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

ConditionsCrohn's Disease RelapseBiological Substance; Adverse Effect
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRambam Health Care Campus

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azithromycin Pill

    Drug

    Tablet - 500 mg azithromycin (as dihydrate)

  • Placebo

    Other intervention

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

Treatment groups

180 Participants
are divided into 2 treatment groups
Group A: AzithromycinExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Anti-drug antibody development

Percent of patients developing anti-drug antibodies defined as measurable antibodies using an anti-lambda ELISA assay

Time frame
1 year after the initiation of therapy

Secondary outcomes

1

Sustained corticosteroid-free clinical remission

Crohn's Disease Activity Index (CDAI) ≤150 without systemic corticosteroid therapy

Time frame
At both 3 months and a 1 year after the initiation of therapy
2

Clinical response

A reduction in CDAI of at least 100 points from baseline.

Time frame
1 year after the initiation of therapy
3

Sustained corticosteroid-free biochemical remission

C-reactive protein (CRP) ≤1.5 upper limit of normal, or fecal calprotectin ≤ 250 mg/kg

Time frame
at both 6 months and a 1 year after the initiation of therapy
4

Treatment durability

Persistent administration of infliximab or adalimumab for 1 year. A 16-week or more interval between infliximab injections, or an 8-week or more interval between adalimumab injections will be considered as treatment cessation. Change in anti-TNF regimen at 26 and 52 weeks defined as increased dosing or decreased dosing interval

Time frame
at both 6 months and a 1 year after the initiation of therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rambam Health Care Campus

Lead sponsor

Source ClinicalTrials.gov
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