Trial document





This trial has been registered retrospectively.
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  DRKS00016731

Trial Description

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Title

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

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Trial Acronym

TRUST BEYOND

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URL of the Trial

http://-

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Brief Summary in Lay Language

In this study, Inflammatory Bowel Disease (IBD) patients are monitored as part of their clinical routine. The aim of the study is to find out if abdominal ultrasound in IBD patients can predict the long-term outcome of patients after initiation of biologics / Janus Kinase (JAK) therapy.

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Brief Summary in Scientific Language

The primary objective of this study is to assess if
(trans)mural response at week 12 after initiation
of TIMs (targeted immunomodulator therapy; biologic
or JAK-inhibitor therapy) in Crohn’s disease (CD) and
ulcerative colitis (UC) patients has a predictive value
for long-term therapeutic response after 52
weeks (clinical remission / steroid-free remission
defined as Harvey-Bradshaw Index (HBI)< 5 for CD or Simple Clinical Colitis Activity Index (SCCAI) ≤ 2 for UC / no
use of steroids for ≥ 8 weeks).

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Organizational Data

  •   DRKS00016731
  •   2019/05/29
  •   [---]*
  •   no
  •   Approved
  •   Bo/43/2018, Ethikkommission bei der Ärztekammer Niedersachsen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   K50 -  Crohn disease [regional enteritis]
  •   K51 -  Ulcerative colitis
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Interventions/Observational Groups

  •   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
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

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).

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Secondary Outcome

• 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).

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Countries of Recruitment

  •   Germany
  •   Austria
  •   Switzerland
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Locations of Recruitment

  • University Medical Center 
  • Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2019/01/24
  •   400
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • AbbVie Deutschland GmbH & Co. KG
    • Mr.  Dr.  Henning  Kleine 
    • Mainzer Straße 81
    • 65189  Wiesbaden
    • Germany
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    •   +49 611 1720 0
    •   [---]*
    •   [---]*
    •   [---]*
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    • AbbVie Deutschland GmbH & Co. KG
    • Mr.  Dipl.-Biol.  Stefan  Rath 
    • Mainzer Straße 81,
    • 65189  Wiesbaden
    • Germany
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    • AbbVie Deutschland GmbH & Co. KG
    • Mr.  Dipl.-Biol.  Stefan  Rath 
    • Mainzer Straße 81,
    • 65189  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • AbbVie Deutschland GmbH & Co. KG
    • Mainzer Straße 81
    • 65189  Wiesbaden
    • Germany
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    •   [---]*
    •   [---]*
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  • [---]*
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* This entry means the parameter is not applicable or has not been set.