Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04775732
• Other study ID #: 200840
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2021
• Source: Imelda GI Clinical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: September 30, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Biological:
• infliximab therapeutic drug monitoring
dose optimization of infliximab based on a predefined dosing algorithm

Locations

Country	Name	City	State
Belgium	Imelda GI clinical research center	Bonheiden
Belgium	AZ Sint Lucas	Gent

Sponsors (1)

Lead Sponsor	Collaborator
Imelda GI Clinical Research Center

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	number of TL measurements per patient per year		one year
Secondary	percentage of interval changes (shortening, prolongation, bidirectional)		one year
Secondary	number of patients with infliximab discontinuation	number of patients with discontinuation of infliximab	one year
Secondary	percentage of patients with sustained clinical remission	number of patients with physician global assessment <1 and all visits	one year
Secondary	number of patients with mucosal remission	number of patients with mucosal remission after one year. (Mucosal remission = simple endoscopic score for CD <3, Rutgeertscore	one year