Clinical trial NCT01176682: Observational Study on Non-steroid Anti-inflammatory Drugs (NSAIDs) Treated Patients With Arthritic Disorder
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Rheumatoid Arthritis
Ankylosing Spondylitis
Keywords: NSAID-treated patients
gastrointestinal events
Non-steroid anti-inflammatory drug (NSAID)
Gastrointestinal events (GI events)
Proton Pump Inhibitors (PPI)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-08-06
Enrollment: 1149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of selected GI events, classified as "symptomatic" or "complicated" GI events. Reported by the patients at the follow-up visits.
timeFrame: 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:
measure: 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.
timeFrame: Health care consumption accumulated over the 6 months study period will be registered.
measure: 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.
timeFrame: Measurements at baseline, 3 months and 6 months
measure: Adherence with NSAIDs and proton pump inhibitors (PPI) measured by Morisky-Green-Levine Medication Assessment Scale (MMAS) at baseline and follow-up visits.
timeFrame: Measurements at baseline, 3 months and 6 months
Other outcomes:
Locations:
city: Alsemberg
country: Belgium
facility: Research Site
city: Anthee
country: Belgium
facility: Research Site
city: Baisy-Thy
country: Belgium
facility: Research Site
city: Blankenberge
country: Belgium
facility: Research Site
city: Bois de Villers
country: Belgium
facility: Research Site
city: Bruxelles
country: Belgium
facility: Research Site
city: Champion
country: Belgium
facility: Research Site
city: Chenee
country: Belgium
facility: Research Site
city: Dour
country: Belgium
facility: Research Site
city: Ecaussinnes
country: Belgium
facility: Research Site
city: Fosses-la-Ville
country: Belgium
facility: Research Site
city: Geel
country: Belgium
facility: Research Site
city: Genly
country: Belgium
facility: Research Site
city: Godinne
country: Belgium
facility: Research Site
city: Gozee
country: Belgium
facility: Research Site
city: Gribomont
country: Belgium
facility: Research Site
city: Halen
country: Belgium
facility: Research Site
city: Ham-sur-Heure Nalinnes
country: Belgium
facility: Research Site
city: Hasselt
country: Belgium
facility: Research Site
city: Hove
country: Belgium
facility: Research Site
city: Kraainem
country: Belgium
facility: Research Site
city: Libramont-Chevigny
country: Belgium
facility: Research Site
city: Linkebeek
country: Belgium
facility: Research Site
city: Lommel
country: Belgium
facility: Research Site
city: Marchovelette
country: Belgium
facility: Research Site
city: Melsbroek
country: Belgium
facility: Research Site
city: Moerkerke-Damme
country: Belgium
facility: Research Site
city: Mont-sur-Marchienne
country: Belgium
facility: Research Site
city: Mouscron
country: Belgium
facility: Research Site
city: Natoye
country: Belgium
facility: Research Site
city: Oostham
country: Belgium
facility: Research Site
city: Retie
country: Belgium
facility: Research Site
city: Ronquieres
country: Belgium
facility: Research Site
city: Rumst
country: Belgium
facility: Research Site
city: Saint-Ghislain
country: Belgium
facility: Research Site
city: Seraing
country: Belgium
facility: Research Site
city: Sint-Amands
country: Belgium
facility: Research Site
city: Thuillies
country: Belgium
facility: Research Site
city: Tremelo
country: Belgium
facility: Research Site
city: Turnhout
country: Belgium
facility: Research Site
city: Veurne
country: Belgium
facility: Research Site
city: Vilvoorde
country: Belgium
facility: Research Site
city: Zoersel
country: Belgium
facility: Research Site
city: Arches
country: France
facility: Research Site
city: Art Sur Meurthe
country: France
facility: Research Site
city: Aubagne
country: France
facility: Research Site
city: Banyuls Sur Mer
country: France
facility: Research Site
city: Bassussarry
country: France
facility: Research Site
city: Cappelle En Pevele
country: France
facility: Research Site
city: Castets
country: France
facility: Research Site
city: Champagnole
country: France
facility: Research Site
city: Charvieu Chavagneux
country: France
facility: Research Site
city: Colmar
country: France
facility: Research Site
city: Couzeix
country: France
facility: Research Site
city: Firminy
country: France
facility: Research Site
city: Fleury Sur Orne
country: France
facility: Research Site
city: Gallardon
country: France
facility: Research Site
city: Gelles
country: France
facility: Research Site
city: La Motte Servolex
country: France
facility: Research Site
city: Lambersart
country: France
facility: Research Site
city: Le Bois D Oingt
country: France
facility: Research Site
city: Le Bouscat
country: France
facility: Research Site
city: Le Cannet
country: France
facility: Research Site
city: Le Pontet
country: France
facility: Research Site
city: Le Russey
country: France
