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

Rheumatoid Arthritis Clinical Trial

— CHARACTERIZE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511926
• Other study ID #: D1120C00044
• Status: Completed
• Phase: N/A
• First received: January 10, 2012
• Last updated: March 9, 2015
• Start date: January 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2015
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeThe Netherlands: Independent Ethics CommitteeBelgium: Institutional Review BoardSpain: Ethics Committee, Ministry of HealthNorway:National Committee for Medical and Health Research EthicsFinland: National Agency for Medicines, Ethics CommitteeGermany: Ethics CommisionSwitzerland: Ethikkommission
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Belgium	Research Site	Aalst
Belgium	Research Site	Dilbeek
Belgium	Research Site	Erembodegem
Belgium	Research Site	Genk
Belgium	Research Site	Halen
Belgium	Research Site	Heers
Belgium	Research Site	Huy
Belgium	Research Site	Langemark
Belgium	Research Site	Lasne
Belgium	Research Site	Lembeke
Belgium	Research Site	Melsele
Belgium	Research Site	Morkhoven
Belgium	Research Site	Olen
Belgium	Research Site	Sart-Lez-Spa
Belgium	Research Site	Sint-Lievens-Houtem
Belgium	Research Site	Tessenderlo
Belgium	Research Site	Wambeek
Belgium	Research Site	Wingene
Belgium	Research Site	Zonhoven
Finland	Research Site	Helsinki
Finland	Research Site	Hyvinkaa
Finland	Research Site	Vantaa
Germany	Research Site	Bad Bruckenau
Germany	Research Site	Blankenhain
Germany	Research Site	Deggingen
Germany	Research Site	Freiberg
Germany	Research Site	Gersthofen
Germany	Research Site	Hagen
Germany	Research Site	Lienen
Germany	Research Site	Lohne
Germany	Research Site	Munchen
Germany	Research Site	Stockach
Netherlands	Research Site	Andijk
Netherlands	Research Site	Beek en Donk
Netherlands	Research Site	Dordrecht
Netherlands	Research Site	Eersel
Netherlands	Research Site	Heesch
Netherlands	Research Site	Hertogenbosch
Netherlands	Research Site	Hoogwoud
Netherlands	Research Site	Midwoud
Netherlands	Research Site	Nijverdal
Netherlands	Research Site	Ravenstein
Netherlands	Research Site	Sint Geertruid
Netherlands	Research Site	Spijkernisse
Netherlands	Research Site	Vlodrop
Norway	Research Site	Boverbru
Norway	Research Site	Eidsvoll
Norway	Research Site	Kirkenaer
Norway	Research Site	Krakeroy
Norway	Research Site	Oslo
Norway	Research Site	Osteras
Norway	Research Site	Roa
Norway	Research Site	Skarnes
Norway	Research Site	Sola
Norway	Research Site	Stavanger
Norway	Research Site	Strommen
Norway	Research Site	Svelvik
Norway	Research Site	Tananger
Norway	Research Site	Tonsberg
Spain	Research Site	Badalona
Spain	Research Site	Barcelona
Spain	Research Site	Benaguasil, Valencia
Spain	Research Site	Elda, Alicante
Spain	Research Site	Esplugues de Llobregat
Spain	Research Site	Las Bayas, Elche	Elche
Spain	Research Site	Merida, Badajoz
Spain	Research Site	Rianxo, A Coruna
Spain	Research Site	San Fernando, Cadiz
Spain	Research Site	Santiago de Compostela
Spain	Research Site	Sevilla
Spain	Research Site	Teruel
Spain	Research Site	Torrelavega, Cantabria
Spain	Research Site	Valencia
Spain	Research Site	Vilanova i la Geltru
Spain	Research Site	Xativa, Valencia
Spain	Research Site	Zaragoza
Switzerland	Research Site	Basel
Switzerland	Research Site	Bellinzona
Switzerland	Research Site	Chur
Switzerland	Research Site	Ebmatingen
Switzerland	Research Site	Neftenbach
Switzerland	Research Site	Paradiso
Switzerland	Research Site	Schiers
Switzerland	Research Site	Seuzach
Switzerland	Research Site	St. Erhard
Switzerland	Research Site	St. Gallen
Switzerland	Research Site	Zurich
United Kingdom	Research Site	Addingham
United Kingdom	Research Site	Basildon
United Kingdom	Research Site	Belfast
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Chippenham
United Kingdom	Research Site	Heywood
United Kingdom	Research Site	Randalstown
United Kingdom	Research Site	Sheffield
United Kingdom	Research Site	Warminster

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences		baseline	No
Primary	Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences		baseline	No

External Links

•   Report Synopsis Redacted