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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01577563
Recruitment Status : Completed
First Posted : April 16, 2012
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):

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).

Condition or disease
Osteoarthritis (OA) Rheumatoid Arthritis (RA) Ankylosing Spondylitis (AS)

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 : Observational
Actual Enrollment : 5383 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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.
Study Start Date : May 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Primary Outcome Measures :
  1. Number of subject with age above 60 years. [ Time Frame: Up to 4 weeks. ]
  2. Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs. [ Time Frame: Up to 4 weeks. ]
  3. Number of patients with previous ulcer history. [ Time Frame: Up to 4 weeks. ]
  4. Number of patients with previous ulcer bleeding history. [ Time Frame: Up to 4 weeks. ]
  5. Number of patients with history of dyspepsia. [ Time Frame: Up to 4 weeks. ]

Secondary Outcome Measures :
  1. Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status. [ Time Frame: Up to 4 weeks. ]
  2. 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. ]
  3. Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI. [ Time Frame: Up to 4 weeks. ]
  4. Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis. [ Time Frame: Up to 4 weeks. ]
  5. 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. ]
  6. 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.

  7. 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.

  8. 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).

  9. 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.

  10. 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).

  11. Health Assessment Questionnaire (HAQ). [ Time Frame: Up to 4 weeks. ]
    Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01577563

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Sponsors and Collaborators
Study Chair: Gustavo Citera, Rheumatologist Universidad Nacional de Buenos Aires. Argentina

Responsible Party: AstraZeneca Identifier: NCT01577563     History of Changes
Other Study ID Numbers: NIS-PLA-XXX-2011/1
First Posted: April 16, 2012    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by AstraZeneca:
osteoarthritis (OA)
rheumatoid arthritis (RA)
ankylosing spondylitis (AS)
gastrointestinal risk factors

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents