N/A
N=1,901
A Study to Evaluate Disease Control and Treatment Pattern in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD) in Real Life Practice
Colitis, Ulcerative · Crohn Disease · Inflammatory Bowel Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03532932 ↗Enrolled (actual)
1,901
Serious AEs
12.1%
Results posted
Mar 2024
Primary outcome: Primary: Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD — 33; 16; 38; 14 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Stratified by Treatment Patterns Associated With Biologics Agents Use or Non-biological Therapy in Participants With Moderate to Severe UC and CD |
33; 16; 38; 14; 192; 30 | — |
| SECONDARY Number of Participants Stratified by Location of Disease |
107; 0; 623; 0; 0; 146 | — |
| SECONDARY Number of Participants Stratified by Disease Severity |
211; 322; 406; 166; 522; 144 | — |
| SECONDARY Number of Participants Based on Usage of Methods for Documentation of Disease Activity in Routine Practice |
1151; 662; 1188; 656; 901; 453 | — |
| SECONDARY Number of Assessments Using Different Methods in Participants With UC and CD Disease Activity |
4.52; 6.74; 2.60; 2.31; 1.38; 1.11 | — |
| SECONDARY UC Participants: Percentage of Participants Who Achieved Combined Clinical and Endoscopic Remission Based on Mayo Index |
18.30; 35.21; 45.27; 1.21; 58.54; 30.49 | — |
| SECONDARY CD Participants: Percentage of Participants Who Achieved Clinical Remission Based on HBI |
50.31; 25.94; 22.50; 1.25; 67.53; 23.71 | — |
| SECONDARY Number of Participants With at Least One Episode of Failure of Biological or Non-biological Therapy |
1203; 670 | — |
| SECONDARY Number of Participants Who Needed Treatment Adjustments Based on Disease Activity Assessment |
0; 1; 14; 10; 11; 15 | — |
| SECONDARY Percentage of Participants Stratified by Achieving the Treatment Goals |
81.3; 70.3; 61.2; 50.6; 29.8; 27.4 | — |
| SECONDARY Percentage of Participants Based on Challenges of Implementing a T2T Strategy in UC and CD Participants in Real Clinical Practice |
28.6; 28.6; 40.0; 45.7; 40.0; 40.0 | — |
| SECONDARY Percentage of Participants Based on Hospitalizations Due to Complications, IBD Related Surgeries, and Disability Determination in Participants With Moderate to Severe UC and CD |
2.14; 3.06; 0.33; 0.73; 29.57; 47.74 | — |
| SECONDARY Percentage of Participants Based on Surgical Treatment by Indications and Type of Surgeries |
0.58; 0.58; 0.49; 0.08; 0.15; 0.99 | — |
Summary
The purpose of this study is to characterize the treatment patterns associated with biologics agents use or non-biological therapy in participants with moderate to severe Ulcerative Colitis (UC) and Crohn's Disease (CD).
Eligibility Criteria
Inclusion Criteria
- Has confirmed diagnosis of CD or UC for at least 2 years prior to enrollment in the study.
- Has a moderate to severe IBD flare at the time of enrollment or in participant anamnesis within 2 years before enrollment treated with steroids or/ and immunosuppressive agents or/ and biologic therapy. IBD flare(s) must be confirmed in the source documentation.
- Current treatment with steroids or/ and immunosuppressive agents or/ and 5-aminosalicylate (ASA) or/ and biologic therapy.
Exclusion Criteria
- Current or previous (within the last two years) indeterminate or not classified colitis.
- Changing of IBD type in anamnesis (that is, from UC to CD, etc) within the last two years.
- Current, previous (within the last two years) or planned (for the next one year) participation in interventional clinical trial.
- Presenting of mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- Has received previous treatment with biologic therapy/immunosuppressive agents for conditions other than IBD ever in their lifetime.
Data sourced from ClinicalTrials.gov (NCT03532932). 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.