facility: Research Site
city: Lembach
country: France
facility: Research Site
city: Marles Les Mines
country: France
facility: Research Site
city: Marseille
country: France
facility: Research Site
city: Mensignac
country: France
facility: Research Site
city: Moreuil
country: France
facility: Research Site
city: Mourmelon Le Petit
country: France
facility: Research Site
city: Narbonne
country: France
facility: Research Site
city: Neuilly Les Dijon
country: France
facility: Research Site
city: Noyon
country: France
facility: Research Site
city: Paris
country: France
facility: Research Site
city: Pisany
country: France
facility: Research Site
city: Puyricard
country: France
facility: Research Site
city: Roissy En France
country: France
facility: Research Site
city: Salles
country: France
facility: Research Site
city: Sonchamp
country: France
facility: Research Site
city: St Cyr Sur Loire
country: France
facility: Research Site
city: St Esteve
country: France
facility: Research Site
city: St Martin de Crau
country: France
facility: Research Site
city: Ste Fortunade
country: France
facility: Research Site
city: Ste Severe Sur Indre
country: France
facility: Research Site
city: Toulon
country: France
facility: Research Site
city: Villejuif
country: France
facility: Research Site
city: Voisins Le Bretonneux
country: France
facility: Research Site
city: Waziers
country: France
facility: Research Site
city: Aiterhofen
country: Germany
facility: Research Site
city: Bad Salzuflen
country: Germany
facility: Research Site
city: Bergkamen
country: Germany
facility: Research Site
city: Blankenhain
country: Germany
facility: Research Site
city: Bockenem
country: Germany
facility: Research Site
city: Deggingen
country: Germany
facility: Research Site
city: Essen
country: Germany
facility: Research Site
city: Gortringen
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Koln
country: Germany
facility: Research Site
city: Lengerich
country: Germany
facility: Research Site
city: Lenne
country: Germany
facility: Research Site
city: Ludwigshafen
country: Germany
facility: Research Site
city: Offenbach
country: Germany
facility: Research Site
city: Potsdam
country: Germany
facility: Research Site
city: Reinfeld
country: Germany
facility: Research Site
city: Remscheid
country: Germany
facility: Research Site
city: Rodgau
country: Germany
facility: Research Site
city: Spaichingen
country: Germany
facility: Research Site
city: Stockach
country: Germany
facility: Research Site
city: Wangen
country: Germany
facility: Research Site
city: Wardenburg
country: Germany
facility: Research Site
city: Weinheim
country: Germany
facility: Research Site
city: Alexandroupolis
country: Greece
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Drama
country: Greece
facility: Research Site
city: Florina
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Karditsa
country: Greece
facility: Research Site
city: Kastoria
country: Greece
facility: Research Site
city: Kozani
country: Greece
facility: Research Site
city: Serres
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Trikala
country: Greece
facility: Research Site
city: Xanthi
country: Greece
facility: Research Site
city: Salerno
country: Italy
facility: Research Site
city: Varese
country: Italy
facility: Research Site
city: Viareggio
country: Italy
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Andijk
country: Netherlands
facility: Research Site
city: Bennebroek
country: Netherlands
facility: Research Site
city: Den Haag
country: Netherlands
facility: Research Site
city: Dordrecht
country: Netherlands
facility: Research Site
city: Ermelo
country: Netherlands
facility: Research Site
city: Lichtenvoorde
country: Netherlands
facility: Research Site
city: Lieshout
country: Netherlands
facility: Research Site
city: Losser
country: Netherlands
facility: Research Site
city: Nijmegen
country: Netherlands
facility: Research Site
city: Nijverdal
country: Netherlands
facility: Research Site
city: Rijswijk
country: Netherlands
facility: Research Site
city: Rilland-bath
country: Netherlands
facility: Research Site
city: Roelofarendsveen
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Soerendonk
country: Netherlands
facility: Research Site
city: Spijkenisse
country: Netherlands
facility: Research Site
city: Volendam
country: Netherlands
facility: Research Site
city: Woerden
country: Netherlands
facility: Research Site
city: Arnes
country: Norway
facility: Research Site
city: Baverbru
country: Norway
facility: Research Site
city: Eydehavn
country: Norway
facility: Research Site
city: Fornebu
country: Norway
facility: Research Site
city: Frogner
country: Norway
facility: Research Site
city: Hurdal
country: Norway
facility: Research Site
city: Kirkenaer
country: Norway
facility: Research Site
city: Lierskogen
country: Norway
facility: Research Site
city: Lillestrom
country: Norway
facility: Research Site
city: Mosterhamn
country: Norway
facility: Research Site
