Phase III Study of MLN0002 (300 mg) in Treatment of Crohn... | NCT02038920 | Trialant
NCT02038920
Sponsor
Takeda
Status
Completed
Last Update Posted
Dec 9, 2019Actual
Enrollment
157Actual
Phase
Phase 3
Conditions
Crohn's Disease
Interventions
Vedolizumab
Vedolizumab placebo
Countries
Japan
Protocol Section
Identification Module
NCT ID
NCT02038920
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MLN0002/CCT-001
Secondary IDs
ID
Type
Description
Link
U1111-1150-2688
Other Identifier
WHO
JapicCTI-142402
Registry Identifier
JapicCTI
Brief Title
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
Official Title
Phase III, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intravenous MLN0002 (300 mg) Infusion in Induction and Maintenance Therapy in Japanese Subjects With Moderate or Severe Crohn's Disease
Acronym
Not provided
Organization
TakedaINDUSTRY
Status Module
Record Verification Date
Nov 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jan 28, 2014Actual
Primary Completion Date
Jan 25, 2019Actual
Completion Date
May 21, 2019Actual
First Submitted Date
Jan 15, 2014
First Submission Date that Met QC Criteria
Jan 15, 2014
First Posted Date
Jan 17, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 20, 2019
Results First Submitted that Met QC Criteria
Nov 20, 2019
Results First Posted Date
Dec 9, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Nov 20, 2019
Last Update Posted Date
Dec 9, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
TakedaINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.
Detailed Description
This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of intravenous vedolizumab (300 mg) infusion in induction and maintenance therapy in Japanese participants with moderately or severely active Crohn's disease.
Conditions Module
Conditions
Crohn's Disease
Keywords
Drug Therapy
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
157Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Induction Phase: Vedolizumab, 300 mg
Experimental
Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.
Drug: Vedolizumab
Induction Phase: Placebo
Placebo Comparator
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
Drug: Vedolizumab placebo
Maintenance Phase: Vedolizumab 300 mg
Experimental
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
Drug: Vedolizumab
Maintenance Phase: Placebo
Placebo Comparator
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Drug: Vedolizumab placebo
Maintenance Phase: Placebo Continuation
Placebo Comparator
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Vedolizumab
Drug
Vedolizumab IV injection
Induction Phase: Vedolizumab, 300 mg
Maintenance Phase: Vedolizumab 300 mg
Open-Label: Vedolizumab 300 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response
A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Week 10
Maintenance Phase: Percentage of Participants With Clinical Remission
Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Week 60
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)
An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
Number of Participants With TEAE Related to Body Weight (Weight Decreased)
Reported events on this outcome measure were "Weight Decreased".
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
Number of Participants With TEAE Related to Vital Signs
Secondary Outcomes
Measure
Description
Time Frame
Induction Phase: Percentage of Participants With Clinical Remission
Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Week 10
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
In the opinion of the investigator, participants were capable of understanding and complying with protocol requirements
Participants or, when applicable, participants legally acceptable representative sign and date the informed consent form prior to initiation of any study procedures
Participants aged 15 to 80 years (inclusive) at the time of consent
A nonsterilized male participant who has a female partner of child-bearing potential has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug
A female participant of child-bearing potential (i.e., nonsterilized or whose last regular menses was within previous 2 years) who has a nonsterilized male partner has to agree to use adequate contraception during the period from the signing of informed consent to 6 months after the last dose of the study drug
Participants with a diagnosis of small-intestinal, large-intestinal, or small-/large-intestinal Crohn's disease (CD) established based on the Revised Diagnostic Criteria for Crohn's disease issued by Research Group for Intractable Inflammatory Bowel Disease Designated as Specified Disease by the Ministry of Health, Labor and Welfare of Japan (2012) at least 3 months before the start of administration of study drug
Participants with baseline CDAI score of 220 to 450(inclusive) and meeting at least one of the followings:
C-reactive protein (CRP) at screening test is above 0.30 mg/dL
