The purpose of this study is to assess the safety and efficacy of vedolizumab intravenous (IV) infusion as induction treatment in Chinese participants with moderately to severely active Crohn's disease (CD) at Week 10.
The drug being tested in this study is called vedolizumab. Vedolizumab will be administered as an intravenous (IV) infusion in Chinese participants. This study will investigate the efficacy and safety of vedolizumab IV as induction and maintenance therapy in participants with moderately to severely active Crohn's Disease (CD). The study will enroll approximately 300 moderately to severely active Chinese patients with CD. Induction Phase: participants will be randomized 2:1 to receive: * Vedolizumab IV 300 mg * Placebo IV Participants will receive vedolizumab 300 mg or matching placebo, intravenous (IV) infusion at Weeks 0, 2, and 6 in the induction phase. At Week 10, participants will be assessed for clinical response. Results of Week 10 clinical response will determine the treatment pathway in the maintenance phase. Maintenance Phase: participants who achieved clinical response at Week 10 will continue to receive the same treatment as they received in Induction Phase; every 8 weeks (Q8W) starting at Week 14. Participants who received vedolizumab IV or placebo in the Induction Phase and did not achieve clinical response at Week 10 will receive vedolizumab every 4 weeks (Q4W) starting at Week 14. This multi-center trial will be conducted in China. The overall time to participate in this study is 60 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 long-term follow-up safety survey.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
215
Vedolizumab IV infusion
Vedolizumab placebo-matching
Gastroenterology
Hefei, Anhui, China
Percentage of Participants With Enhanced Clinical Response in the Induction Phase at Week 10
Enhanced clinical response was defined as ≥100-point decrease from Baseline in the Crohn's Disease Activity Index (CDAI) score at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity.
Time frame: Week 10
Percentage of Participants With Clinical Remission in the Induction Phase at Week 10
Clinical remission was defined as CDAI score of ≤150 points at Week 10. A CDAI is a multi-item instrument which measures severity of active Crohn's Disease monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score is equal to sum of weighted scores for subjective items (number of liquid/soft stools, degree of abdominal pain, general well-being); and objective items (use of anti-diarrhoeal medication, abdominal mass, haematocrit, presence of extraintestinal manifestation, body weight). CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity
Time frame: Week 10
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