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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01176682

Acronym

EVIDENCE

Enrollment

1149

Registered

2010-08-06

Start date

2010-08-31

Completion date

2011-08-31

Last updated

2012-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis, Osteoarthritis, Rheumatoid Arthritis

Keywords

NSAID-treated patients, gastrointestinal events, Non-steroid anti-inflammatory drug (NSAID), Gastrointestinal events (GI events), Proton Pump Inhibitors (PPI)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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 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

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.	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

Countries

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

Outcome results