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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Spinal Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on February 11, 2016