Trial · NCT06257706
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48 | week 48 | Corticosteroid-free is defined as not using corticosteroids at the time of the assessment. Endoscopic remission is defined by a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis (ranges from 0 to 11), because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). |
| Secondary | Percentage of participants with Corticosteroid-free Transmural healing (TMH)+Endoscopic remission+Clinical remission in group 1 and group 2 at week 48 | week 48 | Transmural healing is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound. Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) \<150. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity. |
| Secondary | Percentage of participants with Corticosteroid-free IUS response+Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48 | week 48 | IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS). Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) \<150. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity. |
| Secondary | Percentage of participants with Corticosteroid-free Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48 | week 48 | Endoscopic remission is defined by achievement of a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. Total SES-CD score is then summed up the item scores (range, 0-56 points). Clinical Remission is defined by Crohn's Disease Activity Index (CDAI) \<150. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity. |
| Secondary | Percentage of participants with Corticosteroid-free endoscopic response+Clinical response in group 1 and group 2 at week 48 | week 48 | Endoscopic response is defined by Reduction in total Simple Endoscopic Score for CD (SES-CD) ≥50% from baseline. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, higher scores indicate more severity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). Clinical Response is defined by Crohn's Disease Activity Index (CDAI) decrease of ≥100 points from baseline. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity. |
| Secondary | Percentage of participants with Corticosteroid-free clinical remission in group 1 and group 2 at Week 14, Week 22 and Week 48. | week 14, week 22 and week 48 | Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment. Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) \<150. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity. |
| Secondary | Percentage of participants with Corticosteroid-free Clinical Response in group 1 and group 2 at week 14, week 22 and week 48 | week 14, week 22 and week 48 | Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment. Clinical Response is defined by Crohn's Disease Activity Index (CDAI) decrease of ≥100 points from baseline. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity. |
| Secondary | Crohn's Disease Activity Index(CDAI) total score and corresponding change from baseline during follow-up (Week 6, Week 14, Week 22, Week 30, Week 38, Week 48, Week 64, Week 80, Week 96) in group 1 and group 2 | week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96 | Crohn's Disease Activity Index (CDAI) consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity. |
| Secondary | Percentage of participants with Corticosteroid-free endoscopic response in group 1 and group 2 at week 48 | week 48 | Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment Endoscopic response is defined by Reduction in total Simple Endoscopic Score for CD (SES-CD) ≥50% from baseline. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11, because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). |
| Secondary | SES-CD total score and corresponding change from baseline to Week 48 in group 1 and group 2 | week 48 | The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis, where it ranges from 0 to 11, because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points). |
| Secondary | Percentage of participants with Transmural healing (TMH) in group 1 and group 2 at week 48 | week 48 | Transmural Healing (TMH) is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound |
| Secondary | Percentage of participants with Intestinal Ultrasound (IUS) response in group 1 and group 2 at Week 48 | week 48 | IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS) |
| Secondary | Bowel Wall Thickness (BWT) measured by Intestinal Ultrasound (IUS) in mm and corresponding change from baseline at Week 48 in group 1 and group 2. | week 48 | |
| Secondary | Color Doppler signal (CDS) and corresponding change from baseline at Week 48 in group 1 and group 2. | week 48 | |
| Secondary | International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at Week 48 in group 1 and group 2 | week 48 | International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) is a 0-100 numerical activity index for Crohn's disease calculated from four Intestinal Ultrasound (IUS) parameters |
| Secondary | Percentage of participants with Transmural healing (TMH) at week 14, week 22, week 30, week 38, and week 48 in group 1 | week 14, week 22, week 30, week 38, week 48 | Transmural Healing (TMH) is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound |
| Secondary | Percentage of participants with Intestinal Ultrasound (IUS) response at week 14, week 22, week 30, week 38, and week 48 in group 1 | week 14, week 22, week 30, week 38, week 48 | IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS) |
| Secondary | Bowel Wall Thickness (BWT) measured by Intestinal Ultrasound (IUS) in mm and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1 | week 14, week 22, week 30, week 38, week 48 | |
| Secondary | Color Doppler signal (CDS) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1 | week 14, week 22, week 30, week 38, week 48 | |
| Secondary | International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1 | week 14, week 22, week 30, week 38, week 48 | International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) is a 0-100 numerical activity index for Crohn's disease calculated from four Intestinal Ultrasound (IUS) parameters |
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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