Ulcerative Colitis Clinical Trials

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Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease: Pre-Treatment Prediction of Immunogenicity and Response. A Prospective Observational Study.

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Israel
Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Rony Izhar, PhD
ronyi@tlvmc.gov.il
+97237772613
Backup
Ayal Hirsch, MD
ayalh@tlvmc.gov.il
+972535289492
Time Frame
Start Date: 2025-01-04
Estimated Completion Date: 2028-12
Participants
Target number of participants: 40
Treatments
IBD patients
naïve to anti-TNF therapy
Sponsors
Leads: Shmuel Kivity, MD

This content was sourced from clinicaltrials.gov