Trial Outcomes & Findings for Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD) (NCT NCT04852666)
NCT ID: NCT04852666
Last Updated: 2024-06-14
Results Overview
NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health).
COMPLETED
465 participants
Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
2024-06-14
Participant Flow
Participant milestones
| Measure |
Crohn's Disease (Vedolizumab)
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
141
|
219
|
72
|
33
|
|
Overall Study
COMPLETED
|
141
|
219
|
72
|
33
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
Baseline characteristics by cohort
| Measure |
Crohn's Disease (Vedolizumab)
n=141 Participants
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
n=219 Participants
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
n=72 Participants
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
n=33 Participants
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
Total
n=465 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44 years
n=39 Participants
|
45 years
n=41 Participants
|
42.5 years
n=35 Participants
|
38 years
n=31 Participants
|
42 years
n=146 Participants
|
|
Sex/Gender, Customized
Female
|
100 Participants
n=39 Participants
|
167 Participants
n=41 Participants
|
48 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
332 Participants
n=146 Participants
|
|
Sex/Gender, Customized
Male
|
41 Participants
n=39 Participants
|
52 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
14 Participants
n=31 Participants
|
127 Participants
n=146 Participants
|
|
Sex/Gender, Customized
Data unavailable
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
129 Participants
n=39 Participants
|
193 Participants
n=41 Participants
|
57 Participants
n=35 Participants
|
28 Participants
n=31 Participants
|
407 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
8 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Other or Unknown
|
7 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
11 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
43 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health).
Outcome measures
| Measure |
Crohn's Disease (Vedolizumab)
n=141 Participants
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
n=219 Participants
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
n=72 Participants
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
n=33 Participants
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
|---|---|---|---|---|
|
PROMIS Measures of Pain Interference
|
51.2 T-score
Standard Deviation 10.17
|
51.6 T-score
Standard Deviation 9.94
|
50.1 T-score
Standard Deviation 10.2
|
48.2 T-score
Standard Deviation 9.0
|
PRIMARY outcome
Timeframe: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue (poorer health).
Outcome measures
| Measure |
Crohn's Disease (Vedolizumab)
n=141 Participants
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
n=219 Participants
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
n=72 Participants
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
n=33 Participants
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
|---|---|---|---|---|
|
PROMIS Measures of Fatigue
|
54.7 T-score
Standard Deviation 11.73
|
54.4 T-score
Standard Deviation 12.31
|
52.7 T-score
Standard Deviation 11.8
|
50.6 T-score
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: 4-10 months after medication initiationMedication persistence was defined as continuing index medication.
Outcome measures
| Measure |
Crohn's Disease (Vedolizumab)
n=141 Participants
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
n=219 Participants
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
n=72 Participants
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
n=33 Participants
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
|---|---|---|---|---|
|
Number of Participants With Index Medication Persistence
|
119 Participants
|
203 Participants
|
63 Participants
|
29 Participants
|
SECONDARY outcome
Timeframe: 4-10 months after medication initiationPopulation: All available data are reported.
Participants who reported using corticosteroids.
Outcome measures
| Measure |
Crohn's Disease (Vedolizumab)
n=141 Participants
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
n=219 Participants
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
n=71 Participants
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
n=30 Participants
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
|---|---|---|---|---|
|
Number of Participants Using Corticosteroids at Follow-Up
|
27 Participants
|
28 Participants
|
15 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)Population: This outcome applies only to those participants who have Crohn's disease.
Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patients' symptoms using only a questionnaire, which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, stool frequency, and general well-being reported as a total score. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI with scores ranging from 0 to 600, such that scores,\<150 define remission, 150 to 219 mild activity, 220 to 450 moderate activity, and greater than 450 severe activity.
Outcome measures
| Measure |
Crohn's Disease (Vedolizumab)
n=141 Participants
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
n=219 Participants
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
|---|---|---|---|---|
|
Short Crohn's Disease Activity Index (sCDAI)
|
147 score on a scale
Standard Deviation 89.6
|
144 score on a scale
Standard Deviation 85.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)Population: This outcome applies only to those participants who have ulcerative colitis. All available data are reported.
The Mayo Clinic Score (MCS) asks 2 questions about (1) stool frequency and (2) rectal bleeding with an overall score range (0-6). Higher scores reflect more disease symptomatology.
Outcome measures
| Measure |
Crohn's Disease (Vedolizumab)
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
n=69 Participants
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
n=30 Participants
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
|---|---|---|---|---|
|
Mayo Clinic Score
|
—
|
—
|
1.7 score on a scale
Standard Deviation 1.8
|
1.2 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of social satisfaction. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score for social satisfaction indicates better health.
Outcome measures
| Measure |
Crohn's Disease (Vedolizumab)
n=141 Participants
Participants with Crohn's disease (CD) who reported taking vedolizumab.
|
Crohn's Disease (Ustekinumab)
n=219 Participants
Participants with Crohn's disease (CD) who reported taking ustekinumab.
|
Ulcerative Colitis (Vedolizumab)
n=72 Participants
Participants with Ulcerative colitis (UC) who reported taking vedolizumab.
|
Ulcerative Colitis (Tofacitinib)
n=33 Participants
Participants with Ulcerative colitis (UC) who reported taking tofacitinib.
|
|---|---|---|---|---|
|
PROMIS Social Satisfaction Score
|
49.1 T-score
Standard Deviation 10.59
|
49.3 T-score
Standard Deviation 10.06
|
47.5 T-score
Standard Deviation 11.0
|
50.4 T-score
Standard Deviation 10.6
|
Adverse Events
Crohn's Disease (Vedolizumab)
Crohn's Disease (Ustekinumab)
Ulcerative Colitis (Vedolizumab)
Ulcerative Colitis (Tofacitinib)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Kappelman, MD, MPH
University of North Carolina at Chapel Hill
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place