Trial · NCT04567628
Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
NCT04567628, Completed, Takeda; results first posted 2024-03-15
3 sourcestrials-2026-11-12-0.4.0
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ConductScience Library. Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes. Trials, record NCT04567628. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04567628
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Relationship Between Vedolizumab Therapeutic Drug Monitoring, Biomarkers of Inflammation and Clinical Outcomes
- NCT number
- NCT04567628
- Status
- Completed
- Enrollment
- 7,873 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Interventions
- No Intervention
- First posted
- 2020-09-28
- Last updated
- 2024-03-15
- Results first posted
- 2024-03-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TDM Cohort: Correlation Between Week 6 Vedolizumab TDM and Week 30 Faecal Calprotectin (FCP) | After the first dose of vedolizumab (at Week 30) | The relationship between vedolizumab TDM at Week 6 and FCP levels at Week 30 were studied using univariate and multivariate logistic regression models. Multivariate analyses were performed to control for possible confounding factors such as age, sex, disease type (CD/UC), duration, prior immunomodulator/biologic therapy, vedolizumab start and end dates, vedolizumab dose, vedolizumab frequency, and albumin. FCP was used as a surrogate marker for disease severity, and by extension drug efficacy. The FCP level was detected in participant's stool 30 weeks after the participant's first dose of vedolizumab. FCP was treated as a continuous variable for correlation analysis to determine Spearman's correlation coefficient. This outcome measure was planned to be analyzed only in participants enrolled in the TDM Cohort. |
| Secondary | TDM Cohort: C-reactive Protein (CRP) Level at Week 30 | After the first dose of vedolizumab (at Week 30) | The CRP level were detected in participant's blood 30 weeks after the participant's first dose of vedolizumab. CRP was used as a surrogate marker for disease severity, and by extension drug efficacy. This outcome measure was planned to be analyzed separately in participants with UC and CD who were collectively a part of the TDM Cohort. |
| Secondary | TDM Cohort: Disease Score for Crohn's Disease (CD) Participants Based on Harvey-Bradshaw Index (HBI) at Week 30 | After the first dose of vedolizumab (at Week 30) | Disease activity scores of CD participants were based on HBI. It consists of clinical parameters: general well-being (0 = very well to 4 = terrible), abdominal pain (0 = none to 3 = severe), number of liquid or soft stools per day, abdominal mass (0 = none to 3 = definite and tender), and complications (8 items; 1 score per item). The total score is sum of sub scores, where score \<5 = remission, 5 to 7 = mild disease activity, 8 to 16 = moderate disease activity and \>16 = severe disease activity. This outcome measure was planned to be analyzed only in participants with CD. |
| Secondary | TDM Cohort: Disease Score for Ulcerative Colitis (UC) Participants Based on Partial Mayo Score at Week 30 | After the first dose of vedolizumab (at Week 30) | Disease activity scores of UC participants were based on Partial Mayo score. It consists of 3 sub-scores: stool pattern, most severe rectal bleeding of the day, and global assessment by physician, each graded from 0 to 3 with higher scores indicating more severe disease. These scores are summed to give a total score range of 0 to 9. Here, higher scores indicate more severe disease. This outcome measure was planned to be analyzed only in participants with UC. |
| Secondary | Number of Participants Categorized Based on Dose Escalation | Baseline (Week 0) up to Week 30 (after first dose of vedolizumab) | Dose escalation was defined as a change from doses every 8 weeks to every 4 weeks. |
| Secondary | TDM Cohort: Number of Participants Categorized Based on Treatment Persistence at the End of the TDM Study at Week 30 | After the first dose of vedolizumab (at Week 30) | Treatment persistence was defined as whether the participant was still on the treatment at the end of the TDM study. This outcome measure was planned to be analyzed only in participants enrolled in the TDM Cohort. |
| Secondary | Treatment Duration | From treatment initiation up to discontinuation of treatment or up to data extraction date Oct 2020), whichever occurs first (maximum up to approximately 5 years) | Treatment duration was defined as the length of time a participant remains on treatment (i.e., from the year 2015 to 2020). |
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 | TDM Cohort: Correlation Between Week 6 Vedolizumab TDM and Week 30 Faecal Calprotectin (FCP) | After the first dose of vedolizumab (at Week 30) | Analyzed participants included all participants who were not screen failures, met all the inclusion criteria and had enough information about response to the biological treatment. | correlation coefficient | NUMBER |
