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

Completed

• Conditions: Osteoarthritis (OA); Rheumatoid Arthritis (RA); Ankylosing Spondylitis (AS)

• Registration Number: NCT01577563
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-13
• Study First Posted: 2012-04-16
• Study Start: 2012-05
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-13
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5383

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).	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).
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.
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.

Trial Locations

Locations (1)

Research Site; 🇻🇳 Ho Chi Minh, Vietnam