The degradation and elimination of Infliximab

Pharmacokinetics of Infliximab

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001332-29-AT

Enrollment

200

Registered

2013-11-07

Start date

2013-12-02

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease (Ulcerative Colitis, Crohn's disease) MedDRA version: 17.0 Level: PT Classification code 10011401 Term: Crohn's disease System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 17.0 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 10017947 - Gastrointestinal disorders

Interventions

Trade Name: Remicade Product Name: Remicade Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Other descriptive name: Remicade Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with established diagnosis of Crohn’s disease or ulcerative colitis by standard criteria for at least 3 months between the age of 19 to 75. Males and females. 2. Able and willing to sign informed consent 3. For maintenance cohort: Patients with maintenance Infliximab therapy after having received week 0, 2 and 6 infusions. Earliest possible measurement for trough level being Week 14 (immediately prior to 4th infusion), earliest possible week 4 serum infliximab level measurement at infusion week 10. 4. For infliximab starter cohort: Patients planned for IFX induction and maintenance therapy according to current guidelines without prior exposition to IFX. 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 180 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. History of malignancy, lymphoproliferativen disorders or untreated or unsuccessfully treated cutaneous squamous cell or basal cell carcinoma or carcinoma-in-situ of the cervix. 2. Active or untreated latent tuberculosis, as diagnosed by the current screening recommendations 3. Severe infections, sepsis, abscess or opportunistic infections 4. Subjects with an oostomy or ileoanal pouch 5. Signs and symptoms of intestinal obstruction, clinically or indicated by imaging (praestenotic dilatation, significant prolongation of transition time, ileus signs) 6. Impending or planned surgery for condition under study 7. Heart failure NYHA class 3 and 4 8. Severe unstable hepatic, gastrointestinal, cardiovascular, respiratory, neurological, psychiatric, hematological or renal disease 9. Pregnacy, planning conception or currently breast feeding 10. Investigational agents within 5 halfe lives prior to entry or within the past 30 days 11. Sigificant drug or alcohol abusus, current or past, or other mental condition impairing study participation

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess pharmacokinetics of Infliximab in routinely treated patients with inflammatory bowel disease (Crohn's disease, Ulcerative Colitis);Secondary Objective: not applicable;Primary end point(s): Difference of measured serum infliximab levels at week 4 during maintenance infusion interval and immediately prior to infusion (trough level) versus predicted levels, as calculated by prediction model (see Methods).;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Main Objective: To assess pharmacokinetics of Infliximab in routinely treated patients with inflammatory bowel disease (Crohn's disease, Ulcerative Colitis);Secondary Objective: not applicable;Primary end point(s): Difference of measured serum infliximab levels at week 4 during maintenance infusion interval and immediately prior to infusion (trough level) versus predicted levels, as calculated by prediction model (see Methods).;Timepoint(s) of evaluation of this end point: not applicable

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Secondary

Measure	Time frame
Secondary end point(s): • Rate of mucosal healing in patients with trough levels above 3 µg/ml during maintenance versus trough levels below 3 µg/ml • Rate of steroid free clinical remission in patients with trough levels above 3 µg/ml during maintenance • Fecal Calprotectin, CRP, CD64, IL-6 in patients with rapid elimination kinetics vs. slow elimination at the time points as specified below • Rate of primary remission in CD patients • Rate of primary response in CD patients • Rate of primary remission in UC patients • Rate of primary response in UC patients • Comparison pharmacokinetic properties (c-max, terminal half-life, AUC, clearance) of patients with primary response vs. primary non-responders and patients in remission • Rate of disease worsening • Comparison of pk properties at time of disease worsening (prior infusion interval while responding versus current infusion interval) ;Timepoint(s) of evaluation of this end point: not applicable	—

Measure

Time frame

Secondary end point(s): • Rate of mucosal healing in patients with trough levels above 3 µg/ml during maintenance versus trough levels below 3 µg/ml • Rate of steroid free clinical remission in patients with trough levels above 3 µg/ml during maintenance • Fecal Calprotectin, CRP, CD64, IL-6 in patients with rapid elimination kinetics vs. slow elimination at the time points as specified below • Rate of primary remission in CD patients • Rate of primary response in CD patients • Rate of primary remission in UC patients • Rate of primary response in UC patients • Comparison pharmacokinetic properties (c-max, terminal half-life, AUC, clearance) of patients with primary response vs. primary non-responders and patients in remission • Rate of disease worsening • Comparison of pk properties at time of disease worsening (prior infusion interval while responding versus current infusion interval) ;Timepoint(s) of evaluation of this end point: not applicable

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Countries

Austria

Contacts

Public ContactWorkgroup for IBD

Universitätsklinik für Innere Medizin III, Klinische Abteilung für Gastroenterologie und Hepatologie

alexander.eser@meduniwien.ac.at00431404006245

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026