Crohn's disease MedDRA version: 20.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Trade Name: Stelara
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Ustekinumab
CAS Number: 815610-63-0
Other descriptive name: USTEKINUMAB
Concentration unit: m
Sponsors
UZ Leuven
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • At least 18 years old at inclusion • Established diagnosis of Crohn’s disease with clinical disease activity (Harvery-Bradshaw index (HBI) > 4) and endoscopic activity (Simple Endoscopic Score for Crohn’s disease (SES-CD)= 6 or SES-CD = 4 in patients with ileitis only) • Adequate contraception in female of reproductive age (oral contraception, intra uterine device, sterilisation or barrier method) • Participants must sign an informed consent form indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: • Patients who previously received ustekinumab or an anti-IL23 antibody • Patients with ostomies • Women that are pregnant, nursing, or planning pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the exposure-response relationship of ustekinumab upon IV and SC administration through intensive sampling and identify the best time point to measure ustekinumab during induction to predict long-term outcome and the best time point during maintenance to maintain this outcome;Secondary Objective: To investigate which covariates influence the ustekinumab concentration upon IV and SC administration Additional objectives: 1. Identify biomarkers that can predict treatment outcome 2. Investigate if ustekinumab can be found in the faeces after the first IV infusion and if its presence correlates with treatment outcome 3. Compare blood sampling via DBS with volumetric absorptive micro sampling;Primary end point(s): Difference in ustekinumab concentrations between patients with an endoscopic response (defined as minimal 50% decrease in Simple Endoscopic Score for Crohn’s disease (SES-CD) from baseline) and patients without endoscopic response;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Difference in ustekinumab concentration between patients achieving a certain outcome (see list below) and patients not achieving that outcome (the list is unranked) List of outcomes: • Clinical response defined as reduction in Harvery-Bradshaw index (HBI) of =3 from baseline • Clinical remission defined as reduction in HBI =4 • Biological response defined as a minimal 50% decrease in C-reactive protein (CRP) from baseline or CRP < 5, in patients with CRP = 5 at baseline • Biological remission defined as a CRP < 5, in patients with CRP = 5 at baseline • Minimal 50% decrease in faecal calprotectin from baseline by week 8 • Faecal calprotectin < 250 µg/g by week 24 • Endoscopic remission defined as SES-CD = 3;Timepoint(s) of evaluation of this end point: After 24 weeks of treatment unless specified otherwise in the endpoints | — |
Countries
Belgium
Contacts
Public ContactDienst maag-, darm- en leverziekten
UZ Leuven campus Gasthuisberg
Outcome results
None listed