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).
The drug being tested in this study is called vedolizumab IV. Vedolizumab IV is being tested to treat people who have fistulizing CD. This study will look at fistula healing in people who take vedolizumab IV. The study is planned to enroll approximately 100 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): * Group 1: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 14 and 22, and a placebo infusion at Week 10 (dummy inactive infusion - this is a solution that looks like the study drug but has no active ingredient). * Group 2: Vedolizumab IV 300 mg dose at Weeks 0, 2, 6, 10, 14 and 22. This multi-center trial will be conducted worldwide. The overall time to participate in this study from screening to 18 weeks after the last dose is 44 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 6 months after last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
Vedolizumab 300 mg IV infusion
0.9% sodium chloride IV infusion
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
Percentage of Participants With at Least 50% Reduction From Baseline in the Number of Draining Perianal Fistulae (of Those Draining at Baseline)
Closed fistulae are no longer draining despite gentle finger compression.
Time frame: Baseline, 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
Closed fistulae are no longer draining despite gentle finger compression.
Time frame: Weeks 22 and 30
Percentage of Participants With 100% Perianal Fistulae Closure (of the Fistulae Draining at Baseline)
Closed fistulae are no longer draining despite gentle finger compression.
Time frame: Week 30
Time to First Perianal Fistulae Closure (of Those Fistulae Draining at Baseline)
Closed fistulae are no longer draining despite gentle finger compression.The time to first fistula closure was analyzed descriptively using Kaplan-Meier product limit methods, with participants for which no fistula closure is reported being censored at the time of their last fistulae assessment or date of last record (Week 30 or early discontinuation). Estimated median time to fistula closure (and 95%CI) are reported.
Time frame: Up to Week 30
Time to Last (100%) Perianal Fistulae Closure (of Those Fistulae Draining at Baseline)
Closed fistulae are no longer draining despite gentle finger compression. The time to first fistula closure was analyzed descriptively using Kaplan-Meier product limit methods, with participants for which no fistula closure is reported being censored at the time of their last fistulae assessment or date of last record (Week 30 or early discontinuation). Estimated median time to fistula closure (and 95%CI) are reported.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Virginia Mason Medical Center
Seattle, Washington, United States
University of Calgary
Calgary, Alberta, Canada
GIRI (GI Research Institute)
Vancouver, British Columbia, Canada
CHRU de Lille - Hopital Claude Huriez
Lille, France
Hopital l'Archet II
Nice, France
CHU de Rennes - Hopital de Pontchaillou
Rennes, France
Hopital de Brabois
Vandœuvre-lès-Nancy, France
Azienda Ospedaliera S. Orsola-Malpighi
Bologna, Italy
...and 8 more locations
Time frame: Up to Week 30
Duration of Perianal Fistulae Response (of Those Fistulae Draining at Baseline)
Duration of fistula response was measured by number of days with/without drainage. Duration of perianal fistula response (days) was derived as the sum of days with perianal fistula response between Day 1 and the end of the study (Week 30 or early discontinuation). Perianal fistula response is defined as reduction in the number of draining perianal fistulae (of those draining at Baseline) draining of at least 50%.
Time frame: Up to Week 30