Trial · NCT00790933
An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
NCT00790933, Phase 3, Completed, Takeda; results first posted 2019-03-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease. Trials, record NCT00790933. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00790933
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
- NCT number
- NCT00790933
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,243 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Interventions
- Vedolizumab
- First posted
- 2008-11-14
- Last updated
- 2022-05-24
- Other registries' IDs
- eudract:2008-002784-14
- Results first posted
- 2019-03-12
Source ClinicalTrials.gov
Registered outcomes60
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | 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. |
| 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) | 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. |
| 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) | 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. |
| 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) | A standard 12-lead ECG was performed. Any ECGs assessed by the investigator to be clinically significant were reported as TEAEs. |
| 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) | IBD-related events included hospitalizations, surgeries, or procedures due to ulcerative colitis and Crohn's disease. |
| 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 | 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 registered outcomesOutcomes60
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 outcomesResults by group1,064
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Vedolizumab 300 mg (UC) | TEAEs | 93 | percentage of participants | |
| Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Vedolizumab 300 mg (CD) | TEAEs | 96 | percentage of participants | |
| Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Vedolizumab 300 mg (UC) | SAEs | 31 | percentage of participants | |
| Percentage of Participants With One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Vedolizumab 300 mg (CD) | SAEs | 41 | percentage of participants | |
| Number of Participants With Markedly Abnormal Safety Laboratory Findings | Vedolizumab 300 mg (UC) | Hemoglobin <= 70 g/L | 16 | participants | |
| Number of Participants With Markedly Abnormal Safety Laboratory Findings | Vedolizumab 300 mg (CD) | Hemoglobin <= 70 g/L | 11 | participants | |
| Number of Participants With Markedly Abnormal Safety Laboratory Findings | Vedolizumab 300 mg (UC) | Absolute Lymphocyte Count <0.5 X 10^9/L | 28 | participants | |
| Number of Participants With Markedly Abnormal Safety Laboratory Findings | Vedolizumab 300 mg (CD) | Absolute Lymphocyte Count <0.5 X 10^9/L | 56 | participants | |
| Number of Participants With Markedly Abnormal Safety Laboratory Findings | Vedolizumab 300 mg (UC) | Leukocytes <2.0 X 10^9/L (Absolute Value) | 1 | participants | |
| Number of Participants With Markedly Abnormal Safety Laboratory Findings | Vedolizumab 300 mg (CD) | Leukocytes <2.0 X 10^9/L (Absolute Value) | 3 | participants |
1 to 10 of 1,064Source ClinicalTrials.gov
See all 1,064 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vedolizumab 300 mg (C13006) | 675 | |
| Overall Study | STARTED | Vedolizumab 300 mg (C13007) | 726 | |
| Overall Study | STARTED | Vedolizumab 300 mg (C13011) | 384 | |
| Overall Study | STARTED | Vedolizumab 300 mg (C13004) | 37 | |
| Overall Study | STARTED | Vedolizumab 300 mg (C13008 De Novo Participants) | 421 | |
| Overall Study | COMPLETED | Vedolizumab 300 mg (C13006) | 237 | |
| Overall Study | COMPLETED | Vedolizumab 300 mg (C13007) | 246 | |
| Overall Study | COMPLETED | Vedolizumab 300 mg (C13011) | 115 | |
| Overall Study | COMPLETED | Vedolizumab 300 mg (C13004) | 23 | |
| Overall Study | COMPLETED | Vedolizumab 300 mg (C13008 De Novo Participants) | 145 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events446
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | Vedolizumab 300 mg | 594 | 2,243 | |
| other | Upper respiratory tract infection | Infections and infestations | Vedolizumab 300 mg | 379 | 2,243 | |
| other | Sinusitis | Infections and infestations | Vedolizumab 300 mg | 235 | 2,243 | |
| other | Bronchitis | Infections and infestations | Vedolizumab 300 mg | 216 | 2,243 | |
| other | Gastroenteritis | Infections and infestations | Vedolizumab 300 mg | 216 | 2,243 | |
| other | Influenza | Infections and infestations | Vedolizumab 300 mg | 208 | 2,243 | |
| other | Urinary tract infection | Infections and infestations | Vedolizumab 300 mg | 175 | 2,243 | |
| other | Abdominal pain | Gastrointestinal disorders | Vedolizumab 300 mg | 393 | 2,243 | |
| other | Crohn's disease | Gastrointestinal disorders | Vedolizumab 300 mg | 333 | 2,243 | |
| other | Nausea | Gastrointestinal disorders | Vedolizumab 300 mg | 333 | 2,243 |
1 to 10 of 446Source ClinicalTrials.gov
See all 446 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vedolizumab 300 mg | 10 | 2,243 |
| Total, other adverse events | Vedolizumab 300 mg | 1,820 | 2,243 |
| Total, serious adverse events | Vedolizumab 300 mg | 825 | 2,243 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Vedolizumab 300 mg (UC) vs Vedolizumab 300 mg (CD): Number of Participants With at Least One Clinically Significant Electrocardiogram (ECG) Findings |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00790933
GET https://conductscience.org/api/trials/v1/NCT00790933/registered?page=2