The purpose of this study is to assess the effect of vedolizumab subcutaneous (vedolizumab SC) as maintenance treatment in participants with moderately to severely active CD who achieved clinical response following administration of vedolizumab intravenous (vedolizumab IV) induction therapy.
The drug being tested in this study is called vedolizumab SC. Vedolizumab SC is being tested to treat people who have moderate to severely active CD. This study will look at clinical remission, as well as enhanced clinical response and corticosteroid-free remission in participants with CD who receive vedolizumab SC maintenance therapy after having achieved a clinical response to vedolizumab IV induction therapy. The study will enroll approximately 824 participants. All participants will enter a 6 week Induction Phase where they will be administered open-label vedolizumab IV 300 mg via IV infusion at Week 0 (Day 1) and Week 2 (Day 15), and will then be assessed for a clinical response at Week 6. Participants who achieve a clinical response at Week 6 will be randomly assigned to one of the two treatment groups: * Vedolizumab SC 108 mg Maintenance Arm * Placebo SC Maintenance Arm Participants who do not achieve a clinical response will not be randomized into the Maintenance Period, and instead will receive a third infusion of vedolizumab IV 300 mg at Week 6. This multi-center trial will be conducted worldwide. The overall time to participate in this study is up to 71 weeks. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
644
Vedolizumab SC Injection.
Vedolizumab placebo-matching SC injection.
Vedolizumab IV Injection.
Percentage of Participants Achieving Clinical Remission at Week 52
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score less than or equal to (\<=) 150 at Week 52. 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 52
Percentage of Participants Achieving Enhanced Clinical Response at Week 52
Enhanced clinical response is defined as a decrease from Baseline of greater than or equal to (\>=) 100 points in the CDAI score at Week 52. A CDAI is a multi-item instrument which measures severity of active CD monitored over 7 days includes participant reported symptoms, physician-assessed signs, and laboratory markers. CDAI score = 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 52
Percentage of Participants Achieving Corticosteroid-free Remission at Week 52
Corticosteroid-free remission is defined as participants using oral corticosteroids at Baseline (Week 0) who have discontinued oral corticosteroids and are in clinical remission at Week 52. Clinical remission is defined as a CDAI score \<=150 at Week 52. CDAI score = 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.
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Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, United States
Medical Research Center of Connecticut, LLC
Hamden, Connecticut, United States
Middlesex Gastroenterology Associates
Middletown, Connecticut, United States
Nature Coast Clinical Research, LLC
Inverness, Florida, United States
L & L Research Choices, Inc.
Miami, Florida, United States
Gastroenterology Group of Naples
Naples, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
Atlanta Gastroenterology Specialists, PC
Suwanee, Georgia, United States
...and 184 more locations
Time frame: Week 52
Percentage of TNF-alpha Antagonist Naive Participants Achieving Clinical Remission at Week 52
Clinical remission is defined as CDAI score \<=150 at Week 52. CDAI score = 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 52