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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: April 2, 2012
Last updated: May 13, 2013
Last verified: May 2013

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).

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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Number of subject with age above 60 years. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
  • Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
  • Number of patients with previous ulcer history. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
  • Number of patients with previous ulcer bleeding history. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
  • Number of patients with history of dyspepsia. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
  • Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis. [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Gastrointestinal Symptoms Rating Scale (GSRS). [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
    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). [ Time Frame: Up to 4 weeks. ] [ Designated as safety issue: No ]
    Comprehensive measure of outcome in patients with a wide variety of rheumatic diseases.

Enrollment: 5383
Study Start Date: May 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01577563

  Show 85 Study Locations
Sponsors and Collaborators
Study Chair: Gustavo Citera, Rheumatologist Universidad Nacional de Buenos Aires. Argentina
  More Information

No publications provided

Responsible Party: AstraZeneca Identifier: NCT01577563     History of Changes
Other Study ID Numbers: NIS-PLA-XXX-2011/1
Study First Received: April 2, 2012
Last Updated: May 13, 2013
Health Authority: Argentina: Human Research Bioethics Committee
Colombia: Institutional Review Board
Mexico: Ethics Committee
Venezuela: Institutional Ethical Commmittee or Indendent Ethical Committee
Malaysia: Ministry of Health
Philippines: Department of Health
Thailand: Ethical Committee
Viet Nam: Ministry of Health
Korea: Korean Food and Drug Administration
Russia: Independent Interdisciplinary Ethics Committee on Ethical Review for Clinical Studies

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
Anti-Inflammatory Agents, Non-Steroidal
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents processed this record on April 16, 2014