NL-OMON53012
Recruiting
Phase 4
An open-label interventional phase 4 study to evaluate efficacy , safety and mucosal healing of early versus late use of vedolizumab in Crohn's disease: the LOVE-CD study (LOw countries VEdolizumab in CD study) - LOVE-CD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Crohn's disease
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 130
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Moderately to severely active CD (Crohn disease activity index (CDAI)
- •220\-450\) with objective evidence of ulcerations visualized on endoscopy., \-
- •Anti\-TNF discontinued for at least 4 weeks prior to baseline, \-Age 18 to 80, \-
- •GROUP 1 (EARLY CD):, Diagnosis of CD \< 24 months prior to enrollment ,
- •Demonstrated failure to respond to topical or systemic corticosteroids or
- •intolerance to corticosteroids,
- •and additionally, but not mandatory, lack of efficacy or intolerance to
- •thiopurines (azathioprine, 6\-mercaptopurine or 6\-thioguanine)(any duration).
- •Patients using thiopurines must have been using the agent for \> 3 months (last
- •4 weeks at stable dose)., GROUP 2 (LATE CD), Demonstrated failure to respond to
Exclusion Criteria
- •\- Prior treatment with vedolizumab, alpha4beta7 anti\-bodies, beta7 antibodies
- •and anti MADCAM\-1
- •\- History of colonic dysplasia or colonic cancer
- •\- Presence of stoma
- •\- subjects with a pouch
- •\- Received other biologics within the last 4 weeks of baseline
- •\- subjects with ALT or AST 3x the upper limit of normal measured at screening
- •\- Use of 5\-ASA or corticosteroid enemas/suppositories within 2 weeks of
- •\- Chronic hepatitis B or C infection
- •\- Evidence of or treatment for C. difficile infection or other intestinal
Outcomes
Primary Outcomes
Not specified
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