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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02630966
Date of registration: 11/12/2015
Prospective Registration: Yes
Primary sponsor: Takeda
Public title: Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease ENTERPRISE
Scientific title: A Randomized Double-Blind Phase 4 Study to Evaluate the Safety and Proportion of Subjects With Fistula Healing in 2 Dose Regimens of Entyvio (Vedolizumab IV) in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)
Date of first enrolment: August 10, 2016
Target sample size: 34
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02630966
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
Belgium Canada France Italy Netherlands Spain United Kingdom United States
Contacts
Name:     Medical Director Clinical Science
Address: 
Telephone:
Email:
Affiliation:  Takeda
Key inclusion & exclusion 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-a) 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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Intervention(s)
Drug: Placebo
Drug: Vedolizumab
Primary Outcome(s)
Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline) [Time Frame: Baseline, Week 30]
Secondary Outcome(s)
Duration of Perianal Fistulae Response (of Those Fistulae Draining at Baseline) [Time Frame: Up to Week 30]
Percentage of Participants With 100% Perianal Fistulae Closure (of the Fistulae Draining at Baseline) [Time Frame: Week 30]
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 [Time Frame: Weeks 22 and 30]
Time to First Perianal Fistulae Closure (of Those Fistulae Draining at Baseline) [Time Frame: Up to Week 30]
Time to Last (100%) Perianal Fistulae Closure (of Those Fistulae Draining at Baseline) [Time Frame: Up to Week 30]
Secondary ID(s)
2015-000852-12
U1111-1174-2252
Vedolizumab-4003
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 25/09/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02630966
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