Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder (EVIDENCE)

June 5, 2012 updated by: AstraZeneca

European Real Life Study on NSAIDs Treated Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS): Assessment of Pain Relieve, Gastrointestinal (GI) Symptoms, Adherence and Health Resource Consumption

The aim of this study is to find out how patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving NSAID-therapy are treated and managed by their doctor in usual clinical practice, how patients comply with their treatment and how satisfied they are with their treatment.

Study Overview

Study Type

Observational

Enrollment (Actual)

1149

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Alsemberg, Belgium
        • Research Site
      • Anthee, Belgium
        • Research Site
      • Baisy-Thy, Belgium
        • Research Site
      • Blankenberge, Belgium
        • Research Site
      • Bois de Villers, Belgium
        • Research Site
      • Bruxelles, Belgium
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      • Champion, Belgium
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      • Chenee, Belgium
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      • Dour, Belgium
        • Research Site
      • Ecaussinnes, Belgium
        • Research Site
      • Fosses-la-Ville, Belgium
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      • Geel, Belgium
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      • Genly, Belgium
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      • Godinne, Belgium
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      • Gozee, Belgium
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      • Gribomont, Belgium
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      • Halen, Belgium
        • Research Site
      • Ham-sur-Heure Nalinnes, Belgium
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      • Hasselt, Belgium
        • Research Site
      • Hove, Belgium
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      • Kraainem, Belgium
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      • Libramont-Chevigny, Belgium
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      • Linkebeek, Belgium
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      • Lommel, Belgium
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      • Marchovelette, Belgium
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      • Melsbroek, Belgium
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      • Moerkerke-Damme, Belgium
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      • Mont-sur-Marchienne, Belgium
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      • Mouscron, Belgium
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      • Natoye, Belgium
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      • Oostham, Belgium
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      • Retie, Belgium
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      • Ronquieres, Belgium
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      • Rumst, Belgium
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      • Saint-Ghislain, Belgium
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      • Seraing, Belgium
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      • Sint-Amands, Belgium
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      • Thuillies, Belgium
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      • Tremelo, Belgium
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      • Turnhout, Belgium
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      • Veurne, Belgium
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      • Vilvoorde, Belgium
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      • Zoersel, Belgium
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      • Arches, France
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      • Art Sur Meurthe, France
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      • Aubagne, France
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      • Banyuls Sur Mer, France
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      • Bassussarry, France
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      • Cappelle En Pevele, France
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      • Castets, France
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      • Champagnole, France
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      • Charvieu Chavagneux, France
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      • Colmar, France
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      • Couzeix, France
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      • Firminy, France
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      • Fleury Sur Orne, France
        • Research Site
      • Gallardon, France
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      • Gelles, France
        • Research Site
      • La Motte Servolex, France
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      • Lambersart, France
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      • Le Bois D Oingt, France
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      • Le Bouscat, France
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      • Le Cannet, France
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      • Le Pontet, France
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      • Le Russey, France
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      • Lembach, France
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      • Marles Les Mines, France
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      • Marseille, France
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      • Mensignac, France
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      • Moreuil, France
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      • Mourmelon Le Petit, France
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      • Narbonne, France
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      • Neuilly Les Dijon, France
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      • Noyon, France
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      • Paris, France
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      • Pisany, France
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      • Puyricard, France
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      • Roissy En France, France
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      • Salles, France
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      • Sonchamp, France
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      • St Cyr Sur Loire, France
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      • St Esteve, France
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      • St Martin de Crau, France
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      • Ste Fortunade, France
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      • Ste Severe Sur Indre, France
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      • Toulon, France
        • Research Site
      • Villejuif, France
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      • Voisins Le Bretonneux, France
        • Research Site
      • Waziers, France
        • Research Site
      • Aiterhofen, Germany, 94330
        • Research Site
      • Bad Salzuflen, Germany, 32108
        • Research Site
      • Bergkamen, Germany, 59192
        • Research Site
      • Blankenhain, Germany, 99444
        • Research Site
      • Bockenem, Germany, 31167
        • Research Site
      • Deggingen, Germany, 73326
        • Research Site
      • Essen, Germany, 45279
        • Research Site
      • Gortringen, Germany, 71116
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      • Hamburg, Germany, 20354
        • Research Site
      • Koln, Germany, 51069
        • Research Site
      • Lengerich, Germany, 49525
        • Research Site
