Prospective study to evaluate efficacy and safety of Vedolizumab on Korean patients with early crohn's disease who have not been treated with biological product before
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0008502
- Lead Sponsor
- Chung-Ang Univerisity Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 88
1) Subjects of study whose age is from 19 to 80 years old
2) Study subjects with a CD prevalence period of at least 3 months
3) Study subjects with a CD prevalence period of less than 24 months before registration of the study
4) Study subjects with moderate to severe active Crohn's disease (CDAI score 220-450) during screening period
5) Subject of study with SES-CD ?6 or ?4 on the ileum CD, including ulcer scores obtained from segmented number ?1 on the ileum CD or colon CD within 3 months prior to registration
6) Subjects who do not respond to two or more types of universal treatments, have no response, or have no drug resistance: corticosteroid and immunomodulators [e.g., azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX)]
7) Study subjects who have not received corticosteroid or have received corticosteroid at a stable dose (if the dose is stable for 4 weeks immediately prior to registration or 2 weeks immediately prior to registration of corticosteroid)
8) Subjects who have not been treated with the following drugs now or in the past: infliximab, adalimumab, oustekinumab, Janus kinase (JAK) inhibitor, vedolizumab, or their biosimilar
9) If the subject has registered experience in a clinical study, the subject has been treated for placebo and has never been given a study drug for the treatment of inflammatory bowel disease (IBD) (e.g., low molecular preparations or biological preparations)
10) (Radiological Evaluation Subgroup only) Subjects who received MRE evaluation within 3 months prior to registration and have active diseases in the simplified Magnetic Resonance Imaging Disease Activity (?1) score ()
-1) Study subjects who have been diagnosed with CD for more than 24 months before registration
2) Study subjects diagnosed with ulcerative colitis (UC) or indeterminate colitis
3) Subjects who have previously been or are currently being treated with the following drugs: biological preparations, JAK inhibitors, their biosimilars, or any research drug in clinical studies
4) Study subjects who have previously been exposed to Vedolizumab, or who have a history of hypersensitivity or allergies to vedolizumab, natalizumab, etrolizumab, or onamalimab
5) Study subjects with symptomatic bowel stenosis, intestinal fistula, abdominal abscess, intestinal fistula, or other symptoms that may be expected to require intestinal surgery
6) Study subjects with a history of intestinal surgery related to CD
7) Subjects with Contraindications for Colonoscopy
8) a pregnant or breastfeeding woman
9) Males and women of childbearing age who are not willing to comply with the contraceptive measures specified in the clinical study plan
10) Study subjects who currently have an active TB (TB) infection, have a history of TB infection without description of treatment after standard anti-TB treatment, have an untreated latent TB infection, or have received less than 4 weeks of treatment for latent TB infection prior to registration
11) Study subjects with severe active infections such as sepsis, megacellular virus, listeria, and opportunistic infections such as progressive multifocal leukopenia (PML)
12) Study subjects with the following conditions: past or present history of chronic hepatitis B or C infection, colon dysplasia or colon cancer
13) Study subjects who have experience in medication or medical device treatment due to participation in other clinical studies within 3 months from the date of signing the consent form
14) Subjects with disease conditions that may interfere with the subject's ability to comply with research procedures at the discretion of the researcher
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Percentage of study subjects who experienced clinical remission (CDAI < 150);Percentage of study subjects who experienced endoscopic response from baseline (SES-CD reduction ? 50%)
- Secondary Outcome Measures
Name Time Method