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Completed

NCT Number: NCT04982172

Model-informed Dose De-escalation of Infliximab in Patients With Inflammatory Bowel Diseases

This is a monocentric, two-arm, non-randomised, non-blinded, historically controlled, interventional trial. The purpose of this trial is to investigate the effect of model-informed infliximab dose de-escalation on the infliximab exposure and therapeutic outcome as compared to standard dose de-escalation in patients with inflammatory bowel diseases.

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Key information

Conditions

Inflammatory Bowel Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UZ Leuven

Leuven, Flanders, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject or, when applicable, the subject's legally acceptable representative signs and dates a written informed consent form and any required privacy authorisation prior to the initiation of any study procedures.
  • The subject is aged 18 to 80 years inclusive.
  • The subject has a good understanding of the Dutch language.
  • The subject is diagnosed with moderately to severely active ulcerative colitis or Crohn's disease, confirmed by clinical, endoscopic, histological, and/or imaging criteria.
  • The subject was in maintenance therapy, later lost their response to treatment and subsequently gained steroid-free, clinical and biological remission following infliximab dose escalation (i.e., by increasing the dose and/or shortening the dosing interval) and had an infliximab trough concentration ≥5 mg/L.
  • Adequate contraception in female subjects of reproductive age (oral contraception, intra-uterine device, sterilisation or barrier method).

Exclusion criteria

  • The subject is aged <18 years or >80 years.
  • The subject receives infliximab prophylactically (e.g. in the immediate postoperative setting).
  • The subject has an ostomy or an ileal anal pouch anastomosis.
  • If female subjects, when pregnant (based on a positive serum sample) or lactating or intending to become pregnant or nurse before, during or within 15 weeks after the last dose of study drug; or intending to donate ova during such time period.
  • The subject is participating in another interventional clinical trial.

Treatment and study plan

Infliximab

Drug

Infliximab (Inflectra® [Pfizer]), dosage determined using model-informed precision dosing, intravenously administered

Primary outcomes

  1. Steroid-free, combined clinical and biological remission

    Time frame: During one year after start of infliximab dose de-escalation

    The proportion of patients maintaining steroid-free, combined clinical and biological remission during one year after infliximab dose de-escalation based on a standard dosing algorithm versus a model-informed dosing algorithm.

    Combined clinical and biological remission is defined based on patient-reported outcomes (rectal bleeding score = 0 + stool frequency score ≤1 [ulcerative colitis], mean daily abdominal pain score ≤1 + liquid stool frequency score ≤1.5 [Crohn's disease]) together with normal C-reactive protein (<5 mg/L) and faecal calprotectin (<250 mg/kg). Steroid-free indicates the absence of any dose of any oral or rectal steroid use.

Secondary outcomes

  1. Steroid-free, combined clinical and biological remission

    Time frame: At one year after start of infliximab dose de-escalation

    The proportion of patients maintaining steroid-free, combined clinical and biological remission at one year after infliximab dose de-escalation based on a standard dosing algorithm versus a model-informed dosing algorithm.

    Combined clinical and biological remission is defined based on patient-reported outcomes (rectal bleeding score = 0 + stool frequency score ≤1 [ulcerative colitis], mean daily abdominal pain score ≤1 + liquid stool frequency score ≤1.5 [Crohn's disease]) together with normal C-reactive protein (<5 mg/L) and faecal calprotectin (<250 mg/kg). Steroid-free indicates the absence of any dose of any oral or rectal steroid use.

Other outcomes

  1. Steroid-free clinical remission

    Time frame: At and during one year after start of infliximab dose de-escalation

    The proportion of patients maintaining steroid-free clinical remission at and during one year after infliximab dose de-escalation based on a standard dosing algorithm versus a model-informed dosing algorithm.

    Clinical remission is defined based on patient-reported outcomes (rectal bleeding score = 0 + stool frequency score ≤1 [ulcerative colitis], mean daily abdominal pain score ≤1 + liquid stool frequency score ≤1.5 [Crohn's disease]).

    Steroid-free indicates the absence of any dose of any oral or rectal steroid use.

  2. Steroid-free biological remission

    Time frame: At and during one year after start of infliximab dose de-escalation

    The proportion of patients maintaining steroid-free biological remission at and during one year after infliximab dose de-escalation based on a standard dosing algorithm versus a model-informed dosing algorithm.

    Biological remission is defined as normal C-reactive protein (<5 mg/L) and faecal calprotectin (<250 mg/kg).

    Steroid-free indicates the absence of any dose of any oral or rectal steroid use.

  3. Infliximab trough concentration target attainment and area under the concentration-time curve

    Time frame: At and during one year after start of infliximab dose de-escalation

    Exposure: Trough concentration (target attainment; 5 mg/L) and area under the concentration-time curve.

  4. Total infliximab dose and number of infusions

    Time frame: At and during one year after start of infliximab dose de-escalation

    Dosage: total infliximab dose (# mg) and number of infusions.

  5. Direct costs calculated based on cost of infliximab and cost related to the day hospital needed for the infusion

    Time frame: At one year after start of infliximab dose de-escalation

    Direct costs calculated based on cost of infliximab and cost related to the day hospital needed for the infusion (in euro).

  6. Indirect costs based on questionnaire

    Time frame: At one year after start of infliximab dose de-escalation

    Indirect costs based on questionnaire: iMTA Productivity Cost Questionnaire (iMTA PCQ)

  7. Health-related quality of life based on QoL questionnaire

    Time frame: At one year after start of infliximab dose de-escalation

    Health-related quality of life based on QoL questionnaire: Inflammatory Bowel Disease Questionnaire (IBDQ-32)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Collaborators

  • KU Leuven

Registry information

Official study title

Model-informed Infliximab Dose De-escalation Following Earlier Dose Escalation in Adult Patients With Inflammatory Bowel Diseases

Acronym: MODIFI

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 29, 2021
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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