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Preliminary study on the timing of individualized treatment monitoring and the standardized threshold of anti-Infliximab antibodies for Crohn's disease

Preliminary study on the timing of individualized treatment monitoring and the standardized threshold of anti-Infliximab antibodies for Crohn's disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074489
Enrollment
Unknown
Registered
2023-08-08
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

Crohn's disease

Interventions

Crohn's disease patients:none

Sponsors

Shanghai Changhai Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) The included patients were in line with Chinese consensus on diagnosis and treatment of inflammatory bowel disease(Beijing, 2018). (2) Patients with CD who had been treated with IFX at least once. (3) Complete clinical data such as medical history and auxiliary examination of patients with CD. (4)18-60 years old.

Exclusion criteria

Exclusion criteria: (1) Patients with active infection, radiation enteritis, bacillary dysentery or transient colitis of unknown cause, tuberculosis of the intestine or a history of tuberculosis, who cannot guarantee that they have received a full course of anti-tuberculosis therapy, and a history of colorectal malignancy. (2) Chronic diseases complicated with inflammation, such as congestive heart failure, cirrhosis, renal failure, etc. (3) Use of anti-TNF-a drugs other than IFX or other types of biologics. (4) Patients using IFX for the first time. (5) Pregnant or lactating women. (6) IFX valley concentration and ATIs patients were not detected or refused to be detected. (7) Patients with incomplete clinical and follow-up data.

Design outcomes

Primary

MeasureTime frame
anti-Infliximab antibodies;Infliximab trough concentration ;

Secondary

MeasureTime frame
CRP;ESR;PLT;ALB;Fecal calcaretin;

Countries

China

Contacts

Public ContactTian Jing

Department of Pharmacy,Shanghai Changhai Hospital

smmutj@126.com+86 137 7421 1911

Outcome results

None listed

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