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

An observational study of Osteoarthritis and Rheumatoid Arthritis, run by AstraZeneca at 244 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis, Rheumatoid Arthritis, Ankylosing Spondylitis
How many people: 1,149 participants
Where: 244 sitesin 12 countries
Study dates: Aug 2010to Aug 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

244 sites in 12 countries.

Country

City, postcode or hospital

244 sites in 12 countries

France46 sites

Research Site
Arches
Research Site
Art-sur-Meurthe
Research Site
Aubagne
Research Site
Banyuls de la Marenda
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Bassussarry
Research Site
Cappelle-en-Pévèle
Research Site
Castets
Research Site
Champagnole
Research Site
Charvieu-Chavagneux
Research Site
Colmar
Research Site
Couzeix
Research Site
Firminy
Research Site
Fleury-sur-Orne
Research Site
Gallardon
Research Site
Gelles
Research Site
La Motte-Servolex
Research Site
Lambersart
Research Site
Le Bois-dOingt
Research Site
Le Bouscat
Research Site
Le Cannet
Research Site
Le Pontet
Research Site
Le Russey
Research Site
Lembach
Research Site
Marles-les-Mines
Research Site
Marseille
Research Site
Mensignac
Research Site
Moreuil
Research Site
Mourmelon-le-Petit
Research Site
Narbonne
Research Site
Neuilly-lès-Dijon
Research Site
Noyon
Research Site
Paris
Research Site
Pisany
Research Site
Puyricard
Research Site
Roissy-en-France
Research Site
Saint-Cyr-sur-Loire
Research Site
Saint-Estève
Research Site
Saint-Martin-de-Crau
Research Site
Salles
Research Site
Sonchamp
Research Site
Ste Fortunade
Research Site
Ste Severe Sur Indre
Research Site
Toulon
Research Site
Villejuif
Research Site
Voisins-le-Bretonneux
Research Site
Waziers

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Belgium43 sites

Research Site
Alsemberg
Research Site
Anthée
Research Site
Baisy-Thy
Research Site
Blankenberge
Research Site
Bois-de-Villers
Research Site
Brussels
Research Site
Champion
Research Site
Chênée
Research Site
Dour
Research Site
Ecaussinnes
Research Site
Fosses-la-Ville
Research Site
Geel
Research Site
Genly
Research Site
Godinne
Research Site
Gozée
Research Site
Gribomont
Research Site
Halen
Research Site
Ham-sur-Heure-Nalinnes
Research Site
Hasselt
Research Site
Hove
Research Site
Kraainem
Research Site
Libramont-Chevigny
Research Site
Linkebeek
Research Site
Lommel
Research Site
Marchovelette
Research Site
Melsbroek
Research Site
Moerkerke-Damme
Research Site
Mont-sur-Marchienne
Research Site
Mouscron
Research Site
Natoye
Research Site
Oostham
Research Site
Retie
Research Site
Ronquières
Research Site
Rumst
Research Site
Saint-Ghislain
Research Site
Seraing
Research Site
Sint-Amands
Research Site
Thuillies
Research Site
Tremelo
Research Site
Turnhout
Research Site
Veurne
Research Site
Vilvoorde
Research Site
Zoersel

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United Kingdom33 sites

Research Site
Addlestone, Surrey
Research Site
Ashford, Middlesex
Research Site
Aston Clinton, Bucks
Research Site
Atherstone, Warwickshire
Research Site
Bangor, Northern Ireland
Research Site
Bath
Research Site
Belfast
Research Site
Birmingham
Research Site
Bradford-On-Avon, Wiltshire
Research Site
Cookstown, Northern Ireland
Research Site
Coventry
Research Site
Crawley, West Sussex
Research Site
Cumbernauld
Research Site
Frome, Wiltshire
Research Site
Glasgow
Research Site
Harrow, Middlesex
Research Site
High Valleyfield, Fife
Research Site
Irvine
Research Site
Maidenhead
Research Site
Motherwell
Research Site
New Stevenson
Research Site
Newcastle upon Tyne
Research Site
Pound Hill, Crawley
Research Site
Randalstown
Research Site
Royal Leamington Spa
Research Site
Sneinton, Nottingham
Research Site
Stevenage
Research Site
Titchfield
Research Site
Trowbridge
Research Site
Warminster
Research Site
Watford
Research Site
Wellingborough
Research Site
Woolpit, Bury Saint Edmonds

