A Cohort Study Comparing IFX to CS for Moderate to Severe UC (INSURE)

Sun Yat-sen University

Status: Enrolling

Conditions: Moderate to Severe Ulcerative Colitis

Treatments: Drug: Infliximab; Drug: Corticosteroid

Study type: Observational

Funder types: Other

Identifiers

NCT04879966

2021ZSLYEC-102

Details and patient eligibility

About

The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but only had low grade evidence.We launched this multicenter prospective cohort trial to compare the efficacy and safety of infliximab (IFX) and corticosteroids(CS) when they was used as first-line therapy in UC patients.

Enrollment: 342 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• moderately to severely active ulcerative colitis, defined as a total score of 6 to 12 on the Mayo scale (scores range from 0 to 12, with higher scores indicating more severe disease) and a subscore of at least 2 on the endoscopic component of the Mayo scale (subscores on each of the four components of the Mayo scale range from 0 to 3)
• Patients who had colonic involvement of at least 15 cm
• Patients who had a confirmed diagnosis of ulcerative colitis at least 3 months before screening and confirmed by Pathology

Exclusion criteria

• Patients who had previously used any TNF inhibitor
• Patients who were steroid-dependent or steriod-resistant
• Patients who had undergone subtotal colectomy or total colectomy
• Patients who had stoma

Trial design

342 participants in 1 patient group

UC cohort

Description:

the patiente of Moderate to Severe Ulcerative Colitis who recieved infliximab(IFX) or corticosteroids(CS) as induction therapy would be enrolled in this cohort

Treatment:

Drug: Corticosteroid

Drug: Infliximab