This study has been transitioned to CTIS with ID 2023-507352-72-00 check the CTIS register for the current data. The primary study objective of our study is to assess the efficacy of an IFX intensified induction scheme vs. a standard dosing schedule…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of patients with IFX TL >= 5 µg/mL at week 12 without treatment
escalation.
Secondary outcome
• Proportion of patients with IFX TL >= 5 µg/mL at week 24 without the need for
treatment escalation
• Clinical and biochemical remission at weeks 4, 12, and 24 without the need
for treatment escalation in patients with TL >= 5 µg/mL and in patients with TL
< 5 µg/mL
• Predictors of IFX TLs at weeks 4, 12, and 24. Factors included in this
analysis will be sex, age, body mass index (BMI), wPCDAI, IBD laboratory
values, ATI, dose, and interval of IFX infusions
• Development of ATI until week 24
• Prediction of patients who will respond vs. those who will not despite
adequate TLs at weeks 12 and 24 based on proteomics analysis by OLINK
• Evaluation of quality of life at baseline, week 12, and 24 in all patients
• Adverse event rate over time
Background summary
Crohn*s disease (CD) is a chronic, debilitating inflammatory bowel disease
(IBD) which is diagnosed during childhood in up to one in ten patients. CD
requires lifelong medication and is accompanied by severe complications. The
use of anti-tumor necrosis factor (TNF)-α agents has significantly ameliorated
CD management. Infliximab (IFX) is the first anti-TNF-α agent registered for
pediatric CD. The current dosing recommendation of IFX is extrapolated from
adult studies, and it is a weight-based dose (5 mg/kg) delivered during
induction (infusion at weeks 0, 2, and 6) and maintenance (every 8 weeks).
However, paediatric patients have a 25-40% lower drug exposure compared to
adults, particularly children under 10 years of age, resulting in diminished
efficacy and an increased risk of developing a complicated disease course. We
hypothesize that an IFX intensified induction scheme (instead of the current
dosing recommendation) is more effective in the treatment of pediatric CD
patients.
Study objective
This study has been transitioned to CTIS with ID 2023-507352-72-00 check the CTIS register for the current data.
The primary study objective of our study is to assess the efficacy of an IFX
intensified induction scheme vs. a standard dosing schedule in improving drug
exposure (=therapeutic trough levels) without treatment escalation in pediatric
CD patients.
Study design
An international, multicenter, prospective, open-label trial.
Intervention
IFX will be given intravenously at 10 mg/kg at week 0, and 5 mg/kg at weeks 2,
4, and 8 to all patients (induction). Maintenance will start at week 12, and
then ideally continue every 6 weeks till week 24 (end of study). IFX trough
levels will be measured at weeks 4, 12, and 24. During the maintenance, the IFX
dose and/or interval adjustments, the IFX discontinuation or the start of a
co-medication (i.e., an immunomodulator) will be possible on indication (i.e.,
primary nonresponse, secondary loss of response, intolerance to study
medication) at the physicians* discretion. Follow-up will continue for the
duration of the study (week 24).
Study burden and risks
In total, approximately 7 study visits will take place. In 4 of these visits,
additional blood will be drawn for study purposes during routine blood draws.
Patients are requested to collect 3 stool samples. No additional radiological
investigations or ileocolonoscopy will be performed for the study purposes.
The short-term risk of IFX treatment are the risk of infections and
immunogenicity. However, higher IFX trough levels are not associated with more
severe adverse events. The long-term risks of IFX treatment are currently
unknown. As a result of this study, dosing schedules for IFX could be more
effectively used in pediatric patients with CD, with both improved short- and
long-term outcomes. Moreover, this could lead to a decrease in hospitalizations
and surgical treatments, resulting in a cost reduction over time and an
improvement in quality of life.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
Diagnosed with Crohn's disease, age 1-15, anti-TNF naive, indication to start
Infliximab
Exclusion criteria
Established monogenetic disease, perianal/fistulizing disease, severe
comorbidity (not related to IBD)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EU-CTR | CTIS2023-507352-72-00 |
| EudraCT | EUCTR2022-002648-35-NL |
| ClinicalTrials.gov | NCT05552287 |
| CCMO | NL81536.078.22 |