Clinical trial NCT03488030: A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)
Official title: Real-world Data of Moderate to Severe Inflammatory Bowel Disease in Argentina: A Non-interventional, Multicenter Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Colitis, Ulcerative
Inflammatory Bowel Disease
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-04-04
Enrollment: 246
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with moderate to severe CD or UC will be observed.

Brief summary: The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.

Detailed description: This is a retrospective, cross-sectional, and non-interventional study of participants with IBD. The study will have a cross-sectional evaluation on Day 1 to provide the real-world data of disease activity, treatment patterns, burden of disease and quality of life in participants with moderate to severe CD or UC.

The study will involve an additional retrospective review of medical charts of participants of previous 3 years to describe the IBD treatments and use of other healthcare resources related with management of IBD.

The study will enroll approximately 246 participants. All participants will be enrolled in one observational cohort.

This multi-center trial will be conducted in Argentina. The overall time for data collection in the study will be approximately 3 years before the start of the study (Day 1).

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment based on clinical or endoscopic or image criteria.

Exclusion Criteria:

1. Indeterminate or not classified colitis.
2. Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Primary outcomes:
measure: Crohn's Disease: Percentage of Participants With Active CD at Day 1
timeFrame: Day 1
measure: Ulcerative Colitis: Percentage of Participants With Active UC at Day 1
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe CD or UC Based on Medical History, Comorbidities or Extra Intestinal Manifestation (EIM)
timeFrame: Day 1
measure: Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization
timeFrame: Day 1
measure: Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years
timeFrame: Within previous 3 years including Day 1
measure: Duration of IBD Treatment During Previous 3 Years
timeFrame: Within previous 3 years including Day 1
measure: Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years
timeFrame: Within previous 3 years including Day 1
measure: Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons
timeFrame: Within previous 3 years including Day 1
measure: Number of Participants With Moderate to Severe CD or UC Who Had IBD Treatment Initiation on Day 1
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables
timeFrame: Day 1
measure: Quality of Life Assessed by European Quality of Life 5-dimension (EQ-5D) Health States Visual Analogue Scale (VAS) Score at Day 1
timeFrame: Day 1
measure: Quality of Life as Assessed by 36-item Short Form Health Survey (SF-36) Component Score at Day 1
timeFrame: Day 1
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1
timeFrame: Day 1
measure: Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1
timeFrame: Day 1
measure: Mean of Percentage of Total Work Productivity Impairment (TWPI) Due to CD or UC as Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI)
timeFrame: Day 1
measure: Mean of Percentage of Work Time Missed Due to CD or UC as Assessed by WPAI at Day 1
timeFrame: Day 1
measure: Mean of Percentage of Impairment While Working Due to CD or UC as Assessed by WPAI at Day 1
timeFrame: Day 1
measure: Mean of Percentage of Total Activity Impairment Due to CD or UC as Assessed by WPAI at Day 1
timeFrame: Day 1
measure: Percentage of Participants Who Quit Job Due to IBD and Have Not Been Able to Return to Work
timeFrame: Day 1
measure: Number of Participants With Moderate to Severe CD or UC Who Used Healthcare Resources Over the Previous 3 Years
timeFrame: Within previous 3 years including Day 1
Other outcomes:
Locations:
city: Caba
country: Argentina
facility: Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital Britanico de Buenos Aires
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
state: Buenos Aires
city: Caba
country: Argentina
facility: Sanatorio Mater Dei
state: Buenos Aires
city: La Plata
country: Argentina
facility: Hospital San Martin
state: Buenos Aires
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
state: Santa Fe
city: Cordoba
country: Argentina
facility: Hospital Privado de Cordoba
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Olivera PA, Balderramo D, Lasa JS, Zubiaurre I, Correa G, Lubrano P, Ruffinengo O, Yantorno M, Rausch A, Pinero G, Bolomo A, Amigo C, El-Hakeh J, Leonardi DB, Brion L, Sambuelli A. Real-world clinical characteristics and therapeutic strategies in patients with moderate-to-severe inflammatory bowel disease in Argentina: Data from the RISE-AR study. Gastroenterol Hepatol. 2024 Nov 15:502287. doi: 10.1016/j.gastrohep.2024.502287. Online ahead of print. English, Spanish.
citation: P426 Health-Related Quality of Life and Work Productivity in patients with moderate-to-severe Inflammatory Bowel Disease in Argentina: Data from the RISE AR study. G J Correa, M Yantorno, P Olivera Sendra, J S Lasa, P Lubrano, D C Balderramo, I Zubiaurre, O Ruffinengo, L Brion, D B Leonardi, J El-Hakeh, P N Guimaraens, A Sambuelli. Journal of Crohn's and Colitis, Volume 15, Issue Supplement_1, May 2021, Pages S430-S431, https://doi.org/10.1093/ecco-jcc/jjab076.550