Please select the outcome measures that correspond to the clinical trial below.
Title: Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease
Brief Summary: This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.


Options:
A: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 (Week 6); Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 (Baseline and Week 6); Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 (Week 52)
B: Number of Participants With Adverse Events (From the first date of study drug administration through Day 253); Cmax: Maximum Observed Plasma Concentration of Vedolizumab on Days 1 and 85 (Days 1 and 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.); Cmin: Minimum Observed Plasma Concentration of Vedolizumab (Day 85, prior to and 2, 12, 24, 48, and 72 hours after dosing.); Area Under the Plasma Concentration-Time Curve (AUC) for Vedolizumab (Days 0-14, Days 85-99, Days 85-141); Terminal Phase Elimination Half-life (t½) of Vedolizumab (Pre-dose through Day 253); Maximum Drug Effect (Emax) of Vedolizumab as Measured by Percent Inhibition of the Act-1 Marker (Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253); Maximum Drug Effect (Emax) as Measured by Inhibition of the MAdCAM-1-Fc Marker (Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253); Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the ACT-1 Marker (Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253); Area Under the Drug Effect Time Curve [AUEC(0-last)] as Measured by Inhibition of the MAdCAM-1-Fc Marker (Days 1, 2, 3, 4, 8, 15, 29, 43, 57, 71, 85, 86, 87, 89, 92, 99, 113, 127, 141, 155, 169, 183, 197, 211, 225, 239, and 253)
C: Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to approximately 8.5 years)); Number of Participants With Markedly Abnormal Safety Laboratory Findings (From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)); Percentage of Participants With at Least One Clinically Significant Mean Change Over Time in Vital Sign Measurements (From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)); Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings (From first dose of study drug in this study through 16 weeks after the last dose of study drug (Up to 8.5 years)); Time to Major Inflammatory Bowel Disease (IBD) - Related Events (Baseline (Prior to first dose of study drug in C13008) up to end of study (approximately up to 8.5 years)); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 28 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 300 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300); Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 352 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352); Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28); Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28); Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52); Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52); Change From Baseline in Short Form-36 (SF-36) Physical Component at Week 76 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76); Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 76 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76); Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 100 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100); Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 100 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100); Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 124 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124); Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 124 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124); Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 148 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148); Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 148 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148); Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 172 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172); Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 172 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172); Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 196 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196); Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 196 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196); Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 248 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248); Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 248 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248); Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 300 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300); Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 300 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300); Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 352 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352); Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 352 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 28 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 28 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 52 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 52 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 76 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 76 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 100 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 100 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 124 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 124 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 148 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 148 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 172 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 172 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 196 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 196 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 248 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 248 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 300 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300); Change From Baseline in EuroQol 5D Health States (EQ-5D) Visual Analog Scale (VAS) Score at Week 300 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 300); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Composite Score at Week 352 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352); Change From Baseline in European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Week 352 (Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 352)
D: Number of Participants With Adverse Events (AEs) (From Day 1 to Day 637); Number of Participants With Clinically Significant Laboratory Findings (through Day 637); Number of Participants With Signs and Symptoms of Progressive Multifocal Leukoencephalopathy (PML) (through Day 637); Number of Participants With Human Anti-human Antibodies (HAHA) (Samples collected prior to dosing on Days 1, 43, 155, 267, 379, 491, and 637.)

Answer: D