Trial · NCT01224171
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
NCT01224171, Phase 3, Completed, Millennium Pharmaceuticals, Inc.; results first posted 2014-07-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease. Trials, record NCT01224171. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01224171
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
- NCT number
- NCT01224171
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 416 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Crohn's Disease
- Interventions
- vedolizumab, Placebo
- First posted
- 2010-10-19
- Last updated
- 2014-07-21
- Other registries' IDs
- eudract:2009-016488-12
- Results first posted
- 2014-07-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation | Week 6 | Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. |
| Secondary | Percentage of Participants in Clinical Remission at Week 6 in the Overall Population | Week 6 | Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. |
| Secondary | Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation | Week 10 | Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. |
| Secondary | Percentage of Participants in Clinical Remission at Week 10 in the Overall Population | Week 10 | Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. |
| Secondary | Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population | Week 6 and Week 10 | Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission. |
| Secondary | Percentage of Participants With Sustained Clinical Remission in the Overall Population | Week 6 and Week 10 | Sustained clinical remission is defined as a CDAI score ≤ 150 points at both Week 6 and Week 10. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving sustained clinical remission. |
| Secondary | Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation | Baseline and Week 6 | Enhanced clinical response is defined as a ≥ 100-point decrease in CDAI score from Baseline. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percent deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response. |
| Secondary | Number of Participants With Adverse Events (AEs) | From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments. | An AE was defined as any untoward medical occurrence in a patient administered a pharmaceutical product, which did not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was any AE, occurring at any dose and regardless of causality that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was an important medical event based upon appropriate medical judgment that may have jeopardized the patient and may have required medical or surgical intervention to prevent 1 of the outcomes listed above, or any diagnosis of progressive multifocal leukoencephalopathy (PML). Relationship to study drug administration was determined by the investigator responding yes or no to the question: Is there a reasonable possibility that the AE is associated with the study drug? |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation | Week 6 | TNFα Antagonist Failure Intent-to-treat (ITT) subpopulation which consisted of all randomized participants who received any amount of blinded study drug who met the TNFα antagonist failure criterion. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Clinical Remission at Week 6 in the Overall Population | Week 6 | Overall ITT population, consisting of all randomized participants who received any amount of blinded study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation | Week 10 | TNFα Antagonist Failure Intent-to-treat (ITT) Subpopulation | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants in Clinical Remission at Week 10 in the Overall Population | Week 10 | Overall ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population | Week 6 and Week 10 | TNFα Antagonist Failure ITT Subpopulation | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Clinical Remission in the Overall Population | Week 6 and Week 10 | Overall ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation | Baseline and Week 6 | TNFα Antagonist Failure ITT Subpopulation | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Adverse Events (AEs) | From the date of first study drug administration to Week 22, through the 14 March 2012 database lock date. At the time of this database lock, 7 patients had completed Week 10 or early termination assessments but not Week 22 assessments. | Overall Safety Population | participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation | Placebo | 12.1 | 95% Confidence Interval 7.0 to 17.2 | percentage of participants | |
| Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation | Vedolizumab | 15.2 | 95% Confidence Interval 9.6 to 20.8 | percentage of participants | |
| Percentage of Participants in Clinical Remission at Week 6 in the Overall Population | Placebo | 12.1 | 95% Confidence Interval 7.6 to 16.5 | percentage of participants | |
| Percentage of Participants in Clinical Remission at Week 6 in the Overall Population | Vedolizumab | 19.1 | 95% Confidence Interval 13.8 to 24.5 | percentage of participants | |
| Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation | Placebo | 12.1 | 95% Confidence Interval 7.0 to 17.2 | percentage of participants | |
| Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation | Vedolizumab | 26.6 | 95% Confidence Interval 19.7 to 33.5 | percentage of participants | |
| Percentage of Participants in Clinical Remission at Week 10 in the Overall Population | Placebo | 13.0 | 95% Confidence Interval 8.5 to 17.6 | percentage of participants | |
| Percentage of Participants in Clinical Remission at Week 10 in the Overall Population | Vedolizumab | 28.7 | 95% Confidence Interval 22.6 to 34.8 | percentage of participants | |
| Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population | Placebo | 8.3 | 95% Confidence Interval 4.0 to 12.6 | percentage of participants | |
| Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population | Vedolizumab | 12.0 | 95% Confidence Interval 7.0 to 17.1 | percentage of participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 207 | |
| Overall Study | STARTED | Vedolizumab | 209 | |
| Overall Study | TNFα Antagonist Failure Population | Placebo | 157 | |
| Overall Study | TNFα Antagonist Failure Population | Vedolizumab | 158 | |
| Overall Study | COMPLETED | Placebo | 192 | |
| Overall Study | COMPLETED | Vedolizumab | 196 | |
| Overall Study | NOT COMPLETED | Placebo | 15 | |
| Overall Study | NOT COMPLETED | Vedolizumab | 13 |
Source ClinicalTrials.gov
Adverse events42
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 | Nausea | Gastrointestinal disorders | Placebo | 5 | 207 | |
| other | Nausea | Gastrointestinal disorders | Vedolizumab | 12 | 209 | |
| other | Headache | Nervous system disorders | Placebo | 15 | 207 | |
| other | Headache | Nervous system disorders | Vedolizumab | 11 | 209 | |
| other | Pyrexia | General disorders | Placebo | 13 | 207 | |
| other | Pyrexia | General disorders | Vedolizumab | 7 | 209 | |
| serious | Crohn's disease | Gastrointestinal disorders | Placebo | 11 | 207 | |
| serious | Crohn's disease | Gastrointestinal disorders | Vedolizumab | 2 | 209 | |
| serious | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 207 | |
| serious | Abdominal pain | Gastrointestinal disorders | Vedolizumab | 1 | 209 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Vedolizumab | ||
| Total, other adverse events | Placebo | 29 | 207 |
| Total, other adverse events | Vedolizumab | 25 | 209 |
| Total, serious adverse events | Placebo | 16 | 207 |
| Total, serious adverse events | Vedolizumab | 13 | 209 |
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 vs Placebo: serious adverse events |
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/NCT01224171
GET https://conductscience.org/api/trials/v1/NCT01224171/results?page=2