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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT00790933
First received: November 5, 2008
Last updated: February 17, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Ulcerative Colitis
Crohn's Disease
Drug: Vedolizumab
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Other
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Percentage of Participants with one or more Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose to 16 weeks after the last dose up to data cut off: 21 May 2015 ]
    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 to 16 weeks after the last dose up to data cut-off: 21 May 2015 ]
    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 <0.5X10E9/L, leukocytes <2.0X10E9/L (absolute value), platelets <75.0X10E9/L, absolute neutrophil Count <1.0X10E9/L, prothrombin time >1.25 x upper limit of normal (ULN), alanine aminotransferase (ALT) >3.0xULN, aspartate aminotransferase (AST) >3.0xULN, bilirubin >2.0xULN, amylase >2.0xULN, lipase >2.0xULN.

  • Percentage of Participants with Markedly Abnormal Vital Sign Measurements [ Time Frame: From first dose to 16 weeks after the last dose up to data cut-off: 21 May 2015 ]
    Vital signs (heart rate, respiratory rate, systolic and diastolic blood pressure, and temperature) measurements were collected throughout the study.

  • Number of Participants with Markedly Abnormal Safety Electrocardiogram (ECG) Reported as Adverse Events [ Time Frame: From first dose to 16 weeks after the last dose up to data cut-off: 21 May 2015 ]
    The ECGs collected after vedolizumab administration at Week 0 is captured as AEs if in the opinion of the investigator there has been a clinically significant change from Baseline.

  • Time to Major Inflammatory Bowel Disease (IBD) - Related Events [ Time Frame: Baseline up to data cut-off: 21 May 2015 ]
    IBD-related events included time to hospitalizations, surgeries, or procedures due to ulcerative colitis (UC) and Crohn's disease (CD).

  • Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 [ Time Frame: Baseline 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. The change between the IBDQ total score at Week 28 relative to baseline.

  • Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 [ Time Frame: Baseline 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. The change between the IBDQ total score at Week 52 relative to baseline.

  • Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 [ Time Frame: Baseline 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. The change between the IBDQ total score at Week 76 relative to baseline.

  • Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 [ Time Frame: Baseline 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. The change between the IBDQ total score at Week 100 relative to baseline.

  • Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 [ Time Frame: Baseline 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. The change between the IBDQ total score at Week 124 relative to baseline.

  • Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 [ Time Frame: Baseline 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. The change between the IBDQ total score at Week 148 relative to baseline.

  • Change from Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 [ Time Frame: Baseline 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. The change between the IBDQ total score at Week 196 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 [ Time Frame: Baseline 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 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. The change between the SF-36 physical component score at Week 28 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 [ Time Frame: Baseline 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 8 scales, the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. The change between the SF-36 mental component score at Week 28 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 [ Time Frame: Baseline 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 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. The change between the SF-36 physical component score at Week 52 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 [ Time Frame: Baseline 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 8 scales, the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. The change between the SF-36 mental component score at Week 52 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Physical Component at Week 76 [ Time Frame: Baseline 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 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. The change between the SF-36 physical component score at Week 76 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 [ Time Frame: Baseline 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 8 scales, the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. The change between the SF-36 mental component score at Week 76 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 [ Time Frame: Baseline 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 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. The change between the SF-36 physical component score at Week 100 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 [ Time Frame: Baseline 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 8 scales, the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. The change between the SF-36 mental component score at Week 100 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 124 [ Time Frame: Baseline 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 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. The change between the SF-36 physical component score at Week 124 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 124 [ Time Frame: Baseline 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 8 scales, the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. The change between the SF-36 mental component score at Week 124 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 [ Time Frame: Baseline 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. The change between the SF-36 physical component score at Week 148 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 [ Time Frame: Baseline 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 mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. The change between the SF-36 mental component score at Week 148 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 [ Time Frame: Baseline 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 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. The change between the SF-36 physical component score at Week 196 relative to baseline.

  • Change from Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 [ Time Frame: Baseline 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 8 scales, the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. The change between the SF-36 mental component score at Week 196 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 28 [ Time Frame: Baseline and Week 28 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. The change between the EQ-5D total score at Week 28 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 28 [ Time Frame: Baseline and Week 28 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. The EQ-5D Visual Analog Scale (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. The change between the EQ-5D total score at Week 28 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 52 [ Time Frame: Baseline and Week 52 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. The change between the EQ-5D total score at Week 52 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 52 [ Time Frame: Baseline and Week 52 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. The EQ-5D Visual Analog Scale (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. The change between the EQ-5D total score at Week 52 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 76 [ Time Frame: Baseline and Week 76 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. The change between the EQ-5D total score at Week 76 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 76 [ Time Frame: Baseline and Week 76 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. The EQ-5D Visual Analog Scale (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. The change between the EQ-5D total score at Week 76 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 100 [ Time Frame: Baseline and Week 100 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. The change between the EQ-5D total score at Week 100 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 100 [ Time Frame: Baseline and Week 100 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. The EQ-5D Visual Analog Scale (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. The change between the EQ-5D total score at Week 100 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 124 [ Time Frame: Baseline and Week 124 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. The change between the EQ-5D total score at Week 124 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 124 [ Time Frame: Baseline and Week 124 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. The EQ-5D Visual Analog Scale (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. The change between the EQ-5D total score at Week 124 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 148 [ Time Frame: Baseline and Week 148 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. The change between the EQ-5D total score at Week 148 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 148 [ Time Frame: Baseline and Week 148 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. The EQ-5D Visual Analog Scale (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. The change between the EQ-5D total score at Week 148 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Composite Score at Week 196 [ Time Frame: Baseline and Week 196 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. A composite EQ-5D score can be calculated from the individual scores to assess overall HRQOL. A decrease of ≥0.3 points in the composite EQ-5D score represents improvement in quality of life of participants. The change between the EQ-5D total score at Week 196 relative to baseline.

  • Change from Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 196 [ Time Frame: Baseline and Week 196 ]
    EuroQol 5D health states (EQ-5D) questionnaire is an instrument used to measure general HRQOL in participants with IBD. It considers five attributes of quality of life evaluation, i.e. mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. Each dimension has three possible levels, i.e 1 = none, 2 = moderate or 3 = extreme. The EQ-5D Visual Analog Scale (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. The change between the EQ-5D total score at Week 196 relative to baseline.


Enrollment: 2243
Study Start Date: May 2009
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vedolizumab
Vedolizumab 300 mg, 30-minute intravenous (IV) infusion every 4 weeks, starting at Week 0 for up to 46 months.
Drug: Vedolizumab
Vedolizumab intravenous infusion
Other Name: MLN0002

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 up to 46 months.

This multicenter trial is being conducted worldwide. The overall time to participate in this study was up to March 2016 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790933

  Hide Study Locations
Locations
United States, Alabama
Birmingham, Alabama, United States, 35233
United States, California
San Diego, California, United States, 92114
San Francisco, California, United States, 94115
United States, Colorado
Lafayette, Colorado, United States, 80026
Littleton, Colorado, United States, 80120
Thorton, Colorado, United States, 80229
United States, Connecticut
Hamden, Connecticut, United States, 06518
United States, Florida
Jacksonville, Florida, United States, 32256
Miami, Florida, United States, 33172
Winter Park, Florida, United States, 32789
United States, Georgia
Atlanta, Georgia, United States, 30024
Decatur, Georgia, United States, 30033
Macon, Georgia, United States, 31201
United States, Kansas
Topeka, Kansas, United States, 66606
United States, Kentucky
Louisville, Kentucky, United States, 40202
United States, Louisiana
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Troy, Michigan, United States, 48098
United States, Minnesota
Rochester, Minnesota, United States, 55904
United States, New York
Cheektowaga, New York, United States, 10029
New York, New York, United States, 10029
United States, North Carolina
Charlotte, North Carolina, United States, 28207
Elkin, North Carolina, United States, 28621
United States, Oregon
Portland, Oregon, United States, 97225
United States, Tennessee
Germantown, Tennessee, United States, 38138
United States, Texas
San Antonio, Texas, United States, 78229
Tyler, Texas, United States, 75701
United States, Virginia
Charlottesville, Virginia, United States, 22908
Richmond, Virginia, United States, 23249
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, South Australia
Adelaide, South Australia, Australia, 5000
Belgium
Leuven, Belgium, 3000
Canada, Alberta
Edmonton, Alberta, Canada, T6G2X8
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 0W8
Czech Republic
Praha, Czech Republic, 170 04
Germany
Halle, ST, Germany, 6097
Hungary
Szekszard, Hungary, 7100
Israel
Tel Aviv, Israel, 64239
Korea, Republic of
Seoul, Korea, Republic of, 130-702
Malaysia
Kuala Lumpur, Malaysia, 59100
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Monitor Clinical Science Takeda
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT00790933     History of Changes
Other Study ID Numbers: C13008
2008-002784-14 ( EudraCT Number )
NMRR-08-1040-2195 ( Registry Identifier: Malaysia National Medical Research Register Number )
CTRI/2009/091/000138 ( Registry Identifier: India Clinical Trial Registration Number )
10/H1102/12 ( Registry Identifier: UK National Research Ethics Service Number )
Study First Received: November 5, 2008
Last Updated: February 17, 2017

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Vedolizumab
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colonic Diseases
Pathologic Processes
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 25, 2017