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

NCT01577563 | Completed

• 1 other identifier: NIS-PLA-XXX-2011/1
• Study Type: observational
• Target: 5,383
• Locations: 10 countries
• Sites: 85

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).

Conditions

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

Keywords

osteoarthritis (OA); rheumatoid arthritis (RA); ankylosing spondylitis (AS); gastrointestinal risk factors; NSAIDs

Outcome Measures

Primary Outcomes (5)

• Number of subject with age above 60 years.

  Up to 4 weeks.

• Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.

  Up to 4 weeks.

• Number of patients with previous ulcer history.

  Up to 4 weeks.

• Number of patients with previous ulcer bleeding history.

  Up to 4 weeks.

• Number of patients with history of dyspepsia.

  Up to 4 weeks.

Secondary Outcomes (11)

• Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.

  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.

  Up to 4 weeks.

• Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.

  Up to 4 weeks.

• Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis.

  Up to 4 weeks.

• Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications.

  Up to 4 weeks.

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (85)

Research Site

Avellaneda, Argentina, Argentina

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Bahía Blanca, Argentina, Argentina

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Banfield, Argentina, Argentina

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Campana, Argentina, Argentina

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Capital Federal, Argentina, Argentina

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Corrientes, Argentina, Argentina

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La Plata, Argentina, Argentina

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Luján, Argentina, Argentina

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Mar del Plata, Argentina, Argentina

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Mendoza, Argentina, Argentina

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Olivos, Argentina, Argentina

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Paraná, Argentina, Argentina

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Rio Negro, Argentina, Argentina

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Rosario, Argentina, Argentina

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San Isidro, Argentina, Argentina

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San Justo, Argentina, Argentina

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San Luis, Argentina, Argentina

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San Miguel de Tucumán, Argentina, Argentina

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Santa Fe, Argentina, Argentina

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Sarandi - Avellaneda, Argentina, Argentina

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Venado Tuerto, Argentina, Argentina

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Vicente López, Argentina, Argentina

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Bogotá, Colombia, Colombia

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Bucaramanga, Colombia, Colombia

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Cali, Colombia, Colombia

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Kuala Selangor, Malaysia

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Putrajaya, Malaysia

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Mexico City, Mexico City, Mexico

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Aguascalientes, Mexico, Mexico

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Boca El Rio, Mexico, Mexico

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Cuernavaca, Mexico, Mexico

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Durango, Mexico, Mexico

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Guadalajara, Mexico, Mexico

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Monterrey, Mexico, Mexico

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Saltillo, Mexico, Mexico

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San Luis Potosi, Mexico, Mexico

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Tuxtla Gutierrez, Mexico, Mexico

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Zapopan, Mexico, Mexico

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Naucalpan, State of Mexico, Mexico

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Toluca, State of Mexico, Mexico

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Davao City, Philippines, Philippines

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Manila, Philippines, Philippines

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Barnaul, Russia, Russia

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Chelyabinsk, Russia, Russia

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Electrostal, Russia, Russia

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Irkutsk, Russia, Russia

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Kazan', Russia, Russia

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Kemerovo, Russia, Russia

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Krasnodar, Russia, Russia

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Krasnoyarsk, Russia, Russia

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Moscow, Russia, Russia

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Nizhny Novgorod, Russia, Russia

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Novosibirsk, Russia, Russia

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Perm, Russia, Russia

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Saint Petersburg, Russia, Russia

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Samara, Russia, Russia

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Tyumen, Russia, Russia

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Ufa, Russia, Russia

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Volgograd, Russia, Russia

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Yaroslavl, Russia, Russia

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Yekaterinburg, Russia, Russia

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Bucheon-si, Republic of Korea, South Korea

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Busan, Republic of Korea, South Korea

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Cheongju-si, Republic of Korea, South Korea

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Daegu, Republic of Korea, South Korea

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Hwasun-gun, Republic of Korea, South Korea

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Incheon, Republic of Korea, South Korea

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Jeonju, Republic of Korea, South Korea

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Seoul, Republic of Korea, South Korea

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Suwon, Republic of Korea, South Korea

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Ulsan, Republic of Korea, South Korea

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Wŏnju, Republic of Korea, South Korea

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Hat Yai, Thailand, Thailand

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Klongluang, Thailand, Thailand

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Muang, Thailand, Thailand

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Prannok, Thailand, Thailand

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Barquisimeto, Venezuela, Venezuela

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Caracas, Venezuela, Venezuela

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Maracaibo, Venezuela, Venezuela

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Maturín, Venezuela, Venezuela

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Mérida, Venezuela, Venezuela

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Porlamar, Venezuela, Venezuela

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Punto Fijo, Venezuela, Venezuela

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam

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MeSH Terms

Conditions

Osteoarthritis; Arthritis, Rheumatoid; Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis

Study Officials

• Gustavo Citera, Rheumatologist

  Universidad Nacional de Buenos Aires. Argentina

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2012
• First Posted: April 16, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: May 14, 2013

Record last verified: 2013-05

Locations

PH (2); AR (22); TH (4); MY (2); ME (13); KR (11); RU (19); CO (3); VE (7); VN (2)