OsteoarthritisCHARACTERIZENCT01511926
Descriptive Study in Patients Treated With Vimovo™, Including Registration of the Physicians' Prescribing Patterns
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by AstraZeneca at 96 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- How many people
- 2,000 participants
- Where
- 96 sitesin 8 countries
- Study dates
- Jan 2012to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Risk for developing gastrointestinal ulcer Already prescribed Vimovo
Who cannot join
- 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)
Trial locations and contacts
96 sites in 8 countries.
96 sites in 8 countries
Belgium19 sites
Research Site
Aalst
Research Site
Dilbeek
Research Site
Erembodegem
Research Site
Genk
Research Site
Halen
Research Site
Heers
Research Site
Huy
Research Site
Langemark
Research Site
Lasne
Research Site
Lembeke
Research Site
Melsele
Research Site
Morkhoven
Research Site
Olen
Research Site
Sart-lez-Spa
Research Site
Sint-Lievens-Houtem
Research Site
Tessenderlo
Research Site
Wambeek
Research Site
Wingene
Research Site
Zonhoven
Spain17 sites
Research Site
Badalona
Research Site
Barcelona
Research Site
Benaguasil, Valencia
Research Site
Elda, Alicante
Research Site
Esplugues de Llobregat
Research Site
Las Bayas, Elche, Elche
Research Site
Merida, Badajoz
Research Site
Rianxo, A Coruna
Research Site
San Fernando, Cadiz
Research Site
Santiago de Compostela
Research Site
Seville
Research Site
Teruel
Research Site
Torrelavega, Cantabria
Research Site
Valencia
Research Site
Vilanova i la Geltrú
Research Site
Xativa, Valencia
Research Site
Zaragoza
Norway14 sites
Research Site
Bøverbru
Research Site
Eidsvoll
Research Site
Kirkenær
Research Site
Kråkerøy
Research Site
Oslo
Research Site
Østerås
Research Site
Røa
Research Site
Skarnes
Research Site
Sola
Research Site
Stavanger
Research Site
Strømmen
Research Site
Svelvik
Research Site
Tananger
Research Site
Tønsberg
Netherlands13 sites
Research Site
's-Hertogenbosch
Research Site
Andijk
Research Site
Beek en Donk
Research Site
Dordrecht
Research Site
Eersel
Research Site
Heesch
Research Site
Hoogwoud
Research Site
Midwoud
Research Site
Nijverdal
Research Site
Ravenstein
Research Site
Sint Geertruid
Research Site
Spijkernisse
Research Site
Vlodrop
Switzerland11 sites
Research Site
Basel
Research Site
Bellinzona
Research Site
Chur
Research Site
Ebmatingen
Research Site
Neftenbach / Dorf Neftenbach
Research Site
Paradiso
Research Site
Sankt Gallen
Research Site
Schiers
Research Site
Seuzach Dorf
Research Site
St. Erhard
Research Site
Zurich
Germany10 sites
Research Site
Bad Brückenau
Research Site
Blankenhain
Research Site
Deggingen
Research Site
Freiberg
Research Site
Gersthofen
Research Site
Hagen
Research Site
Lienen
Research Site
Löhne
Research Site
München
Research Site
Stockach
United Kingdom9 sites
Research Site
Addingham
Research Site
Basildon
Research Site
Belfast
Research Site
Birmingham
Research Site
Chippenham
Research Site
Heywood
Research Site
Randalstown
Research Site
Sheffield
Research Site
Warminster
Finland3 sites
Research Site
Helsinki
Research Site
Hyvinkää
Research Site
Vantaa
About this study
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
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.
Read the 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
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- Vimovo™ treated patients and prescribing patterns, Risk of gastrointestinal side effects
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences
Measured: baseline
Patients' part of questionnaire score covering demography, medical history and Vimovo™ prescribing preferences
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Nuevo, MSC, Study director, Medical Department, AstraZeneca Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511926
- Sponsor's protocol ID
- D1120C00044
- Acronym
- CHARACTERIZE
- Status last verified
- Mar 2015
- First submitted
- 10 Jan 2012
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01511926
- Acronym / sponsor ID
- CHARACTERIZE / D1120C00044
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- Vimovo™ treated patients and prescribing patterns, Risk of gastrointestinal side effects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Adult patients treated with Vimovo™ for diagnosed osteoarthritis (OA), rheumatoid arthritis (RA) or ankylosing spondylitis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis) Risk for developing gastrointestinal ulcer Already prescribed Vimovo
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
- Report Synopsis RedactedLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Nuevo, MSC study director
Medical Department, AstraZeneca Spain
96 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis and Rheumatoid Arthritis, run by AstraZeneca at 96 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 96 sites in Belgium, Spain, Norway, Netherlands, Switzerland and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physicians' part of questionnaire score covering speciality, practice setting and NSAIDs prescribing preferences (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2015.