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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01511926

Acronym

CHARACTERIZE

Enrollment

2000

Registered

2012-01-19

Start date

2012-01-31

Completion date

2014-03-31

Last updated

2015-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Osteoarthritis, Rheumatoid Arthritis

Keywords

Vimovo™ treated patients and prescribing patterns, Risk of gastrointestinal side effects

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	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

Countries

Belgium, Finland, Germany, Netherlands, Norway, Spain, Switzerland, United Kingdom

Outcome results