A Study of Moderate to Severe Inflammatory Bowel Disease, Including Ulcerative Colitis (UC) and Crohn's Disease (CD)
RISE-MX
Real-world Data of Moderate to Severe Inflammatory Bowel Disease (UC and CD) in Mexico: a Multicenter, Non-interventional Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Patient Reported Outcomes
2 other identifiers
observational
335
1 country
12
Brief Summary
The main aim of this study is to check the disease activity in people with moderate to severe ulcerative colitis and Crohn's disease. Participants will complete questionnaires about their disease and quality of life on Day 1 clinic visit. They will do this during a standard scheduled appointment with their doctor. Some of this study will also involve collecting information about participants from their medical records.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2021
Shorter than P25 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2021
CompletedFirst Posted
Study publicly available on registry
May 5, 2021
CompletedStudy Start
First participant enrolled
August 30, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 17, 2022
CompletedResults Posted
Study results publicly available
November 7, 2024
CompletedNovember 7, 2024
August 1, 2024
9 months
April 23, 2021
May 11, 2023
August 27, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With Active CD at Day 1
Percentage of participants with active CD 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. 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 ranges from 0 to 600 points. Higher score indicates more severe disease. HBI score was used to measure disease activity of CD and consisted of 5 clinical parameters: general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications. Total score is 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 indicate more severe disease. Percentages are rounded off to whole number at the nearest decimal.
Day 1
Percentage of Participants With Active UC at Day 1
Percentage of participants with active disease UC disease will be observed, where UC is defined as 9-point Partial Mayo Score (pMayo score) \>=5. The Mayo score is composed of four categories (bleeding, stool frequency, physician assessment, and endoscopic appearance) rated from 0-3 that are summed into a total score ranging from 0-12. pMayo score consists of 3 sub scores: stool frequency, rectal bleeding, and physician global assessment of disease severity, each graded from 0 to 3. These scores are summed to give a total score range of 0 to 9; where higher scores indicating more severe disease. The pMayo score when compared with the full Mayo score and categorizes UC patients as being in remission (score of 0 to 2), having mild activity (pMayo of 3 or 4) or moderate to severe activity (pMayo of \>=5).
Day 1
Secondary Outcomes (20)
Number of Participants With CD Based on Clinical Presentation
Day 1
Number of Participants With UC Based on Clinical Presentation
Day 1
Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies
From 3 years prior to Day 1 until Day 1
Duration of IBD Therapies
From 3 years prior to Day 1 until Day 1
Percentage of Participants With UC or CD Based on Biologic-experience
From 3 years prior to Day 1 until Day 1
- +15 more secondary outcomes
Study Arms (4)
Moderate to Severe Crohn's Disease
Participants diagnosed with moderate to severe Crohn's Disease (CD) were 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.
Mild to None Crohn's Disease
Participants diagnosed with mild to none activity of CD were 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of CD.
Moderate to Severe Ulcerative Colitis
Participants diagnosed with moderate to severe Ulcerative Colitis (UC) were 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Mild to None Ulcerative Colitis
Participants diagnosed with mild to none activity of UC were 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 prior to Day 1 to assess the IBD treatments and use of other healthcare resources related with the management of UC.
Eligibility Criteria
Adult participants diagnosed with moderate to severe UC or CD will be enrolled.
You may qualify if:
- Diagnosed with moderate to severe CD or UC established for at least 6 months prior to Day 1 appointment, based on clinical, endoscopic or image criteria.
- Participants aged 18 years or older (at the time of diagnosis of moderate to severe UC or CD).
You may not qualify if:
- Has indeterminate or not classified colitis.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (12)
Unidad de Enfermedades Reumaticas y Cronico degenerativas
Torreón, Coahuila, 27000, Mexico
Centro De Investigacion Clinica De Alta Especialidad "Cicae"
Torreón, Coahuila, 27010, Mexico
Endoamer S.C.
Guadalajara, Jalisco, 44600, Mexico
CIMESAP Sociedad de Responsabilidad Limitada de Capital Variable
Zapopan, Jalisco, 45138, Mexico
Hospital Medica Sur Tlalpan
Mexico City, Mexico City, 14050, Mexico
Instituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14080, Mexico
Fundacion Santos y de la Garza Evia
Monterrey, Nuevo León, 64710, Mexico
Oncare Oncology
San Pedro Garza García, Nuevo León, 66220, Mexico
Hospital Zambrano Hellion TecSalud
San Pedro Garza García, Nuevo León, 66278, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Oaxaca, 68020, Mexico
Torre Medica Sanatorio Toluca
Toluca, 50120, Mexico
Arke SMO S.A. De C.V
Veracruz, 91910, Mexico
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda
Study Officials
- STUDY DIRECTOR
Study 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
April 23, 2021
First Posted
May 5, 2021
Study Start
August 30, 2021
Primary Completion
May 17, 2022
Study Completion
May 17, 2022
Last Updated
November 7, 2024
Results First Posted
November 7, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.