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

Rheumatoid Arthritis Clinical Trial

— EVIDENCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176682
• Other study ID #: NIS-GEU-DUM-2010/1
• Status: Completed
• Phase: N/A
• First received: July 30, 2010
• Last updated: June 5, 2012
• Start date: August 2010
• Est. completion date: August 2011

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardFrance: National Consultative Ethics Committee for Health and Life SciencesFrance: French Data Protection AuthorityGermany: Ethics CommissionGreece: Ethics CommitteeGreece: Ministry of Health and WelfareItaly: Ethics CommitteeNetherlands: Independent Ethics CommitteeNorway:National Committee for Medical and Health Research EthicsPortugal: Ethics Committee for Clinical ResearchSpain: Ethics CommitteeSweden: Regional Ethical Review BoardSwitzerland: EthikkommissionTurkey: Ministry of HealthUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1149
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Rheumatoid
• Osteoarthritis
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Belgium	Research Site	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	Research Site	Champion
Belgium	Research Site	Chenee
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	Gozee
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	Ronquieres
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
France	Research Site	Arches
France	Research Site	Art Sur Meurthe
France	Research Site	Aubagne
France	Research Site	Banyuls Sur Mer
France	Research Site	Bassussarry
France	Research Site	Cappelle En Pevele
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 D Oingt
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 Les 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	Salles
France	Research Site	Sonchamp
France	Research Site	St Cyr Sur Loire
France	Research Site	St Esteve
France	Research Site	St Martin de Crau
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
Germany	Research Site	Aiterhofen
Germany	Research Site	Bad Salzuflen
Germany	Research Site	Bergkamen
Germany	Research Site	Blankenhain
Germany	Research Site	Bockenem
Germany	Research Site	Deggingen
Germany	Research Site	Essen
Germany	Research Site	Gortringen
Germany	Research Site	Hamburg
Germany	Research Site	Koln
Germany	Research Site	Lengerich
Germany	Research Site	Lenne
Germany	Research Site	Ludwigshafen
Germany	Research Site	Offenbach
Germany	Research Site	Potsdam
Germany	Research Site	Reinfeld
Germany	Research Site	Remscheid
Germany	Research Site	Rodgau
Germany	Research Site	Spaichingen
Germany	Research Site	Stockach
Germany	Research Site	Wangen
Germany	Research Site	Wardenburg
Germany	Research Site	Weinheim
Greece	Research Site	Alexandroupolis
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	Xanthi
Italy	Research Site	Salerno
Italy	Research Site	Varese
Italy	Research Site	Viareggio
Netherlands	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	Research Site	Soerendonk
Netherlands	Research Site	Spijkenisse
Netherlands	Research Site	Volendam
Netherlands	Research Site	Woerden
Norway	Research Site	Arnes
Norway	Research Site	Baverbru
Norway	Research Site	Eydehavn
Norway	Research Site	Fornebu
Norway	Research Site	Frogner
Norway	Research Site	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
Spain	Research Site	Campotejar
Spain	Research Site	Granada
Spain	Research Site	Huelva
Spain	Research Site	Malaga
Spain	Research Site	Nigran
Spain	Research Site	Tomino
Spain	Research Site	Vigo
Sweden	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
Switzerland	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
Turkey	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
United Kingdom	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	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	Research Site	Warminster
United Kingdom	Research Site	Watford
United Kingdom	Research Site	Wellingborough
United Kingdom	Research Site	Woolpit, Bury St Edmonds

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Greece,  Italy,  Netherlands,  Norway,  Spain,  Sweden,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	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	No
Secondary	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	No