Predictive value of ultrasonographic parameters for therapy response in Crohn’s disease and ulcerative colitis patients

Predictive value of ultrasonographic parameters for therapy response in Crohn’s disease and ulcerative colitis patients - TRUST BEYOND

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00016731

Enrollment

400

Registered

2019-05-29

Start date

2019-01-24

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K50 K51

Interventions

Group 1: In this study it is now being investigated to what extent the improvement of certain ultrasound parameters after initiation therapy is linked to long-term results

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Written informed consent - Patients = 18 years - CD: Patients with a proven diagnosis of Crohn’s disease or ulcerative colitis, and moderate to severe disease activity who have been selected for start of TIM therapy. - Patients with increased bowel wall thickness (BWT) at baseline

Exclusion criteria

Exclusion criteria: - Patients post bowel resection surgery, patients with ileal stoma or ileoanal pouch - CD patients with disease restricted to small bowel other than terminal ileum, gastroduodenal or anorectal areas - UC patients having disease limited to the rectum (ulcerative proctitis) - Patients with therapy failure to more than 2 prior biologics/JAK-therapy - Patients who cannot be examined by ultrasound - Pregnant at study start - Infectious colitis (e.g. Cytomegalovirus (CMV), Clostridium Difficile (C.diff) - Preparation of endoscopy at day of Gastrointestinal Ultrasound (GIUS) assessment or on the day before

Design outcomes

Primary

Measure	Time frame
Proportion of patients with therapeutic remission at week 52 defined as clinical remission / steroid-free remission (HBI <5 or CD (Crohn’s Disease) or SCCAI = 2 for UC / no use of steroids for = 8 weeks).	—

Secondary

Measure	Time frame
• Proportion of patients with endoscopic remission (defined as Crohn’s Disease Endoscopic Index of Severity (CDEIS)<4 without deep ulceration in CD or endoscopic mayo-subscore = 1 in UC) at week 52. • Proportion of patients with (trans) mural response (at least 30% reduction in bowel wall thickness for terminal ileum and colon compared to baseline) at week 52. • Percentage of patients with (trans) mural healing (normal bowel wall thickness [less than 3 mm for the terminal ileum, less than 4 mm in the sigmoid and less than 3 mm in the other colon sections]) at week 52. • Number of clinical relapses (clinical relapses are defined as HBI = 7 in CD or SCCAI = 5 in UC for at least 7 days) after week 12 to week 52. • Proportion of patients with biochemical remission (defined as fecal calprotectin <250 µg / g and C-Reactive Protein (CRP) <5 mg /L) at week 52. • Occurrence of complications (IBD-related surgery and / or hospitalization) after week 12 until week 52. • Proportion of patients with a need to change or intensify therapy between week 12 and week 52. • Duration to loss of clinical response after week 12 (defined as HBI = 7 in CD or SCCAI = 5 in UC for a minimum of 7 days and / or IBD-related surgery and / or hospitalization).	—

Measure

Time frame

• Proportion of patients with endoscopic remission (defined as Crohn’s Disease Endoscopic Index of Severity (CDEIS)<4 without deep ulceration in CD or endoscopic mayo-subscore = 1 in UC) at week 52. • Proportion of patients with (trans) mural response (at least 30% reduction in bowel wall thickness for terminal ileum and colon compared to baseline) at week 52. • Percentage of patients with (trans) mural healing (normal bowel wall thickness [less than 3 mm for the terminal ileum, less than 4 mm in the sigmoid and less than 3 mm in the other colon sections]) at week 52. • Number of clinical relapses (clinical relapses are defined as HBI = 7 in CD or SCCAI = 5 in UC for at least 7 days) after week 12 to week 52. • Proportion of patients with biochemical remission (defined as fecal calprotectin <250 µg / g and C-Reactive Protein (CRP) <5 mg /L) at week 52. • Occurrence of complications (IBD-related surgery and / or hospitalization) after week 12 until week 52. • Proportion of patients with a need to change or intensify therapy between week 12 and week 52. • Duration to loss of clinical response after week 12 (defined as HBI = 7 in CD or SCCAI = 5 in UC for a minimum of 7 days and / or IBD-related surgery and / or hospitalization).

—

Countries

Austria, Germany, Switzerland

Contacts

Public ContactStefan Rath

AbbVie Deutschland GmbH & Co. KG

stefan.rath@abbvie.com+491511403833

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 11, 2026