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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • Belgium
      • Alsemberg, Belgium
        • Research Site
      • Anthee, Belgium
        • Research Site
      • Baisy-Thy, Belgium
        • Research Site
      • Blankenberge, Belgium
        • Research Site
      • Bois de Villers, Belgium
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      • Bruxelles, Belgium
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      • Champion, Belgium
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      • Chenee, Belgium
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      • Dour, Belgium
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      • Ecaussinnes, Belgium
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      • 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
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      • Ham-sur-Heure Nalinnes, Belgium
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      • Hasselt, Belgium
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      • 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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  • France
      • Arches, France
        • Research Site
      • 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
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      • Gallardon, France
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      • Gelles, France
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      • 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
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      • Villejuif, France
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      • Voisins Le Bretonneux, France
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      • Waziers, France
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  • Germany
      • Aiterhofen, Germany, 94330
        • Research Site
      • Bad Salzuflen, Germany, 32108
        • Research Site
      • Bergkamen, Germany, 59192
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      • Blankenhain, Germany, 99444
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      • Bockenem, Germany, 31167
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      • Deggingen, Germany, 73326
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      • Essen, Germany, 45279
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      • Gortringen, Germany, 71116
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      • Hamburg, Germany, 20354
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      • Koln, Germany, 51069
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      • Lengerich, Germany, 49525
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      • Lenne, Germany, 32584
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      • Ludwigshafen, Germany, 67067
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      • Offenbach, Germany, 63073
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      • Potsdam, Germany, 14482
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      • Reinfeld, Germany, 23858
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      • Remscheid, Germany, 42855
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      • Rodgau, Germany, 63110
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      • Spaichingen, Germany, 78549
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      • Stockach, Germany, 78333
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      • Wangen, Germany, 88239
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      • Wardenburg, Germany, 26203
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      • Weinheim, Germany, 69469
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  • Greece
      • Alexandroupolis, Greece
        • Research Site
      • Athens, Greece
        • Research Site
      • Drama, Greece
        • Research Site
      • Florina, Greece
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      • Heraklion, Greece
        • Research Site
      • Karditsa, Greece
        • Research Site
      • Kastoria, Greece
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      • Kozani, Greece
        • Research Site
      • Serres, Greece
        • Research Site
      • Thessaloniki, Greece
        • Research Site
      • Trikala, Greece
        • Research Site
      • Xanthi, Greece
        • Research Site
  • Italy
      • Salerno, Italy
        • Research Site
      • Varese, Italy
        • Research Site
      • Viareggio, Italy
        • Research Site
  • Netherlands
      • Amsterdam, Netherlands
        • Research Site
      • Andijk, Netherlands
        • Research Site
      • Bennebroek, Netherlands
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      • Den Haag, Netherlands
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      • Dordrecht, Netherlands
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      • Ermelo, Netherlands
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      • Lichtenvoorde, Netherlands
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      • Lieshout, Netherlands
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      • Losser, Netherlands
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      • Nijmegen, Netherlands
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      • Nijverdal, Netherlands
        • Research Site
      • Rijswijk, Netherlands
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      • Rilland-bath, Netherlands
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      • Roelofarendsveen, Netherlands
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      • Rotterdam, Netherlands
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      • Soerendonk, Netherlands
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      • Spijkenisse, Netherlands
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      • Volendam, Netherlands
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      • Woerden, Netherlands
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  • Norway
      • Arnes, Norway
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      • Baverbru, Norway
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      • Eydehavn, Norway
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      • Fornebu, Norway
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      • Frogner, Norway
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      • Hurdal, Norway
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      • Kirkenaer, Norway
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      • Lierskogen, Norway
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      • Lillestrom, Norway
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      • Mosterhamn, Norway
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      • Nordlenangen, Norway
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      • Oslo, Norway
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      • Rodal, Norway
        • Research Site
      • Skien, Norway
        • Research Site
      • Strommen, Norway
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      • Svelvik, Norway
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      • Tanager, Norway
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  • Spain
      • Campotejar, Spain
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      • Granada, Spain
        • Research Site
      • Huelva, Spain
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      • Malaga, Spain
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      • Nigran, Spain
        • Research Site
      • Tomino, Spain
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      • Vigo, Spain
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  • Sweden
      • Dalby, Sweden
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      • Goteborg, Sweden
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      • Kristianstad, Sweden
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      • Lidingo, Sweden
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      • Limhamn, Sweden
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      • Pitee, Sweden
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      • Skanor, Sweden
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      • Stockholm, Sweden
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      • Vonnes, Sweden
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      • Ystad, Sweden
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  • Switzerland
      • Baden, Switzerland
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      • Basel, Switzerland
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      • Brittnau, Switzerland
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      • Buchs, Switzerland
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      • Chiasso, Switzerland
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      • Chur, Switzerland
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      • Egg bei Zurich, Switzerland
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      • Ilanz, Switzerland
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      • Oberwil, Switzerland
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      • Sarmenstorf, Switzerland
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      • Schiers, Switzerland
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      • St. Gallen, Switzerland
        • Research Site
      • Wallisellen, Switzerland
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      • Zurich, Switzerland
        • Research Site
  • Turkey
      • ?stanbul, Turkey
        • Research Site
      • ?zmir, Turkey
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      • Ankara, Turkey
        • Research Site
      • Antalya, Turkey
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      • Ayd?n, Turkey
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      • Bursa, Turkey
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      • Diyarbak?r, Turkey
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      • Elaz??, Turkey
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      • Erzurum, Turkey
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      • Eski?ehir, Turkey
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      • Isparta, Turkey
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      • Kastamonu, Turkey
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      • Kayseri, Turkey
        • Research Site
      • Konya, Turkey
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      • Manisa, Turkey
        • Research Site
      • Trabzon, Turkey
        • Research Site
      • Van, Turkey
        • Research Site
  • United Kingdom
      • Addlestone, Surrey, United Kingdom
        • Research Site
      • Ashford, Middlesex, United Kingdom
        • Research Site
      • Aston Clinton, Bucks, United Kingdom
        • Research Site
      • Atherstone, Warwickshire, United Kingdom
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      • Bangor, Northern Ireland, United Kingdom
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      • Bath, United Kingdom
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      • Belfast, United Kingdom
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      • Birmingham, United Kingdom
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      • Bradford-On-Avon, Wiltshire, United Kingdom
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      • Cookstown, Northern Ireland, United Kingdom
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      • Coventry, United Kingdom
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      • Crawley, West Sussex, United Kingdom
        • Research Site
      • Cumbernauld, United Kingdom
        • Research Site
      • Frome, Wiltshire, United Kingdom
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      • Glasgow, United Kingdom
        • Research Site
      • Harrow, Middlesex, United Kingdom
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      • High Valleyfield, Fife, United Kingdom
        • Research Site
      • Irvine, United Kingdom
        • Research Site
      • Leamington Spa, United Kingdom
        • Research Site
      • Maidenhead, United Kingdom
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      • Motherwell, United Kingdom
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      • New Stevenson, United Kingdom
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      • Newcastle-upon-Tyne, United Kingdom
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      • Pound Hill, Crawley, United Kingdom
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      • Randalstown, United Kingdom
        • Research Site
      • Sneinton, Nottingham, United Kingdom
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      • Stevenage, United Kingdom
        • Research Site
      • Titchfield, United Kingdom
        • Research Site
      • Trowbridge, United Kingdom
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      • Warminster, United Kingdom
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      • Watford, United Kingdom
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      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 30, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 5, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 6, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS-GEU-DUM-2010/1

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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