Clinical trial NCT04873700: A Study of Moderate to Severe Inflammatory Bowel Disease, Including Ulcerative Colitis (UC) and Crohn's Disease (CD)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Colitis, Ulcerative
Crohn Disease
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-05-05
Enrollment: 335
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: Adult participants diagnosed with moderate to severe UC or CD will be enrolled.

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.

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).

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Participants aged 18 years or older (at the time of diagnosis of moderate to severe UC or CD).

Exclusion Criteria:

1. Has indeterminate or not classified colitis.
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.

Primary outcomes:
measure: Percentage of Participants With Active CD at Day 1
timeFrame: Day 1
measure: Percentage of Participants With Active UC at Day 1
timeFrame: Day 1
Secondary outcomes:
measure: Number of Participants With CD Based on Clinical Presentation
timeFrame: Day 1
measure: Number of Participants With UC Based on Clinical Presentation
timeFrame: Day 1
measure: Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies
timeFrame: From 3 years prior to Day 1 until Day 1
measure: Duration of IBD Therapies
timeFrame: From 3 years prior to Day 1 until Day 1
measure: Percentage of Participants With UC or CD Based on Biologic-experience
timeFrame: From 3 years prior to Day 1 until Day 1
measure: Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies
timeFrame: From 3 years prior to Day 1 until Day 1
measure: Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies
timeFrame: From 3 years prior to Day 1 until Day 1
measure: Number of Participants With UC or CD Introduced With IBD Treatment at Day 1
timeFrame: Day 1
measure: Number of Participants With HBI >=8 or CDAI >=220 Points Versus HBI <8 or CDAI <220 Points Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in CD Participants
timeFrame: Day 1
measure: Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants
timeFrame: Day 1
measure: Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants
timeFrame: Day 1
measure: Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants
timeFrame: Day 1
measure: Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants
timeFrame: The last 7 days prior to Day 1
measure: Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants
timeFrame: The last 7 days prior to Day 1
measure: Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants
timeFrame: The last 7 days prior to Day 1
measure: Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants
timeFrame: The last 7 days prior to Day 1
measure: Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work
timeFrame: Day 1
measure: Percentage of Participants With UC or CD Categorized Based on Healthcare Resources
timeFrame: From 3 years prior to Day 1 until Day 1
measure: Total Direct Medical Cost for Participants With UC or CD
timeFrame: From 3 years prior to Day 1 until Day 1
measure: Indirect Cost for Participants With UC or CD
timeFrame: From 3 years prior to Day 1 until Day 1
Other outcomes:
Locations:
city: Torreon
country: Mexico
facility: Unidad de Enfermedades Reumaticas y Cronico degenerativas
state: Coahuila
city: Torreon
country: Mexico
facility: Centro De Investigacion Clinica De Alta Especialidad "Cicae"
state: Coahuila
city: Ciudad de Mexico
country: Mexico
facility: Hospital Medica Sur Tlalpan
state: Distrito Federal
city: Ciudad de Mexico
country: Mexico
facility: Instituto Nacional de Ciencias Medicas Y Nutricion Salvador Zubiran
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Endoamer S.C.
state: Jalisco
city: Zapopan
country: Mexico
facility: CIMESAP Sociedad de Responsabilidad Limitada de Capital Variable
state: Jalisco
city: Monterrey
country: Mexico
facility: Fundacion Santos y de la Garza Evia
state: Nuevo Leon
city: San Pedro Garza Garcia
country: Mexico
facility: Oncare Oncology
state: Nuevo Leon
city: San Pedro Garza Garcia
country: Mexico
facility: Hospital Zambrano Hellion TecSalud
state: Nuevo Leon
city: Oaxaca de Juarez
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca
state: Oaxaca
city: Toluca
country: Mexico
facility: Torre Medica Sanatorio Toluca
city: Veracruz
country: Mexico
facility: Arke SMO S.A. De C.V
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: