Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease

ConditionsIBD (Inflammatory Bowel Disease)Crohn Disease (CD)Ulcerative Colitis (UC)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorShmuel Kivity, MD

About this trial

This observational study aims to identify genes that may affect how patients with inflammatory bowel disease respond to anti-TNF treatment and why some patients lose response to treatment over time. The study will examine whether genetic markers can help predict which patients are more likely to respond to anti-TNF therapy.

Participants who have not previously received anti-TNF treatment and are about to start advanced therapy will provide a blood sample to test for the genetic markers. Participants will also undergo regular assessments of current treatment, disease activity, and inflammatory markers during follow-up.

Eligibility criteria

Qualifiers

Established IBD: Crohn's disease (CD) or ulcerative colitis (UC)

Anti-TNF naïve

Clinically active disease (HBI>5 for CD, p-MS≥ 3 for UC)

Elevated inflammatory indices CRP>10 or fecal calprotectin>250

Disqualifiers

Unable to provide informed consent

Anti-TNF experienced

Unable to complete the study protocol

Trial design

Treatments tested in this trial

This is an observational study with no intervention. Patients will receive anti- TNF therapy as part of their standard care

Treatment groups

40 Participants

are divided into 1 treatment group

Sponsors and collaborators

Shmuel Kivity, MD

Lead sponsor

Tel-Aviv Sourasky Medical Center

Sponsor institution

Source ClinicalTrials.gov