Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With C… (NCT05599347) | Clinical Trial Compass
RecruitingPhase 2
Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease
Israel180 participantsStarted 2023-04-24
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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).
* Thiopurine and corticosteroid co-therapy will be permitted.
Exclusion Criteria:
* 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
* Patients with ongoing fluid collection/abscess either internal or perianal
* Known history of allergy to the study intervention formulation or any of its excipients or components of the delivery device
* Prolonged QTc interval or conditions leading to additional risk for QT prolongation
* Chronic kidney disease stage 5 (GFR \< 10)
* Crohn's Disease complication requiring surgical treatment
* Planned/ongoing methotrexate co-therapy
* Feca…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.