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)

Phase 4

Recruiting

• Conditions: Crohn's disease; Inflammatory bowel disease; 10017969

• Registration Number: NL-OMON53012
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 130

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
at least 3 months of thiopurines or intolerance to thiopurines and: failure to
respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response
to at least 1 anti-TNF.

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
enrollment
- Chronic hepatitis B or C infection
- Evidence of or treatment for C. difficile infection or other intestinal
pathogen at screening within 4 weeks prior to enrollment
- Active or latent tuberculosis
- Early CD group: previous exposure to any anti-TNF

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the proportion of patients with clinical and endoscopic<br /><br>remission at Week 26 and 52-54, defined as CDAI of 150 or lower and SES-CD < 4.</p><br>