Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRambam Health Care Campus
About this trial
This is a randomized placebo-controlled trial in Crohn's 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
Qualifiers
Ability to provide written informed consent prior to any study procedures and willing and able to attend all study visits, comply with the study procedures, read and write in order to complete questionnaires, and be able to complete the study period.
Aged 18 to 80 years of age, inclusive, at the time of signing the informed consent.
Diagnosis of CD with an onset of symptoms for a minimum of 3 months prior to Screening as determined by the investigator based on clinical history, exclusion of infectious causes, and characteristic endoscopic and histologic findings.
Prior decision of starting infliximab or adalimumab therapy (including biosimilar drugs).
Disqualifiers
Inclusion in another interventional study
Patients who cannot provide informed consent and do not have a legal guardian
Patients with perianal involvement who are expected to require antibiotic therapy for their disease
Patients on chronic antibiotic therapy due to any cause
Trial design
Treatments tested in this trial
- Azithromycin Pill
- Placebo
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov