Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease

NCT04775732 | Completed Phase 4

• 1 other identifier: 200840
• Study Type: interventional
• Target: 187
• Locations: 1 country
• Sites: 2

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

Keywords

therapeutic drug monitoring; inflammatory bowel disease; point of care testing; infliximab

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• percentage of patients with sustained clinical remission

  one year

• number of patients with mucosal remission

  one year

Study Arms (2)

ultra proactive arm

EXPERIMENTAL

Biological: infliximab therapeutic drug monitoring

reactive arm

ACTIVE COMPARATOR

Biological: infliximab therapeutic drug monitoring

Interventions

infliximab therapeutic drug monitoring BIOLOGICAL

dose optimization of infliximab based on a predefined dosing algorithm

reactive arm; ultra proactive arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Imelda GI Clinical Research Center: lead

Study Sites (2)

Imelda GI clinical research center

Bonheiden, 2820, Belgium

Location

AZ Sint Lucas

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: pragmatic cluster trial

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: June 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: September 30, 2019
• Last Updated: August 5, 2021

Record last verified: 2021-07

Locations

BE (2)