Clinical trial NCT01511926: Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns
Official title: European Study in Patients With Osteoarthritis, Rheumatoid Arthritis, or Ankylosing Spondylitis at Gastrointestinal Risk: A Retrospective, Non-interventional Study of Vimovo™ Prescribing Patterns
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Keywords: Vimovo™ treated patients and prescribing patterns
Risk of gastrointestinal side effects
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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)

Primary outcomes:
measure: Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences
timeFrame: baseline
measure: Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Research Site
city: Dilbeek
country: Belgium
facility: Research Site
city: Erembodegem
country: Belgium
facility: Research Site
city: Genk
country: Belgium
facility: Research Site
city: Halen
country: Belgium
facility: Research Site
city: Heers
country: Belgium
facility: Research Site
city: Huy
country: Belgium
facility: Research Site
city: Langemark
country: Belgium
facility: Research Site
city: Lasne
country: Belgium
facility: Research Site
city: Lembeke
country: Belgium
facility: Research Site
city: Melsele
country: Belgium
facility: Research Site
city: Morkhoven
country: Belgium
facility: Research Site
city: Olen
country: Belgium
facility: Research Site
city: Sart-Lez-Spa
country: Belgium
facility: Research Site
city: Sint-Lievens-Houtem
country: Belgium
facility: Research Site
city: Tessenderlo
country: Belgium
facility: Research Site
city: Wambeek
country: Belgium
facility: Research Site
city: Wingene
country: Belgium
facility: Research Site
city: Zonhoven
country: Belgium
facility: Research Site
city: Helsinki
country: Finland
facility: Research Site
city: Hyvinkaa
country: Finland
facility: Research Site
city: Vantaa
country: Finland
facility: Research Site
city: Bad Bruckenau
country: Germany
facility: Research Site
city: Blankenhain
country: Germany
facility: Research Site
city: Deggingen
country: Germany
facility: Research Site
city: Freiberg
country: Germany
facility: Research Site
city: Gersthofen
country: Germany
facility: Research Site
city: Hagen
country: Germany
facility: Research Site
city: Lienen
country: Germany
facility: Research Site
city: Lohne
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Stockach
country: Germany
facility: Research Site
city: Andijk
country: Netherlands
facility: Research Site
city: Beek en Donk
country: Netherlands
facility: Research Site
city: Dordrecht
country: Netherlands
facility: Research Site
city: Eersel
country: Netherlands
facility: Research Site
city: Heesch
country: Netherlands
facility: Research Site
city: Hertogenbosch
country: Netherlands
facility: Research Site
city: Hoogwoud
country: Netherlands
facility: Research Site
city: Midwoud
country: Netherlands
facility: Research Site
city: Nijverdal
country: Netherlands
facility: Research Site
city: Ravenstein
country: Netherlands
facility: Research Site
city: Sint Geertruid
country: Netherlands
facility: Research Site
city: Spijkernisse
country: Netherlands
facility: Research Site
city: Vlodrop
country: Netherlands
facility: Research Site
city: Boverbru
country: Norway
facility: Research Site
city: Eidsvoll
country: Norway
facility: Research Site
city: Kirkenaer
country: Norway
facility: Research Site
city: Krakeroy
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Osteras
country: Norway
facility: Research Site
city: Roa
country: Norway
facility: Research Site
city: Skarnes
country: Norway
facility: Research Site
city: Sola
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: Strommen
country: Norway
facility: Research Site
city: Svelvik
country: Norway
facility: Research Site
city: Tananger
country: Norway
facility: Research Site
city: Tonsberg
country: Norway
facility: Research Site
city: Las Bayas, Elche
country: Spain
facility: Research Site
state: Elche
city: Badalona
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Benaguasil, Valencia
country: Spain
facility: Research Site
city: Elda, Alicante
country: Spain
facility: Research Site
city: Esplugues de Llobregat
country: Spain
facility: Research Site
city: Merida, Badajoz
country: Spain
facility: Research Site
city: Rianxo, A Coruna
country: Spain
facility: Research Site
city: San Fernando, Cadiz
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Teruel
country: Spain
facility: Research Site
city: Torrelavega, Cantabria
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Vilanova i la Geltru
country: Spain
facility: Research Site
city: Xativa, Valencia
country: Spain
facility: Research Site
city: Zaragoza
country: Spain
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Bellinzona
country: Switzerland
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Ebmatingen
country: Switzerland
facility: Research Site
city: Neftenbach
country: Switzerland
facility: Research Site
city: Paradiso
country: Switzerland
facility: Research Site
city: Schiers
country: Switzerland
facility: Research Site
city: Seuzach
country: Switzerland
facility: Research Site
city: St. Erhard
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: Addingham
country: United Kingdom
facility: Research Site
city: Basildon
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Chippenham
country: United Kingdom
facility: Research Site
city: Heywood
country: United Kingdom
facility: Research Site
city: Randalstown
country: United Kingdom
facility: Research Site
city: Sheffield
country: United Kingdom
facility: Research Site
city: Warminster
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Medical Department, AstraZeneca Spain
name: Javier Nuevo, MSC
role: STUDY_DIRECTOR
References: