Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder
EVIDENCE
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
1 other identifier
observational
1,149
12 countries
244
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Shorter than P25 for all trials
244 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedFirst Posted
Study publicly available on registry
August 6, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedJune 6, 2012
June 1, 2012
1 year
July 30, 2010
June 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The incidence of selected GI events, classified as "symptomatic" or "complicated" GI events. Reported by the patients at the follow-up visits.
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 Outcomes (3)
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.
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.
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.
Measurements at baseline, 3 months and 6 months
Study Arms (1)
1
Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors
Eligibility Criteria
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.
You may qualify if:
- Diagnosis of arthritic disorder (osteoarthritis, rheumatoid arthritis or ankylosing spondylitis)
- Already receiving NSAID treatment at enrolment visit
You may not qualify if:
- Inability to complete the study related questionnaires
- Current participation in any interventional study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (244)
Research Site
Alsemberg, Belgium
Research Site
Anthée, Belgium
Research Site
Baisy-Thy, Belgium
Research Site
Blankenberge, Belgium
Research Site
Bois-de-Villers, Belgium
Research Site
Brussels, Belgium
Research Site
Champion, Belgium
Research Site
Chênée, Belgium
Research Site
Dour, Belgium
Research Site
Ecaussinnes, Belgium
Research Site
Fosses-la-Ville, Belgium
Research Site
Geel, Belgium
Research Site
Genly, Belgium
Research Site
Godinne, Belgium
Research Site
Gozée, Belgium
Research Site
Gribomont, Belgium
Research Site
Halen, Belgium
Research Site
Ham-sur-Heure-Nalinnes, Belgium
Research Site
Hasselt, Belgium
Research Site
Hove, Belgium
Research Site
Kraainem, Belgium
Research Site
Libramont-Chevigny, Belgium
Research Site
Linkebeek, Belgium
Research Site
Lommel, Belgium
Research Site
Marchovelette, Belgium
Research Site
Melsbroek, Belgium
Research Site
Moerkerke-Damme, Belgium
Research Site
Mont-sur-Marchienne, Belgium
Research Site
Mouscron, Belgium
Research Site
Natoye, Belgium
Research Site
Oostham, Belgium
Research Site
Retie, Belgium
Research Site
Ronquières, Belgium
Research Site
Rumst, Belgium
Research Site
Saint-Ghislain, Belgium
Research Site
Seraing, Belgium
Research Site
Sint-Amands, Belgium
Research Site
Thuillies, Belgium
Research Site
Tremelo, Belgium
Research Site
Turnhout, Belgium
Research Site
Veurne, Belgium
Research Site
Vilvoorde, Belgium
Research Site
Zoersel, Belgium
Research Site
Arches, France
Research Site
Art-sur-Meurthe, France
Research Site
Aubagne, France
Research Site
Banyuls de la Marenda, France
Research Site
Bassussarry, France
Research Site
Cappelle-en-Pévèle, France
Research Site
Castets, France
Research Site
Champagnole, France
Research Site
Charvieu-Chavagneux, France
Research Site
Colmar, France
Research Site
Couzeix, France
Research Site
Firminy, France
Research Site
Fleury-sur-Orne, France
Research Site
Gallardon, France
Research Site
Gelles, France
Research Site
La Motte-Servolex, France
Research Site
Lambersart, France
Research Site
Le Bois-dOingt, France
Research Site
Le Bouscat, France
Research Site
Le Cannet, France
Research Site
Le Pontet, France
Research Site
Le Russey, France
Research Site
Lembach, France
Research Site
Marles-les-Mines, France
Research Site
Marseille, France
Research Site
Mensignac, France
Research Site
Moreuil, France
Research Site
Mourmelon-le-Petit, France
Research Site
Narbonne, France
Research Site
Neuilly-lès-Dijon, France
Research Site
Noyon, France
Research Site
Paris, France
Research Site
Pisany, France
Research Site
Puyricard, France
Research Site
Roissy-en-France, France
Research Site
Saint-Cyr-sur-Loire, France
Research Site
Saint-Estève, France
Research Site
Saint-Martin-de-Crau, France
Research Site
Salles, France
Research Site
Sonchamp, France
Research Site
Ste Fortunade, France
Research Site
Ste Severe Sur Indre, France
Research Site
Toulon, France
Research Site
Villejuif, France
Research Site
Voisins-le-Bretonneux, France
Research Site
Waziers, France
Research Site
Aiterhofen, 94330, Germany
Research Site
Bad Salzuflen, 32108, Germany
Research Site
Bergkamen, 59192, Germany
Research Site
Blankenhain, 99444, Germany
Research Site
Bockenem, 31167, Germany
Research Site
Cologne, 51069, Germany
Research Site
Deggingen, 73326, Germany
Research Site
Essen, 45279, Germany
Research Site
Gortringen, 71116, Germany
Research Site
Hamburg, 20354, Germany
Research Site
Lengerich, 49525, Germany
Research Site
Lenne, 32584, Germany
Research Site
Ludwigshafen, 67067, Germany
Research Site
Offenbach, 63073, Germany
Research Site
Potsdam, 14482, Germany
Research Site
Reinfeld, 23858, Germany
Research Site
Remscheid, 42855, Germany
Research Site
Rodgau, 63110, Germany
Research Site
Spaichingen, 78549, Germany
Research Site
Stockach, 78333, Germany
Research Site
Wangen, 88239, Germany
Research Site
Wardenburg, 26203, Germany
Research Site
Weinheim, 69469, Germany
Research Site
Alexandroupoli, Greece
Research Site
Athens, Greece
Research Site
Drama, Greece
Research Site
Florina, Greece
Research Site
Heraklion, Greece
Research Site
Karditsa, Greece
Research Site
Kastoria, Greece
Research Site
Kozani, Greece
Research Site
Serres, Greece
Research Site
Thessaloniki, Greece
Research Site
Trikala, Greece
Research Site
Xánthi, 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
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, Netherlands
Research Site
Roelofarendsveen, Netherlands
Research Site
Rotterdam, Netherlands
Research Site
Soerendonk, Netherlands
Research Site
Spijkenisse, Netherlands
Research Site
The Hague, Netherlands
Research Site
Volendam, Netherlands
Research Site
Woerden, Netherlands
Research Site
Årnes, Norway
Research Site
Baverbru, Norway
Research Site
Eydehavn, Norway
Research Site
Fornebu, Norway
Research Site
Frogner, Norway
Research Site
Hurdal, Norway
Research Site
Kirkenær, Norway
Research Site
Lierskogen, Norway
Research Site
Lillestrøm, Norway
Research Site
Mosterhamn, Norway
Research Site
Nordlenangen, Norway
Research Site
Oslo, Norway
Research Site
Rodal, Norway
Research Site
Skien, Norway
Research Site
Strømmen, Norway
Research Site
Svelvik, Norway
Research Site
Tanager, Norway
Research Site
Campotéjar, Spain
Research Site
Granada, Spain
Research Site
Huelva, Spain
Research Site
Málaga, Spain
Research Site
Nigrán, Spain
Research Site
Tomiño, Spain
Research Site
Vigo, Spain
Research Site
Dalby, Sweden
Research Site
Gothenburg, Sweden
Research Site
Kristianstad, Sweden
Research Site
Lidingö, Sweden
Research Site
Limhamn, Sweden
Research Site
Pitee, Sweden
Research Site
Skanör, 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
Sankt Gallen, Switzerland
Research Site
Sarmenstorf, Switzerland
Research Site
Schiers, Switzerland
Research Site
Wallisellen, Switzerland
Research Site
Zurich, Switzerland
Research Site
?stanbul, Turkey (Türkiye)
Research Site
?zmir, Turkey (Türkiye)
Research Site
Ankara, Turkey (Türkiye)
Research Site
Antalya, Turkey (Türkiye)
Research Site
Ayd?n, Turkey (Türkiye)
Research Site
Bursa, Turkey (Türkiye)
Research Site
Diyarbak?r, Turkey (Türkiye)
Research Site
Elaz??, Turkey (Türkiye)
Research Site
Erzurum, Turkey (Türkiye)
Research Site
Eski?ehir, Turkey (Türkiye)
Research Site
Isparta, Turkey (Türkiye)
Research Site
Kastamonu, Turkey (Türkiye)
Research Site
Kayseri, Turkey (Türkiye)
Research Site
Konya, Turkey (Türkiye)
Research Site
Manisa, Turkey (Türkiye)
Research Site
Trabzon, Turkey (Türkiye)
Research Site
Van, Turkey (Türkiye)
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
Research Site
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
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
Royal Leamington Spa, United Kingdom
Research Site
Sneinton, Nottingham, United Kingdom
Research Site
Stevenage, United Kingdom
Research Site
Titchfield, United Kingdom
Research Site
Trowbridge, United Kingdom
Research Site
Warminster, United Kingdom
Research Site
Watford, United Kingdom
Research Site
Wellingborough, United Kingdom
Research Site
Woolpit, Bury Saint Edmonds, United Kingdom
Related Publications (1)
Lanas A, Boers M, Nuevo J. Gastrointestinal events in at-risk patients starting non-steroidal anti-inflammatory drugs (NSAIDs) for rheumatic diseases: the EVIDENCE study of European routine practice. Ann Rheum Dis. 2015 Apr;74(4):675-81. doi: 10.1136/annrheumdis-2013-204155. Epub 2013 Dec 18.
PMID: 24351518DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Javier Nuevo, MSc
Medical Department.AstraZeneca Spain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2010
First Posted
August 6, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
June 6, 2012
Record last verified: 2012-06