Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04873700
Status:
COMPLETED
Last Update Posted:
2022-05-31
First Post:
2021-04-23
Brief Title:
A Study of Moderate to Severe Inflammatory Bowel Disease Including Ulcerative Colitis UC and Crohns Disease CD
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISE-MX
Brief Summary:
The main aim of this study is to check the disease activity in people with moderate to severe ulcerative colitis and Crohns 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
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
Detailed Description:
This is a retrospective cross-sectional and non-interventional study of participants with moderate to severe IBD UC or CD 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 UC or CD
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 the management of UC or DC
The study will enroll approximately 335 participants All participants will be enrolled in one observational cohort
This multi-center trial will be conducted in Mexico The overall time for data collection in the study will be approximately 3 years before the start of the study Day 1
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 the management of UC or DC
The study will enroll approximately 335 participants All participants will be enrolled in one observational cohort
This multi-center trial will be conducted in Mexico The overall time for data collection in the study will be approximately 3 years before the start of the study Day 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U1111-1262-1609 | REGISTRY | WHO | None |