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

May 13, 2013 updated by: AstraZeneca

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5383

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • 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, Argentina
        • Research Site
  • Colombia
      • Bogota, Colombia
        • Research Site
      • Bucaramanga, Colombia
        • Research Site
      • Cali, Colombia
        • Research Site
  • Korea, Republic of
    • Republic of Korea
      • 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, Korea, Republic of
        • Research Site
  • Malaysia
      • Putrajaya, Malaysia
        • Research Site
      • Selangor, Malaysia
        • Research Site
  • Mexico
      • 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, Mexico
        • Research Site
  • Philippines
      • Davao City, Philippines
        • Research Site
      • Manila, Philippines
        • Research Site
  • Russian Federation
    • Russia
      • 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, Russian Federation
        • Research Site
  • Thailand
      • Hat Yai, Thailand
        • Research Site
      • Klongluang, Thailand
        • Research Site
      • Muang, Thailand
        • Research Site
      • Prannok, Thailand
        • Research Site
  • Venezuela
      • 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, Venezuela
        • Research Site
  • Vietnam
      • Hanoi, Vietnam
        • Research Site
      • Ho Chi Minh, Vietnam
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients over 21 years old, diagnosed with OA, RA or AS who are receiving at least one dose of NSAIDs for at least 2 weeks (15 days) before study visit, who attend to primary care centres, specialists offices, hospitals, private centres, urban or rural.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of subject with age above 60 years.
Time Frame: Up to 4 weeks.
Up to 4 weeks.
Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.
Time Frame: Up to 4 weeks.
Up to 4 weeks.
Number of patients with previous ulcer history.
Time Frame: Up to 4 weeks.
Up to 4 weeks.
Number of patients with previous ulcer bleeding history.
Time Frame: Up to 4 weeks.
Up to 4 weeks.
Number of patients with history of dyspepsia.
Time Frame: Up to 4 weeks.
Up to 4 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.
Time Frame: Up to 4 weeks.
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.
Time Frame: Up to 4 weeks.
Up to 4 weeks.
Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.
Time Frame: Up to 4 weeks.
Up to 4 weeks.
Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis.
Time Frame: Up to 4 weeks.
Up to 4 weeks.
Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications.
Time Frame: Up to 4 weeks.
Up to 4 weeks.
Gastrointestinal Symptoms Rating Scale (GSRS).
Time Frame: 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.
Up to 4 weeks.
Treatment Satisfaction for medication for OA patients (TSQM).
Time Frame: Up to 4 weeks.
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).
Time Frame: 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).
Up to 4 weeks.
Patient Quality of Life (EQ-5D).
Time Frame: 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.
Up to 4 weeks.
Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1).
Time Frame: 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).
Up to 4 weeks.
Health Assessment Questionnaire (HAQ).
Time Frame: Up to 4 weeks.
Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases.
Up to 4 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Gustavo Citera, Rheumatologist, Universidad Nacional de Buenos Aires. Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIS-PLA-XXX-2011/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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