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NCT05599347
Pre-treatment With Azithromycin to Reduce Immunogenicity to Anti-Tumor Necrosis Factor-α Agents in Patients With Inflammatory Bowel Disease
Conditions: Inflammatory Bowel Diseases, Biological Substance; Adverse Effect
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 180
Sponsor: Rambam Health Care Campus
Location: Israel
Summary
This will be a randomized placebo-controlled trial in inflammatory bowel disease patients before initiation of anti-tumor necrosis factor-α (anti-TNF) therapy that aims to test the effect of a pre-treatment short course of azithromycin therapy on immunogenicity
Eligibility Criteria
Inclusion Criteria:All consenting adult (≥18 years) IBD patients starting infliximab or adalimumab therapy.Exclusion Criteria:Inclusion in another interventional studyPatients who cannot provide informed consent and do not have a legal guardianPatients with perianal involvement that are expected to require antibiotic therapy for their diseasePatients on chronic antibiotic therapy due to any causeCrohn's Disease complication requiring surgical treatmentPlanned/ongoing methotrexate co-therapyPregnancyPatients who received azithromycin therapy in the previous year (we will not exclude prior use of other antibiotic therapy)
Source: ClinicalTrials.gov (NCT05599347). StuddyBuddy aggregates publicly available trial information.