Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease

Recruiting now

Conditions studied: IBD (Inflammatory Bowel Disease), Crohn Disease (CD), Ulcerative Colitis (UC)

In brief

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.

Key facts

Study ID

NCT07644117

Run by

Shmuel Kivity, MD

People needed

40

Starts

2025-01-04

Expected to finish

2028-12-01

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Unable to provide informed consent
• Anti-TNF experienced
• Unable to complete the study protocol

Where it is running

• Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (enrolling)

Full record on ClinicalTrials.gov

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