city: Nordlenangen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Rodal
country: Norway
facility: Research Site
city: Skien
country: Norway
facility: Research Site
city: Strommen
country: Norway
facility: Research Site
city: Svelvik
country: Norway
facility: Research Site
city: Tanager
country: Norway
facility: Research Site
city: Campotejar
country: Spain
facility: Research Site
city: Granada
country: Spain
facility: Research Site
city: Huelva
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Nigran
country: Spain
facility: Research Site
city: Tomino
country: Spain
facility: Research Site
city: Vigo
country: Spain
facility: Research Site
city: Dalby
country: Sweden
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Kristianstad
country: Sweden
facility: Research Site
city: Lidingo
country: Sweden
facility: Research Site
city: Limhamn
country: Sweden
facility: Research Site
city: Pitee
country: Sweden
facility: Research Site
city: Skanor
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Vonnes
country: Sweden
facility: Research Site
city: Ystad
country: Sweden
facility: Research Site
city: Baden
country: Switzerland
facility: Research Site
city: Basel
country: Switzerland
facility: Research Site
city: Brittnau
country: Switzerland
facility: Research Site
city: Buchs
country: Switzerland
facility: Research Site
city: Chiasso
country: Switzerland
facility: Research Site
city: Chur
country: Switzerland
facility: Research Site
city: Egg bei Zurich
country: Switzerland
facility: Research Site
city: Ilanz
country: Switzerland
facility: Research Site
city: Oberwil
country: Switzerland
facility: Research Site
city: Sarmenstorf
country: Switzerland
facility: Research Site
city: Schiers
country: Switzerland
facility: Research Site
city: St. Gallen
country: Switzerland
facility: Research Site
city: Wallisellen
country: Switzerland
facility: Research Site
city: Zurich
country: Switzerland
facility: Research Site
city: ?stanbul
country: Turkey
facility: Research Site
city: ?zmir
country: Turkey
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Antalya
country: Turkey
facility: Research Site
city: Ayd?n
country: Turkey
facility: Research Site
city: Bursa
country: Turkey
facility: Research Site
city: Diyarbak?r
country: Turkey
facility: Research Site
city: Elaz??
country: Turkey
facility: Research Site
city: Erzurum
country: Turkey
facility: Research Site
city: Eski?ehir
country: Turkey
facility: Research Site
city: Isparta
country: Turkey
facility: Research Site
city: Kastamonu
country: Turkey
facility: Research Site
city: Kayseri
country: Turkey
facility: Research Site
city: Konya
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
city: Trabzon
country: Turkey
facility: Research Site
city: Van
country: Turkey
facility: Research Site
city: Addlestone, Surrey
country: United Kingdom
facility: Research Site
city: Ashford, Middlesex
country: United Kingdom
facility: Research Site
city: Aston Clinton, Bucks
country: United Kingdom
facility: Research Site
city: Atherstone, Warwickshire
country: United Kingdom
facility: Research Site
city: Bangor, Northern Ireland
country: United Kingdom
facility: Research Site
city: Bath
country: United Kingdom
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Bradford-On-Avon, Wiltshire
country: United Kingdom
facility: Research Site
city: Cookstown, Northern Ireland
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Crawley, West Sussex
country: United Kingdom
facility: Research Site
city: Cumbernauld
country: United Kingdom
facility: Research Site
city: Frome, Wiltshire
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Harrow, Middlesex
country: United Kingdom
facility: Research Site
city: High Valleyfield, Fife
country: United Kingdom
facility: Research Site
city: Irvine
country: United Kingdom
facility: Research Site
city: Leamington Spa
country: United Kingdom
facility: Research Site
city: Maidenhead
country: United Kingdom
facility: Research Site
city: Motherwell
country: United Kingdom
facility: Research Site
city: New Stevenson
country: United Kingdom
facility: Research Site
city: Newcastle-upon-Tyne
country: United Kingdom
facility: Research Site
city: Pound Hill, Crawley
country: United Kingdom
facility: Research Site
city: Randalstown
country: United Kingdom
facility: Research Site
city: Sneinton, Nottingham
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Titchfield
country: United Kingdom
facility: Research Site
city: Trowbridge
country: United Kingdom
facility: Research Site
city: Warminster
country: United Kingdom
facility: Research Site
city: Watford
country: United Kingdom
facility: Research Site
city: Wellingborough
country: United Kingdom
facility: Research Site
city: Woolpit, Bury St Edmonds
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Medical Department.AstraZeneca Spain
name: Javier Nuevo, MSc
role: STUDY_DIRECTOR
References:
citation: 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.