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

Rheumatoid Arthritis (RA) Clinical Trial

— RATIONAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577563
• Other study ID #: NIS-PLA-XXX-2011/1
• Status: Completed
• Phase: N/A
• First received: April 2, 2012
• Last updated: May 13, 2013
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Human Research Bioethics CommitteeColombia: Institutional Review BoardMexico: Ethics CommitteeVenezuela: Institutional Ethical Commmittee or Indendent Ethical CommitteeMalaysia: Ministry of HealthPhilippines: Department of HealthThailand: Ethical CommitteeViet Nam: Ministry of HealthKorea: Korean Food and Drug AdministrationRussia: Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies
• Study type: Observational

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5383
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Argentina	Research Site	Avellaneda
Argentina	Research Site	Bahia Blanca
Argentina	Research Site	Banfield
Argentina	Research Site	Campana
Argentina	Research Site	Capital Federal
Argentina	Research Site	Corrientes
Argentina	Research Site	La Plata
Argentina	Research Site	Lujan
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Olivos
Argentina	Research Site	Parana
Argentina	Research Site	Rio Negro
Argentina	Research Site	Rosario
Argentina	Research Site	San Isidro
Argentina	Research Site	San Justo
Argentina	Research Site	San Luis
Argentina	Research Site	Santa Fe
Argentina	Research Site	Sarandi - Avellaneda
Argentina	Research Site	Tucuman
Argentina	Research Site	Venado Tuerto
Argentina	Research Site	Vicente Lopez
Colombia	Research Site	Bogota
Colombia	Research Site	Bucaramanga
Colombia	Research Site	Cali
Korea, Republic of	Research Site	Bucheon	Republic of Korea
Korea, Republic of	Research Site	Busan	Republic of Korea
Korea, Republic of	Research Site	Cheongju	Republic of Korea
Korea, Republic of	Research Site	Daegu	Republic of Korea
Korea, Republic of	Research Site	Hwasun-gun	Republic of Korea
Korea, Republic of	Research Site	Incheon	Republic of Korea
Korea, Republic of	Research Site	Jeonju	Republic of Korea
Korea, Republic of	Research Site	Seoul	Republic of Korea
Korea, Republic of	Research Site	Suwon	Republic of Korea
Korea, Republic of	Research Site	Ulsan	Republic of Korea
Korea, Republic of	Research Site	Wonju	Republic of Korea
Malaysia	Research Site	Putrajaya
Malaysia	Research Site	Selangor
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Boca el rio
Mexico	Research Site	Ciudad de Mexico
Mexico	Research Site	Cuernavaca
Mexico	Research Site	Durango
Mexico	Research Site	Guadalajara
Mexico	Research Site	Monterrey
Mexico	Research Site	Naucalpan
Mexico	Research Site	Saltillo
Mexico	Research Site	San Luis Potosi
Mexico	Research Site	Toluca
Mexico	Research Site	Tuxtla Gutierrez
Mexico	Research Site	Zapopan
Philippines	Research Site	Davao City
Philippines	Research Site	Manila
Russian Federation	Research Site	Barnaul	Russia
Russian Federation	Research Site	Chelyabinsk	Russia
Russian Federation	Research Site	Ekaterinburg	Russia
Russian Federation	Research Site	Electrostal	Russia
Russian Federation	Research Site	Irkutsk	Russia
Russian Federation	Research Site	Kazan	Russia
Russian Federation	Research Site	Kemerovo	Russia
Russian Federation	Research Site	Krasnodar	Russia
Russian Federation	Research Site	Krasnoyarsk	Russia
Russian Federation	Research Site	Moscow	Russia
Russian Federation	Research Site	N. Novgorod	Russia
Russian Federation	Research Site	Novosibirsk	Russia
Russian Federation	Research Site	Perm	Russia
Russian Federation	Research Site	Samara	Russia
Russian Federation	Research Site	St. Petersburg	Russia
Russian Federation	Research Site	Tumen	Russia
Russian Federation	Research Site	Ufa	Russia
Russian Federation	Research Site	Volgograd	Russia
Russian Federation	Research Site	Yaroslavl	Russia
Thailand	Research Site	Hat Yai
Thailand	Research Site	Klongluang
Thailand	Research Site	Muang
Thailand	Research Site	Prannok
Venezuela	Research Site	Barquisimeto
Venezuela	Research Site	Caracas
Venezuela	Research Site	Maracaibo
Venezuela	Research Site	Maturin
Venezuela	Research Site	Merida
Venezuela	Research Site	Porlamar
Venezuela	Research Site	Punto Fijo
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Colombia,  Korea, Republic of,  Malaysia,  Mexico,  Philippines,  Russian Federation,  Thailand,  Venezuela,  Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subject with age above 60 years.		Up to 4 weeks.	No
Primary	Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.		Up to 4 weeks.	No
Primary	Number of patients with previous ulcer history.		Up to 4 weeks.	No
Primary	Number of patients with previous ulcer bleeding history.		Up to 4 weeks.	No
Primary	Number of patients with history of dyspepsia.		Up to 4 weeks.	No
Secondary	Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.		Up to 4 weeks.	No
Secondary	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.	No
Secondary	Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.		Up to 4 weeks.	No
Secondary	Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis.		Up to 4 weeks.	No
Secondary	Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications.		Up to 4 weeks.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No
Secondary	Health Assessment Questionnaire (HAQ).	Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases.	Up to 4 weeks.	No