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Improved outcomes for pediatric patients with inflammatory bowel disease receiving proactive therapeutic drug monitoring of infliximab

Application of active therapeutic drug monitoring of infliximab in pediatric inflammatory bowel disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073537
Enrollment
Unknown
Registered
2023-07-13
Start date
2020-09-01
Completion date
Unknown
Last updated
2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBD

Interventions

Active TDM:The treatment group adjusts the treatment plan based on IFX concentration
Control group:During the treatment period, there will be no monitoring of IFX blood drug concentration and ATI, and empirical medication adjustments will be made based on clinical, biochemical, endosc

Sponsors

Shengjing Hospital of CMU
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1) confirmed IBD and regular treatment with IFX; and 2) an age of 0–14 years.

Exclusion criteria

Exclusion criteria: 1) used biological agents other than IFX, 2) had serious organic diseases, such as hepatitis B, tuberculosis, or tumors, 3) did not undergo regular follow-up, and 4) had a treatment period <14 weeks.

Design outcomes

Primary

MeasureTime frame
Pediatric Crohn’s disease activity index, PCDAI;Pediatric ulceratie colitis activity index , PUCAI;—

Secondary

MeasureTime frame
IFX concentration;ATI concentration;—

Countries

China

Contacts

Public ContactLingfen Xu

Shengjing Hospital of CMU

xulingfen7408@163.com+86 189 4025 7408

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026