RecruitingPhase 2NCT05599347

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

Pre-treatment With Azithromycin to Reduce Immunogenicity to Anti-Tumor Necrosis Factor-α Agents in Patients With Crohn's Disease


Sponsor

Rambam Health Care Campus

Enrollment

180 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether taking an antibiotic called azithromycin before starting a biologic medication (anti-TNF agent) for Crohn's disease helps reduce the chance the body develops antibodies against the medication. When the immune system targets the biologic drug, it stops working — a major problem in Crohn's management. **You may be eligible if...** - You are age 18 to 80 - You have been diagnosed with Crohn's disease - You are about to start a new anti-TNF medication (such as infliximab or adalimumab) and have not taken these before - You are willing to attend all study visits and follow the study procedures **You may NOT be eligible if...** - You have already taken an anti-TNF medication for Crohn's disease - You have a known allergy to azithromycin or similar antibiotics - You are pregnant or planning to become pregnant - You have serious liver disease or abnormal heart rhythm (QT prolongation) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzithromycin Pill

Tablet - 500 mg azithromycin (as dihydrate)

OTHERPlacebo

Placebo tablet identical in shape and appearance to the azithromycin tablet used in the treatment arm


Locations(9)

Soroka University Medical Center

Beersheba, Israel

Bnei Zion

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Rambam Health Care Campus

Haifa, Israel

Wolfson Medical Center

Holon, Israel

Hadassah Medical Center

Jerusalem, Israel

Shaare Zedek

Jerusalem, Israel

Zvulun

Kiryat Bialik, Israel

Rabin Medical Center

Petah Tikva, Israel

View Full Details on ClinicalTrials.gov

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NCT05599347


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