      • Lenne, Germany, 32584
        • Research Site
      • Ludwigshafen, Germany, 67067
        • Research Site
      • Offenbach, Germany, 63073
        • Research Site
      • Potsdam, Germany, 14482
        • Research Site
      • Reinfeld, Germany, 23858
        • Research Site
      • Remscheid, Germany, 42855
        • Research Site
      • Rodgau, Germany, 63110
        • Research Site
      • Spaichingen, Germany, 78549
        • Research Site
      • Stockach, Germany, 78333
        • Research Site
      • Wangen, Germany, 88239
        • Research Site
      • Wardenburg, Germany, 26203
        • Research Site
      • Weinheim, Germany, 69469
        • Research Site
      • Alexandroupolis, Greece
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      • Athens, Greece
        • Research Site
      • Drama, Greece
        • Research Site
      • Florina, Greece
        • Research Site
      • Heraklion, Greece
        • Research Site
      • Karditsa, Greece
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      • Kastoria, Greece
        • Research Site
      • Kozani, Greece
        • Research Site
      • Serres, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
      • Trikala, Greece
        • Research Site
      • Xanthi, Greece
        • Research Site
      • Salerno, Italy
        • Research Site
      • Varese, Italy
        • Research Site
      • Viareggio, Italy
        • Research Site
      • Amsterdam, Netherlands
        • Research Site
      • Andijk, Netherlands
        • Research Site
      • Bennebroek, Netherlands
        • Research Site
      • Den Haag, Netherlands
        • Research Site
      • Dordrecht, Netherlands
        • Research Site
      • Ermelo, Netherlands
        • Research Site
      • Lichtenvoorde, Netherlands
        • Research Site
      • Lieshout, Netherlands
        • Research Site
      • Losser, Netherlands
        • Research Site
      • Nijmegen, Netherlands
        • Research Site
      • Nijverdal, Netherlands
        • Research Site
      • Rijswijk, Netherlands
        • Research Site
      • Rilland-bath, Netherlands
        • Research Site
      • Roelofarendsveen, Netherlands
        • Research Site
      • Rotterdam, Netherlands
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      • Soerendonk, Netherlands
        • Research Site
      • Spijkenisse, Netherlands
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      • Volendam, Netherlands
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      • Woerden, Netherlands
        • Research Site
      • Arnes, Norway
        • Research Site
      • Baverbru, Norway
        • Research Site
      • Eydehavn, Norway
        • Research Site
      • Fornebu, Norway
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      • Frogner, Norway
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      • Hurdal, Norway
        • Research Site
      • Kirkenaer, Norway
        • Research Site
      • Lierskogen, Norway
        • Research Site
      • Lillestrom, Norway
        • Research Site
      • Mosterhamn, Norway
        • Research Site
      • Nordlenangen, Norway
        • Research Site
      • Oslo, Norway
        • Research Site
      • Rodal, Norway
        • Research Site
      • Skien, Norway
        • Research Site
      • Strommen, Norway
        • Research Site
      • Svelvik, Norway
        • Research Site
      • Tanager, Norway
        • Research Site
      • Campotejar, Spain
        • Research Site
      • Granada, Spain
        • Research Site
      • Huelva, Spain
        • Research Site
      • Malaga, Spain
        • Research Site
      • Nigran, Spain
        • Research Site
      • Tomino, Spain
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      • Vigo, Spain
        • Research Site
      • Dalby, Sweden
        • Research Site
      • Goteborg, Sweden
        • Research Site
      • Kristianstad, Sweden
        • Research Site
      • Lidingo, Sweden
        • Research Site
      • Limhamn, Sweden
        • Research Site
      • Pitee, Sweden
        • Research Site
      • Skanor, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
      • Vonnes, Sweden
        • Research Site
      • Ystad, Sweden
        • Research Site
      • Baden, Switzerland
        • Research Site
      • Basel, Switzerland
        • Research Site
      • Brittnau, Switzerland
        • Research Site
      • Buchs, Switzerland
        • Research Site
      • Chiasso, Switzerland
        • Research Site
      • Chur, Switzerland
        • Research Site
      • Egg bei Zurich, Switzerland
        • Research Site
      • Ilanz, Switzerland
        • Research Site
      • Oberwil, Switzerland
        • Research Site
      • Sarmenstorf, Switzerland
        • Research Site
      • Schiers, Switzerland
        • Research Site
      • St. Gallen, Switzerland
        • Research Site
      • Wallisellen, Switzerland
        • Research Site
      • Zurich, Switzerland
        • Research Site
      • ?stanbul, Turkey
        • Research Site
      • ?zmir, Turkey
        • Research Site
      • Ankara, Turkey
        • Research Site
      • Antalya, Turkey
        • Research Site
      • Ayd?n, Turkey
        • Research Site
      • Bursa, Turkey
        • Research Site
      • Diyarbak?r, Turkey
        • Research Site
      • Elaz??, Turkey
        • Research Site
      • Erzurum, Turkey
        • Research Site
      • Eski?ehir, Turkey
        • Research Site
      • Isparta, Turkey
        • Research Site
      • Kastamonu, Turkey
        • Research Site
      • Kayseri, Turkey
        • Research Site
      • Konya, Turkey
        • Research Site
      • Manisa, Turkey
        • Research Site
      • Trabzon, Turkey
        • Research Site
      • Van, Turkey
        • Research Site
      • Addlestone, Surrey, United Kingdom
        • Research Site
      • Ashford, Middlesex, United Kingdom
        • Research Site
      • Aston Clinton, Bucks, United Kingdom
        • Research Site
      • Atherstone, Warwickshire, United Kingdom
        • Research Site
      • Bangor, Northern Ireland, United Kingdom
        • Research Site
      • Bath, United Kingdom
        • Research Site
      • Belfast, United Kingdom
        • Research Site
      • Birmingham, United Kingdom
        • Research Site
      • Bradford-On-Avon, Wiltshire, United Kingdom
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      • Cookstown, Northern Ireland, United Kingdom
        • Research Site
      • Coventry, United Kingdom
        • Research Site
      • Crawley, West Sussex, United Kingdom
        • Research Site
      • Cumbernauld, United Kingdom
        • Research Site
      • Frome, Wiltshire, United Kingdom
        • Research Site
      • Glasgow, United Kingdom
        • Research Site
      • Harrow, Middlesex, United Kingdom
        • Research Site
      • High Valleyfield, Fife, United Kingdom
        • Research Site
      • Irvine, United Kingdom
        • Research Site
      • Leamington Spa, United Kingdom
        • Research Site
      • Maidenhead, United Kingdom
        • Research Site
      • Motherwell, United Kingdom
        • Research Site
      • New Stevenson, United Kingdom
        • Research Site
      • Newcastle-upon-Tyne, United Kingdom
        • Research Site
      • Pound Hill, Crawley, United Kingdom
        • Research Site
      • Randalstown, United Kingdom
        • Research Site
      • Sneinton, Nottingham, United Kingdom
        • Research Site
      • Stevenage, United Kingdom
        • Research Site
      • Titchfield, United Kingdom
        • Research Site
      • Trowbridge, United Kingdom
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      • Warminster, United Kingdom
        • Research Site
      • Watford, United Kingdom
        • Research Site
      • Wellingborough, United Kingdom
        • Research Site
      • Woolpit, Bury St Edmonds, United Kingdom
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors. The patients will be asked to participate by their treating doctors at GP centres, specialist centres or hospitals.

Participating investigators will belong to a variety of centres representing the reality of how and where these patients are managed in each country.

Description

Inclusion Criteria:

  • Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis)
  • Already receiving NSAID treatment at enrolment visit

Exclusion Criteria:

  • Inability to complete the study related questionnaires
  • Current participation in any interventional study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
1
Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of selected GI events, classified as "symptomatic" or "complicated" GI events. Reported by the patients at the follow-up visits.
Time Frame: Time from NSAID treatment prescription to first diagnosis of the GI event for each patient will be registered. Each patient will be followed up for 6 months.
Time from NSAID treatment prescription to first diagnosis of the GI event for each patient will be registered. Each patient will be followed up for 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of health care visits and days of hospitalisation (health care consumption) related to arthritic disorder and/or GI events as reported by the patients at the follow-up visits.
Time Frame: Health care consumption accumulated over the 6 months study period will be registered.
Health care consumption accumulated over the 6 months study period will be registered.
Quality of life assessed by EuroQol-5 Dimension (EQ-5D) at baseline and the follow-up visits. Measure how selected GI events impact the EQ-5D score.
Time Frame: Measurements at baseline, 3 months and 6 months
Measurements at baseline, 3 months and 6 months
Adherence with NSAIDs and proton pump inhibitors (PPI) measured by Morisky-Green-Levine Medication Assessment Scale (MMAS) at baseline and follow-up visits.
Time Frame: Measurements at baseline, 3 months and 6 months
Measurements at baseline, 3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Javier Nuevo, MSc, Medical Department.AstraZeneca Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

July 30, 2010

First Submitted That Met QC Criteria

August 5, 2010

First Posted (Estimate)

August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

June 6, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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