Individualizing Anti-TNF Therapy in IBD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study follows patients with inflammatory bowel disease who have not yet received anti-TNF therapy and are starting such treatment. Blood samples will be tested for genetic markers, and participants will have regular assessments of disease activity and inflammatory markers during follow-up. The goal is to see if specific genes, including TREM1 and HLA-DQA1, can help predict who will respond or lose response to anti-TNF therapy over time. No experimental treatment is given; anti-TNF therapy is standard of care for all participants. The study situates itself within the broader context of personalized medicine in IBD, acknowledging variability in treatment response despite available biologics.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

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

Where it's running

• Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
  Tel Aviv, Israel Recruiting

Study contacts

• Principal investigator: Ayal Hirsch, MD — Tel Aviv Sourasky University Medical Center
• Study coordinator: Rony Izhar, PhD
• Email: ronyi@tlvmc.gov.il
• Phone: +97237772613

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.