Near-infrared Fluorescence Molecular Imaging of Adalimumab-800CW to Study Drug Distribution in Inflamed Tissue for Inflammatory Bowel Disease and Rheumatoid Arthritis

What this Trial Is About

Researchers are studying inflammatory bowel disease (IBD) and rheumatoid arthritis (RA), both autoimmune diseases causing chronic inflammation in the bowel and joints respectively. The study focuses on adalimumab, an antibody targeting a protein called TNF alpha involved in inflammation. Since some patients do not respond well to adalimumab and it is unclear how well the drug reaches the inflamed tissue, this study aims to explore a new imaging method for tracking the drug within affected tissues to better understand drug distribution and response. This study uses a special version of adalimumab linked to a fluorescent dye called adalimumab-800CW to create a visible signal in inflamed tissue. Participants receive different doses of this fluorescent drug (4.5 mg, 15 mg, or 25 mg) or no drug before undergoing fluorescence imaging. In RA patients, fluorescence imaging is done using a fiber device attached to a camera to scan hand joints, while in IBD patients, the imaging probe is inserted during a standard colonoscopy to detect drug presence in the bowel. Participants will be monitored for safety signs such as changes in vital signs and adverse events shortly after the drug infusion. Fluorescence imaging results will be collected both during and after the procedures, correlating the fluorescence signals with disease activity scores and biopsy pathology over up to one year. The study evaluates how well the fluorescent drug distinguishes inflamed from normal tissue and its potential to predict clinical response, with total participation duration up to one year.

Fluorescence Imaging of IBD and RA Using Adalimumab-800CW