18 and older, any sex, with Crohn's Disease or Ulcerative Colitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
PROMIS Measures of Pain InterferencePrimary· 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).
Group
Value
95% CI
Crohn's Disease (Vedolizumab)
51.2
± 10.17
Crohn's Disease (Ustekinumab)
51.6
± 9.94
Ulcerative Colitis (Vedolizumab)
50.1
± 10.2
Ulcerative Colitis (Tofacitinib)
48.2
± 9.0
PROMIS Measures of FatiguePrimary· 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).
Group
Value
95% CI
Crohn's Disease (Vedolizumab)
54.7
± 11.73
Crohn's Disease (Ustekinumab)
54.4
± 12.31
Ulcerative Colitis (Vedolizumab)
52.7
± 11.8
Ulcerative Colitis (Tofacitinib)
50.6
± 9.4
Number of Participants With Index Medication PersistenceSecondary· 4-10 months after medication initiation
Medication persistence was defined as continuing index medication.
Group
Value
95% CI
Crohn's Disease (Vedolizumab)
119
Crohn's Disease (Ustekinumab)
203
Ulcerative Colitis (Vedolizumab)
63
Ulcerative Colitis (Tofacitinib)
29
Number of Participants Using Corticosteroids at Follow-UpSecondary· 4-10 months after medication initiation
Participants who reported using corticosteroids.
Group
Value
95% CI
Crohn's Disease (Vedolizumab)
27
Crohn's Disease (Ustekinumab)
28
Ulcerative Colitis (Vedolizumab)
15
Ulcerative Colitis (Tofacitinib)
1
Short Crohn's Disease Activity Index (sCDAI)Secondary· Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
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.
Group
Value
95% CI
Crohn's Disease (Vedolizumab)
147
± 89.6
Crohn's Disease (Ustekinumab)
144
± 85.8
Mayo Clinic ScoreSecondary· Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)
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.
Group
Value
95% CI
Ulcerative Colitis (Vedolizumab)
1.7
± 1.8
Ulcerative Colitis (Tofacitinib)
1.2
± 1.5
PROMIS Social Satisfaction ScoreSecondary· 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.
Group
Value
95% CI
Crohn's Disease (Vedolizumab)
49.1
± 10.59
Crohn's Disease (Ustekinumab)
49.3
± 10.06
Ulcerative Colitis (Vedolizumab)
47.5
± 11.0
Ulcerative Colitis (Tofacitinib)
50.4
± 10.6
Sponsor's own description
The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 14 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04852666.