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

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.

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Key information

Conditions

Osteoarthritis Ankylosing Spondylitis Ankylosis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Axial Spondyloarthritis Bone Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Rheumatoid Arthritis Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Alsemberg, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: EVIDENCE

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Aug 6, 2010
Registry last updated: Jun 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed