Status:
RECRUITING
Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease
Lead Sponsor:
University Medical Center Groningen
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Crohn's Disease (CD) and Ulcerative Colitis (UC) are chronic inflammatory bowel diseases (IBD). Adalimumab is a human monoclonal antibody against TNF-alpha, a pro-inflammatory cytokine that mediates t...
Eligibility Criteria
Inclusion
- Established IBD diagnosis (UC or CD)
- Active disease (clinically defined as at least mild activity using dedicated scoring indices and biochemically defined by a fecal calprotectin \> 60 µg/g, measured within the last 6 weeks before inclusion)
- Patients must be eligible for adalimumab therapy
- Clinical indication for an endoscopic procedure
- Age: 18 years or older
- Written informed consent
- For female patients of premenopausal age with intact reproductive organs or who are less than 2 years postmenopausal, a negative pregnancy test must be available.
Exclusion
- Pregnancy or breast feeding
- Female patient of premenopausal age who does not use any reliable form of contraception at the time of adalimumab-680LT administration and the following 10 weeks.
- Medical or psychiatric conditions that compromise the patient's ability to give informed consent
- Prior anti-TNF therapy in the last 6 weeks before inclusion
- Active extra gastrointestinal manifestations of Crohn's disease
- Previous treatment with adalimumab and detectable anti-adalimumab antibodies levels
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT06117423
Start Date
March 1 2024
End Date
June 1 2025
Last Update
March 12 2024
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Netherlands, 9713GZ