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Germany23 sites

Research Site
Aiterhofen, 94330
Research Site
Bad Salzuflen, 32108
Research Site
Bergkamen, 59192
Research Site
Blankenhain, 99444
Research Site
Bockenem, 31167
Research Site
Cologne, 51069
Research Site
Deggingen, 73326
Research Site
Essen, 45279
Research Site
Gortringen, 71116
Research Site
Hamburg, 20354
Research Site
Lengerich, 49525
Research Site
Lenne, 32584
Research Site
Ludwigshafen, 67067
Research Site
Offenbach, 63073
Research Site
Potsdam, 14482
Research Site
Reinfeld, 23858
Research Site
Remscheid, 42855
Research Site
Rodgau, 63110
Research Site
Spaichingen, 78549
Research Site
Stockach, 78333
Research Site
Wangen, 88239
Research Site
Wardenburg, 26203
Research Site
Weinheim, 69469

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Netherlands19 sites

Research Site
Amsterdam
Research Site
Andijk
Research Site
Bennebroek
Research Site
Dordrecht
Research Site
Ermelo
Research Site
Lichtenvoorde
Research Site
Lieshout
Research Site
Losser
Research Site
Nijmegen
Research Site
Nijverdal
Research Site
Rijswijk
Research Site
Rilland
Research Site
Roelofarendsveen
Research Site
Rotterdam
Research Site
Soerendonk
Research Site
Spijkenisse
Research Site
The Hague
Research Site
Volendam
Research Site
Woerden

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Norway17 sites

Research Site
Årnes
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Baverbru
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Eydehavn
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Fornebu
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Frogner
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Hurdal
Research Site
Kirkenær
Research Site
Lierskogen
Research Site
Lillestrøm
Research Site
Mosterhamn
Research Site
Nordlenangen
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Oslo
Research Site
Rodal
Research Site
Skien
Research Site
Strømmen
Research Site
Svelvik
Research Site
Tanager

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Turkey (Türkiye)17 sites

Research Site
?stanbul
Research Site
?zmir
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Ankara
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Antalya
Research Site
Aydin
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Bursa
Research Site
Diyarbak?r
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Elaz??
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Erzurum
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Eski?ehir
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Isparta
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Kastamonu
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Kayseri
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Konya
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Manisa
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Trabzon
Research Site
Van

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Switzerland14 sites

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Baden
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Basel
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Brittnau
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Buchs
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Chiasso
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Chur
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Egg Bei Zurich
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Ilanz
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Oberwil
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Sankt Gallen
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Sarmenstorf
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Schiers
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Wallisellen
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Zurich

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Greece12 sites

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Alexandroupoli
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Athens
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Drama
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Florina
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Heraklion
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Karditsa
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Kastoria
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Kozani
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Serres
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Thessaloniki
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Trikala
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Xánthi

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Sweden10 sites

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Dalby
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Gothenburg
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Kristianstad
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Lidingö
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Limhamn
Research Site
Pitee
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Skanör
Research Site
Stockholm
Research Site
Vonnes
Research Site
Ystad

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Spain7 sites

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Campotéjar
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Granada
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Huelva
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Málaga
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Nigrán
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Tomiño
Research Site
Vigo

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Italy3 sites

Research Site
Salerno
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Varese
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Viareggio

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About this study

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

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)
Medical subject headings: Osteoarthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01176682
Study group	Role	What they receive
1		Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors

What is being measured

The primary outcome is the main question the study is designed to answer.

The incidence of selected GI events, classified as "symptomatic" or "complicated" GI events. Reported by the patients at the follow-up visits.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Measurements at baseline, 3 months and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2010Aug 2011

First posted6 Aug 2010 (estimated)
Study startAug 2010
Primary completionAug 2011
Study completionAug 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,149 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01176682
Sponsor's protocol ID: NIS-GEU-DUM-2010/1
Acronym: EVIDENCE
Status last verified: Jun 2012
First submitted: 30 Jul 2010
Last updated: 6 Jun 2012
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 24351518

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01176682
Acronym / sponsor ID: EVIDENCE / NIS-GEU-DUM-2010/1
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)
Study type: Observational
Recruitment status: Completed
Enrolment: 1,149 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2010
Primary completion: Aug 2011 (actual)
Study completion: Aug 2011 (actual)
First posted: 6 Aug 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	–Adult patients treated with NSAID therapy for diagnosed OA, RA or AS, and with GI risk factors

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

3 secondary outcomes

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.
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
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2012.
Derived from this study: PubMed 24351518Lanas 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.

Related trials for Osteoarthritis

Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Javier Nuevo, MSc study director

Medical Department.AstraZeneca Spain

244 sites in 12 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Osteoarthritis and Rheumatoid Arthritis, run by AstraZeneca at 244 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 244 sites in France, Belgium, United Kingdom, Germany, Netherlands and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01176682, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2012.