Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Vedolizumab; Placebo
Intervention description: Vedolizumab 300 mg IV infusion; 0.9% sodium chloride IV infusion
Intervention MeSH terms: Vedolizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Drug therapy; Fistulizing Crohn´s disease; Perianal Fistula

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:

          1. In the opinion of the investigator, the participant is capable of understanding and
             complying with protocol requirements.

          2. 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.

          3. Has a diagnosis of CD established at least 3 months prior to randomization by clinical
             and endoscopic evidence and corroborated by a histopathology report.

          4. 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.

          5. 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.

          6. 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:

          1. Has a diagnosis of ulcerative colitis or indeterminate colitis.

          2. 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.

          3. Has a Crohn's Disease Activity Index (CDAI) score >400.

          4. Has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

          5. Has significant anal or rectal stenosis.

          6. Has active or latent tuberculosis (TB), regardless of treatment history.

          7. Has evidence of active Clostridium difficile (C. difficile) infection or is having
             treatment for C. difficile infection or other intestinal pathogens during Screening.

          8. Has current rectovaginal fistula.

          9. Currently has more than 3 draining perianal fistulae. Note: Other protocol-defined
             inclusion/exclusion criteria may apply