Crohn's Disease, Ulcerative Colitis
Conditions
Keywords
Drug therapy
Brief summary
The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.
Detailed description
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis or Crohn's disease. This study will determine the safety profile of long-term vedolizumab treatment. The study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300 mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received: • Vedolizumab 300 mg All participants received vedolizumab intravenous infusion every 4 weeks for approximately up to 510 weeks. This multicenter trial is being conducted worldwide. The overall time to participate in this study was up to October 2017 until vedolizumab was available in the country in which the participant resided, or until participant withdrawal, whichever came first. Participants made multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab and were being followed up for 2-years during which a safety questionnaire was administered by telephone for follow-up assessments.
Interventions
DRUGVedolizumab
Vedolizumab intravenous infusion
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002) 2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol
Exclusion criteria
1\. Development of any new, unstable, or uncontrolled disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years) | An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. |
| Number of Participants With Markedly Abnormal Safety Laboratory Findings | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) | A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin \<= 70 g/L, absolute lymphocyte count \<0.5 X 10\^9/L, leukocytes \<2.0 X 10\^9/L (absolute value), platelets \<75.0 X 10\^9/L, absolute neutrophil Count \<1.0 X 10\^9/L, prothrombin time \>1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) \>3.0 x ULN, aspartate aminotransferase (AST) \>3.0 x ULN, bilirubin \>2.0 x ULN, amylase \>2.0 x ULN, lipase \>2.0 x ULN. |
| Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) | Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE. |
| Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings | From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years) | A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs. |
| Time to Major Inflammatory Bowel Disease (IBD) - Related Events | Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years) | IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 | The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 | The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 | EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement. |
| Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352 | EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement. |
Countries
Australia, Belgium, Canada, Czechia, Germany, Hungary, Israel, Malaysia, South Korea, United States
Participant flow
Recruitment details
Participants took part in study at 298 sites in North America, Western/Northern Europe, Central Europe, Eastern Europe, Asia, Australia and Africa from 22 May 2009 to 31 October 2017.
Pre-assignment details
Participants with a diagnosis of ulcerative colitis and Crohn's disease who participated in previous studies: C13004 (NCT00619489), C13006 (NCT00783718), C13007 (NCT00783692) and C13011 (NCT01224171) and DeNovo participants were enrolled into 1 treatment group, vedolizumab 300 mg, 30-minute intravenous (IV) infusion, every 4 weeks (Q4W).
Participants by arm
| Arm | Count |
|---|---|
| Vedolizumab 300 mg (C13006) Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 430 weeks including treatment in the previous study. In study C13006: participants received either vedolizumab matching placebo or vedolizumab every Q4W or vedolizumab Q8W, IV infusion up to Week 52. | 675 |
| Vedolizumab 300 mg (C13007) Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 429 weeks including treatment in the previous study. In study C13007: participants received either vedolizumab matching placebo or vedolizumab Q4W or vedolizumab Q8W, IV infusion up to Week 52. | 726 |
| Vedolizumab 300 mg (C13011) Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 315 weeks including treatment in the previous study. In study C13011: participants received either vedolizumab matching placebo or vedolizumab 300 mg, IV infusion, at Weeks 0, 2 and 6. | 384 |
| Vedolizumab 300 mg (C13004) Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 510 weeks including treatment in the previous study. In study C13004: participants received either vedolizumab 2 mg/kg or 6 mg/kg, IV infusion Q8W up to Week 78. | 37 |
| Vedolizumab 300 mg (C13008 De Novo Participants) Vedolizumab 300 mg, 30-minute IV infusion, Q4W in this study. Treatment duration was up to approximately 260 weeks in participants with Crohn's disease (CD) or ulcerative colitis (UC) not treated in a previous study. | 421 |
| Total | 2,243 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 94 | 119 | 65 | 5 | 69 |
| Overall Study | Lack of Efficacy | 192 | 176 | 130 | 1 | 121 |
| Overall Study | Lost to Follow-up | 13 | 31 | 10 | 1 | 15 |
| Overall Study | Protocol Violation(s) | 8 | 18 | 7 | 0 | 12 |
| Overall Study | Reason Not Specified | 8 | 16 | 4 | 1 | 9 |
| Overall Study | Study Terminated by Sponsor | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 123 | 120 | 52 | 6 | 50 |
Baseline characteristics
| Characteristic | Vedolizumab 300 mg (C13007) | Vedolizumab 300 mg (C13011) | Vedolizumab 300 mg (C13004) | Vedolizumab 300 mg (C13008 De Novo Participants) | Total | Vedolizumab 300 mg (C13006) |
|---|---|---|---|---|---|---|
| Age, Continuous | 37.3 years STANDARD_DEVIATION 12.26 | 38.3 years STANDARD_DEVIATION 12.87 | 43.9 years STANDARD_DEVIATION 14.24 | 39.3 years STANDARD_DEVIATION 14.23 | 39.1 years STANDARD_DEVIATION 13.19 | 41.2 years STANDARD_DEVIATION 13.27 |
| Age, Customized <65 | 710 Participants | 376 Participants | 35 Participants | 400 Participants | 2167 Participants | 646 Participants |
| Age, Customized >=65 | 16 Participants | 8 Participants | 2 Participants | 21 Participants | 76 Participants | 29 Participants |
| BMI | 24.61 kg/m^2 STANDARD_DEVIATION 6.039 | 24.56 kg/m^2 STANDARD_DEVIATION 5.783 | 27.11 kg/m^2 STANDARD_DEVIATION 6.523 | — | 24.94 kg/m^2 STANDARD_DEVIATION 5.779 | 25.39 kg/m^2 STANDARD_DEVIATION 5.391 |
| Body Weight | 71.70 kg STANDARD_DEVIATION 19.6 | 71.29 kg STANDARD_DEVIATION 18.951 | 77.66 kg STANDARD_DEVIATION 18.907 | 75.45 kg STANDARD_DEVIATION 18.814 | 73.15 kg STANDARD_DEVIATION 18.9 | 74.10 kg STANDARD_DEVIATION 17.934 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 7 Participants | 0 Participants | 19 Participants | 67 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 700 Participants | 372 Participants | 36 Participants | 400 Participants | 2139 Participants | 631 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants | 5 Participants | 1 Participants | 2 Participants | 37 Participants | 15 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 66 Participants | 14 Participants | 0 Participants | 9 Participants | 187 Participants | 98 Participants |
| Race/Ethnicity, Customized Black | 17 Participants | 7 Participants | 0 Participants | 8 Participants | 42 Participants | 10 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 3 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 11 Participants | 0 Participants | 5 Participants | 24 Participants | 6 Participants |
| Race/Ethnicity, Customized White | 641 Participants | 349 Participants | 36 Participants | 398 Participants | 1981 Participants | 557 Participants |
| Region of Enrollment Australia | 30 Participants | 8 Participants | 0 Participants | 21 Participants | 100 Participants | 41 Participants |
| Region of Enrollment Austria | 9 Participants | 3 Participants | 0 Participants | 0 Participants | 25 Participants | 13 Participants |
| Region of Enrollment Belgium | 48 Participants | 33 Participants | 0 Participants | 46 Participants | 175 Participants | 48 Participants |
| Region of Enrollment Bulgaria | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 11 Participants | 5 Participants |
| Region of Enrollment Canada | 98 Participants | 75 Participants | 22 Participants | 87 Participants | 355 Participants | 73 Participants |
| Region of Enrollment Czech Republic | 67 Participants | 36 Participants | 0 Participants | 69 Participants | 206 Participants | 34 Participants |
| Region of Enrollment Denmark | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment Estonia | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 14 Participants | 9 Participants |
| Region of Enrollment France | 25 Participants | 10 Participants | 0 Participants | 0 Participants | 46 Participants | 11 Participants |
| Region of Enrollment Germany | 25 Participants | 4 Participants | 0 Participants | 5 Participants | 44 Participants | 10 Participants |
| Region of Enrollment Greece | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 5 Participants |
| Region of Enrollment Hong Kong | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants |
| Region of Enrollment Hungary | 47 Participants | 22 Participants | 0 Participants | 17 Participants | 98 Participants | 12 Participants |
| Region of Enrollment Iceland | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 3 Participants |
| Region of Enrollment India | 24 Participants | 0 Participants | 0 Participants | 0 Participants | 63 Participants | 39 Participants |
| Region of Enrollment Ireland | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Israel | 12 Participants | 21 Participants | 0 Participants | 21 Participants | 56 Participants | 2 Participants |
| Region of Enrollment Italy | 7 Participants | 4 Participants | 0 Participants | 0 Participants | 23 Participants | 12 Participants |
| Region of Enrollment Korea, Republic Of | 18 Participants | 7 Participants | 0 Participants | 0 Participants | 59 Participants | 34 Participants |
| Region of Enrollment Latvia | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants |
| Region of Enrollment Malaysia | 6 Participants | 3 Participants | 0 Participants | 0 Participants | 17 Participants | 8 Participants |
| Region of Enrollment Netherlands | 5 Participants | 12 Participants | 0 Participants | 0 Participants | 19 Participants | 2 Participants |
| Region of Enrollment New Zealand | 8 Participants | 1 Participants | 0 Participants | 8 Participants | 26 Participants | 9 Participants |
| Region of Enrollment Norway | 5 Participants | 2 Participants | 0 Participants | 0 Participants | 14 Participants | 7 Participants |
| Region of Enrollment Poland | 20 Participants | 9 Participants | 0 Participants | 0 Participants | 82 Participants | 53 Participants |
| Region of Enrollment Romania | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 0 Participants |
| Region of Enrollment Russia | 24 Participants | 0 Participants | 15 Participants | 0 Participants | 85 Participants | 46 Participants |
| Region of Enrollment Serbia | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants |
| Region of Enrollment Singapore | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants |
| Region of Enrollment Slovakia | 14 Participants | 17 Participants | 0 Participants | 0 Participants | 31 Participants | 0 Participants |
| Region of Enrollment South Africa | 15 Participants | 8 Participants | 0 Participants | 0 Participants | 36 Participants | 13 Participants |
| Region of Enrollment Spain | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 1 Participants |
| Region of Enrollment Sweden | 5 Participants | 0 Participants | 0 Participants | 0 Participants | 5 Participants | 0 Participants |
| Region of Enrollment Switzerland | 4 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 2 Participants |
| Region of Enrollment Taiwan, Province Of China | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants | 1 Participants |
| Region of Enrollment Turkey | 3 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 6 Participants |
| Region of Enrollment Ukraine | 9 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants | 0 Participants |
| Region of Enrollment United Kingdom | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Region of Enrollment United States | 166 Participants | 109 Participants | 0 Participants | 147 Participants | 591 Participants | 169 Participants |
| Sex: Female, Male Female | 384 Participants | 216 Participants | 20 Participants | 215 Participants | 1115 Participants | 280 Participants |
| Sex: Female, Male Male | 342 Participants | 168 Participants | 17 Participants | 206 Participants | 1128 Participants | 395 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 10 / 2,243 |
| other Total, other adverse events | 1,820 / 2,243 |
| serious Total, serious adverse events | 825 / 2,243 |
Outcome results
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.48 score on a scale | Standard Deviation 1.451 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.48 score on a scale | Standard Deviation 1.602 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.22 score on a scale | Standard Deviation 1.325 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.26 score on a scale | Standard Deviation 1.528 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.55 score on a scale | Standard Deviation 1.391 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.43 score on a scale | Standard Deviation 1.452 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 8.04 score on a scale | Standard Deviation 1.507 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.64 score on a scale | Standard Deviation 1.773 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.73 score on a scale | Standard Deviation 1.741 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.69 score on a scale | Standard Deviation 1.446 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.62 score on a scale | Standard Deviation 1.394 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.67 score on a scale | Standard Deviation 1.375 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.04 score on a scale | Standard Deviation 1.609 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.71 score on a scale | Standard Deviation 1.428 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.71 score on a scale | Standard Deviation 1.507 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.16 score on a scale | Standard Deviation 1.538 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.28 score on a scale | Standard Deviation 1.36 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -1.37 score on a scale | Standard Deviation 1.477 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Baseline | 7.53 score on a scale | Standard Deviation 1.401 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 | Change at Week 100 | -0.98 score on a scale | Standard Deviation 1.473 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.33 score on a scale | Standard Deviation 1.271 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.52 score on a scale | Standard Deviation 1.805 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.24 score on a scale | Standard Deviation 1.329 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.07 score on a scale | Standard Deviation 1.566 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.61 score on a scale | Standard Deviation 1.406 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.52 score on a scale | Standard Deviation 1.539 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 8.14 score on a scale | Standard Deviation 1.457 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.70 score on a scale | Standard Deviation 1.655 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.60 score on a scale | Standard Deviation 1.69 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.62 score on a scale | Standard Deviation 1.423 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.69 score on a scale | Standard Deviation 1.56 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.69 score on a scale | Standard Deviation 1.446 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -0.85 score on a scale | Standard Deviation 1.662 