N/A
N=326
A Study of Moderate to Severe Inflammatory Bowel Disease, Including Ulcerative Colitis (UC) and Crohn's Disease (CD)
Inflammatory Bowel Diseases · Colitis, Ulcerative · Crohn Disease
Bottom Line
View on ClinicalTrials.gov: NCT04873700 ↗Enrolled (actual)
326
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Percentage of Participants With Active CD at Day 1 — 45.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Active CD at Day 1 |
45.3 | — |
| PRIMARY Percentage of Participants With Active UC at Day 1 |
18.2 | — |
| SECONDARY Number of Participants With CD Based on Clinical Presentation |
0; 9; 0; 1; 1; 5 | =0.0701 |
| SECONDARY Number of Participants With UC Based on Clinical Presentation |
2; 10; 3; 14; 5; 22 | =0.2896 |
| SECONDARY Number of Participants With UC or CD Based on Inflammatory Bowel Disease (IBD) Therapies |
1; 1; 6; 14; 20; 25 | — |
| SECONDARY Duration of IBD Therapies |
0.2; 33.3; 62.3; 42.1; 34.3; 8.4 | — |
| SECONDARY Percentage of Participants With UC or CD Based on Biologic-experience |
72.0; 61.5; 33.0; 33.8 | — |
| SECONDARY Percentage of Participants With UC or CD Who Have Not Responded Previously to Biologic Therapies |
65.1; 25.0; 28.5; 20.1 | — |
| SECONDARY Percentage of Participants With UC or CD Based on Reasons for Non-response to Previous Biologic Therapies |
34.8; 15.3; 11.9; 9.5; 6.9; 0 | — |
| SECONDARY Number of Participants With UC or CD Introduced With IBD Treatment at Day 1 |
0; 1; 0; 2; 0; 0 | — |
| SECONDARY 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 |
43 | — |
| SECONDARY Number of Participants With pMayo Score >=5 Versus pMayo Score <5 Categorized Based on Socio-demographic, Clinical and Treatment-related Variables in UC Participants |
42 | — |
| SECONDARY Mean Score of Components of 36-item Short Form Health Survey (SF-36) of UC or CD Participants |
64.2; 77.5; 71.1; 81.1; 52.7; 65.0 | — |
| SECONDARY Mean Total Score of Inflammatory Bowel Disease Questionnaire (IBDQ) of UC or CD Participants |
144.8; 159.03; 140.2; 165.7 | — |
| SECONDARY Mean of Percentage of Total Work Impairment Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) in UC or CD Participants |
20.337; 21.184; 24.152; 17.700 | — |
| SECONDARY Mean of Percentage of Work Time Missed Assessed by WPAI in UC or CD Participants |
19.873; 17.285; 9.798; 10.590 | — |
| SECONDARY Mean of Percentage of Impairment While Working Assessed by WPAI in UC or CD Participants |
33.3; 30.0; 29.5; 23.1 | — |
| SECONDARY Mean Percentage of Total Activity Impairment Assessed by WPAI in UC or CD Participants |
45.7; 33.1; 44.0; 27.4 | — |
| SECONDARY Percentage of Participants With UC or CD Who Quit Their Job Due to IBD and Unable to Return to Work |
0; 0; 4.8; 0 | — |
| SECONDARY Percentage of Participants With UC or CD Categorized Based on Healthcare Resources |
37.2; 17.3; 28.6; 12.7; 67.4; 59.6 | — |
| SECONDARY Total Direct Medical Cost for Participants With UC or CD |
16362506.13; 12611636.50; 9673667.75; 33842289.53 | — |
| SECONDARY Indirect Cost for Participants With UC or CD |
394402.91; 276419.13; 77869.29; 458451.24 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- Has indeterminate or not classified colitis.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Data sourced from ClinicalTrials.gov (NCT04873700). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.