Trial · NCT00783692
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
NCT00783692, 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 (MLN0002) in Patients With Moderate to Severe Crohn's Disease. Trials, record NCT00783692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00783692
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
- NCT number
- NCT00783692
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,116 participants, actual
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Conditions
- Crohn's Disease
- Interventions
- vedolizumab, Placebo
- First posted
- 2008-11-03
- Last updated
- 2014-07-21
- Other registries' IDs
- eudract:2008-002783-33
- Results first posted
- 2014-07-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 | 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. |
| Primary | Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 | Baseline and Week 6 | Enhanced clinical response is defined as a CDAI score at least 100 points lower than 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; * Percentage deviation from standard weight. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response. |
| Primary | Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 | Week 52 | Clinical remission is defined as a CDAI score ≤ 150. 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 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission. |
| Secondary | Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6 | Baseline and Week 6 | C-reactive protein (CRP) is a protein found in the blood, the levels of which rise in response to inflammation. Normal concentration in healthy human serum is usually lower than 10 mg/L, slightly increasing with age. Higher levels indicate mild inflammation (10-40 mg/L) and active inflammation (40-200 mg/L). |
| Secondary | Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52 | Baseline and Week 52 | Enhanced clinical response is defined as a CDAI score at least 100 points lower than the Baseline value. 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 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving enhanced clinical response. |
| Secondary | Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52 | Week 52 | Participants using oral corticosteroids at Baseline, who discontinued corticosteroids and were in clinical remission (CDAI score ≤ 150) at Week 52 achieved corticosteroid-free clinical remission. The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving corticosteroid-free clinical remission. |
| Secondary | Maintenance Phase: Percentage of Participants With Durable Clinical Remission | Assessed every 4 weeks from Week 6 to Week 50, and at Week 52 | Durable clinical remission is defined as CDAI score ≤ 150 points at 80% or more of study visits during the Maintenance Phase, including the Week 52 visit (11 of 13 study visits). The CDAI quantifies the symptoms of patients with Crohn's disease and consists of eight factors, summed after adjustment with a weighting factor. The total score ranges from 0 to 600 with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving durable clinical remission |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 | Week 6 | Induction Study Intention to Treat (ITT) Population, which consisted of all randomized patients in Cohort 1 who received any amount of blinded study drug. | percentage of participants | NUMBER |
| PRIMARY | Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 | Baseline and Week 6 | Induction Study ITT Population | percentage of participants | NUMBER |
| PRIMARY | Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 | Week 52 | Maintenance Study ITT Population, defined as all randomized participants who received vedolizumab during the Induction Phase and met the protocol definition of clinical response at Week 6, as assessed by the investigator, were randomized, and received any amount of double-blind study drug in the Maintenance Phase. | percentage of participants | NUMBER |
| SECONDARY | Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6 | Baseline and Week 6 | Induction Study ITT Population; last observation carried forward (LOCF) imputation was used. Baseline CRP was missing for one participant in the placebo group. | mg/L | MEDIAN |
| SECONDARY | Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52 | Baseline and Week 52 | Maintenance Study ITT Population | percentage of participants | NUMBER |
| SECONDARY | Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52 | Week 52 | Maintenance Study ITT Population, participants who were on corticosteroids at Baseline. | percentage of participants | NUMBER |
| SECONDARY | Maintenance Phase: Percentage of Participants With Durable Clinical Remission | Assessed every 4 weeks from Week 6 to Week 50, and at Week 52 | Maintenance Study ITT Population | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 | Placebo | 6.8 | 95% Confidence Interval 2.7 to 10.8 | percentage of participants | |
| Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 | DB Vedolizumab | 14.5 | 95% Confidence Interval 9.9 to 19.2 | percentage of participants | |
| Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 | Placebo | 25.7 | 95% Confidence Interval 18.6 to 32.7 | percentage of participants | |
| Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 | DB Vedolizumab | 31.4 | 95% Confidence Interval 25.2 to 37.5 | percentage of participants | |
| Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 | Placebo | 21.6 | 95% Confidence Interval 15.1 to 28.1 | percentage of participants | |
| Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 | Vedolizumab Q8W | 39.0 | 95% Confidence Interval 31.3 to 46.7 | percentage of participants | |
| Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 | Vedolizumab Q4W | 36.4 | 95% Confidence Interval 28.8 to 44.0 | percentage of participants | |
| Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6 | Placebo | -0.5 | Full Range -27.6 to 12.1 | mg/L | |
| Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6 | DB Vedolizumab | -0.9 | Full Range -20.6 to 10.3 | mg/L | |
| Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52 | Placebo | 30.1 | 95% Confidence Interval 22.8 to 37.3 | percentage of participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow49
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Induction Phase | STARTED | Placebo | 148 | |
| Induction Phase | STARTED | Induction Phase: DB Vedolizumab | 220 | |
| Induction Phase | STARTED | Induction Phase: OL Vedolizumab | 748 | |
| Induction Phase | STARTED | Maintenance Phase: Placebo | 0 | |
| Induction Phase | STARTED | Maintenance Phase: Vedolizumab Q8W | 0 | |
| Induction Phase | STARTED | Maintenance Phase: Vedolizumab Q4W | 0 | |
| Induction Phase | STARTED | Maintenance Phase: Non-Responders | 0 | |
| Induction Phase | Treated | Placebo | 148 | |
| Induction Phase | Treated | Induction Phase: DB Vedolizumab | 220 | |
| Induction Phase | Treated | Induction Phase: OL Vedolizumab | 747 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 participant flowAdverse events465
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 | 12 | 148 | |
| other | Nausea | Gastrointestinal disorders | VDZ/PBO | 18 | 153 | |
| other | Nausea | Gastrointestinal disorders | VDZ/VDZ | 88 | 814 | |
| other | Crohn's disease | Gastrointestinal disorders | Placebo | 28 | 148 | |
| other | Crohn's disease | Gastrointestinal disorders | VDZ/PBO | 23 | 153 | |
| other | Crohn's disease | Gastrointestinal disorders | VDZ/VDZ | 84 | 814 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 21 | 148 | |
| other | Abdominal pain | Gastrointestinal disorders | VDZ/PBO | 18 | 153 | |
| other | Abdominal pain | Gastrointestinal disorders | VDZ/VDZ | 79 | 814 | |
| other | Vomiting | Gastrointestinal disorders | Placebo | 10 | 148 |
1 to 10 of 465Source ClinicalTrials.gov
See all 465 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | VDZ/PBO | ||
| Total, all-cause mortality | VDZ/VDZ | ||
| Total, other adverse events | Placebo | 96 | 148 |
| Total, other adverse events | VDZ/PBO | 96 | 153 |
| Total, other adverse events | VDZ/VDZ | 476 | 814 |
| Total, serious adverse events | Placebo | 23 | 148 |
| Total, serious adverse events | VDZ/PBO | 23 | 153 |
| Total, serious adverse events | VDZ/VDZ | 199 | 814 |
Source ClinicalTrials.gov
Papers9
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00783692
GET https://conductscience.org/api/trials/v1/NCT00783692/flow?page=2