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.73 score on a scale | Standard Deviation 1.441 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.65 score on a scale | Standard Deviation 1.51 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.05 score on a scale | Standard Deviation 1.637 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.28 score on a scale | Standard Deviation 1.223 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.34 score on a scale | Standard Deviation 1.56 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Baseline | 7.54 score on a scale | Standard Deviation 1.401 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 | Change at Week 124 | -1.07 score on a scale | Standard Deviation 1.639 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.33 score on a scale | Standard Deviation 1.271 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.30 score on a scale | Standard Deviation 1.589 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.20 score on a scale | Standard Deviation 1.337 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.26 score on a scale | Standard Deviation 1.544 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.64 score on a scale | Standard Deviation 1.415 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.62 score on a scale | Standard Deviation 1.417 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 8.17 score on a scale | Standard Deviation 1.447 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.66 score on a scale | Standard Deviation 1.559 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.74 score on a scale | Standard Deviation 1.774 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.60 score on a scale | Standard Deviation 1.45 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.67 score on a scale | Standard Deviation 1.175 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.65 score on a scale | Standard Deviation 1.37 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.11 score on a scale | Standard Deviation 1.74 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.75 score on a scale | Standard Deviation 1.434 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.72 score on a scale | Standard Deviation 1.541 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.36 score on a scale | Standard Deviation 1.679 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.31 score on a scale | Standard Deviation 1.376 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.47 score on a scale | Standard Deviation 1.591 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Baseline | 7.52 score on a scale | Standard Deviation 1.396 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 | Change at Week 148 | -1.24 score on a scale | Standard Deviation 1.644 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.24 score on a scale | Standard Deviation 1.535 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.28 score on a scale | Standard Deviation 1.308 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.17 score on a scale | Standard Deviation 1.326 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.19 score on a scale | Standard Deviation 1.665 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.45 score on a scale | Standard Deviation 1.569 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.67 score on a scale | Standard Deviation 1.449 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 8.03 score on a scale | Standard Deviation 1.385 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.76 score on a scale | Standard Deviation 1.747 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.65 score on a scale | Standard Deviation 1.446 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.74 score on a scale | Standard Deviation 1.747 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.70 score on a scale | Standard Deviation 1.337 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.72 score on a scale | Standard Deviation 1.098 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.07 score on a scale | Standard Deviation 1.722 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.71 score on a scale | Standard Deviation 1.436 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.27 score on a scale | Standard Deviation 1.695 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.81 score on a scale | Standard Deviation 1.548 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.33 score on a scale | Standard Deviation 1.407 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.52 score on a scale | Standard Deviation 1.546 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Change at Week 172 | -1.23 score on a scale | Standard Deviation 1.653 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 | Baseline | 7.62 score on a scale | Standard Deviation 1.428 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.30 score on a scale | Standard Deviation 1.436 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.33 score on a scale | Standard Deviation 1.271 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.14 score on a scale | Standard Deviation 1.325 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.06 score on a scale | Standard Deviation 1.49 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.54 score on a scale | Standard Deviation 1.312 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.52 score on a scale | Standard Deviation 1.426 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.89 score on a scale | Standard Deviation 1.449 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 8.11 score on a scale | Standard Deviation 1.487 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.68 score on a scale | Standard Deviation 1.474 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.85 score on a scale | Standard Deviation 1.783 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.66 score on a scale | Standard Deviation 1.389 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.90 score on a scale | Standard Deviation 1.375 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.71 score on a scale | Standard Deviation 1.476 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.12 score on a scale | Standard Deviation 1.687 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.82 score on a scale | Standard Deviation 1.579 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.42 score on a scale | Standard Deviation 1.555 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.44 score on a scale | Standard Deviation 1.656 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.34 score on a scale | Standard Deviation 1.292 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Baseline | 7.61 score on a scale | Standard Deviation 1.297 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 | Change at Week 196 | -1.37 score on a scale | Standard Deviation 1.697 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -1.67 score on a scale | Standard Deviation 1.653 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.48 score on a scale | Standard Deviation 1.365 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -1.03 score on a scale | Standard Deviation 1.619 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.21 score on a scale | Standard Deviation 1.119 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.69 score on a scale | Standard Deviation 1.215 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -1.58 score on a scale | Standard Deviation 1.339 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -2.03 score on a scale | Standard Deviation 1.425 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 8.09 score on a scale | Standard Deviation 1.51 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.66 score on a scale | Standard Deviation 1.45 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -1.81 score on a scale | Standard Deviation 1.554 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.84 score on a scale | Standard Deviation 1.463 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -1.97 score on a scale | Standard Deviation 1.538 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -1.05 score on a scale | Standard Deviation 2.039 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.63 score on a scale | Standard Deviation 1.532 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.89 score on a scale | Standard Deviation 1.541 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -1.57 score on a scale | Standard Deviation 1.521 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.33 score on a scale | Standard Deviation 1.155 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -2.00 score on a scale | Standard Deviation 1 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Change at Week 248 | -2.00 score on a scale | Standard Deviation 1.414 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 | Baseline | 7.75 score on a scale | Standard Deviation 1.5 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -1.29 score on a scale | Standard Deviation 1.873 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.42 score on a scale | Standard Deviation 1.328 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -1.03 score on a scale | Standard Deviation 1.705 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.21 score on a scale | Standard Deviation 1.354 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -1.44 score on a scale | Standard Deviation 1.568 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.54 score on a scale | Standard Deviation 1.399 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 8.00 score on a scale | Standard Deviation 1.559 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -1.65 score on a scale | Standard Deviation 1.867 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -1.82 score on a scale | Standard Deviation 1.675 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.77 score on a scale | Standard Deviation 1.442 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.73 score on a scale | Standard Deviation 1.434 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -1.46 score on a scale | Standard Deviation 1.51 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -0.75 score on a scale | Standard Deviation 1.648 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.67 score on a scale | Standard Deviation 1.475 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.85 score on a scale | Standard Deviation 1.525 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -0.90 score on a scale | Standard Deviation 1.634 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.30 score on a scale | Standard Deviation 1.36 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -0.96 score on a scale | Standard Deviation 1.38 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Change at Week 28 | -0.69 score on a scale | Standard Deviation 1.493 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 | Baseline | 7.48 score on a scale | Standard Deviation 1.42 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Change at Week 300 | -2.29 score on a scale | Standard Deviation 1.799 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline | 8.14 score on a scale | Standard Deviation 1.069 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline | 7.50 score on a scale | Standard Deviation 0.941 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Change at Week 300 | -1.43 score on a scale | Standard Deviation 2.065 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Change at Week 300 | -1.77 score on a scale | Standard Deviation 1.363 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline | 8.08 score on a scale | Standard Deviation 1.115 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline | 8.33 score on a scale | Standard Deviation 1.803 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Change at Week 300 | -2.11 score on a scale | Standard Deviation 1.965 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Change at Week 300 | -2.00 score on a scale | Standard Deviation 2.138 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline | 7.88 score on a scale | Standard Deviation 1.356 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline | 7.94 score on a scale | Standard Deviation 1.063 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Change at Week 300 | -2.25 score on a scale | Standard Deviation 1.438 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline | 7.75 score on a scale | Standard Deviation 2.062 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Change at Week 300 | -1.50 score on a scale | Standard Deviation 1.291 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Baseline | 7.00 score on a scale | Standard Deviation 0 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 | Change at Week 300 | 0.50 score on a scale | Standard Deviation 2.121 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Baseline | 8.00 score on a scale | — |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Change at Week 352 | -2.00 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Baseline | 8.00 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Change at Week 352 | -3.00 score on a scale | — |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Baseline | 8.33 score on a scale | Standard Deviation 0.577 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Change at Week 352 | -1.33 score on a scale | Standard Deviation 1.528 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Baseline | 12.00 score on a scale | — |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Change at Week 352 | -6.00 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Baseline | 8.00 score on a scale | Standard Deviation 1.414 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Change at Week 352 | -1.00 score on a scale | Standard Deviation 0 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Baseline | 9.00 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 | Change at Week 352 | -4.00 score on a scale | — |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -1.59 score on a scale | Standard Deviation 1.775 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.50 score on a scale | Standard Deviation 1.368 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -1.00 score on a scale | Standard Deviation 1.571 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.17 score on a scale | Standard Deviation 1.318 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.54 score on a scale | Standard Deviation 1.39 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -1.43 score on a scale | Standard Deviation 1.556 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 8.08 score on a scale | Standard Deviation 1.499 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -1.60 score on a scale | Standard Deviation 1.673 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -1.77 score on a scale | Standard Deviation 1.64 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.75 score on a scale | Standard Deviation 1.468 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.65 score on a scale | Standard Deviation 1.358 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -1.46 score on a scale | Standard Deviation 1.457 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -0.87 score on a scale | Standard Deviation 1.666 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.62 score on a scale | Standard Deviation 1.398 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.74 score on a scale | Standard Deviation 1.538 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -1.15 score on a scale | Standard Deviation 1.703 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.33 score on a scale | Standard Deviation 1.386 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -0.95 score on a scale | Standard Deviation 1.551 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Change at Week 52 | -0.85 score on a scale | Standard Deviation 1.637 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 | Baseline | 7.49 score on a scale | Standard Deviation 1.429 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76
EQ-5D health states questionnaire is an instrument used to measure general health related quality of life (HRQOL) in participants with infectious bowel disease (IBD). It considers five attributes of quality of life evaluation: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels: 1=none, 2=moderate or 3=extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A composite EQ-5D score is calculated as a sum of all 5 sub-scores. The total sub-score ranges from 5 to 15. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. A negative change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.48 score on a scale | Standard Deviation 1.379 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.38 score on a scale | Standard Deviation 1.498 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.18 score on a scale | Standard Deviation 1.337 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.05 score on a scale | Standard Deviation 1.583 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.56 score on a scale | Standard Deviation 1.267 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.33 score on a scale | Standard Deviation 1.513 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 8.11 score on a scale | Standard Deviation 1.434 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.67 score on a scale | Standard Deviation 1.43 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.50 score on a scale | Standard Deviation 1.724 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.72 score on a scale | Standard Deviation 1.42 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.52 score on a scale | Standard Deviation 1.466 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.64 score on a scale | Standard Deviation 1.385 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.11 score on a scale | Standard Deviation 1.518 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.69 score on a scale | Standard Deviation 1.489 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.74 score on a scale | Standard Deviation 1.545 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.14 score on a scale | Standard Deviation 1.496 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.28 score on a scale | Standard Deviation 1.348 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.26 score on a scale | Standard Deviation 1.481 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Baseline | 7.52 score on a scale | Standard Deviation 1.464 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 | Change at Week 76 | -1.05 score on a scale | Standard Deviation 1.546 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 59.2 score on a scale | Standard Deviation 22.81 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 20.4 score on a scale | Standard Deviation 27.47 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 20.7 score on a scale | Standard Deviation 17.45 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 61.3 score on a scale | Standard Deviation 16.8 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 26.4 score on a scale | Standard Deviation 21.82 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 52.9 score on a scale | Standard Deviation 16.94 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 50.7 score on a scale | Standard Deviation 16.81 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 26.9 score on a scale | Standard Deviation 22.39 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 29.4 score on a scale | Standard Deviation 23.09 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 53.8 score on a scale | Standard Deviation 18.76 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 26.9 score on a scale | Standard Deviation 21.76 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 51.9 score on a scale | Standard Deviation 19.02 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 51.9 score on a scale | Standard Deviation 16.53 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 22.3 score on a scale | Standard Deviation 20.11 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 23.1 score on a scale | Standard Deviation 21.82 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 52.2 score on a scale | Standard Deviation 19.18 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 56.5 score on a scale | Standard Deviation 20.68 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 19.4 score on a scale | Standard Deviation 26.78 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Baseline | 55.3 score on a scale | Standard Deviation 16.49 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 | Change at Week 100 | 16.6 score on a scale | Standard Deviation 21.92 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 61.2 score on a scale | Standard Deviation 21.6 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 24.0 score on a scale | Standard Deviation 25.45 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 19.7 score on a scale | Standard Deviation 18.12 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 61.6 score on a scale | Standard Deviation 16.98 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 23.8 score on a scale | Standard Deviation 21.39 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 52.0 score on a scale | Standard Deviation 16.58 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 50.0 score on a scale | Standard Deviation 16.87 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 29.4 score on a scale | Standard Deviation 21.15 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 28.1 score on a scale | Standard Deviation 20.71 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 54.8 score on a scale | Standard Deviation 17.87 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 52.4 score on a scale | Standard Deviation 19.58 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 24.5 score on a scale | Standard Deviation 28.36 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 51.8 score on a scale | Standard Deviation 16.77 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 21.1 score on a scale | Standard Deviation 21.77 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 52.8 score on a scale | Standard Deviation 19.62 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 23.8 score on a scale | Standard Deviation 21.41 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 56.1 score on a scale | Standard Deviation 20.59 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 22.2 score on a scale | Standard Deviation 26.13 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Change at Week 124 | 18.1 score on a scale | Standard Deviation 24 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 | Baseline | 55.6 score on a scale | Standard Deviation 15.81 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 61.2 score on a scale | Standard Deviation 21.6 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 23.4 score on a scale | Standard Deviation 27.31 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 61.5 score on a scale | Standard Deviation 17.24 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 21.9 score on a scale | Standard Deviation 18.53 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 51.4 score on a scale | Standard Deviation 16.62 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 28.7 score on a scale | Standard Deviation 19.43 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 49.4 score on a scale | Standard Deviation 17.04 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 28.2 score on a scale | Standard Deviation 20.56 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 54.3 score on a scale | Standard Deviation 18.04 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 28.2 score on a scale | Standard Deviation 21.3 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 24.7 score on a scale | Standard Deviation 22.11 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 52.1 score on a scale | Standard Deviation 19.63 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 51.5 score on a scale | Standard Deviation 16.66 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 24.9 score on a scale | Standard Deviation 25.63 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 52.0 score on a scale | Standard Deviation 19.73 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 24.6 score on a scale | Standard Deviation 22.24 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 56.2 score on a scale | Standard Deviation 20.93 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 23.9 score on a scale | Standard Deviation 23.4 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Change at Week 148 | 21.1 score on a scale | Standard Deviation 22.5 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 | Baseline | 55.6 score on a scale | Standard Deviation 16.31 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 19.8 score on a scale | Standard Deviation 27.91 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 61.6 score on a scale | Standard Deviation 22.4 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 62.1 score on a scale | Standard Deviation 16.84 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 20.3 score on a scale | Standard Deviation 21.59 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 25.9 score on a scale | Standard Deviation 21.53 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 51.3 score on a scale | Standard Deviation 16.87 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 49.7 score on a scale | Standard Deviation 17.87 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 29.2 score on a scale | Standard Deviation 22.92 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 29.4 score on a scale | Standard Deviation 21.4 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 54.2 score on a scale | Standard Deviation 17.79 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 25.9 score on a scale | Standard Deviation 25.7 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 52.4 score on a scale | Standard Deviation 20.42 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 26.0 score on a scale | Standard Deviation 20.3 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 51.3 score on a scale | Standard Deviation 16.58 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 50.9 score on a scale | Standard Deviation 19.4 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 23.9 score on a scale | Standard Deviation 23.72 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 55.9 score on a scale | Standard Deviation 20.95 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 25.2 score on a scale | Standard Deviation 22.04 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Change at Week 172 | 22.2 score on a scale | Standard Deviation 21.21 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 | Baseline | 55.4 score on a scale | Standard Deviation 15.9 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 61.2 score on a scale | Standard Deviation 21.6 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 22.9 score on a scale | Standard Deviation 28.01 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 61.3 score on a scale | Standard Deviation 16.63 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 21.6 score on a scale | Standard Deviation 17.2 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 52.5 score on a scale | Standard Deviation 17.01 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 26.4 score on a scale | Standard Deviation 20.17 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 49.0 score on a scale | Standard Deviation 18.41 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 31.9 score on a scale | Standard Deviation 23.39 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 29.1 score on a scale | Standard Deviation 22.45 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 54.2 score on a scale | Standard Deviation 17.71 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 29.2 score on a scale | Standard Deviation 22.32 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 52.8 score on a scale | Standard Deviation 20.56 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 24.6 score on a scale | Standard Deviation 21.32 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 51.5 score on a scale | Standard Deviation 16.72 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 51.5 score on a scale | Standard Deviation 19.58 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 23.3 score on a scale | Standard Deviation 26.17 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 56.7 score on a scale | Standard Deviation 20.21 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 22.1 score on a scale | Standard Deviation 22.91 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Baseline | 56.5 score on a scale | Standard Deviation 14.35 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 | Change at Week 196 | 23.2 score on a scale | Standard Deviation 18.14 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 27.5 score on a scale | Standard Deviation 25.77 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 57.2 score on a scale | Standard Deviation 21.28 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 17.7 score on a scale | Standard Deviation 18.62 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 61.6 score on a scale | Standard Deviation 16.17 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 28.0 score on a scale | Standard Deviation 22.14 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 52.1 score on a scale | Standard Deviation 16.63 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 47.2 score on a scale | Standard Deviation 18.17 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 34.9 score on a scale | Standard Deviation 18.79 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 32.1 score on a scale | Standard Deviation 19.98 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 52.3 score on a scale | Standard Deviation 16.4 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 53.2 score on a scale | Standard Deviation 19.72 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 29.9 score on a scale | Standard Deviation 24.37 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 24.7 score on a scale | Standard Deviation 25.34 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 50.8 score on a scale | Standard Deviation 17.39 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 49.0 score on a scale | Standard Deviation 19.37 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 28.9 score on a scale | Standard Deviation 27.65 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 61.3 score on a scale | Standard Deviation 28.11 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 28.7 score on a scale | Standard Deviation 32.72 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Change at Week 248 | 34.3 score on a scale | Standard Deviation 11.44 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 | Baseline | 47.5 score on a scale | Standard Deviation 7.33 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 58.4 score on a scale | Standard Deviation 20.96 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 22.7 score on a scale | Standard Deviation 24.11 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 62.1 score on a scale | Standard Deviation 16.54 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 20.0 score on a scale | Standard Deviation 18.75 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 53.5 score on a scale | Standard Deviation 17.3 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 25.1 score on a scale | Standard Deviation 22.09 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 51.5 score on a scale | Standard Deviation 17.57 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 23.8 score on a scale | Standard Deviation 23.79 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 27.6 score on a scale | Standard Deviation 22.58 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 52.2 score on a scale | Standard Deviation 18.72 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 23.7 score on a scale | Standard Deviation 22.51 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 52.3 score on a scale | Standard Deviation 18.39 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 16.8 score on a scale | Standard Deviation 22.55 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 53.2 score on a scale | Standard Deviation 18.02 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 51.3 score on a scale | Standard Deviation 19.09 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 19.9 score on a scale | Standard Deviation 22.44 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 56.4 score on a scale | Standard Deviation 19.64 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 17.1 score on a scale | Standard Deviation 21.75 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Baseline | 55.6 score on a scale | Standard Deviation 16.72 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 | Change at Week 28 | 13.4 score on a scale | Standard Deviation 19.48 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Baseline | 52.0 score on a scale | — |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Change at Week 352 | 46.0 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Baseline | 50.0 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Change at Week 352 | 40.0 score on a scale | — |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Baseline | 48.0 score on a scale | Standard Deviation 8.19 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Change at Week 352 | 24.3 score on a scale | Standard Deviation 20.11 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Baseline | 15.0 score on a scale | — |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Change at Week 352 | 64.0 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Baseline | 50.0 score on a scale | Standard Deviation 14.14 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Change at Week 352 | 24.0 score on a scale | Standard Deviation 8.49 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Baseline | 31.0 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 | Change at Week 352 | 59.0 score on a scale | — |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 57.5 score on a scale | Standard Deviation 21.39 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 22.9 score on a scale | Standard Deviation 27.46 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 61.9 score on a scale | Standard Deviation 16.18 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 18.5 score on a scale | Standard Deviation 20.31 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 52.3 score on a scale | Standard Deviation 18.09 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 27.0 score on a scale | Standard Deviation 21.87 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 50.8 score on a scale | Standard Deviation 17.82 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 27.9 score on a scale | Standard Deviation 20.7 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 30.8 score on a scale | Standard Deviation 21.59 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 52.6 score on a scale | Standard Deviation 19.43 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 25.0 score on a scale | Standard Deviation 18.85 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 52.7 score on a scale | Standard Deviation 18.38 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 19.9 score on a scale | Standard Deviation 22.83 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 53.3 score on a scale | Standard Deviation 17.21 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 52.2 score on a scale | Standard Deviation 18.94 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 23.5 score on a scale | Standard Deviation 23.03 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 55.9 score on a scale | Standard Deviation 20.51 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 20.8 score on a scale | Standard Deviation 21.93 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Baseline | 56.3 score on a scale | Standard Deviation 16.21 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 | Change at Week 52 | 17.6 score on a scale | Standard Deviation 22.69 |
Primary
Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 58.8 score on a scale | Standard Deviation 21.93 |
| Vedolizumab 300 mg (UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 20.9 score on a scale | Standard Deviation 25.66 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 62.3 score on a scale | Standard Deviation 17.01 |
| Vedolizumab 300 mg (CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 18.7 score on a scale | Standard Deviation 20.65 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 52.0 score on a scale | Standard Deviation 18.47 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 25.1 score on a scale | Standard Deviation 19.62 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 50.7 score on a scale | Standard Deviation 16.81 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 27.3 score on a scale | Standard Deviation 18.87 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 30.3 score on a scale | Standard Deviation 23.68 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 52.0 score on a scale | Standard Deviation 19.38 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 27.0 score on a scale | Standard Deviation 21.49 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 52.4 score on a scale | Standard Deviation 18.88 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 22.2 score on a scale | Standard Deviation 20.82 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 52.5 score on a scale | Standard Deviation 17.18 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 51.4 score on a scale | Standard Deviation 18.99 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 23.3 score on a scale | Standard Deviation 21.4 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 56.1 score on a scale | Standard Deviation 20.36 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 19.2 score on a scale | Standard Deviation 25.1 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Baseline | 55.8 score on a scale | Standard Deviation 16.19 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 | Change at Week 76 | 17.8 score on a scale | Standard Deviation 22.04 |
Primary
Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300
EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline | 58.1 score on a scale | Standard Deviation 20.27 |
| Vedolizumab 300 mg (UC) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Change at Week 300 | 23.6 score on a scale | Standard Deviation 29.14 |
| Vedolizumab 300 mg (CD) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline | 64.9 score on a scale | Standard Deviation 11.82 |
| Vedolizumab 300 mg (CD) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Change at Week 300 | 20.4 score on a scale | Standard Deviation 17.92 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline | 55.7 score on a scale | Standard Deviation 10.1 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Change at Week 300 | 28.4 score on a scale | Standard Deviation 14.78 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline | 50.4 score on a scale | Standard Deviation 22.34 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Change at Week 300 | 33.2 score on a scale | Standard Deviation 25.83 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline | 53.1 score on a scale | Standard Deviation 15.8 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Change at Week 300 | 31.3 score on a scale | Standard Deviation 17.47 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline | 42.9 score on a scale | Standard Deviation 19.54 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Change at Week 300 | 43.6 score on a scale | Standard Deviation 23.17 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Change at Week 300 | 40.3 score on a scale | Standard Deviation 9.5 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline | 43.5 score on a scale | Standard Deviation 19.12 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Baseline | 52.0 score on a scale | Standard Deviation 24.04 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 | Change at Week 300 | 13.0 score on a scale | Standard Deviation 11.31 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 39.56 score on a scale | Standard Deviation 11.833 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 8.80 score on a scale | Standard Deviation 14.395 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 41.10 score on a scale | Standard Deviation 11.14 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 9.87 score on a scale | Standard Deviation 10.552 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 38.21 score on a scale | Standard Deviation 10.885 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 10.82 score on a scale | Standard Deviation 12.303 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 35.61 score on a scale | Standard Deviation 11.568 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 10.64 score on a scale | Standard Deviation 13.629 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 8.94 score on a scale | Standard Deviation 13.798 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 38.76 score on a scale | Standard Deviation 10.215 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 9.98 score on a scale | Standard Deviation 11.45 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 37.41 score on a scale | Standard Deviation 11.857 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 8.25 score on a scale | Standard Deviation 12.562 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 36.61 score on a scale | Standard Deviation 11.894 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 39.43 score on a scale | Standard Deviation 12.474 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 7.93 score on a scale | Standard Deviation 11.053 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 40.39 score on a scale | Standard Deviation 11.559 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 7.66 score on a scale | Standard Deviation 10.685 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Baseline | 39.04 score on a scale | Standard Deviation 11.604 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 | Change at Week 100 | 6.94 score on a scale | Standard Deviation 13.189 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 40.34 score on a scale | Standard Deviation 12.065 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 6.89 score on a scale | Standard Deviation 14.522 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 41.20 score on a scale | Standard Deviation 11.115 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 9.79 score on a scale | Standard Deviation 11.176 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 37.48 score on a scale | Standard Deviation 11.101 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 11.09 score on a scale | Standard Deviation 12.299 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 35.05 score on a scale | Standard Deviation 11.782 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 10.47 score on a scale | Standard Deviation 12.517 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 9.27 score on a scale | Standard Deviation 11.72 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 38.56 score on a scale | Standard Deviation 10.221 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 9.81 score on a scale | Standard Deviation 12.524 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 39.21 score on a scale | Standard Deviation 12.368 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 8.91 score on a scale | Standard Deviation 12.68 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 36.71 score on a scale | Standard Deviation 12.021 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 39.36 score on a scale | Standard Deviation 12.612 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 8.26 score on a scale | Standard Deviation 12.835 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 42.40 score on a scale | Standard Deviation 8.427 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 6.44 score on a scale | Standard Deviation 12.279 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Baseline | 41.67 score on a scale | Standard Deviation 10.953 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 | Change at Week 148 | 6.85 score on a scale | Standard Deviation 12.118 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline | 39.46 score on a scale | Standard Deviation 13.424 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Change at Week 196 | 9.37 score on a scale | Standard Deviation 12.087 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline | 42.74 score on a scale | Standard Deviation 10.517 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Change at Week 196 | 9.43 score on a scale | Standard Deviation 9.349 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline | 40.40 score on a scale | Standard Deviation 9.771 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Change at Week 196 | 9.79 score on a scale | Standard Deviation 11.516 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline | 36.17 score on a scale | Standard Deviation 12.536 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Change at Week 196 | 12.62 score on a scale | Standard Deviation 14.386 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline | 39.07 score on a scale | Standard Deviation 10.804 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Change at Week 196 | 10.05 score on a scale | Standard Deviation 15.471 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline | 37.63 score on a scale | Standard Deviation 12.199 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Change at Week 196 | 9.26 score on a scale | Standard Deviation 12.732 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Change at Week 196 | 8.59 score on a scale | Standard Deviation 14.645 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline | 40.11 score on a scale | Standard Deviation 10.932 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Baseline | 40.05 score on a scale | Standard Deviation 13.807 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 | Change at Week 196 | 9.75 score on a scale | Standard Deviation 14.824 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 38.00 score on a scale | Standard Deviation 12.537 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 11.99 score on a scale | Standard Deviation 13.421 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 41.76 score on a scale | Standard Deviation 10.579 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 6.13 score on a scale | Standard Deviation 9.986 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 38.01 score on a scale | Standard Deviation 10.876 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 10.41 score on a scale | Standard Deviation 13.081 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 34.26 score on a scale | Standard Deviation 12.252 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 12.70 score on a scale | Standard Deviation 12.14 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 9.84 score on a scale | Standard Deviation 11.433 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 38.06 score on a scale | Standard Deviation 10.3 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 10.61 score on a scale | Standard Deviation 11.204 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 38.04 score on a scale | Standard Deviation 11.32 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 7.37 score on a scale | Standard Deviation 16.473 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 36.41 score on a scale | Standard Deviation 13.568 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 36.77 score on a scale | Standard Deviation 12.333 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 10.61 score on a scale | Standard Deviation 12.188 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 38.65 score on a scale | Standard Deviation 18.372 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 7.64 score on a scale | Standard Deviation 18.599 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Baseline | 31.20 score on a scale | Standard Deviation 4.603 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 | Change at Week 248 | 15.98 score on a scale | Standard Deviation 13.355 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline | 34.53 score on a scale | Standard Deviation 12.53 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Change at Week 300 | 21.86 score on a scale | Standard Deviation 13.935 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline | 43.55 score on a scale | Standard Deviation 9.074 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Change at Week 300 | 4.82 score on a scale | Standard Deviation 10.738 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline | 35.77 score on a scale | Standard Deviation 8.585 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Change at Week 300 | 9.82 score on a scale | Standard Deviation 11.463 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Change at Week 300 | 13.46 score on a scale | Standard Deviation 15.324 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline | 33.38 score on a scale | Standard Deviation 11.168 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Change at Week 300 | 6.31 score on a scale | Standard Deviation 11.916 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline | 39.40 score on a scale | Standard Deviation 11.144 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Change at Week 300 | 14.79 score on a scale | Standard Deviation 15.281 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline | 35.79 score on a scale | Standard Deviation 12.157 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Change at Week 300 | 19.87 score on a scale | Standard Deviation 6.588 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline | 31.35 score on a scale | Standard Deviation 13.76 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Change at Week 300 | -3.67 score on a scale | Standard Deviation 20.577 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 | Baseline | 46.99 score on a scale | Standard Deviation 7.729 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Baseline | 42.19 score on a scale | — |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Change at Week 352 | 17.40 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Baseline | 35.34 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Change at Week 352 | 19.87 score on a scale | — |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Baseline | 32.72 score on a scale | Standard Deviation 7.252 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Change at Week 352 | 14.14 score on a scale | Standard Deviation 10.114 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Baseline | 22.18 score on a scale | — |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Change at Week 352 | 25.04 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Baseline | 39.80 score on a scale | Standard Deviation 14.563 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Change at Week 352 | 8.65 score on a scale | Standard Deviation 7.463 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Baseline | 42.98 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 | Change at Week 352 | 13.08 score on a scale | — |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 39.33 score on a scale | Standard Deviation 11.878 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 10.27 score on a scale | Standard Deviation 12.895 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 41.18 score on a scale | Standard Deviation 11.15 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 10.40 score on a scale | Standard Deviation 10.777 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 38.29 score on a scale | Standard Deviation 11.062 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 12.18 score on a scale | Standard Deviation 11.506 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 35.43 score on a scale | Standard Deviation 11.445 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 12.68 score on a scale | Standard Deviation 11.843 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 10.54 score on a scale | Standard Deviation 11.719 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 39.45 score on a scale | Standard Deviation 9.91 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 8.40 score on a scale | Standard Deviation 11.598 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 38.98 score on a scale | Standard Deviation 11.963 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 8.27 score on a scale | Standard Deviation 11.77 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 36.80 score on a scale | Standard Deviation 11.052 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 38.54 score on a scale | Standard Deviation 12.379 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 7.86 score on a scale | Standard Deviation 13.129 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 40.32 score on a scale | Standard Deviation 11.333 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 6.71 score on a scale | Standard Deviation 10.363 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline | 39.16 score on a scale | Standard Deviation 11.518 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Change at Week 52 | 6.23 score on a scale | Standard Deviation 12.306 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 39.41 score on a scale | Standard Deviation 11.201 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 9.64 score on a scale | Standard Deviation 14.272 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 41.30 score on a scale | Standard Deviation 10.71 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 8.52 score on a scale | Standard Deviation 11.462 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 38.26 score on a scale | Standard Deviation 10.974 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 10.51 score on a scale | Standard Deviation 12.334 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 35.50 score on a scale | Standard Deviation 11.582 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 12.92 score on a scale | Standard Deviation 13.174 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 8.02 score on a scale | Standard Deviation 14.02 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 38.86 score on a scale | Standard Deviation 10.046 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 9.13 score on a scale | Standard Deviation 13.719 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 38.52 score on a scale | Standard Deviation 12.244 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 8.27 score on a scale | Standard Deviation 12.72 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 36.68 score on a scale | Standard Deviation 11.947 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 39.03 score on a scale | Standard Deviation 12.679 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 8.26 score on a scale | Standard Deviation 12.809 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 40.32 score on a scale | Standard Deviation 11.673 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 7.77 score on a scale | Standard Deviation 10.989 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Baseline | 39.16 score on a scale | Standard Deviation 11.712 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 | Change at Week 76 | 7.16 score on a scale | Standard Deviation 13.144 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 40.34 score on a scale | Standard Deviation 12.065 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 9.53 score on a scale | Standard Deviation 16.289 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 40.81 score on a scale | Standard Deviation 11.132 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 10.02 score on a scale | Standard Deviation 10.734 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 37.85 score on a scale | Standard Deviation 11.106 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 9.70 score on a scale | Standard Deviation 12.781 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 35.29 score on a scale | Standard Deviation 11.668 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 11.35 score on a scale | Standard Deviation 12.681 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 9.20 score on a scale | Standard Deviation 12.521 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 38.59 score on a scale | Standard Deviation 9.956 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 10.38 score on a scale | Standard Deviation 13.23 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 38.33 score on a scale | Standard Deviation 12.409 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 8.50 score on a scale | Standard Deviation 12.808 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 39.04 score on a scale | Standard Deviation 12.421 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 36.64 score on a scale | Standard Deviation 11.938 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 8.78 score on a scale | Standard Deviation 13.283 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 40.87 score on a scale | Standard Deviation 11.156 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 7.73 score on a scale | Standard Deviation 11.048 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Baseline | 38.90 score on a scale | Standard Deviation 11.427 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 | Change at Week 124 | 6.26 score on a scale | Standard Deviation 13.274 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 40.79 score on a scale | Standard Deviation 12.254 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 7.43 score on a scale | Standard Deviation 12.227 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 41.49 score on a scale | Standard Deviation 11.015 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 10.37 score on a scale | Standard Deviation 10.42 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 37.00 score on a scale | Standard Deviation 10.963 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 9.57 score on a scale | Standard Deviation 12.85 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 35.47 score on a scale | Standard Deviation 11.757 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 12.84 score on a scale | Standard Deviation 12.281 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 9.12 score on a scale | Standard Deviation 14.244 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 38.77 score on a scale | Standard Deviation 10.268 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 8.45 score on a scale | Standard Deviation 13.317 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 39.83 score on a scale | Standard Deviation 12.249 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 8.78 score on a scale | Standard Deviation 13.283 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 36.64 score on a scale | Standard Deviation 11.938 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 39.01 score on a scale | Standard Deviation 12.258 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 7.52 score on a scale | Standard Deviation 12.609 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 40.98 score on a scale | Standard Deviation 11.479 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 8.66 score on a scale | Standard Deviation 10.767 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Baseline | 38.85 score on a scale | Standard Deviation 11.972 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 | Change at Week 172 | 7.48 score on a scale | Standard Deviation 12.329 |
Primary
Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 39.98 score on a scale | Standard Deviation 11.349 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 8.36 score on a scale | Standard Deviation 13.096 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 40.70 score on a scale | Standard Deviation 11.226 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 11.10 score on a scale | Standard Deviation 11.098 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 38.28 score on a scale | Standard Deviation 11.039 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 11.52 score on a scale | Standard Deviation 12.464 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 35.49 score on a scale | Standard Deviation 11.139 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 13.35 score on a scale | Standard Deviation 11.857 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 10.88 score on a scale | Standard Deviation 12.396 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 38.53 score on a scale | Standard Deviation 10.631 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 10.94 score on a scale | Standard Deviation 12.386 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 37.70 score on a scale | Standard Deviation 12.423 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 7.48 score on a scale | Standard Deviation 12.061 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 36.60 score on a scale | Standard Deviation 11.545 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 38.04 score on a scale | Standard Deviation 12.567 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 6.34 score on a scale | Standard Deviation 13.161 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 40.87 score on a scale | Standard Deviation 11.385 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 6.48 score on a scale | Standard Deviation 10.809 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline | 39.29 score on a scale | Standard Deviation 11.535 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Change at Week 28 | 3.72 score on a scale | Standard Deviation 12.377 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 39.79 score on a scale | Standard Deviation 8.801 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 9.69 score on a scale | Standard Deviation 9.714 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 41.33 score on a scale | Standard Deviation 8.517 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 8.97 score on a scale | Standard Deviation 8.891 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 40.07 score on a scale | Standard Deviation 7.625 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 10.54 score on a scale | Standard Deviation 6.416 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 37.03 score on a scale | Standard Deviation 7.675 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 10.48 score on a scale | Standard Deviation 7.797 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 11.98 score on a scale | Standard Deviation 9.496 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 37.92 score on a scale | Standard Deviation 8.353 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 10.28 score on a scale | Standard Deviation 7.651 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 39.59 score on a scale | Standard Deviation 7.809 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 7.77 score on a scale | Standard Deviation 8.397 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 37.53 score on a scale | Standard Deviation 8.286 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 37.47 score on a scale | Standard Deviation 8.147 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 8.82 score on a scale | Standard Deviation 8.501 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 40.73 score on a scale | Standard Deviation 8.552 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 9.73 score on a scale | Standard Deviation 8.461 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Baseline | 39.25 score on a scale | Standard Deviation 7.667 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 | Change at Week 76 | 7.31 score on a scale | Standard Deviation 8.436 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 10.28 score on a scale | Standard Deviation 8.418 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 41.26 score on a scale | Standard Deviation 8.825 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 9.41 score on a scale | Standard Deviation 7.934 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 41.03 score on a scale | Standard Deviation 8.26 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 40.29 score on a scale | Standard Deviation 7.48 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 9.42 score on a scale | Standard Deviation 7.556 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 11.18 score on a scale | Standard Deviation 8.322 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 36.97 score on a scale | Standard Deviation 7.677 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 38.11 score on a scale | Standard Deviation 8.169 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 12.97 score on a scale | Standard Deviation 9.396 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 39.59 score on a scale | Standard Deviation 7.989 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 10.78 score on a scale | Standard Deviation 8.926 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 37.26 score on a scale | Standard Deviation 7.974 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 8.47 score on a scale | Standard Deviation 8.096 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 37.90 score on a scale | Standard Deviation 8.297 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 9.45 score on a scale | Standard Deviation 8.747 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 9.70 score on a scale | Standard Deviation 8.869 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 41.13 score on a scale | Standard Deviation 8.579 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Baseline | 39.28 score on a scale | Standard Deviation 7.458 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 | Change at Week 100 | 7.40 score on a scale | Standard Deviation 8.473 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 41.75 score on a scale | Standard Deviation 7.947 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 9.08 score on a scale | Standard Deviation 9.09 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 41.33 score on a scale | Standard Deviation 8.438 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 9.35 score on a scale | Standard Deviation 8.228 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 39.86 score on a scale | Standard Deviation 7.312 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 10.34 score on a scale | Standard Deviation 6.524 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 36.68 score on a scale | Standard Deviation 8.055 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 12.15 score on a scale | Standard Deviation 9.941 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 12.54 score on a scale | Standard Deviation 9.695 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 39.22 score on a scale | Standard Deviation 7.511 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 11.26 score on a scale | Standard Deviation 7.231 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 39.21 score on a scale | Standard Deviation 8.303 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 9.37 score on a scale | Standard Deviation 8.223 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 36.94 score on a scale | Standard Deviation 8.087 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 37.99 score on a scale | Standard Deviation 8.43 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 8.94 score on a scale | Standard Deviation 8.442 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 43.32 score on a scale | Standard Deviation 10.405 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 9.81 score on a scale | Standard Deviation 8.727 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Baseline | 38.77 score on a scale | Standard Deviation 7.024 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 | Change at Week 148 | 10.39 score on a scale | Standard Deviation 6.824 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline | 40.72 score on a scale | Standard Deviation 7.823 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Change at Week 196 | 11.82 score on a scale | Standard Deviation 9.37 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline | 40.83 score on a scale | Standard Deviation 8.135 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Change at Week 196 | 9.98 score on a scale | Standard Deviation 7.569 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline | 40.52 score on a scale | Standard Deviation 7.242 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Change at Week 196 | 9.31 score on a scale | Standard Deviation 5.771 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline | 35.64 score on a scale | Standard Deviation 7.862 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Change at Week 196 | 12.35 score on a scale | Standard Deviation 8.867 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline | 36.65 score on a scale | Standard Deviation 9.25 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Change at Week 196 | 14.10 score on a scale | Standard Deviation 10.616 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline | 39.33 score on a scale | Standard Deviation 8.136 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Change at Week 196 | 11.75 score on a scale | Standard Deviation 8.261 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Change at Week 196 | 6.94 score on a scale | Standard Deviation 8.667 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline | 39.53 score on a scale | Standard Deviation 7.83 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Baseline | 38.40 score on a scale | Standard Deviation 9.68 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 | Change at Week 196 | 9.83 score on a scale | Standard Deviation 8.111 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 39.99 score on a scale | Standard Deviation 7.219 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 11.22 score on a scale | Standard Deviation 10.562 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 40.71 score on a scale | Standard Deviation 7.605 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 9.95 score on a scale | Standard Deviation 8.355 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 39.33 score on a scale | Standard Deviation 6.82 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 11.43 score on a scale | Standard Deviation 8.047 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 37.54 score on a scale | Standard Deviation 8.054 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 11.70 score on a scale | Standard Deviation 6.541 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 13.88 score on a scale | Standard Deviation 8.511 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 38.32 score on a scale | Standard Deviation 8.047 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 9.98 score on a scale | Standard Deviation 9.027 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 40.28 score on a scale | Standard Deviation 8.878 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 9.32 score on a scale | Standard Deviation 9.261 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 37.95 score on a scale | Standard Deviation 8.232 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 37.77 score on a scale | Standard Deviation 8.654 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 10.50 score on a scale | Standard Deviation 8.803 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 39.17 score on a scale | Standard Deviation 13.987 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 15.98 score on a scale | Standard Deviation 7.868 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Baseline | 38.79 score on a scale | Standard Deviation 7.735 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 | Change at Week 248 | 9.88 score on a scale | Standard Deviation 6.977 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline | 36.89 score on a scale | Standard Deviation 5.913 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Change at Week 300 | 12.03 score on a scale | Standard Deviation 10.338 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline | 38.84 score on a scale | Standard Deviation 7.72 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Change at Week 300 | 10.58 score on a scale | Standard Deviation 8.335 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline | 39.22 score on a scale | Standard Deviation 5.469 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Change at Week 300 | 11.15 score on a scale | Standard Deviation 6.497 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline | 36.56 score on a scale | Standard Deviation 8.514 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Change at Week 300 | 15.47 score on a scale | Standard Deviation 9.92 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline | 34.80 score on a scale | Standard Deviation 8.431 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Change at Week 300 | 14.42 score on a scale | Standard Deviation 6.749 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline | 39.97 score on a scale | Standard Deviation 6.626 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Change at Week 300 | 10.69 score on a scale | Standard Deviation 6.448 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Change at Week 300 | 9.10 score on a scale | Standard Deviation 9.33 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline | 41.04 score on a scale | Standard Deviation 12.016 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Baseline | 34.80 score on a scale | Standard Deviation 10.515 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 | Change at Week 300 | 6.41 score on a scale | Standard Deviation 9.023 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 8 scales, the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Baseline | 35.68 score on a scale | — |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Change at Week 352 | 17.97 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Baseline | 38.32 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Change at Week 352 | 17.87 score on a scale | — |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Baseline | 44.36 score on a scale | Standard Deviation 0.92 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Change at Week 352 | 5.06 score on a scale | Standard Deviation 5.188 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Baseline | 31.07 score on a scale | — |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Change at Week 352 | 24.06 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Baseline | 37.14 score on a scale | Standard Deviation 3.711 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Change at Week 352 | 11.18 score on a scale | Standard Deviation 2.116 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Baseline | 33.67 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 | Change at Week 352 | 18.02 score on a scale | — |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 39.94 score on a scale | Standard Deviation 8.93 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 9.55 score on a scale | Standard Deviation 10.155 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 41.72 score on a scale | Standard Deviation 8.314 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 8.57 score on a scale | Standard Deviation 7.889 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 40.12 score on a scale | Standard Deviation 7.694 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 9.77 score on a scale | Standard Deviation 6.766 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 36.75 score on a scale | Standard Deviation 7.51 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 9.43 score on a scale | Standard Deviation 9.088 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 12.97 score on a scale | Standard Deviation 9.147 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 37.82 score on a scale | Standard Deviation 8.301 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 9.98 score on a scale | Standard Deviation 7.824 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 39.23 score on a scale | Standard Deviation 7.807 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 7.48 score on a scale | Standard Deviation 8.8 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 37.87 score on a scale | Standard Deviation 7.992 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 37.40 score on a scale | Standard Deviation 8.171 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 8.97 score on a scale | Standard Deviation 8.743 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 40.51 score on a scale | Standard Deviation 8.454 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 8.37 score on a scale | Standard Deviation 8.401 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline | 39.27 score on a scale | Standard Deviation 7.469 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Change at Week 52 | 6.72 score on a scale | Standard Deviation 7.842 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 41.75 score on a scale | Standard Deviation 7.947 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 10.12 score on a scale | Standard Deviation 9.685 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 41.08 score on a scale | Standard Deviation 8.219 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 7.91 score on a scale | Standard Deviation 9.483 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 39.88 score on a scale | Standard Deviation 7.332 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 10.15 score on a scale | Standard Deviation 8.551 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 37.00 score on a scale | Standard Deviation 7.854 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 11.79 score on a scale | Standard Deviation 8.053 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 12.87 score on a scale | Standard Deviation 8.803 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 38.58 score on a scale | Standard Deviation 8.078 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 11.01 score on a scale | Standard Deviation 8.319 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 39.31 score on a scale | Standard Deviation 8.279 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 8.36 score on a scale | Standard Deviation 7.495 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 37.09 score on a scale | Standard Deviation 8.044 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 38.36 score on a scale | Standard Deviation 8.24 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 7.77 score on a scale | Standard Deviation 9.228 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 41.10 score on a scale | Standard Deviation 8.747 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 10.56 score on a scale | Standard Deviation 8.804 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Baseline | 39.01 score on a scale | Standard Deviation 7.363 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 | Change at Week 124 | 9.27 score on a scale | Standard Deviation 8.274 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 42.23 score on a scale | Standard Deviation 8.073 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 10.08 score on a scale | Standard Deviation 8.996 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 41.52 score on a scale | Standard Deviation 8.401 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 9.20 score on a scale | Standard Deviation 8.324 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 40.23 score on a scale | Standard Deviation 6.713 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 9.68 score on a scale | Standard Deviation 6.804 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 37.29 score on a scale | Standard Deviation 8.057 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 11.83 score on a scale | Standard Deviation 8.042 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 13.21 score on a scale | Standard Deviation 9.194 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 38.82 score on a scale | Standard Deviation 8.231 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 10.88 score on a scale | Standard Deviation 7.837 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 39.16 score on a scale | Standard Deviation 8.177 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 9.61 score on a scale | Standard Deviation 8.461 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 36.92 score on a scale | Standard Deviation 8.023 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 37.85 score on a scale | Standard Deviation 8.538 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 9.07 score on a scale | Standard Deviation 7.519 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 41.12 score on a scale | Standard Deviation 9.029 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 10.47 score on a scale | Standard Deviation 8.921 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Baseline | 39.30 score on a scale | Standard Deviation 7.264 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 | Change at Week 172 | 8.55 score on a scale | Standard Deviation 8.546 |
Primary
Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28
The Short Form-36 (SF-36) is a questionnaire that evaluates a person's HRQOL. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 39.57 score on a scale | Standard Deviation 8.599 |
| Vedolizumab 300 mg (UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 10.20 score on a scale | Standard Deviation 8.792 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 41.15 score on a scale | Standard Deviation 8.313 |
| Vedolizumab 300 mg (CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 8.22 score on a scale | Standard Deviation 9.015 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 40.05 score on a scale | Standard Deviation 7.634 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 8.89 score on a scale | Standard Deviation 7.11 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 37.05 score on a scale | Standard Deviation 7.522 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 9.85 score on a scale | Standard Deviation 8.789 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 12.46 score on a scale | Standard Deviation 8.9 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 37.87 score on a scale | Standard Deviation 8.113 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 9.60 score on a scale | Standard Deviation 7.62 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 39.09 score on a scale | Standard Deviation 7.771 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 6.48 score on a scale | Standard Deviation 8.514 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 37.92 score on a scale | Standard Deviation 8.355 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 36.81 score on a scale | Standard Deviation 8.274 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 7.74 score on a scale | Standard Deviation 9.31 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 40.06 score on a scale | Standard Deviation 8.631 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 7.07 score on a scale | Standard Deviation 8.752 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline | 39.20 score on a scale | Standard Deviation 7.306 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Change at Week 28 | 5.67 score on a scale | Standard Deviation 7.695 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 124.70 score on a scale | Standard Deviation 37.614 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 61.83 score on a scale | Standard Deviation 41.505 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 130.90 score on a scale | Standard Deviation 34.361 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 62.46 score on a scale | Standard Deviation 32.502 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 124.52 score on a scale | Standard Deviation 30.033 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 62.83 score on a scale | Standard Deviation 34.475 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 120.89 score on a scale | Standard Deviation 29.745 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 57.04 score on a scale | Standard Deviation 38.448 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 58.53 score on a scale | Standard Deviation 45.644 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 129.53 score on a scale | Standard Deviation 35.261 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 53.40 score on a scale | Standard Deviation 32.651 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 128.25 score on a scale | Standard Deviation 32.333 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 49.89 score on a scale | Standard Deviation 36.806 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 123.50 score on a scale | Standard Deviation 29.662 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 128.35 score on a scale | Standard Deviation 33.793 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 46.95 score on a scale | Standard Deviation 34.691 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 132.41 score on a scale | Standard Deviation 28.538 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 52.50 score on a scale | Standard Deviation 32.267 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline | 132.48 score on a scale | Standard Deviation 32.305 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Change at Week 100 | 38.52 score on a scale | Standard Deviation 36.982 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 127.33 score on a scale | Standard Deviation 36.47 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 63.94 score on a scale | Standard Deviation 44.48 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 130.83 score on a scale | Standard Deviation 34.399 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 60.94 score on a scale | Standard Deviation 37.769 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 123.65 score on a scale | Standard Deviation 30.18 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 63.71 score on a scale | Standard Deviation 34.542 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 119.77 score on a scale | Standard Deviation 29.963 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 61.91 score on a scale | Standard Deviation 36.288 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 53.91 score on a scale | Standard Deviation 44.023 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 132.36 score on a scale | Standard Deviation 34.573 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 53.74 score on a scale | Standard Deviation 34.514 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 130.01 score on a scale | Standard Deviation 33.454 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 46.62 score on a scale | Standard Deviation 38.435 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 122.91 score on a scale | Standard Deviation 29.869 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 129.08 score on a scale | Standard Deviation 33.576 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 47.60 score on a scale | Standard Deviation 40.634 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 132.75 score on a scale | Standard Deviation 28.131 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 54.47 score on a scale | Standard Deviation 29.636 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline | 131.56 score on a scale | Standard Deviation 31.567 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Change at Week 124 | 40.35 score on a scale | Standard Deviation 41.543 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 127.33 score on a scale | Standard Deviation 36.47 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 60.66 score on a scale | Standard Deviation 41.786 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 131.95 score on a scale | Standard Deviation 34.649 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 62.72 score on a scale | Standard Deviation 33.786 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 123.02 score on a scale | Standard Deviation 29.685 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 65.81 score on a scale | Standard Deviation 33.232 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 119.07 score on a scale | Standard Deviation 30.344 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 60.41 score on a scale | Standard Deviation 36.074 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 54.53 score on a scale | Standard Deviation 48.036 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 132.23 score on a scale | Standard Deviation 35.877 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 56.08 score on a scale | Standard Deviation 32.954 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 130.25 score on a scale | Standard Deviation 34.108 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 52.30 score on a scale | Standard Deviation 39.123 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 122.01 score on a scale | Standard Deviation 28.967 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 128.66 score on a scale | Standard Deviation 34.624 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 49.40 score on a scale | Standard Deviation 36.88 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 133.36 score on a scale | Standard Deviation 28.616 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 54.50 score on a scale | Standard Deviation 32.874 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline | 132.38 score on a scale | Standard Deviation 32.172 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Change at Week 148 | 42.13 score on a scale | Standard Deviation 40.03 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 130.25 score on a scale | Standard Deviation 36.65 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 58.67 score on a scale | Standard Deviation 42.513 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 132.93 score on a scale | Standard Deviation 34.216 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 62.20 score on a scale | Standard Deviation 33.187 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 123.47 score on a scale | Standard Deviation 30.141 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 62.16 score on a scale | Standard Deviation 33.969 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 120.49 score on a scale | Standard Deviation 30.221 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 65.43 score on a scale | Standard Deviation 35.35 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 54.91 score on a scale | Standard Deviation 40.758 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 131.60 score on a scale | Standard Deviation 36.013 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 53.92 score on a scale | Standard Deviation 33.132 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 132.31 score on a scale | Standard Deviation 33.86 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 51.55 score on a scale | Standard Deviation 40.714 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 120.70 score on a scale | Standard Deviation 27.535 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 127.42 score on a scale | Standard Deviation 34.779 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 47.97 score on a scale | Standard Deviation 35.121 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 133.34 score on a scale | Standard Deviation 28.981 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 56.02 score on a scale | Standard Deviation 33.863 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline | 131.69 score on a scale | Standard Deviation 32.229 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Change at Week 172 | 41.18 score on a scale | Standard Deviation 40.805 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 127.33 score on a scale | Standard Deviation 36.47 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 63.19 score on a scale | Standard Deviation 38.061 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 135.33 score on a scale | Standard Deviation 33.596 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 59.13 score on a scale | Standard Deviation 33.318 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 122.00 score on a scale | Standard Deviation 30.129 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 68.89 score on a scale | Standard Deviation 34.578 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 119.35 score on a scale | Standard Deviation 31.651 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 64.81 score on a scale | Standard Deviation 36.563 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 58.90 score on a scale | Standard Deviation 46.107 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 130.39 score on a scale | Standard Deviation 36.41 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 55.67 score on a scale | Standard Deviation 32.453 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 132.16 score on a scale | Standard Deviation 34.217 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 52.22 score on a scale | Standard Deviation 42.363 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 121.15 score on a scale | Standard Deviation 28.703 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 126.44 score on a scale | Standard Deviation 34.826 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 49.41 score on a scale | Standard Deviation 35.662 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 136.55 score on a scale | Standard Deviation 27.551 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 49.05 score on a scale | Standard Deviation 30.39 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline | 137.27 score on a scale | Standard Deviation 30.844 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Change at Week 196 | 36.35 score on a scale | Standard Deviation 41.424 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 116.05 score on a scale | Standard Deviation 31.747 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 76.21 score on a scale | Standard Deviation 38.693 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 133.61 score on a scale | Standard Deviation 32.538 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 57.52 score on a scale | Standard Deviation 31.841 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 120.28 score on a scale | Standard Deviation 30.875 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 69.56 score on a scale | Standard Deviation 38.68 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 116.63 score on a scale | Standard Deviation 32.888 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 65.72 score on a scale | Standard Deviation 34.776 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 54.97 score on a scale | Standard Deviation 41.658 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 131.81 score on a scale | Standard Deviation 35.906 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 58.76 score on a scale | Standard Deviation 35.25 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 129.37 score on a scale | Standard Deviation 31.455 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 51.39 score on a scale | Standard Deviation 45.95 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 122.00 score on a scale | Standard Deviation 27.231 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 125.93 score on a scale | Standard Deviation 35.08 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 53.04 score on a scale | Standard Deviation 38.83 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 127.00 score on a scale | Standard Deviation 63.93 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 73.00 score on a scale | Standard Deviation 48.446 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline | 128.00 score on a scale | Standard Deviation 35.749 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Change at Week 248 | 72.00 score on a scale | Standard Deviation 32.156 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28
Population: Intent to treat (ITT) population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 125.34 score on a scale | Standard Deviation 34.895 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 60.00 score on a scale | Standard Deviation 41.165 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 129.12 score on a scale | Standard Deviation 34.289 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 62.71 score on a scale | Standard Deviation 34.6 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 124.37 score on a scale | Standard Deviation 31.632 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 62.53 score on a scale | Standard Deviation 35.072 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 122.33 score on a scale | Standard Deviation 31.114 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 57.17 score on a scale | Standard Deviation 38.851 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 57.52 score on a scale | Standard Deviation 42.561 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 127.56 score on a scale | Standard Deviation 33.718 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 51.48 score on a scale | Standard Deviation 34.576 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 127.11 score on a scale | Standard Deviation 30.537 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 41.71 score on a scale | Standard Deviation 36.508 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 123.88 score on a scale | Standard Deviation 31.62 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 124.35 score on a scale | Standard Deviation 33.31 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 40.49 score on a scale | Standard Deviation 39.733 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 131.44 score on a scale | Standard Deviation 27.715 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 42.90 score on a scale | Standard Deviation 32.581 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Baseline | 132.14 score on a scale | Standard Deviation 32.245 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 | Change at Week 28 | 30.84 score on a scale | Standard Deviation 34.614 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300
Population: ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable (NA) for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline | 100.71 score on a scale | Standard Deviation 21.831 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Change at Week 300 | 94.29 score on a scale | Standard Deviation 38.612 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline | 137.50 score on a scale | Standard Deviation 30.478 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Change at Week 300 | 55.43 score on a scale | Standard Deviation 41.694 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline | 120.38 score on a scale | Standard Deviation 24.401 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Change at Week 300 | 67.54 score on a scale | Standard Deviation 27.823 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline | 119.67 score on a scale | Standard Deviation 33.463 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Change at Week 300 | 69.00 score on a scale | Standard Deviation 41.192 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline | 134.88 score on a scale | Standard Deviation 36.957 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Change at Week 300 | 53.00 score on a scale | Standard Deviation 41.542 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline | 121.38 score on a scale | Standard Deviation 30.133 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Change at Week 300 | 72.00 score on a scale | Standard Deviation 35.219 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Change at Week 300 | 73.50 score on a scale | Standard Deviation 12.342 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline | 120.25 score on a scale | Standard Deviation 19.085 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Baseline | 162.50 score on a scale | Standard Deviation 47.376 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 | Change at Week 300 | 2.00 score on a scale | Standard Deviation 5.657 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352
Population: ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Baseline | 89.00 score on a scale | — |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Change at Week 352 | 123.00 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Baseline | 120.00 score on a scale | — |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Change at Week 352 | 86.00 score on a scale | — |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Baseline | 118.00 score on a scale | Standard Deviation 32.047 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Change at Week 352 | 66.00 score on a scale | Standard Deviation 33.181 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Baseline | 70.00 score on a scale | — |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Change at Week 352 | 131.00 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Baseline | 137.00 score on a scale | Standard Deviation 28.284 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Change at Week 352 | 37.50 score on a scale | Standard Deviation 28.991 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Baseline | 126.00 score on a scale | — |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 | Change at Week 352 | 84.00 score on a scale | — |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 123.53 score on a scale | Standard Deviation 36.16 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 66.84 score on a scale | Standard Deviation 41.733 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 59.89 score on a scale | Standard Deviation 33.17 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 131.17 score on a scale | Standard Deviation 33.675 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 125.03 score on a scale | Standard Deviation 32.56 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 61.06 score on a scale | Standard Deviation 37.386 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 59.31 score on a scale | Standard Deviation 34.837 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 120.29 score on a scale | Standard Deviation 30.894 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 58.87 score on a scale | Standard Deviation 40.707 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 129.46 score on a scale | Standard Deviation 34.799 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 52.30 score on a scale | Standard Deviation 29.385 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 128.69 score on a scale | Standard Deviation 30.461 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 44.31 score on a scale | Standard Deviation 37.923 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 125.30 score on a scale | Standard Deviation 30.075 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 125.31 score on a scale | Standard Deviation 34.14 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 47.38 score on a scale | Standard Deviation 37.687 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 130.63 score on a scale | Standard Deviation 28.446 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 47.07 score on a scale | Standard Deviation 30.463 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline | 132.71 score on a scale | Standard Deviation 33.108 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Change at Week 52 | 37.33 score on a scale | Standard Deviation 40.232 |
Primary
Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76
The IBDQ is an instrument used to assess quality of life in adult participants with inflammatory bowel disease (IBD). It includes 32 questions on 4 domains of Health-Related Quality-of-Life (HRQOL): Bowel Systems (10 items), Emotional Function (12 items), Social Function (5 items), and Systemic Function (5 items). Participants are asked to recall symptoms and quality of life from the last 2 weeks and rate each item on a 7-point Likert scale (1=worst to 7=best). A total IBDQ score is calculated by summing the scores from each domain; the total IBDQ score ranges from 32 to 224, with lower scores reflecting worse HRQOL. A positive change from Baseline indicates improvement.
Time frame: Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76
Population: The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 123.66 score on a scale | Standard Deviation 36.115 |
| Vedolizumab 300 mg (UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 65.53 score on a scale | Standard Deviation 40.584 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 59.88 score on a scale | Standard Deviation 35.29 |
| Vedolizumab 300 mg (CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 131.31 score on a scale | Standard Deviation 33.726 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 64.27 score on a scale | Standard Deviation 32.443 |
| Vedolizumab 300 mg (C13006 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 123.87 score on a scale | Standard Deviation 31.752 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 59.91 score on a scale | Standard Deviation 34.449 |
| Vedolizumab 300 mg (C13007 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 120.00 score on a scale | Standard Deviation 29.667 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 128.47 score on a scale | Standard Deviation 34.724 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q8W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 55.05 score on a scale | Standard Deviation 47.181 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 129.06 score on a scale | Standard Deviation 31.694 |
| Vedolizumab 300 mg (C13007 Vedolizumab Q4W) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 52.85 score on a scale | Standard Deviation 36.486 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 124.89 score on a scale | Standard Deviation 31.629 |
| Vedolizumab 300 mg (C13011 Placebo) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 47.43 score on a scale | Standard Deviation 35.811 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 46.32 score on a scale | Standard Deviation 36.397 |
| Vedolizumab 300 mg (C13011 Vedolizumab) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 125.89 score on a scale | Standard Deviation 34.478 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 130.75 score on a scale | Standard Deviation 28.587 |
| Vedolizumab 300 mg (C13008 De Novo Participants - UC) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 50.59 score on a scale | Standard Deviation 30.794 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Change at Week 76 | 40.14 score on a scale | Standard Deviation 39.305 |
| Vedolizumab 300 mg (C13008 De Novo Participants - CD) | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline | 132.46 score on a scale | Standard Deviation 33.245 |
Primary
Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings
A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs.
Time frame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
Population: The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vedolizumab 300 mg (UC) | Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings | 7 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings | 7 participants |
Primary
Number of Participants With Markedly Abnormal Safety Laboratory Findings
A laboratory value was considered a marked abnormality if it met the predefined criteria or parameters and the on-treatment value was more extreme than the Baseline value for the following parameters: hemoglobin \<= 70 g/L, absolute lymphocyte count \<0.5 X 10\^9/L, leukocytes \<2.0 X 10\^9/L (absolute value), platelets \<75.0 X 10\^9/L, absolute neutrophil Count \<1.0 X 10\^9/L, prothrombin time \>1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) \>3.0 x ULN, aspartate aminotransferase (AST) \>3.0 x ULN, bilirubin \>2.0 x ULN, amylase \>2.0 x ULN, lipase \>2.0 x ULN.
Time frame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
Population: The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Hemoglobin <= 70 g/L | 16 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Absolute Lymphocyte Count <0.5 X 10^9/L | 28 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Leukocytes <2.0 X 10^9/L (Absolute Value) | 1 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Platelets <75.0 X 10^9/L | 2 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Absolute Neutrophil Count <1.0 X 10^9/L | 9 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Prothrombin Time >1.25 x ULN | 42 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | ALT >3.0 x ULN | 30 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | AST >3.0 x ULN | 35 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Bilirubin >2.0 x ULN | 12 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Amylase >2.0 x ULN | 16 participants |
| Vedolizumab 300 mg (UC) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Lipase >2.0 x ULN | 27 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | AST >3.0 x ULN | 34 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Hemoglobin <= 70 g/L | 11 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Prothrombin Time >1.25 x ULN | 37 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Amylase >2.0 x ULN | 36 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Absolute Lymphocyte Count <0.5 X 10^9/L | 56 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Lipase >2.0 x ULN | 41 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Leukocytes <2.0 X 10^9/L (Absolute Value) | 3 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | ALT >3.0 x ULN | 47 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Platelets <75.0 X 10^9/L | 5 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Bilirubin >2.0 x ULN | 14 participants |
| Vedolizumab 300 mg (CD) | Number of Participants With Markedly Abnormal Safety Laboratory Findings | Absolute Neutrophil Count <1.0 X 10^9/L | 9 participants |
Primary
Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements
Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study. Any clinically significant mean change in vital signs over time as assessed by the investigator was reported as a TEAE.
Time frame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)
Population: The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vedolizumab 300 mg (UC) | Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements | 0 percentage of participants |
| Vedolizumab 300 mg (CD) | Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements | 0 percentage of participants |
Primary
Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, 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 treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)
Population: The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vedolizumab 300 mg (UC) | Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 93 percentage of participants |
| Vedolizumab 300 mg (UC) | Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 31 percentage of participants |
| Vedolizumab 300 mg (CD) | Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAEs | 96 percentage of participants |
| Vedolizumab 300 mg (CD) | Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | SAEs | 41 percentage of participants |
Primary
Time to Major Inflammatory Bowel Disease (IBD) - Related Events
IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease.
Time frame: Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)
Population: Efficacy population included participants who received at least one dose of vedolizumab and had at least one postbaseline disease activity measurement.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Vedolizumab 300 mg (UC) | Time to Major Inflammatory Bowel Disease (IBD) - Related Events | IBD-related events, UC | NA weeks |
| Vedolizumab 300 mg (UC) | Time to Major Inflammatory Bowel Disease (IBD) - Related Events | IBD-related events, CD | NA weeks |