Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Primary outcome measure(s)

• Rates of clinical response in UC patients — Week 8
  Defined as decrease from baseline in partial Mayo score (p-MS) of ≥30%, plus a decrease in each sub score of ≥1.
• Rates of clinical response in UC patients — Week 24
  Defined as decrease from baseline in partial Mayo score (p-MS) of ≥30%, plus a decrease in each sub score of ≥1.
• Rates of clinical response in UC patients — Week 52
  Defined as decrease from baseline in partial Mayo score (p-MS) of ≥30%, plus a decrease in each sub score of ≥1.
• Rates of clinical response in CD patients — Week 8
  Defined as decrease of at least 30% in Harvey-Bradshaw index (HBI).
• Rates of clinical response in CD patients — Week 24
  Defined as decrease of at least 30% in Harvey-Bradshaw index (HBI).
• Rates of clinical response in CD patients — Week 52
  Defined as decrease of at least 30% in Harvey-Bradshaw index (HBI).
• Rates of clinical remission for UC — Week 8
  p-MS \<3 and no sub score\>1
• Rates of clinical remission for UC — Week 24
  p-MS \<3 and no sub score\>1
• Rates of clinical remission for UC — Week 52
  p-MS \<3 and no sub score\>1
• Rates of clinical remission for CD — Week 8
  defined as HBI≤4
• Rates of clinical remission for CD — Week 24
  defined as HBI≤4
• Rates of clinical remission for CD — Week 52
  defined as HBI≤4

Trial sites (1)

More Shmuel Kivity, MD trials in Israel

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