Response Assessment in SB CD
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|ClinicalTrials.gov Identifier: NCT03646708|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 28, 2018
|Condition or disease|
|Small Bowel Crohn's Disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Triangular Phenotyping and Response Assessment in Small Bowel Crohn's Disease Using Magnetic Resonance Enterography (MRE) and Novel Proteomic Biomarkers|
|Actual Study Start Date :||May 9, 2018|
|Estimated Primary Completion Date :||May 30, 2023|
|Estimated Study Completion Date :||May 30, 2023|
SBCD patients starting a new biologic therapy
As part of your standard clinical care (soc), patient will be started on a biologic (anti-tumor necrosis factor (TNF)s, vedolizumab and ustekinumab) based on your interactions with your treating gastroenterologist after standard of care clinical assessment.
- Corticosteroid free remission (CFR) [ Time Frame: 52 ± 4 weeks ]Corticosteroid free remission (CFR) will be assessed at the in-person visit at 52 ± 4 weeks where remission will be defined as using Harvey-Bradshaw index (HBI) criteria of 4 points or lower, free of any corticosteroid usage for ≥30 days.
- Mucosal healing (MH) [ Time Frame: 52 ± 4 weeks. ]Secondary endpoint will be MH in the terminal ileum using criteria of Simple Endoscopic Score for Crohn's Disease (SES-CD) score of 0 to 2 at the ileocolonoscopy at 52 ± 4 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646708
|Contact: Darren Nixemail@example.com|
|Contact: Parakkal Deepak, MBBS, MSfirstname.lastname@example.org|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Darren Nix 314-362-3201 bnix@DOM.wustl.edu|
|Principal Investigator:||Parakkal Deepak, MBBS, MS||Washington University School of Medicine|