Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease
Observational · No treatment assigned · 1 site · Shmuel Kivity, MD
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: IBD (Inflammatory Bowel Disease), Crohn Disease (CD) and Ulcerative Colitis (UC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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)
Plus 1 more requirement(s). There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2025-01-04.
- Main results expected around 2028-05 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Israel.
Main thing being measured
- Rates of clinical response in UC patients (Week 8)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | IBD (Inflammatory Bowel Disease); Crohn Disease (CD); Ulcerative Colitis (UC) |
| Lead sponsor | Shmuel Kivity, MD |
| Enrollment | 40 (estimated) |
| Start date | 2025-01-04 |
| Primary completion (est.) | 2028-05 |
| First posted | 2026-06-12 |
| Last updated | 2026-06-12 |
| Official title | Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease: Pre-Treatment Prediction of Immunogenicity and Response. A Prospective Observational Study. |
| ClinicalTrials.gov ID | NCT07644117 |
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
Full eligibility criteria (from the record)
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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Dep. of Gastroenterology, Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.