Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

Imelda GI Clinical Research Center

Status and phase: Completed; Phase 4

Conditions: Ulcerative Colitis; Crohn Disease

Treatments: Biological: infliximab therapeutic drug monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT04775732

200840

Details and patient eligibility

About

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.

Enrollment: 187 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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187 participants in 2 patient groups

ultra proactive arm

Experimental group

Treatment:

Biological: infliximab therapeutic drug monitoring

reactive arm

Active Comparator group

Treatment:

Biological: infliximab therapeutic drug monitoring