Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).

Study Overview
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Brief Summary
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RATIONAL is a multinational, multicentre, observational, cross sectional study of adult patients in treatment with NSAID therapy for OA, RA or AS during for at least 2 weeks before study visit (at least one dose).

Detailed Description
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Prevalence study of gastrointestinal risk factors in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving treatment with non- steroidal anti- inflammatory drugs.

Official Title
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Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis, Rheumatoid Arthritis and Ankylosing Spondylitis Receiving Treatment With Non- Steroidal Anti- Inflammatory Drugs.

Conditions
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Osteoarthritis (OA), Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS)

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of subject informed consent. Female and/or male, aged > 21 years. Patients diagnosis with RA (ACR 1987 or ACR/EULAR 2010 criteria), OA (ACR 1986, 1990 and 1991 criteria) or AS (New York 1984 criteria or ESSG 2002 criteria) (documented in the medical record). Patients receiving at least one dose of NSAIDs. Exclusion Criteria: Participation in any interventional study involving investigational drugs. Patient refuses to fill in the study questionnaires. Pregnant or breastfeeding women. Patients with active neoplastic disease in the last 5 years, except basal-cell carcinoma.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subject with age above 60 years. |  | Up to 4 weeks. | 
| Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs. |  | Up to 4 weeks. | 
| Number of patients with previous ulcer history. |  | Up to 4 weeks. | 
| Number of patients with previous ulcer bleeding history. |  | Up to 4 weeks. | 
| Number of patients with history of dyspepsia. |  | Up to 4 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status. |  | Up to 4 weeks. | 
| Descriptive profile of medical history: nicotine use, relevant medical conditions, history peptic ulcer, chronic drug therapy related to relevant medical conditions. |  | Up to 4 weeks. | 
| Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI. |  | Up to 4 weeks. | 
| Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis. |  | Up to 4 weeks. | 
| Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications. |  | Up to 4 weeks. | 
| Gastrointestinal Symptoms Rating Scale (GSRS). | Rating scale for gastrointestinal symptoms in patients, consisting of five areas: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. | Up to 4 weeks. | 
| Treatment Satisfaction for medication for OA patients (TSQM). | Assessment of patients' satisfaction with medication, providing scores on four scales: side effects, effectiveness, convenience and global satisfaction. | Up to 4 weeks. | 
| Treatment adherence (Morisky Medication Assessment Scale- MMAs-4). | A generic self-reported, medication-taking behaviour scale in which the specific health issue (e.g. rheumatic pain and dyspepsia) is inserted for the health concern. The MMAS-4 consists of four items with a scoring scheme of Yes = 0 and No = 1. The items are added together to give a range of scores from low adherence to high adherence (0 to 4). | Up to 4 weeks. | 
| Patient Quality of Life (EQ-5D). | The questionnaire consists of 2 aspects: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems and severe problems. | Up to 4 weeks. | 
| Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1). | Osteoarthritis Index, self-administered, to report health status which is designed to capture elements of pain, stiffness and physical disability in patients with OA of the knee and/or hip joints. The index consists of 24 questions (5 questions about pain, 2 on stiffness and 17 about physical function). | Up to 4 weeks. | 
| Health Assessment Questionnaire (HAQ). | Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases. | Up to 4 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), gastrointestinal risk factors, NSAIDs