Using azithromycin to reduce immune reactions in Crohn's disease patients starting anti-TNF therapy
Pre-treatment With Azithromycin to Reduce Immunogenicity to Anti-Tumor Necrosis Factor-α Agents in Patients With Crohn's Disease
This study is testing if taking azithromycin can help people with Crohn's disease starting anti-TNF therapy avoid developing antibodies that might make their treatment less effective.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rambam Health Care Campus Academic / other |
| Drugs / interventions | infliximab, adalimumab, methotrexate |
| Locations | 9 sites (Beersheba and 8 other locations) |
| Trial ID | NCT05599347 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized placebo-controlled study aimed at Crohn's disease patients who are about to begin anti-TNF therapy. It investigates whether a short course of azithromycin can lower the development of anti-drug antibodies (ADA), which can reduce the effectiveness of these treatments. The study will compare the outcomes of patients receiving azithromycin with those receiving a placebo, while also analyzing historical data for additional insights. The primary outcome measure will be the rate of ADA development after one year of therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of Crohn's disease who are about to start infliximab or adalimumab therapy.
Not a fit: Patients with perianal involvement requiring antibiotic therapy or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the effectiveness of anti-TNF therapies for Crohn's disease patients by reducing immune reactions.
How similar studies have performed: Previous studies have suggested that antibiotic use may reduce anti-drug antibody development, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Beersheba and 8 other locations
- Soroka University Medical Center — Beersheba, Israel (Recruiting)
- Bnei Zion — Haifa, Israel (Recruiting)
- Carmel Medical Center — Haifa, Israel (Recruiting)
- Rambam Health Care Campus — 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)
Study contacts
- Study coordinator: Haggai Bar-Yosef, MD
- Email: h_bar-yoseph@rmc.gov.il
- Phone: 050-2064878
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.