Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease
Recruiting · NCT07644117 · Observational (researchers observe without assigning treatment) · Lead sponsor: Shmuel Kivity, MD
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 is running
1 location listed.
- Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center - Tel Aviv, Israel