Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

NCT ID: NCT04775732

Last Updated: 2021-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2019-09-30

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.

Conditions

Crohn Disease; Ulcerative Colitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ultra proactive arm

Group Type: EXPERIMENTAL

infliximab therapeutic drug monitoring

Intervention Type: BIOLOGICAL

dose optimization of infliximab based on a predefined dosing algorithm

reactive arm

Group Type: ACTIVE_COMPARATOR

infliximab therapeutic drug monitoring

Intervention Type: BIOLOGICAL

dose optimization of infliximab based on a predefined dosing algorithm

Interventions

infliximab therapeutic drug monitoring

dose optimization of infliximab based on a predefined dosing algorithm

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imelda GI Clinical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Peter Bossuyt

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Imelda GI clinical research center

Bonheiden, , Belgium

AZ Sint Lucas

Ghent, , Belgium

Countries

Belgium

Other Identifiers

200840

Identifier Type: -

Identifier Source: org_study_id