Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease

NCT07644117 | Recruiting

• 1 other identifier: 0156-TLV-GN
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

IBD (Inflammatory Bowel Disease); Crohn Disease (CD); Ulcerative Colitis (UC)

Keywords

IBD; Anti-TNF; Response to treatment

Outcome Measures

Primary Outcomes (12)

• Rates of clinical response in UC patients

  Defined as decrease from baseline in partial Mayo score (p-MS) of ≥30%, plus a decrease in each sub score of ≥1.

  Week 8

• Rates of clinical response in UC patients

  Defined as decrease from baseline in partial Mayo score (p-MS) of ≥30%, plus a decrease in each sub score of ≥1.

  Week 24

• Rates of clinical response in UC patients

  Defined as decrease from baseline in partial Mayo score (p-MS) of ≥30%, plus a decrease in each sub score of ≥1.

  Week 52

• Rates of clinical response in CD patients

  Defined as decrease of at least 30% in Harvey-Bradshaw index (HBI).

  Week 8

• Rates of clinical response in CD patients

  Defined as decrease of at least 30% in Harvey-Bradshaw index (HBI).

  Week 24

• Rates of clinical response in CD patients

  Defined as decrease of at least 30% in Harvey-Bradshaw index (HBI).

  Week 52

• Rates of clinical remission for UC

  p-MS \<3 and no sub score\>1

  Week 8

• Rates of clinical remission for UC

  p-MS \<3 and no sub score\>1

  Week 24

• Rates of clinical remission for UC

  p-MS \<3 and no sub score\>1

  Week 52

• Rates of clinical remission for CD

  defined as HBI≤4

  Week 8

• Rates of clinical remission for CD

  defined as HBI≤4

  Week 24

• Rates of clinical remission for CD

  defined as HBI≤4

  Week 52

Secondary Outcomes (17)

• c-reactive protein (CRP) levels

  Week 8

• CRP levels

  Week 24

• CRP levels

  Week 52

• Fecal calprotectin levels

  Week 8

• Fecal calprotectin levels

  Week 24

Study Arms (1)

IBD patients

naïve to anti-TNF therapy

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

Interventions

This is an observational study with no intervention. Patients will receive anti- TNF therapy as part of their standard care OTHER

Patients will receive therapy as part of their standard care according to the standard dose

Also known as: Infliximab (Remicade), Adalimumab (Humira), Certolizumab pegol (Cimzia), Golimumab (Simponi)

IBD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients followed in the IBD unit in TLVMC starting or switching biologic therapy

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

Sponsors & Collaborators

• Shmuel Kivity, MD: lead

Study Sites (1)

Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample for analysis of HLA class II gene HLA-DQA1\*05 presence

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Interventions

Infliximab; Adalimumab; Certolizumab Pegol; golimumab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Antibodies, Monoclonal, Humanized; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides

Study Officials

• Ayal Hirsch, MD

  Tel Aviv Sourasky University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rony Izhar, PhD

CONTACT

+97237772613; ronyi@tlvmc.gov.il

Ayal Hirsch, MD

CONTACT

+972535289492; ayalh@tlvmc.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 52 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 31, 2026
• First Posted: June 12, 2026
• Study Start: January 4, 2025
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-05

Locations

IL (1)