Fluorescence Imaging of Adalimumab-680LT in Inflammatory Bowel Disease

Launched by UNIVERSITY MEDICAL CENTER GRONINGEN · Oct 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new version of the medication adalimumab, called adalimumab-680LT, to see how it works in patients with Crohn's Disease and Ulcerative Colitis, which are chronic conditions that cause inflammation in the intestines. The researchers want to understand how well this fluorescently labeled drug can help visualize and measure its concentration in the body, which may help predict how well patients will respond to treatment. The trial is currently recruiting participants who are at least 18 years old, have a confirmed diagnosis of either Crohn's Disease or Ulcerative Colitis, and have active disease that requires treatment with adalimumab.

Eligible participants will undergo an endoscopic procedure, which is a way for doctors to look inside the intestines, and will receive the new medication during the study. Before joining, participants will need to give written consent and, for some women, confirm they are not pregnant. It's important to note that pregnant or breastfeeding women cannot join, and those who have had certain treatments recently or have other specific medical conditions will be excluded. This trial is a step toward improving treatments for inflammatory bowel diseases and understanding how to better manage these conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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