N/A
Completed N=465
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
Source: ClinicalTrials.gov NCT04852666 ↗Enrolled (actual)
465
Serious AEs
—
Results posted
Jun 2024
Primary outcomePrimary: PROMIS Measures of Pain Interference — 51.2; 51.6; 50.1; 48.2 T-score — p=0.751
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PROMIS Measures of Pain Interference |
51.2; 51.6; 50.1; 48.2 | 0.751 |
| PRIMARY PROMIS Measures of Fatigue |
54.7; 54.4; 52.7; 50.6 | 0.778 |
| SECONDARY Number of Participants With Index Medication Persistence |
119; 203; 63; 29 | 0.012 sig |
| SECONDARY Number of Participants Using Corticosteroids at Follow-Up |
27; 28; 15; 1 | 0.103 |
| SECONDARY Short Crohn's Disease Activity Index (sCDAI) |
147; 144 | 0.785 |
| SECONDARY Mayo Clinic Score |
1.7; 1.2 | 0.200 |
| SECONDARY PROMIS Social Satisfaction Score |
49.1; 49.3; 47.5; 50.4 | 0.887 |
Eligibility Criteria
Inclusion Criteria
- age greater than or equal to 18;
- diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort);
- initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.
Exclusion Criteria
- less than 18 years of age
Data sourced from ClinicalTrials.gov (NCT04852666). 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.