Phase 4
N=34
Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02630966 ↗Enrolled (actual)
34
Serious AEs
20.6%
Results posted
Sep 2019
Primary outcome: Primary: Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) — 75.0; 75.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vedolizumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) |
75.0; 75.0 | — |
| SECONDARY Percentage of Participants With at Least 50% Reduction of From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) at Both Weeks 22 and 30 |
72.7; 62.5 | — |
| SECONDARY Percentage of Participants With 100% Perianal Fistulae Closure (of the Fistulae Draining at Baseline) |
58.3; 62.5 | — |
| SECONDARY Time to First Perianal Fistulae Closure (of Those Fistulae Draining at Baseline) |
30.5; 159.0 | — |
| SECONDARY Time to Last (100%) Perianal Fistulae Closure (of Those Fistulae Draining at Baseline) |
45.0; 159.0 | — |
| SECONDARY Duration of Perianal Fistulae Response (of Those Fistulae Draining at Baseline) |
158.5; 33.5 | — |
Summary
The purpose of this study is to evaluate the percentage of participants with perianal fistula healing at Week 30 in 2 different dose regimens of vedolizumab intravenous (IV) 300 milligram (mg) in participants with fistulizing Crohn's disease (CD).
Eligibility Criteria
Inclusion Criteria
- In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant or, when applicable, the participant's legally acceptable representative has signed and dated a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
- Has a diagnosis of CD established at least 3 months prior to randomization by clinical and endoscopic evidence and corroborated by a histopathology report.
- Has a diagnosis of a minimum of 1 perianal draining fistula of at least 2 weeks duration as a complication of moderately to severely active CD, as identified on magnetic resonance image (MRI) at Screening. Other types of fistulae (enterocutaneous, abdominal) except rectovaginal fistulae are permitted, but the number of perianal draining fistulae is limited to 3.
- All countries except France: The participant, historically, had an inadequate response with, lost response to, or was intolerant to either conventional therapy or a tumor necrosis factor-alpha (TNF-α) antagonist for their underlying CD (does not require treatment failure for currently active draining fistula).
France only: The participant, historically, failed (ie, had an inadequate response with, lost response to, or was intolerant to) infliximab for treatment of their underlying CD or fistulizing CD.
- If the participant had noncutting perianal seton placement as part of standard care, seton must be removed by Week 14 of the study.
Exclusion Criteria
- Has a diagnosis of ulcerative colitis or indeterminate colitis.
- Has a perianal abscess greater than (>) 2 centimeter (cm) or an abscess that the investigator feels requires drainage based on either clinical assessment or MRI.
- Has a Crohn's Disease Activity Index (CDAI) score >400.
- Has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- Has significant anal or rectal stenosis.
- Has active or latent tuberculosis (TB), regardless of treatment history.
- Has evidence of active Clostridium difficile (C. difficile) infection or is having treatment for C. difficile infection or other intestinal pathogens during Screening.
- Has current rectovaginal fistula.
- Currently has more than 3 draining perianal fistulae. Note: Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02630966). 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.