Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

Phase 4

Completed

• Conditions: Crohn Disease; Ulcerative Colitis
• Interventions: Biological: infliximab therapeutic drug monitoring

• Registration Number: NCT04775732
• Lead Sponsor: Imelda GI Clinical Research Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-09-30
• Study First Submitted: 2021-02-25
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-01
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-29
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultra proactive arm	infliximab therapeutic drug monitoring	-
reactive arm	infliximab therapeutic drug monitoring	-

Primary Outcome Measures

Name	Time	Method
number of patients with infliximab failure	one year	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)

Secondary Outcome Measures

Name	Time	Method
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	one year	number of patients with discontinuation of infliximab
percentage of patients with sustained clinical remission	one year	number of patients with physician global assessment \<1 and all visits
number of patients with mucosal remission	one year	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)

Trial Locations

Locations (2)

Imelda GI clinical research center; 🇧🇪 Bonheiden, Belgium

AZ Sint Lucas; 🇧🇪 Gent, Belgium