tananger, Norway
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Tønsberg, Norway
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Østerås, Norway
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Las Bayas, Elche, Elche, Spain
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Badalona, Spain
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Barcelona, Spain
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Benaguasil, Valencia, Spain
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Elda, Alicante, Spain
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Esplugues de Llobregat, Spain
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Merida, Badajoz, Spain
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Rianxo, A Coruna, Spain
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San Fernando, Cadiz, Spain
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Santiago de Compostela, Spain
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Seville, Spain
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Teruel, Spain
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Torrelavega, Cantabria, Spain
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Valencia, Spain
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Vilanova i la Geltrú, Spain
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Xativa, Valencia, Spain
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Zaragoza, Spain
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Basel, Switzerland
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Bellinzona, Switzerland
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Chur, Switzerland
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Ebmatingen, Switzerland
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Neftenbach / Dorf Neftenbach, Switzerland
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Paradiso, Switzerland
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Sankt Gallen, Switzerland
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Schiers, Switzerland
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Seuzach Dorf, Switzerland
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St. Erhard, Switzerland
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Zurich, Switzerland
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Addingham, United Kingdom
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Basildon, United Kingdom
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Belfast, United Kingdom
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Birmingham, United Kingdom
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Chippenham, United Kingdom
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Heywood, United Kingdom
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Randalstown, United Kingdom
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Sheffield, United Kingdom
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Warminster, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Javier Nuevo, MSC
Medical Department, AstraZeneca Spain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2012
First Posted
January 19, 2012
Study Start
January 1, 2012
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
March 10, 2015
Record last verified: 2015-03