Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

Ultra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point-of-care-testing in Inflammatory Bowel Disease: a Pragmatic Trial

This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm is applied as follows. All patients have an ELISA TL measurement at baseline, of which the result determined the follow-up pathway: (A) TL between 3-7μg/mL: continuation at same dose and interval; (B) TL >7μg/mL: interval prolongation allowed; (C) TL <3μg/mL: interval shortening with minimum 2 weeks, with the next IFX TL measured using a POCT. (i) If the POCT showed an IFX TL <3μg/mL, dose was optimized ad hoc using a linear dosing formula (Dosen = (TL target * Dose n-1) / TL measured), followed by a new POCT test at next visit with the same interval. (ii) If the POCT showed an IFX TL ≥3µg/mL, no additional dose was given and routine TL testing with ELISA was retaken at next visit. At every visit this algorithm was reapplied to all patients.

The patients from cohort A will be compared with the patients from cohort B. The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period. Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms. Data will be collected retrospectively to avoid treatment optimization bias.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Biological: infliximab therapeutic drug monitoring

• Study Type: Interventional
• Enrollment (Actual): 187
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda GI Clinical Research Center
  • Gent, Belgium, 9000
    • AZ Sint Lucas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all adult IBD patients treated for at least 14 weeks with infliximab were included

Exclusion Criteria:

• induction treatment with infliximab (<14 weeks)
• treatment with other biological for IBD

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ultra proactive arm	Biological: infliximab therapeutic drug monitoring; dose optimization of infliximab based on a predefined dosing algorithm
ACTIVE_COMPARATOR: reactive arm	Biological: infliximab therapeutic drug monitoring; dose optimization of infliximab based on a predefined dosing algorithm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of patients with infliximab failure	number of patients with infliximab failure after one year (infliximab failure = infliximab discontinuation, IBD related surgery, IBD related hospitalization, add-on IBD treatment, and allergic reaction to infliximab)	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of TL measurements per patient per year		one year
percentage of interval changes (shortening, prolongation, bidirectional)		one year
number of patients with infliximab discontinuation	number of patients with discontinuation of infliximab	one year
percentage of patients with sustained clinical remission	number of patients with physician global assessment <1 and all visits	one year
number of patients with mucosal remission	number of patients with mucosal remission after one year. (Mucosal remission = simple endoscopic score for CD <3, Rutgeertscore <i2 for, Mayo endoscopic subscore <1 and faecal calprotectin <250 µg/ml. Endoscopy and/or faecal calprotectin between 6 and 12 months after inclusion. If endoscopy and faecal calprotectin at the same moment, then endoscopy was dominant)	one year

Collaborators and Investigators

• Sponsor: Imelda GI Clinical Research Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2018
• Primary Completion (ACTUAL): August 31, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: February 25, 2021
• First Submitted That Met QC Criteria: February 26, 2021
• First Posted (ACTUAL): March 1, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 5, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: point of care testing; infliximab; inflammatory bowel disease; therapeutic drug monitoring
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: 200840

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No