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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 246
- Locations
- 7
- Primary Endpoint
- Crohn's Disease: Percentage of Participants With Active CD at Day 1
Study Overview
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •Indeterminate or not classified colitis.
- •Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Outcomes
Primary Outcomes
Crohn's Disease: Percentage of Participants With Active CD at Day 1
Time Frame: 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.
Ulcerative Colitis: Percentage of Participants With Active UC at Day 1
Time Frame: 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).
Secondary Outcomes
- 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 Who Used Various Types of Therapies for IBD in Previous 3 Years(Within previous 3 years including Day 1)
- Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information(Day 1)
- Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization(Day 1)
- Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years(Within previous 3 years including Day 1)
- Quality of Life Assessed by European Quality of Life 5-dimension (EQ-5D) Health States Visual Analogue Scale (VAS) Score at Day 1(Day 1)
- Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization(Day 1)
- Number of Participants With Moderate to Severe CD or UC Who Had IBD Treatment Initiation on Day 1(Day 1)
- Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables(Day 1)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1(Day 1)
- Mean of Percentage of Impairment While Working Due to CD or UC as Assessed by WPAI at Day 1(Day 1)
- Percentage of Participants Who Quit Job Due to IBD and Have Not Been Able to Return to Work(Day 1)
- Number of Participants With Moderate to Severe CD or UC Based on Medical History, Comorbidities or Extra Intestinal Manifestation (EIM)(Day 1)
- Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons(Within previous 3 years including Day 1)
- Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1(Day 1)
- Number of Participants With Moderate to Severe CD or UC Who Used Healthcare Resources Over the Previous 3 Years(Within previous 3 years including Day 1)
- Duration of IBD Treatment During Previous 3 Years(Within previous 3 years including Day 1)
- Mean of Percentage of Total Work Productivity Impairment (TWPI) Due to CD or UC as Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI)(Day 1)
- Quality of Life as Assessed by 36-item Short Form Health Survey (SF-36) Component Score at Day 1(Day 1)
- Mean of Percentage of Work Time Missed Due to CD or UC as Assessed by WPAI at Day 1(Day 1)
- Mean of Percentage of Total Activity Impairment Due to CD or UC as Assessed by WPAI at Day 1(Day 1)