| SECONDARY | TDM Cohort: C-reactive Protein (CRP) Level at Week 30 | After the first dose of vedolizumab (at Week 30) | Analyzed participants included all participants who were not screen failures, met all the inclusion criteria and had enough information about response to the biological treatment. Overall number analyzed are the number of participants with data available for analyses. | mg/L | MEDIAN |
| SECONDARY | TDM Cohort: Disease Score for Crohn's Disease (CD) Participants Based on Harvey-Bradshaw Index (HBI) at Week 30 | After the first dose of vedolizumab (at Week 30) | Analyzed participants included all participants who were not screen failures, met all the inclusion criteria and had enough information about response to the biological treatment. Overall number analyzed are the number of participants with data available for analyses. | score on a scale | MEDIAN |
| SECONDARY | TDM Cohort: Disease Score for Ulcerative Colitis (UC) Participants Based on Partial Mayo Score at Week 30 | After the first dose of vedolizumab (at Week 30) | Analyzed participants included all participants who were not screen failures, met all the inclusion criteria and had enough information about response to the biological treatment. Overall number analyzed are the number of participants with data available for analyses. | score on a scale | MEDIAN |
| SECONDARY | Number of Participants Categorized Based on Dose Escalation | Baseline (Week 0) up to Week 30 (after first dose of vedolizumab) | Analyzed participants included all participants who were not screen failures, met all the inclusion criteria and had enough information about response to the biological treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | TDM Cohort: Number of Participants Categorized Based on Treatment Persistence at the End of the TDM Study at Week 30 | After the first dose of vedolizumab (at Week 30) | Analyzed participants included all participants who were not screen failures, met all the inclusion criteria and had enough information about response to the biological treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Treatment Duration | From treatment initiation up to discontinuation of treatment or up to data extraction date Oct 2020), whichever occurs first (maximum up to approximately 5 years) | Analyzed participants included all participants who were not screen failures, met all the inclusion criteria and had enough information about response to the biological treatment. Overall number analyzed are the number of participants with data available for analyses. | days | MEDIAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| TDM Cohort: Correlation Between Week 6 Vedolizumab TDM and Week 30 Faecal Calprotectin (FCP) | TDM Cohort | -0.23 | correlation coefficient | ||
| TDM Cohort: C-reactive Protein (CRP) Level at Week 30 | TDM Cohort: Ulcerative Colitis | 2 | Inter-Quartile Range 1 to 5 | mg/L | |
| TDM Cohort: C-reactive Protein (CRP) Level at Week 30 | TDM Cohort: Crohn's Disease | 3 | Inter-Quartile Range 1 to 6 | mg/L | |
| TDM Cohort: Disease Score for Crohn's Disease (CD) Participants Based on Harvey-Bradshaw Index (HBI) at Week 30 | TDM Cohort: Crohn's Disease | 3 | Inter-Quartile Range 1 to 6 | score on a scale | |
| TDM Cohort: Disease Score for Ulcerative Colitis (UC) Participants Based on Partial Mayo Score at Week 30 | TDM Cohort: Ulcerative Colitis | 1 | Inter-Quartile Range 0 to 3 | score on a scale | |
| Number of Participants Categorized Based on Dose Escalation | TDM Cohort | 173 | Participants | ||
| Number of Participants Categorized Based on Dose Escalation | Historical Cohort | 852 | Participants | ||
| TDM Cohort: Number of Participants Categorized Based on Treatment Persistence at the End of the TDM Study at Week 30 | TDM Cohort | Treatment Persistence | 360 | Participants | |
| TDM Cohort: Number of Participants Categorized Based on Treatment Persistence at the End of the TDM Study at Week 30 | TDM Cohort | Did not Persist on Treatment | 76 | Participants | |
| Treatment Duration | TDM Cohort | 378.0 | Inter-Quartile Range 238.0 to 553.5 | days |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TDM Cohort | 436 | |
| Overall Study | STARTED | Historical Cohort | 4,758 | |
| Overall Study | COMPLETED | TDM Cohort | 436 | |
| Overall Study | COMPLETED | Historical Cohort | 4,758 | |
| Overall Study | NOT COMPLETED | TDM Cohort | 0 | |
| Overall Study | NOT COMPLETED | Historical Cohort | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TDM Cohort | 0 | 436 |
| Total, all-cause mortality | Historical Cohort | 0 | 4,758 |
| Total, other adverse events | TDM Cohort | 0 | 0 |
| Total, other adverse events | Historical Cohort | 0 | 0 |
| Total, serious adverse events | TDM Cohort | 0 | 0 |
| Total, serious adverse events | Historical Cohort | 0 | 0 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 39139218 | DERIVED |
Source PubMed
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TDM Cohort vs Historical Cohort: Number of Participants Categorized Based on Dose Escalation | Trial comparisons |
| TDM Cohort vs Historical Cohort: deaths from any cause | 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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT04567628
GET https://conductscience.org/api/trials/v1/NCT04567628/registered