Participants with irregular or semicircular ulcers or multiple aphthae (10 or more) observed over an extensive area of the small or large intestine on endoscopy or imaging test within the 4 months before the start of administration of study drugs
Participants with longitudinal ulcers or a cobblestone appearance observed in the small or large intestine on endoscopy or imaging test within 4 months before the start of administration of study drugs
In case of the participants who meet any of the following criteria; participants with ≥ 8-year history of extensive or limited colitis, participants aged ≥ 50 years, or participants with a first-degree family history of colon cancer, those whom the complication of colon cancer or dysplasia was ruled out by total colonoscopy at the start of study drug administration (or the results from total colonoscopy performed within 1 year before giving consent are available)
Participants meeting the criteria for treatment failure below with at least one of the following agents received within previous 5 year period before giving consent
Corticosteroids
Resistance
Dependence
Intolerance
Immunomodulators (azathioprine, 6-mercaptopurine or methotrexate)
Participants with an evidence of or suspected abdominal abscess
Participants with a history of subtotal or total colectomy
Participants who have had a resection of the small intestine in at least 3 locations or have a diagnosis of short bowel syndrome
Participants with ileostomy, colostomy, or internal fistula, or severe intestinal stenosis
Participants who have a treatment history with natalizumab, efalizumab or rituximab
Participants who started 5-aminosalicylic acid oral drug or probiotics treatment, antimicrobials to treat Crohn's disease, or 30 mg/day or less of oral corticosteroids within 13 days before initiation of study drug administration. If these drugs were used within 14 days before initiation of study drug administration, the dosage must have been changed or their use discontinued within 13 days before the initiation of study drug administration
Participants who had received 5-aminosalicylic acid or corticosteroid enemas/suppositories, intravenous corticosteroid injections, or more than 30 mg/day of oral corticosteroids, medications for diarrhea-predominant irritable bowel syndrome, or Chinese herbal medicine for the treatment of Crohn's disease (e.g., Daikenchuto) within 13 days before initiation of study drug administration
Participants who had received azathioprine, 6-mercaptopurine, or methotrexate within 27 days before initiation of study drug administration. However, this shall not apply to participants who have received these drugs for 83 or more days before initiation of the study drug administration and continued the steady dose administration of the drugs for 27 or more days before initiation of the study drug administration
Participants who had received cyclosporin, tacrolimus, tofacitinib or any study drugs for treatment of ulcerative colitis within 27 days before initiation of the study drug administration
Participants who had received adalimumab within 27 days before initiation of study drug administration or any biological drugs other than adalimumab within 55 days before initiation of study drug administration. Topical administration (such as intraocular implantation for treatment of age-related maculopacy) is allowed
Participants who had received any live vaccinations within 27 days before initiation of study drug administration
Participants who had undergone intestinal resection within 27 days before initiation of study drug administration or those anticipated to require intestinal resection during the study
Participants who had received leukocytapheresis or granulocyte apheresis within 27 days before initiation of the study drug administration
Participants who had received intravenous hyperalimentation or total enteral nutrition within the 20 days before initiation of the study drug administration or participants who are fasted
Participants who had received enteral nutrition at > 900 kcal/day or started enteral nutrition at <= 900 kcal/day within the 20 days before initiation of the study drug administration. Participants receiving 900 kcal/day or less of enteral nutrition for at least 21 days before initiation of the study drug administration whom these dosage was changed or the medications were discontinued within 20 days before initiation of the study drug administration
Participants who had been infected with Clostridium difficile, cytomegalovirus, or any other intestinal pathogen within 27 days before the first dose of the study drug
Participants with evidence of adenomatous colonic polyps that need to be removed at the start of study drug administration
Participants with a history or an complication of dysplasia of the small or large intestine
Participants who were suspected to have enteritis other than CD
Participants who were hepatitis B surface (HBs) antigen-positive or hepatitis C virus (HCV) antibody-positive at the screening. Or participants who are hepatitis B core (HBc) antibodypositive or HBs antibody positive, even though HBs antigen-negative. However, this does not apply to participants who are only HBs antibody-positive due to hepatitis B virus (HBV) vaccination, HBV-DNA-negative, HCV antigen-negative, or HCV-RNA-negative
Participants who had an evidence of history of tuberculosis or a suspected history of tuberculosis (including those who have findings suggesting previous tuberculosis on chest imaging procedure at the screening). However, this does not apply to participants who had completed prophylactic isoniazid, or participants who had been receiving prophylactic isoniazid for more than 21 days before the first dose of the study drug (in the latter case, the screening period are allowed to extend up to 28 days to ensure at least 21-day prophylactic isoniazid and then the study treatment is allowed to start)
Participants who had positive T-SPOT test or QuantiFERON test at the screening
Participants who had a history or complication of identified congenital or acquire immunodeficiency syndrome (eg, not-classifiable immunodeficiency, human immunodeficiency virus [HIV] infection or organ transplantation)
Participants who had been affected by extraintestinal infection (eg, pneumonia, sepsis, active hepatitis or pyelonephritis) within 27 days before the first dose of the study drug
Participants who had a treatment history with MLN0002
Female participants who are lactating at the screening, or have positive urine pregnancy test either at the screening or baseline
Participants who had serious complications in the heart, lung, liver, kidney, metabolism, gastrointestinal system, urinary system, endocrine system or blood
Participants who had a history of a surgery requiring general anesthesia within 27 days before the first dose of the study drug, or with a schedule of a surgery requiring hospitalization during the study period
Participants who had a complication or a history of malignancy. However, this does not apply to the following participants:
Participants who had a curative resection of localized skin basal cell carcinoma or have completed curative radiotherapy
Participants who had not experienced recurrence for more than 1 year since completion of a curative resection or curative radiotherapy for skin squamous cell carcinoma
Participants who had not experienced recurrence for more than 3 years since completion of a curative resection or curative radiotherapy for intraepithelial carcinoma of uterine cervix For participants who had a substantially distant history of malignancy (eg, 10 years or longer without recurrence since treatment completion), the investigator and the sponsor had a discussion to decide eligibility on the basis of type of malignancy and treatment applied
Participants who had a history or a complication of the central nervous disorder, including stroke, multiple sclerosis, brain tumor, or neurodegenerative disease.
Participants who had any subjective symptoms in the subjective PML checklist at the screening or baseline
Participants who had any of the following laboratory abnormalities at the screening;
Hemoglobin ≤8 g/dL
White blood cells ≤3,000/μL
Lymphocytes ≤500/μL
Platelets ≤100,000/μL or ≥1,200,000/μL
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3×upper limit of normal (ULN)
Alkaline phosphatase (ALP) ≥3×ULN
Creatinine ≥2×ULN
Participants who had a history or a complication of alcohol dependence or illicit drug use within one year before the first dose of the study drug
Participants who had a history or a complication of psychotic disorder that could obstruct compliance with the study procedures
Okamoto H, Dirks NL, Rosario M, Hori T, Hibi T. Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn's disease. Intest Res. 2021 Jan;19(1):95-105. doi: 10.5217/ir.2019.09167. Epub 2020 Jul 10.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Participants with moderate to severe Crohn's disease were enrolled. 157 participants enrolled in induction phase, 41 participants entered maintenance phase and 134 participants entered open-label cohort and received placebo or vedolizumab 300 mg. Open-label cohort occurred between Week 10 and 154 through study with maximum of 94 weeks of treatment.
Recruitment Details
Participants took part in the study at 77 investigative sites in Japan from 28 Jan 2014 to 21 May 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, intravenous (IV) infusion, once at Weeks 0, 2 and 6 in the induction phase.
FG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Drug: Vedolizumab
MLN0002
Vedolizumab placebo
Drug
Vedolizumab placebo-matching IV infusion
Induction Phase: Placebo
Maintenance Phase: Placebo
Maintenance Phase: Placebo Continuation
Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were "Pyrexia", "Body temperature increased", "Hypertension", and "Orthostatic hypotension".
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]
Reported events on this outcome measure were "Bundle Branch Block Right".
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values
The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /microL, White Blood Cell (WBC) <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) >3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal.
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values
Baseline to Week 10
Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response
A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Week 60
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Durable clinical remission is defined as participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
From Week 14 and Week 60
Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission
Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Week 60
Serum Vedolizumab Concentration in Induction Phase
Weeks 2, 6, 10 and 14
Serum Vedolizumab Concentration in Maintenance Phase
Weeks 2, 6, 10, 14, 22, 30 and 60
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase
Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase
Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort
Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase
Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase
Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort
Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort
Toyota
Aichi-ken
Japan
Hirosaki
Aomori
Japan
Abiko
Chiba
Japan
Kashiwa
Chiba
Japan
Sakura
Chiba
Japan
Matsuyama
Ehime
Japan
Chikushino-shi
Fukuoka
Japan
Kasuga
Fukuoka
Japan
Kitakyushu
Fukuoka
Japan
Takasaki
Gunma
Japan
Fukuyama
Hiroshima
Japan
Hatsukaichi
Hiroshima
Japan
Asahikawa
Hokkaido
Japan
Sapporo
Hokkaido
Japan
Tomakomai
Hokkaido
Japan
Akashi
Hyōgo
Japan
Nishinomiya
Hyōgo
Japan
Takamatsu
Kagawa-ken
Japan
Kamakura
Kanagawa
Japan
Kawasaki
Kanagawa
Japan
Sagamihara
Kanagawa
Japan
Yokohama
Kanagawa
Japan
Kochi
Kochi
Japan
Sendai
Miyagi
Japan
Kurashiki
Okayama-ken
Japan
Moriguchi
Osaka
Japan
Suita
Osaka
Japan
Tokorozawa
Saitama
Japan
Ōtsu
Shiga
Japan
Hamamatsu
Shizuoka
Japan
Shimotsuke
Tochigi
Japan
Adachi-ku
Tokyo
Japan
Bunkyo-ku
Tokyo
Japan
Chiyoda-ku
Tokyo
Japan
Minato-ku
Tokyo
Japan
Shinagawa-ku
Tokyo
Japan
Shinjuku-ku
Tokyo
Japan
Shūnan
Yamaguchi
Japan
Kofu
Yamanashi
Japan
Chiba
Japan
Fukui
Japan
Fukuoka
Japan
Hiroshima
Japan
Kagoshima
Japan
Kumamoto
Japan
Kyoto
Japan
Nagasaki
Japan
Niigata
Japan
Okayama
Japan
Okinawa
Japan
Osaka
Japan
Ōita
Japan
Saga
Japan
Saitama
Japan
Wakayama
Japan
FG002
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved Crohn's Disease Activity Index (CDAI)-70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
FG003
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
FG004
Maintenance Phase: Placebo Continuation
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
FG005
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
FG00079 subjects
FG00178 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
COMPLETED
FG00073 subjects
FG00166 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
NOT COMPLETED
FG0006 subjects
FG00112 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Type
Comment
Reasons
Pretreatment Event/Adverse Event
FG0003 subjects
FG00111 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Voluntary Withdrawal
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Maintenance Phase (Week 14 to 60)
Type
Comment
Milestone Data
STARTED
Participants who achieved clinical response at Week 10 entered into the maintenance phase.
FG0000 subjects
FG0010 subjects
FG00212 subjects
FG00312 subjects
FG00417 subjects
FG0050 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0027 subjects
FG0034 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Pretreatment Event/Adverse Event
FG0000 subjects
FG0010 subjects
FG0022 subjects
FG003
Open Label Cohort (Week 10 to 154)
Type
Comment
Milestone Data
STARTED
23 out of 157 participants from induction/maintenance phase did not enter the open-label cohort.
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG005134 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Pretreatment Event/Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All participants who entered in the induction phase.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
BG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00079
BG00178
BG002157
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002157
Title
Measurements
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Japan
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Height
Mean
Standard Deviation
cm
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Weight
Mean
Standard Deviation
kg
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Body Mass Index (BMI)
Body Mass Index = weight(kg)/[height(m)^2]
Mean
Standard Deviation
kg/m^2
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Duration of Crohn's Disease
Duration between the first diagnosis of Crohn's disease and the start of the study was reported.
Median
Full Range
years
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
C-Reactive Protein (CRP)
Mean
Standard Deviation
mg/dL
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
CDAI Score at Week 0
CDAI is scoring system for the Assessment of Crohn's Disease Activity. The total CDAI score ranges from 0 to approximately 600 , where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Mean
Standard Deviation
score on a scale
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Disease Localization
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Smoking Classification
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Extraintestinal Manifestations (Based on CDAI subscore)
CDAI is scoring system for the Assessment of Crohn's Disease Activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Extraintestinal Manifestations (Based on Case Report Form)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
History of Prior Surgery for Crohn's Disease (CD)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Current Medical Condition Related to Fistula
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00079
ParticipantsBG00178
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Induction Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response
A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Full analysis set (FAS) in the induction phase included participants who were randomized and received at least one dose of the study drug in induction phase.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
OG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
Units
Counts
Participants
OG00079
OG00178
Title
Denominators
Categories
Title
Measurements
OG00026.6(17.268 to 37.720)
OG00116.7(9.184 to 26.813)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.1448
Odds Ratio (OR)
1.80
2-Sided
95
0.816
3.958
MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.
Superiority
Primary
Maintenance Phase: Percentage of Participants With Clinical Remission
Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.
Posted
Number
95% Confidence Interval
percentage of participants
Week 60
ID
Title
Description
OG000
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG001
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Primary
Number of Participants Who Experienced at Least One or More Treatment-Emergent Adverse Events (TEAEs)
An Adverse event (AE) is defined as any untoward medical occurrence in a study participant who received a drug (including a study drug); it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug.
Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.
Posted
Count of Participants
Participants
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
OG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
OG002
Maintenance Phase: Vedolizumab 300 mg
Primary
Number of Participants With TEAE Related to Body Weight (Weight Decreased)
Reported events on this outcome measure were "Weight Decreased".
Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.
Posted
Count of Participants
Participants
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
OG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
OG002
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG003
Maintenance Phase: Placebo
Primary
Number of Participants With TEAE Related to Vital Signs
Vital signs included body temperature (axilla), sitting blood pressure (after the participant has rested for at least 5 minutes), and pulse (bpm). Reported events on this outcome measure were "Pyrexia", "Body temperature increased", "Hypertension", and "Orthostatic hypotension".
Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.
Posted
Count of Participants
Participants
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
OG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
OG002
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
Primary
Number of Participants With TEAE Related to Electrocardiogram (ECG) [Bundle Branch Block Right]
Reported events on this outcome measure were "Bundle Branch Block Right".
Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.
Posted
Count of Participants
Participants
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
OG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
OG002
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG003
Primary
Number of Participants With Markedly Abnormal Values of Laboratory Parameters Values
The laboratory values outside the range (Hemoglobin <=7 g/dL, Lymphocytes <500 /microL, White Blood Cell (WBC) <2000 /microL, Platelets <7.5 10^4/microL, Neutrophils <1000 /microL, Alanine Aminotransferase (ALT) (Glutamic Pyruvic Transaminase; GPT) >3.0 U/L x upper limit of normal (ULN), Aspartate Aminotransferase (AST) (Glutamic Oxaloacetic Transaminase; GOT) >3.0 U/L x ULN, Total Bilirubin >2.0 mg/dL x ULN, Amylase >2.0 (U/L) x ULN are considered markedly abnormal.
Safety analysis set included participants who received at least one dose of the study drug in either the induction phase, the maintenance phase or the open-label cohort.
Posted
Count of Participants
Participants
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
OG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
OG002
Maintenance Phase: Vedolizumab 300 mg
Secondary
Induction Phase: Percentage of Participants With Clinical Remission
Clinical remission is defined as the CDAI score ≤150. CDAI is scoring system for the assessment of Crohn's disease activity. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
FAS in the induction phase included participants who were randomized and received at least one dose of the study drug in induction phase.
Posted
Number
95% Confidence Interval
percentage of participants
Week 10
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
OG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
Units
Counts
Participants
OG000
Secondary
Induction Phase: Change From Baseline in C-reactive Protein (CRP) Values
Participants from 'FAS in the induction phase' with CRP value exceeding 0.30 mg/dL at Baseline were analyzed at given time point. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Mean
Standard Deviation
mg/dL
Baseline to Week 10
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
OG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
Units
Counts
Participants
OG000
Secondary
Maintenance Phase: Percentage of Participants With Crohn's Disease Activity Index (CDAI)-100 Response
A response to therapy is considered a decrease from baseline of at least 100 points in the CDAI score at Week 10. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.
Posted
Number
95% Confidence Interval
percentage of participants
Week 60
ID
Title
Description
OG000
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG001
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Secondary
Maintenance Phase: Percentage of Participants With Durable Clinical Remission
Durable clinical remission is defined as participants with CDAI score ≤ 150 at both Weeks 14 and 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
FAS in the maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase. The FAS in the maintenance phase does not include participants who received placebo in the induction phase and were enrolled into the maintenance phase.
Posted
Number
95% Confidence Interval
percentage of participants
From Week 14 and Week 60
ID
Title
Description
OG000
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG001
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Secondary
Maintenance Phase: Percentage of Participants With Corticosteroid-free Clinical Remission
Corticosteroid-free clinical remission is defined as participants using oral corticosteroids at baseline (Week 0) who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 60. CDAI is scoring system for the assessment of Crohn's disease activity. The total CDAI score ranges from 0 to approximately 600, where higher scores indicate more severe disease. Index values of 150 and below are associated with quiescent disease; values above that indicate active disease.
Participants from FAS in maintenance phase included participants who were randomized and received at least one dose of the study drug in the maintenance phase and administered oral corticosteroids concomitantly at Week 0, were analyzed at the given timepoint.
Posted
Number
95% Confidence Interval
percentage of participants
Week 60
ID
Title
Description
OG000
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG001
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Secondary
Serum Vedolizumab Concentration in Induction Phase
Participants from 'FAS in Induction Phase', who were randomized and received at least one dose of the study drug in the induction phase and for whom samples were available for pharmacokinetic (PK) analysis. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Mean
Standard Deviation
ug/mL
Weeks 2, 6, 10 and 14
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
Units
Counts
Participants
OG00079
Secondary
Serum Vedolizumab Concentration in Maintenance Phase
Participants from 'FAS in Maintenance Phase', who were randomized and received at least one dose of the study drug in the maintenance phase and for whom samples were available for PK analysis. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Mean
Standard Deviation
ug/mL
Weeks 2, 6, 10, 14, 22, 30 and 60
ID
Title
Description
OG000
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG001
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Units
Counts
Participants
Secondary
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Induction Phase
Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Count of Participants
Participants
Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
Units
Counts
Participants
OG00079
Secondary
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Maintenance Phase
Participants who underwent proper AVA test out of the 'FAS in Maintenance Phase', the participants who received at least one dose of study drug in the maintenance phase were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Count of Participants
Participants
Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase
ID
Title
Description
OG000
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG001
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Units
Counts
Participants
Secondary
Number of Participants With Anti-vedolizumab Antibodies (AVA) in Open Label Cohort
Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Count of Participants
Participants
Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort
ID
Title
Description
OG000
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Induction Phase
Participants who underwent proper AVA test out of 'the FAS in the induction phase' were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Count of Participants
Participants
Weeks 0, 10 and 16 weeks after the last dose of study drug in induction phase
ID
Title
Description
OG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
Units
Counts
Participants
OG000
Secondary
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Maintenance Phase
Participants who underwent proper AVA test out of the 'FAS in Maintenance Phase', the participants who received at least one dose of study drug in the maintenance phase were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Count of Participants
Participants
Weeks 0, 10, 30, 60 and 16 weeks after the last dose of study drug in maintenance phase
ID
Title
Description
OG000
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG001
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
Units
Counts
Participants
Secondary
Number of Participants With Neutralizing Anti-vedolizumab Antibodies (AVA) in Open Label Cohort
Participants who underwent proper AVA test out of the 'FAS in Open Label Cohort', the participants who received at least one dose of study drug in the open label cohort were analyzed in this outcome measure. Number analyzed is the number of participants with evaluable data at the given time-point.
Posted
Count of Participants
Participants
Weeks 0, 10, 30, 62, 94 and 16 weeks after the last dose of study drug in open-label cohort
ID
Title
Description
OG000
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Units
Counts
Participants
OG000
Time Frame
From Baseline up to 16 weeks after the last dose of study drug (Up to approximately 170 weeks)
Description
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Induction Phase: Vedolizumab, 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 in the induction phase.
0
79
8
79
17
79
EG001
Induction Phase: Placebo
Vedolizumab placebo-matching IV infusion once at Weeks 0, 2 and 6 in the induction phase.
0
78
10
78
19
78
EG002
Maintenance Phase: Vedolizumab 300 mg
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
0
12
2
12
9
12
EG003
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
0
12
4
12
7
12
EG004
Maintenance Phase: Placebo Continuation
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
0
17
2
17
12
17
EG005
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
0
134
70
134
113
134
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Crohn's disease
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0002 affected79 at risk
EG00110 affected78 at risk
EG0021 affected12 at risk
EG0032 affected12 at risk
EG0041 affected17 at risk
EG00535 affected134 at risk
Anal fistula
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0011 affected78 at risk
EG0020 affected12 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0011 affected78 at risk
EG0020 affected12 at risk
EG003
Anaphylactoid reaction
Immune system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0011 affected78 at risk
EG0020 affected12 at risk
EG003
Anal abscess
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA: 21.0
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Thyroid adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 21.0
Systematic Assessment
EG0001 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Abdominal adhesions
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Cellulitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Erythema nodosum
Skin and subcutaneous tissue disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Intestinal stenosis
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Enterovesical fistula
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Ileal stenosis
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Large intestinal stenosis
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Large intestine perforation
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Melaena
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Small intestinal obstruction
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Inflammation
General disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Drug-induced liver injury
Hepatobiliary disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Abdominal abscess
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Device related infection
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Mesenteric abscess
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Mycotic endophthalmitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Otitis media
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Periumbilical abscess
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Pneumonia
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Pneumonia bacterial
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Rectal abscess
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Sepsis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Septic shock
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Intestinal anastomosis complication
Injury, poisoning and procedural complications
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Post lumbar puncture syndrome
Injury, poisoning and procedural complications
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Hypocalcaemia
Metabolism and nutrition disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Hypomagnesaemia
Metabolism and nutrition disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Dizziness
Nervous system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Dyslalia
Nervous system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Intracranial hypotension
Nervous system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Pleurisy
Respiratory, thoracic and mediastinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Mediastinitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Crohn's disease
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0015 affected78 at risk
EG0020 affected12 at risk
EG0030 affected12 at risk
EG0042 affected17 at risk
EG00527 affected134 at risk
Nasopharyngitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG00011 affected79 at risk
EG00111 affected78 at risk
EG0024 affected12 at risk
EG003
Enteritis infectious
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0004 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA: 21.0
Systematic Assessment
EG0001 affected79 at risk
EG0014 affected78 at risk
EG0020 affected12 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA: 21.0
Systematic Assessment
EG0004 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Pyrexia
General disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Chest pain
General disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Swelling
General disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Allergy to metals
Immune system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Anal abscess
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Dermatophytosis of nail
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Rhinitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Heat illness
Injury, poisoning and procedural complications
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Blood urine present
Investigations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Glucose urine present
Investigations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Ocular neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Upper respiratory tract inflammation
Respiratory, thoracic and mediastinal disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Hypertension
Vascular disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0021 affected12 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Influenza
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA: 21.0
Systematic Assessment
EG0000 affected79 at risk
EG0010 affected78 at risk
EG0020 affected12 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG003
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
OG004
Maintenance Phase: Placebo Continuation
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
OG005
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Units
Counts
Participants
OG00079
OG00178
OG00212
OG00312
OG00417
OG005134
Title
Denominators
Categories
Title
Measurements
OG00049
OG00142
OG0029
OG00310
OG00412
OG005130
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
OG004
Maintenance Phase: Placebo Continuation
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
OG005
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Units
Counts
Participants
OG00079
OG00178
OG00212
OG00312
OG00417
OG005134
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0052
OG003
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
OG004
Maintenance Phase: Placebo Continuation
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
OG005
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Units
Counts
Participants
OG00079
OG00178
OG00212
OG00312
OG00417
OG005134
Title
Denominators
Categories
Pyrexia
Title
Measurements
OG0003
OG0011
OG0020
OG0031
OG0041
OG00519
Body Temperature Increased
Title
Measurements
OG0001
OG0010
OG0020
OG003
Hypertension
Title
Measurements
OG0000
OG0010
OG0021
OG003
Orthostatic Hypotension
Title
Measurements
OG0000
OG0010
OG0020
OG003
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
OG004
Maintenance Phase: Placebo Continuation
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
OG005
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Units
Counts
Participants
OG00079
OG00178
OG00212
OG00312
OG00417
OG005134
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0051
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI -70 response at Week 10 and were randomized to receive vedolizumab in maintenance phase.
OG003
Maintenance Phase: Placebo
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab in induction phase and achieved CDAI-70 response at Week 10 and were randomized to receive placebo in maintenance phase.
OG004
Maintenance Phase: Placebo Continuation
Vedolizumab placebo-matching, IV infusion, once at Weeks 14, 22, 30, 38, 46 and 54 in maintenance phase. Participants received vedolizumab placebo-matching in induction phase and achieved CDAI-70 response at Week 10 received placebo in maintenance phase without randomization.
OG005
Open-Label: Vedolizumab 300 mg
Vedolizumab 300 mg, IV infusion, once at Weeks 0, 2 and 6 and then every 8 weeks thereafter up to Week 94 as a maximum duration in open-label phase.
Units
Counts
Participants
OG00079
OG00178
OG00211
OG00312
OG00417
OG005134
Title
Denominators
Categories
Hemoglobin (g/dL) <=7
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0054
Lymphocytes (/uL) <500
Title
Measurements
OG0007
OG0016
OG0021
OG003
WBC (/uL) <2000
Title
Measurements
OG0000
OG0010
OG0020
OG003
Platelets (10^4/uL) <7.5
Title
Measurements
OG0000
OG0010
OG0020
OG003
Neutrophils (/uL) <1000
Title
Measurements
OG0000
OG0010
OG0020
OG003
ALT (GPT) (U/L) >3.0 x ULN
Title
Measurements
OG0001
OG0011
OG0020
OG003
AST (GOT) (U/L) >3.0 x ULN
Title
Measurements
OG0001
OG0010
OG0020
OG003
Total Bilirubin (mg/dL) >2.0 x ULN
Title
Measurements
OG0000
OG0010
OG0020
OG003
Amylase (U/L) >2.0 x ULN
Title
Measurements
OG0001
OG0010
OG0020
OG003
79
OG00178
Title
Denominators
Categories
Title
Measurements
OG00017.7(10.041 to 27.942)
OG00110.3(4.533 to 19.213)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
0.1963
Odds Ratio (OR)
1.83
2-Sided
95
0.720
4.673
MLN0002 group/placebo group. Cochran-Mantel-Haenszel (CMH) test was used for analysis. Prior tumor necrosis factor alpha (TNFα) antagonist use (yes/no) was used as stratification factor.