Trial · NCT06180382
Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.
NCT06180382, Phase 4, Recruiting, Centre Hospitalier Universitaire de Saint Etienne
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration. Trials, record NCT06180382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06180382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.
- NCT number
- NCT06180382
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 220 participants, estimated
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Conditions
- Crohn's Disease
- Interventions
- Adalimumab, Vedolizumab
- First posted
- 2023-12-22
- Last updated
- 2026-05-05
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ADA optimized versus Vedolizumab as second line | Week 24 | The primary objective will be to compare the proportion of clinical and biomarker remission (composite score) in the two groups of CD patients by 24 weeks after inclusion. |
| Secondary | Proportion of deep remission | Weeks 0; 24 | To compare the proportion of deep remissions, the composite score is : * Clinical and biomarker remission at week 24 ; * AND Mucosal remission at week 24; * AND no treatment failure between inclusion and week 24. |
| Secondary | Proportion of clinical remission | Weeks 0; 24 | A patient is considered to be in clinical remission if they present: * A Crohn's Disease Activity Index (CDAI score) \< 150 at week 24 ; * OR a CDAI score ≥ 150 at week 24 AND a CDAI score \< 150 at inclusion AND an increase \< 70 points between inclusion and week 24. CDAI is the Crohn's disease activity score most commonly used in clinical trials. A CDAI below 150 corresponds to inactive Crohn's disease; between 150 and 450 to active Crohn's disease; above 450 to severe Crohn's disease. |
| Secondary | faecal calprotectin (microG / g) | Week 24 | Biomarkers are considered to be standardised if the following are observed \- normalisation of faecal calprotectin: faecal calprotectin \< 250 µg/g at week 24. |
| Secondary | serum C-reactive protein (CRP) mg/l | Week 24 | Biomarkers are considered to be standardised if the following are observed \- Normalisation of serum C-reactive protein (CRP) : serum CRP \< 5 mg/L at week 24 ; |
| Secondary | Proportion of endoscopic remissions according to Crohn's Disease Endoscopic Index score (CDEIS) | Week 24 | A patient is considered to be in endoscopic remission if they have: \- a CDEIS score \< 3 at week 24 using ileocolonoscopy ; The CDEIS is an index of the severity of intestinal lesions caused by Crohn's disease. The CDEIS ranges from 0 to 44 0: no lesions 44: most severe lesions Endoscopic remission defined by a CDEIS ≤ 7 |
| Secondary | Proportion of endoscopic remissions according to Lewis score | Week 24 | A patient is considered to be in endoscopic remission if they have: \- a Lewis score \< 135 at week 24 in the small bowel using VCE (video endoscopy); The Lewis score analyses 5 mucosal parameters for each of the four segments of the small bowel (duodenum, jejunum, proximal and distal ileum): erythema, oedema, presence of nodular lesions, ulcerations and stenosis. A Lewis score \< 135 indicates inactive disease. |
| Secondary | Proportion of endoscopic remissions according to the number of ulcerations | Week 24 | A patient is considered to be in endoscopic remission if they have: \- no ulceration using endoscopic video capsule (VCE) at week 24; |
| Secondary | Proportion of endoscopic remissions according to the Magnetic Resonance Imaging (MRI) activity | Week 24 | A patient is considered to be in endoscopic remission if they have: \- no activity on MRI at week 24 (defined as segmental MaRIA score \< 7); The MaRIA (Magnetic Resonance Index of Activity) scoring system is used to assess ileocolic Crohn's disease activity on contrast-enhanced MRI enterography. The segmental index represents the severity of disease in a segment of the bowel, while assessing six defined anatomical regions that can be combined to form an overall MaRIA index. The cut-off points for the MaRIA score are as follows: moderate disease: ≥7 severe disease: ≥11 |
| Secondary | Proportion of endoscopic remissions according to bowel thickness | Week 24 | A patient is considered to be in endoscopic remission if they have: \- no bowel thickness on ultrasound at week 24 (\< 3mm with no other signs of activity). |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06180382
GET https://conductscience.org/api/trials/v1/NCT06180382/registered