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Not Yet Recruiting 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05599347). StuddyBuddy aggregates publicly available trial information.