Osteoarthritis (OA)RATIONALNCT01577563
Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).
An observational study of Osteoarthritis (OA) and Rheumatoid Arthritis (RA), run by AstraZeneca at 85 sites in 10 countries.
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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis (OA), Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS)
- How many people
- 5,383 participants
- Where
- 85 sitesin 10 countries
- Study dates
- May 2012to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
85 sites in 10 countries.
85 sites in 10 countries
Argentina22 sites
Research Site
Avellaneda, Argentina
Research Site
Bahía 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
Luján, Argentina
Research Site
Mar del Plata, Argentina
Research Site
Mendoza, Argentina
Research Site
Olivos, Argentina
Research Site
Paraná, 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
San Miguel de Tucumán, Argentina
Research Site
Santa Fe, Argentina
Research Site
Sarandi - Avellaneda, Argentina
Research Site
Venado Tuerto, Argentina
Research Site
Vicente López, Argentina
Russia19 sites
Research Site
Barnaul, Russia
Research Site
Chelyabinsk, Russia
Research Site
Electrostal, Russia
Research Site
Irkutsk, Russia
Research Site
Kazan', Russia
Research Site
Kemerovo, Russia
Research Site
Krasnodar, Russia
Research Site
Krasnoyarsk, Russia
Research Site
Moscow, Russia
Research Site
Nizhny Novgorod, Russia
Research Site
Novosibirsk, Russia
Research Site
Perm, Russia
Research Site
Saint Petersburg, Russia
Research Site
Samara, Russia
Research Site
Tyumen, Russia
Research Site
Ufa, Russia
Research Site
Volgograd, Russia
Research Site
Yaroslavl, Russia
Research Site
Yekaterinburg, Russia
Mexico13 sites
Research Site
Aguascalientes, Mexico
Research Site
Boca El Rio, Mexico
Research Site
Cuernavaca, Mexico
Research Site
Durango, Mexico
Research Site
Guadalajara, Mexico
Research Site
Mexico City, Mexico City
Research Site
Monterrey, Mexico
Research Site
Naucalpan, State of Mexico
Research Site
Saltillo, Mexico
Research Site
San Luis Potosi, Mexico
Research Site
Toluca, State of Mexico
Research Site
Tuxtla Gutierrez, Mexico
Research Site
Zapopan, Mexico
South Korea11 sites
Research Site
Bucheon-si, Republic of Korea
Research Site
Busan, Republic of Korea
Research Site
Cheongju-si, Republic of Korea
Research Site
Daegu, Republic of Korea
Research Site
Hwasun-gun, Republic of Korea
Research Site
Incheon, Republic of Korea
Research Site
Jeonju, Republic of Korea
Research Site
Seoul, Republic of Korea
Research Site
Suwon, Republic of Korea
Research Site
Ulsan, Republic of Korea
Research Site
Wŏnju, Republic of Korea
Venezuela7 sites
Research Site
Barquisimeto, Venezuela
Research Site
Caracas, Venezuela
Research Site
Maracaibo, Venezuela
Research Site
Maturín, Venezuela
Research Site
Mérida, Venezuela
Research Site
Porlamar, Venezuela
Research Site
Punto Fijo, Venezuela
Thailand4 sites
Research Site
Hat Yai, Thailand
Research Site
Klongluang, Thailand
Research Site
Muang, Thailand
Research Site
Prannok, Thailand
Colombia3 sites
Research Site
Bogotá, Colombia
Research Site
Bucaramanga, Colombia
Research Site
Cali, Colombia
Philippines2 sites
Research Site
Davao City, Philippines
Research Site
Manila, Philippines
About this study
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.
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).
Read the 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.
- Keywords
- osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), gastrointestinal risk factors, NSAIDs
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Spondylitis, Ankylosing
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subject with age above 60 years.
Measured: Up to 4 weeks.
Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.
Measured: Up to 4 weeks.
Number of patients with previous ulcer history.
Measured: Up to 4 weeks.
Number of patients with previous ulcer bleeding history.
Measured: Up to 4 weeks.
Number of patients with history of dyspepsia.
Measured: Up to 4 weeks.
Secondary outcomes (11)
Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.
Measured: 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.
Measured: Up to 4 weeks.
Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.
Measured: Up to 4 weeks.
Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis.
Measured: Up to 4 weeks.
Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Up to 4 weeks.
Health Assessment Questionnaire (HAQ).
Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases.
Measured: Up to 4 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis (OA)Studies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 5,383 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gustavo Citera, Rheumatologist, Study chair, Universidad Nacional de Buenos Aires. Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577563
- Sponsor's protocol ID
- NIS-PLA-XXX-2011/1
- Acronym
- RATIONAL
- Status last verified
- May 2013
- First submitted
- 2 Apr 2012
- Last updated
- 14 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01577563
- Acronym / sponsor ID
- RATIONAL / NIS-PLA-XXX-2011/1
- Keywords
- osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis (AS), gastrointestinal risk factors, NSAIDs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,383 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subject with age above 60 years.
Time frame: Up to 4 weeks.
Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.
Time frame: Up to 4 weeks.
Number of patients with previous ulcer history.
Time frame: Up to 4 weeks.
Number of patients with previous ulcer bleeding history.
Time frame: Up to 4 weeks.
Number of patients with history of dyspepsia.
Time frame: Up to 4 weeks.
11 secondary outcomes
Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.
Time frame: 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.
Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.
Time frame: 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.
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.
Gastrointestinal Symptoms Rating Scale (GSRS).
Time frame: Up to 4 weeks.
Treatment Satisfaction for medication for OA patients (TSQM).
Time frame: Up to 4 weeks.
Treatment adherence (Morisky Medication Assessment Scale- MMAs-4).
Time frame: Up to 4 weeks.
Patient Quality of Life (EQ-5D).
Time frame: Up to 4 weeks.
Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1).
Time frame: Up to 4 weeks.
Health Assessment Questionnaire (HAQ).
Time frame: Up to 4 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
Related trials for Osteoarthritis (OA)
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Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingPhase 3
A Study to Learn About Study Medicine Called Berobenatide in Adults With Knee Pain and Overweight or Obesity (VESPER-OA 1)
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RecruitingPhase 3
A Study to Learn About Berobenatide Given Once Weekly in Adults With Knee Osteoarthritis and Overweight or Obesity With or Without Type 2 Diabetes (VESPER-OA 2)
Obesity, Overweight and/or Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustavo Citera, Rheumatologist study chair
Universidad Nacional de Buenos Aires. Argentina
85 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis (OA) and Rheumatoid Arthritis (RA), run by AstraZeneca at 85 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 85 sites in Argentina, Russia, Mexico, South Korea, Venezuela and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subject with age above 60 years. (time frame: Up to 4 weeks.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2013.