Individualizing Anti-TNF Therapy in Patients With Inflammatory Bowel Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorShmuel Kivity, MD
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unable to provide informed consent
Anti-TNF experienced
Unable to complete the study protocol
Trial population
Patients followed in the IBD unit in TLVMC starting or switching biologic therapy
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
This is an observational study with no intervention. Patients will receive anti- TNF therapy as part of their standard care
Other interventionPatients will receive therapy as part of their standard care according to the standard dose
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: IBD patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Week 82
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.
Time frame
Week 243
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.
Time frame
Week 524
Rates of clinical response in CD patients
Defined as decrease of at least 30% in Harvey-Bradshaw index (HBI).
Time frame
Week 8Secondary outcomes
1
c-reactive protein (CRP) levels
Change from baseline in CRP levels
Time frame
Week 82
CRP levels
Change from baseline in CRP levels
Time frame
Week 243
CRP levels
Change from baseline in CRP levels
Time frame
Week 524
Fecal calprotectin levels
Change from baseline in fecal calprotectin levels
Time frame
Week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Shmuel Kivity, MD
Lead sponsor
Tel-Aviv Sourasky Medical Center
Sponsor institution
Source ClinicalTrials.gov