Trial · NCT06180382
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| 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). |
| Secondary | Treatment failure | Weeks : 24; 52 | Compare treatment failure at week 24 or week 52 in the 2 groups. Treatment failure is defined as: * The performance of a CD-related surgery between inclusion and week 24 ; * OR use of steroids between baseline and week 24; * OR treatment dose optimisation between inclusion and week 24; * OR a change in treatment between inclusion and week 24. |
| Secondary | Adverse events | Week 24 | Compare the percentage of adverse events in both arms at week 52 |
| Secondary | Symptomatic remission at week 24 | Week 24 | Symptomatic remission at week 24 is a composite criterion measured by PRO2 defined as: Stool frequency (SF) \< 3 with abdominal pain score (AP) \< 2 at week 24; AND absence of therapeutic failure between inclusion and week 24. |
| Secondary | Changes in quality of life score (Inflammatory Bowel Disease Questionnaire (IBDQ)-32 | Weeks : 0; 24 | Compare evolution of IBDQ-32 in the two groups of patients between inclusion and week 24. The IBDQ-32 questionnaire consists of 32 questions. Each question is answered on a scale from 1 to 7, with 1 being the lowest score and 7 the highest. Adding up the different scores gives a total score, ranging from 32 (worst score) to 224 (best score). The higher the score, the better the quality of life. |
| Secondary | Clinical and biomarker remission | Weeks : 12; 52 | Compare rates of clinical and biomarker remission at week 12 and week 52. |
| Secondary | Mucosal remission | Week 24 | Rate of Mucosal remission at week 24. Mucosal remission is definied by ; * 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. * Or a Lewis score \< 135 at week 24 in the small bowel using VCE (video endoscopy) * Or no ulceration using endoscopic video capsule (VCE) at week 24; * Or no activity on MRI at week 24 (defined as segmental MaRIA score \< 7); * Or no bowel thickness on ultrasound at week 24 (\< 3mm with no other signs of activity). |
| Secondary | Clinical Decision Support Tool (CDST) score | Week 52 | Analyze the CDST score for prediction of remission under vedolizumab and adalimumab optimization. A CDST score : * \< 13 points is considered a low probability of remission; * Between 13 and 19 points is considered an intermediate probability of remission; * \> 19 points is considered a high probability of remission. |
| Secondary | Pharmacodynamic failure | Week 52 | Compare the efficacy of each strategy based on baseline serum ADA levels, classified into three groups: Pharmacodynamic failure: Therapeutic level of ADA in blood (\> 7.5 µg/mL) Pharmacokinetic failure: Subtherapeutic level of ADA in blood (\< 7.5 µg/mL) Immunogenic failure (undetectable serum ADA level with the presence of anti-ADA antibodies \>50 ng/mL). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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