Ankylosing Spondylitis (AS), Osteoarthritis (OA), Rheumatoid Arthritis (RA)
Conditions
Keywords
osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), gastrointestinal risk factors, NSAIDs
Brief summary
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
Prevalence study of gastrointestinal risk factors in patients with osteoarthritis, rheumatoid arthritis and ankylosing spondylitis receiving treatment with non- steroidal anti- inflammatory drugs.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| Gastrointestinal Symptoms Rating Scale (GSRS). | Up to 4 weeks. | Rating scale for gastrointestinal symptoms in patients, consisting of five areas: reflux syndrome, abdominal pain, constipation syndrome, diarrhoea syndrome and indigestion syndrome. |
| Treatment Satisfaction for medication for OA patients (TSQM). | Up to 4 weeks. | Assessment of patients' satisfaction with medication, providing scores on four scales: side effects, effectiveness, convenience and global satisfaction. |
| Treatment adherence (Morisky Medication Assessment Scale- MMAs-4). | Up to 4 weeks. | 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). |
| Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status. | Up to 4 weeks. | — |
| Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1). | Up to 4 weeks. | 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). |
| Health Assessment Questionnaire (HAQ). | Up to 4 weeks. | Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases. |
| Patient Quality of Life (EQ-5D). | Up to 4 weeks. | 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. |
| 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. | — |
Countries
Argentina, Colombia, Malaysia, Mexico, Philippines, Russia, South Korea, Thailand, Venezuela, Vietnam
Outcome results
None listed