Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease (GEMINI LTS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00790933
Recruitment Status : Completed
First Posted : November 14, 2008
Results First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE November 5, 2008
First Posted Date  ICMJE November 14, 2008
Results First Submitted Date  ICMJE October 31, 2018
Results First Posted Date  ICMJE March 12, 2019
Last Update Posted Date March 12, 2019
Actual Study Start Date  ICMJE May 22, 2009
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 15, 2019)
  • Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ 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) ]
    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 [ Time Frame: 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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 52 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 352 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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 [ 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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 13, 2008)
To determine adverse events, serious adverse events, results of standard laboratory tests and ECGs, time to major IBD-related events (hospitalizations, surgeries or procedures), and improvements in quality of life. [ Time Frame: A maximum of 100 weeks or until vedolizumab (MLN0002) becomes commercially available, whichever occurs first. ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
Official Title  ICMJE A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Ulcerative Colitis
  • Crohn's Disease
Intervention  ICMJE Drug: Vedolizumab
Vedolizumab intravenous infusion
Other Name: MLN0002
Study Arms  ICMJE Experimental: Vedolizumab 300 mg
Vedolizumab 300 mg, 30-minute intravenous (IV) infusion every 4 weeks, starting at Week 0 for approximately up to 510 weeks.
Intervention: Drug: Vedolizumab
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2017)
2243
Original Estimated Enrollment  ICMJE
 (submitted: November 13, 2008)
1500
Actual Study Completion Date  ICMJE October 31, 2017
Actual Primary Completion Date October 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   Czechia,   Germany,   Hungary,   Israel,   Korea, Republic of,   Malaysia,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT00790933
Other Study ID Numbers  ICMJE C13008
2008-002784-14 ( EudraCT Number )
NMRR-08-1040-2195 ( Registry Identifier: NMRR )
CTRI/2009/091/000138 ( Registry Identifier: CTRI )
10/H1102/12 ( Registry Identifier: NRES )
NL25209.096.08 ( Registry Identifier: CCMO )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Clinical Science Takeda
PRS Account Takeda
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP