Azithromycin to Improve Anti-TNF Treatment for Crohn's Disease

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

Recruiting Phase 2 Interventional Study
Crohn's Disease Relapse Biological Substance; Adverse Effect
Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
180 (estimated)
Sponsor
Rambam Health Care Campus · Other
Who this trial is looking for

This trial is looking for adults with Crohn's disease who are starting anti-TNF therapy. Participants will take a short course of azithromycin before beginning their treatment.

Are You a Good Fit for This Trial?
Must be taking ThiopurineCorticosteroid
Rules you out Severe complications of Crohn's diseaseProlonged QTc interval

You may be able to join if

  • I am between 18 and 80 years old.
  • I have been diagnosed with Crohn's disease for at least 3 months.
  • I plan to start treatment with infliximab or adalimumab.
  • I can read and write to complete questionnaires.
  • I can provide written consent and attend all study visits.

You may not be able to join if

  • I am involved in another clinical trial.
  • I cannot provide informed consent.
  • I have ongoing infection or abscess related to Crohn's disease.
  • I have a history of allergy to azithromycin.
  • I am pregnant.
  • I have chronic kidney disease stage 5.
  • I have taken azithromycin in the past year.
  • I have received antibiotics in the last 4 weeks.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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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

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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 a…
Contacts

Haggai Bar-Yosef, MD

050-2064878

h_bar-yoseph@rmc.gov.il

CONTACT

Anastasia Weis, MD

A_WEIS@rambam.health.gov.il

CONTACT