N/A
Completed N=246
A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)
Crohn disease · Colitis, Ulcerative · Inflammatory Bowel Disease
Source: ClinicalTrials.gov NCT03488030 ↗
Enrolled (actual)
246
Serious AEs
—
Results posted
Jun 2020
Primary outcomePrimary: Crohn's Disease: Percentage of Participants With Active CD at Day 1 — 9.3 percentage of participants
Summary
The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Crohn's Disease: Percentage of Participants With Active CD at Day 1 |
9.3 | — |
| PRIMARY Ulcerative Colitis: Percentage of Participants With Active UC at Day 1 |
7.7 | — |
| SECONDARY Number of Participants With Moderate to Severe CD or UC Stratified by Steroid Behavior |
28; 71; 16; 12; 5; 7 | — |
| SECONDARY Number of Participants With Moderate to Severe CD or UC Stratified by Anthropometric Information |
NA; NA; NA; NA; 3; 8 | — |
| SECONDARY Number of Participants With Moderate to Severe CD or UC Based on Medical History, Comorbidities or Extra Intestinal Manifestation (EIM) |
49; 74; 52; 71 | — |
| SECONDARY Crohn's Disease: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization |
9; 2; 52; 0; 33; 4 | — |
| SECONDARY Ulcerative Colitis: Number of Participants With Moderate to Severe CD Stratified by Clinical Characterization |
13; 4; 60; 66; 66; 33 | — |
| SECONDARY Number of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years |
63; 142; 56; 101; 66; 85 | — |
| SECONDARY Duration of IBD Treatment During Previous 3 Years |
35.90; 33.11; 3.74; 3.96; 21.13; 19.54 | — |
| SECONDARY Number of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy During Previous 3 Years |
17; 23; 51; 18; 2; 1 | — |
| SECONDARY Number of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies With Reasons |
4; 0; 1; 2; 4; 0 | — |
| SECONDARY Number of Participants With Moderate to Severe CD or UC Who Had IBD Treatment Initiation on Day 1 |
11; 20 | — |
| SECONDARY Number of Participants With Moderate to Severe and No or Mild Activity of CD or UC Stratified by Socio-demographic Variables |
3; 44; 3; 61; 6; 44 | — |
| SECONDARY Quality of Life Assessed by European Quality of Life 5-dimension (EQ-5D) Health States Visual Analogue Scale (VAS) Score at Day 1 |
74.82; 75.74 | — |
| SECONDARY Quality of Life as Assessed by 36-item Short Form Health Survey (SF-36) Component Score at Day 1 |
43.61; 45.85; 50.47; 50.37 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1 |
22.07; 22.38 | — |
| SECONDARY Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1 |
5.64; 5.73; 5.21; 5.38; 5.15; 5.15 | — |
| SECONDARY Mean of Percentage of Total Work Productivity Impairment (TWPI) Due to CD or UC as Assessed by Work Productivity and Activity Impairment Questionnaire (WPAI) |
98.83; 98.79 | — |
| SECONDARY Mean of Percentage of Work Time Missed Due to CD or UC as Assessed by WPAI at Day 1 |
9.65; 7.81 | — |
| SECONDARY Mean of Percentage of Impairment While Working Due to CD or UC as Assessed by WPAI at Day 1 |
10.86; 11.95 | — |
| SECONDARY Mean of Percentage of Total Activity Impairment Due to CD or UC as Assessed by WPAI at Day 1 |
21.49; 22.62 | — |
| SECONDARY Percentage of Participants Who Quit Job Due to IBD and Have Not Been Able to Return to Work |
— | — |
| SECONDARY Number of Participants With Moderate to Severe CD or UC Who Used Healthcare Resources Over the Previous 3 Years |
100; 141; 18; 2; 34; 31 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03488030). 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. Informational only — not medical advice.