Crohn'sRecruiting
Pre-treatment With Azithromycin to Reduce Immunogenicity to to Anti-TNF Agents in Patients With Crohn's Disease
Phase 2 · Testing Azithromycin Pill · 9 sites · Rambam Health Care Campus
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Azithromycin Pill (a drug) to see if it can prevent disease or complications. Condition(s) listed: Crohn's Disease Relapse and Biological Substance; Adverse Effect.
Participants are assigned to groups by chance (randomized).
Some participants receive a placebo or sham for comparison.
It is blinded: participants and the study team do not know who receives what.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
- 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.
Plus 2 more requirement(s). There are also 17 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 180 participants are expected to take part.
- Start date: 2023-04-24.
- Main results expected around 2026-09-10 (estimate from the record).
- 9 study sites listed (9 marked recruiting) in Israel.
Main thing being measured
- Anti-drug antibody development (1 year after the initiation of therapy)
In the researchers’ words
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
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Crohn's Disease Relapse; Biological Substance; Adverse Effect |
| Lead sponsor | Rambam Health Care Campus |
| Enrollment | 180 (estimated) |
| Start date | 2023-04-24 |
| Primary completion (est.) | 2026-09-10 |
| First posted | 2022-10-31 |
| Last updated | 2026-07-29 |
| Official title | Pre-treatment With Azithromycin to Reduce Immunogenicity to Anti-Tumor Necrosis Factor-α Agents in Patients With Crohn's Disease |
| ClinicalTrials.gov ID | NCT05599347 |
Interventions
- Azithromycin Pill (Drug)
Tablet - 500 mg azithromycin (as dihydrate) - Placebo (Other)
Placebo tablet identical in shape and appearance to the azithromycin tablet used in the treatment arm
Full eligibility criteria (from the record)
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 * Fecal microbiota transplantation within 8 weeks prior to randomization * Participant has any disorder that, in the opinion of the investigator, may compromise the ability to participate in the study * Pregnancy * Patients who received azithromycin therapy in the previous year (we will not exclude prior use of other antibiotic therapy) * Patients who received any antibiotic treatment within 4 weeks prior to randomization * Re-induction of the same anti-TNF medication * Patients who are on chronic therapy which cannot be withheld in one of these medications: colchicine, phenytoin, and digoxin
Locations (9)
| Site | City | Country | Site status |
|---|---|---|---|
| Soroka University Medical Center | Beersheba | Israel | Recruiting |
| Bnei Zion | Haifa | Israel | Recruiting |
| Carmel Medical Center | Haifa | Israel | Recruiting |
| Wolfson Medical Center | Holon | Israel | Recruiting |
| Hadassah Medical Center | Jerusalem | Israel | Recruiting |
| Shaare Zedek | Jerusalem | Israel | Recruiting |
| Zvulun | Kiryat Bialik | Israel | Recruiting |
| Rabin Medical Center | Petah Tikva | Israel | Recruiting |
| Rambam Health Care Campus | Haifa, Haifa District | Israel | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.