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

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.

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Key information

Conditions

Osteoarthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aalst, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences

Time frame: baseline
Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences

Time frame: baseline

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: CHARACTERIZE

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jan 19, 2012
Registry last updated: Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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