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)
RISE AR
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
2 other identifiers
observational
246
1 country
7
Brief Summary
The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Shorter than P25 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 27, 2018
CompletedFirst Posted
Study publicly available on registry
April 4, 2018
CompletedStudy Start
First participant enrolled
December 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedResults Posted
Study results publicly available
June 12, 2020
CompletedFebruary 8, 2022
February 1, 2022
6 months
March 27, 2018
May 27, 2020
February 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Crohn's Disease: Percentage of Participants With Active CD at Day 1
Percentage of participants with active CD were observed, where active CD was defined as Harvey Bradshaw index (HBI) greater than or equal to (\>=) 8 or Crohn's disease active index (CDAI) \>= 220 points. CDAI assessed CD based on clinical signs and symptoms such as number of liquid stools, intensity of abdominal pain, general wellbeing, presence of comorbid conditions, use of antidiarrheal, physical examination and laboratory findings. Total score ranged from 0 to 600 points. Higher score indicated more severe disease. HBI consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score was sum of individual parameters. Score ranges from a minimum score of 0 to no pre-specified maximum score as it depends on number of liquid stools, where higher scores indicated more severe disease.
Day 1
Ulcerative Colitis: Percentage of Participants With Active UC at Day 1
Percentage of participants with active disease UC disease were observed, where UC was defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score was composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0 to 3 that are summed to give a total score that ranges from 0 to 12. The pMayo score was previously compared with the full Mayo score and categorized participants as being in remission (score of 0 to 2), having mild disease (pMayo of 3 or 4) or moderate to severe disease (pMayo of \>=5).
Day 1
Secondary Outcomes (21)
Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior
Day 1
Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information
Day 1
Number of Participants With Moderate to Severe CD or UC Based on Medical History, Comorbidities or Extra Intestinal Manifestation (EIM)
Day 1
Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization
Day 1
Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization
Day 1
- +16 more secondary outcomes
Study Arms (1)
All Participants
Participants diagnosed with moderate to severe UC or CD from the 7 participating sites will be observed on Day 1 for cross-sectional evaluation of disease activity, treatment patterns, burden of disease and quality of life along with retrospective data collection for previous 3 years from the date of UC or CD diagnosis until Day 1 to assess the IBD treatments, medical history and comorbidities, treatment patterns and use of health resources.
Eligibility Criteria
Participants diagnosed with moderate to severe CD or UC will be observed.
You may qualify if:
- \. 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.
You may not qualify if:
- Indeterminate or not classified colitis.
- Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (7)
Centro de Educacion Medica e Investigaciones Clinicas Norberto Quirno (CEMIC)
CABA, Buenos Aires, Argentina
Hospital Britanico de Buenos Aires
CABA, Buenos Aires, Argentina
Hospital de Gastroenterologia Dr. Carlos Bonorino Udaondo
CABA, Buenos Aires, Argentina
Sanatorio Mater Dei
CABA, Buenos Aires, Argentina
Hospital San Martin
La Plata, Buenos Aires, Argentina
Hospital Provincial del Centenario
Rosario, Santa Fe Province, Argentina
Hospital Privado de Cordoba
Córdoba, Argentina
Related Publications (2)
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. 2025 Oct;48(8):502287. doi: 10.1016/j.gastrohep.2024.502287. Epub 2024 Nov 15. English, Spanish.
PMID: 39549817RESULTP426 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
RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 27, 2018
First Posted
April 4, 2018
Study Start
December 12, 2018
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
February 8, 2022
Results First Posted
June 12, 2020
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will share
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.