Testing a Short Course of Azithromycin to Lower Immune Reaction to Anti-TNF Therapy in Adults with Crohns Disease

What this Trial Is About

Researchers are investigating the use of azithromycin as a pre-treatment to reduce immune reactions in patients with Crohns disease who are about to start anti-tumor necrosis factor-alpha anti-TNF therapy. This randomized, placebo-controlled trial aims to test whether a short course of azithromycin before beginning anti-TNF treatment can lower the development of anti-drug antibodies, which often reduce the effectiveness of anti-TNF medications. This approach is being explored because current immunosuppressive combinations carry risks like infections and malignancies, and prior antibiotic use has been linked to antibody development. Participants will be randomly assigned to receive either a 5-day course of oral azithromycin at 500 mg once daily or a matching placebo for 5 days. The study compares these groups to historical data with clinical and serological information. The primary focus is on the rate of antibody development against the anti-TNF drugs after one year of therapy, with additional evaluations of clinical remission, drug levels, and treatment durability at various time points up to one year. During the study, participants will be monitored regularly for immune responses, clinical symptoms, biochemical markers, and endoscopic findings. The researchers will assess corticosteroid-free remission, clinical response, and treatment durability at multiple intervals, including 6 weeks, 14 weeks, 26 weeks, and one year after starting anti-TNF therapy. Safety and treatment effectiveness measures will be collected through questionnaires, lab tests, and clinical evaluations, with the study lasting up to one year after therapy initiation.

Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease