NCT04879966

A Cohort Study Comparing IFX to CS for Moderate to Severe UC

A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 342 (estimated)
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Moderate to Severe Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Infliximab	Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher
DRUG	Corticosteroid	Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher

Timeline

• Start date: 2021-05-17
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2021-05-10
• Last updated: 2022-11-25

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study