Vedolizumab IV 300 mg in the Treatment of Fistulizing Crohn's Disease (ENTERPRISE)
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|ClinicalTrials.gov Identifier: NCT02630966|
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Drug: Vedolizumab Drug: Placebo||Phase 4|
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 will 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 (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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)|
|Actual Study Start Date :||August 10, 2016|
|Actual Primary Completion Date :||September 4, 2018|
|Actual Study Completion Date :||November 14, 2018|
Experimental: Group 1: Vedolizumab IV 300 mg + Placebo
Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 14, and 22, and vedolizumab placebo-matching, IV, once, at Week 10.
Vedolizumab 300 mg IV
0.9% sodium chloride used as vedolizumab placebo-matching IV
Experimental: Group 2: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once, at Weeks 0, 2, 6, 10, 14, and 22.
Vedolizumab 300 mg IV
- Percentage of Participants with a Reduction of at Least 50% from Day 1 in the Number of Draining Perianal Fistulae at Week 30 [ Time Frame: Day 1, Week 30 ]Closed fistulae are no longer draining despite gentle finger compression
- Percentage of Participants with a Reduction of at Least 50% from Day 1 in the Number of Draining Perianal Fistulae at Weeks 22 and 30 [ Time Frame: Weeks 22 and 30 ]Closed fistulae are no longer draining despite gentle finger compression.
- Percentage of Participants with 100% Perianal Fistulae Closure at Week 30 [ Time Frame: Week 30 ]Closed fistulae are no longer draining despite gentle finger compression.
- Time to First Perianal Fistulae Closure [ Time Frame: Up to Week 30 ]Closed fistulae are no longer draining despite gentle finger compression.
- Time to Last (100%) Perianal Fistulae Closure [ Time Frame: Up to Week 30 ]Closed fistulae are no longer draining despite gentle finger compression.
- Duration of Perianal Fistulae Response [ Time Frame: Up to Week 30 ]Duration of fistula response will be measured by number of days with/without drainage.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630966
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37212-1375|
|United States, Texas|
|Texas Digestive Disease Consultants|
|Southlake, Texas, United States, 76092|
|United States, Washington|
|Virginia Mason Medical Center|
|Seattle, Washington, United States, 98101|
|University of Calgary|
|Calgary, Alberta, Canada, T2N 4Z6|
|Canada, British Columbia|
|GIRI (GI Research Institute)|
|Vancouver, British Columbia, Canada, V6Z 2K5|
|CHRU de Lille - Hopital Claude Huriez|
|Lille cedex, France, 59037|
|Hopital l'Archet II|
|Nice Cedex 3, France, 06202|
|CHU de Rennes - Hopital de Pontchaillou|
|Rennes cedex 9, France, 35033|
|Hopital de Brabois|
|Vandoeuvre les Nancy, France, 54511|
|Azienda Ospedaliera S. Orsola-Malpighi|
|Bologna, Italy, 40138|
|Istituto Clinico Humanitas IRCCS|
|Milan, Italy, 20089|
|Academic Medical Center|
|Amsterdam, Netherlands, 1105 AZ|
|Leids Universitair Medisch Centrum|
|Leiden, Netherlands, 2333 ZA|
|Rotterdam, Netherlands, 3015 CE|
|Hospital Clinic Barcelona|
|Barcelona, Spain, 08036|
|Hospital Universitario y Politecnico La Fe|
|Valencia, Spain, 46026|
|Nottingham University Hospitals NHS Trust|
|Nottingham, United Kingdom, NG7 2UH|
|John Radcliffe Hospital|
|Oxford, United Kingdom, OX3 9DU|
|Study Director:||Medical Director Clinical Science||Takeda|