Trial · NCT00790933
Outcomes60
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 60
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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) | The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population. | percentage of participants | NUMBER |
| PRIMARY | 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) | The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population. | participants | NUMBER |
| PRIMARY | 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) | The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population. | percentage of participants | NUMBER |
| PRIMARY | 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) | The safety population was defined as all participants who participated in Studies C13004, C13006, C13007, and C13011 and received any amount of vedolizumab in Study C13008. De novo participants who received any amount of vedolizumab in Study C13008 were also included in the safety population. | participants | NUMBER |
| PRIMARY | 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) | Efficacy population included participants who received at least one dose of vedolizumab and had at least one postbaseline disease activity measurement. | weeks | MEDIAN |
| PRIMARY | 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 | Intent to treat (ITT) population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 52 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 76 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 76 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 76. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 100 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 100 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 100. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 124 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 124 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 124. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 148 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 148 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 148. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 172 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 172 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 172. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 196 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 196 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 196. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in the Inflammatory Bowel Disease Questionnaire (IBDQ) Scores at Week 248 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 248 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 248. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | 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 | ITT population from studies C13006, C13007 and C13011 who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies with data available at both Baseline and Week 300. Not applicable (NA) for Vedolizumab 300 mg (C13004) arm group. Data is not available for de novo participants at this time point. | score on a scale | MEAN |
| PRIMARY | 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 | ITT population from studies C13006 and C13007 who received vedolizumab in study C13008. Data is provided for completers in previous studies with data available at both Baseline and Week 352. NA for Vedolizumab 300 mg (C13004) arm group. Data is not available for C13011 Placebo and Vedolizumab arm groups and de novo participants at this time point. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Short Form-36 (SF-36) Physical Component Scores at Week 28 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Short Form-36 (SF-36) Mental Component Scores at Week 28 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 28 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 28. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 52 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
| PRIMARY | Change From Baseline in Short Form-36 (SF-36) Mental Component Score at Week 52 | Baseline (prior to first dose of study drug in C13008; for rollover participants this was the last assessment from the previous study) and Week 52 | The ITT population from studies C13006, C13007, C13011 and de novo participants who received vedolizumab in study C13008. Data is provided for participants who were completers in previous studies and de novo participants for whom data was collected at both Baseline and Week 52. Not applicable for Vedolizumab 300 mg (C13004) arm group. | score on a scale | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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