Clinical trial NCT01577563: Prevalence Study of Gastrointestinal Risk Factors in Patients With Osteoarthritis (OA), Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS).
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis (OA)
Rheumatoid Arthritis (RA)
Ankylosing Spondylitis (AS)
Keywords: osteoarthritis (OA)
rheumatoid arthritis (RA)
ankylosing spondylitis (AS)
gastrointestinal risk factors
NSAIDs
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-04-16
Enrollment: 5383
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of subject with age above 60 years.
timeFrame: Up to 4 weeks.
measure: Number of patients treated concomitantly with acetylsalicylic acid, oral corticosteroids or anticoagulants or NSAIDs.
timeFrame: Up to 4 weeks.
measure: Number of patients with previous ulcer history.
timeFrame: Up to 4 weeks.
measure: Number of patients with previous ulcer bleeding history.
timeFrame: Up to 4 weeks.
measure: Number of patients with history of dyspepsia.
timeFrame: Up to 4 weeks.
Secondary outcomes:
measure: Descriptive profile of patients demographics: gender, ethnicity, age, educational level, professional status.
timeFrame: Up to 4 weeks.
measure: Descriptive profile of medical history: nicotine use, relevant medical conditions, history peptic ulcer, chronic drug therapy related to relevant medical conditions.
timeFrame: Up to 4 weeks.
measure: Descriptive profile of medical treatment with NSAIDs, ASA, PPI, DMARDs, SSRI.
timeFrame: Up to 4 weeks.
measure: Descriptive profile of disease: type of rheumatic disorder: OA, RA or AS and date of first diagnosis.
timeFrame: Up to 4 weeks.
measure: Descriptive profile of Health Care Resources consumption: number of hospitalizations due to the rheumatic disorder and/or GI complications.
timeFrame: Up to 4 weeks.
measure: Gastrointestinal Symptoms Rating Scale (GSRS).
timeFrame: Up to 4 weeks.
measure: Treatment Satisfaction for medication for OA patients (TSQM).
timeFrame: Up to 4 weeks.
measure: Treatment adherence (Morisky Medication Assessment Scale- MMAs-4).
timeFrame: Up to 4 weeks.
measure: Patient Quality of Life (EQ-5D).
timeFrame: Up to 4 weeks.
measure: Osteoarthritis Index capturing elements of pain and physical disability (WOMAC VA3.1).
timeFrame: Up to 4 weeks.
measure: Health Assessment Questionnaire (HAQ).
timeFrame: Up to 4 weeks.
Other outcomes:
Locations:
city: Avellaneda
country: Argentina
facility: Research Site
city: Bahia Blanca
country: Argentina
facility: Research Site
city: Banfield
country: Argentina
facility: Research Site
city: Campana
country: Argentina
facility: Research Site
city: Capital Federal
country: Argentina
facility: Research Site
city: Corrientes
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: Lujan
country: Argentina
facility: Research Site
city: Mar del Plata
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Olivos
country: Argentina
facility: Research Site
city: Parana
country: Argentina
facility: Research Site
city: Rio Negro
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Isidro
country: Argentina
facility: Research Site
city: San Justo
country: Argentina
facility: Research Site
city: San Luis
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Sarandi - Avellaneda
country: Argentina
facility: Research Site
city: Tucuman
country: Argentina
facility: Research Site
city: Venado Tuerto
country: Argentina
facility: Research Site
city: Vicente Lopez
country: Argentina
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Bucaramanga
country: Colombia
facility: Research Site
city: Cali
country: Colombia
facility: Research Site
city: Bucheon
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Busan
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Cheongju
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Daegu
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Hwasun-gun
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Incheon
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Jeonju
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Seoul
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Suwon
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Ulsan
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Wonju
country: Korea, Republic of
facility: Research Site
state: Republic of Korea
city: Putrajaya
country: Malaysia
facility: Research Site
city: Selangor
country: Malaysia
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Boca el rio
country: Mexico
facility: Research Site
city: Ciudad de Mexico
country: Mexico
facility: Research Site
city: Cuernavaca
country: Mexico
facility: Research Site
city: Durango
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Naucalpan
country: Mexico
facility: Research Site
city: Saltillo
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: Toluca
country: Mexico
facility: Research Site
city: Tuxtla Gutierrez
country: Mexico
facility: Research Site
city: Zapopan
country: Mexico
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
state: Russia
city: Chelyabinsk
country: Russian Federation
facility: Research Site
state: Russia
city: Ekaterinburg
country: Russian Federation
facility: Research Site
state: Russia
city: Electrostal
country: Russian Federation
facility: Research Site
state: Russia
city: Irkutsk
country: Russian Federation
facility: Research Site
state: Russia
city: Kazan
country: Russian Federation
facility: Research Site
state: Russia
city: Kemerovo
country: Russian Federation
facility: Research Site
state: Russia
city: Krasnodar
country: Russian Federation
facility: Research Site
state: Russia
city: Krasnoyarsk
country: Russian Federation
facility: Research Site
state: Russia
city: Moscow
country: Russian Federation
facility: Research Site
state: Russia
city: N. Novgorod
country: Russian Federation
facility: Research Site
state: Russia
city: Novosibirsk
country: Russian Federation
facility: Research Site
state: Russia
city: Perm
country: Russian Federation
facility: Research Site
state: Russia
city: Samara
country: Russian Federation
facility: Research Site
state: Russia
city: St. Petersburg
country: Russian Federation
facility: Research Site
state: Russia
city: Tumen
country: Russian Federation
facility: Research Site
state: Russia
city: Ufa
country: Russian Federation
facility: Research Site
state: Russia
city: Volgograd
country: Russian Federation
facility: Research Site
state: Russia
city: Yaroslavl
country: Russian Federation
facility: Research Site
state: Russia
city: Hat Yai
country: Thailand
facility: Research Site
city: Klongluang
country: Thailand
facility: Research Site
city: Muang
country: Thailand
facility: Research Site
city: Prannok
country: Thailand
facility: Research Site
city: Barquisimeto
country: Venezuela
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
city: Maracaibo
country: Venezuela
facility: Research Site
city: Maturin
country: Venezuela
facility: Research Site
city: Merida
country: Venezuela
facility: Research Site
city: Porlamar
country: Venezuela
facility: Research Site
city: Punto Fijo
country: Venezuela
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
affiliation: Universidad Nacional de Buenos Aires. Argentina
name: Gustavo Citera, Rheumatologist
role: STUDY_CHAIR
References: