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

Moderate to Severe Ulcerative Colitis Clinical Trial

— INSURE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879966
• Other study ID #: 2021ZSLYEC-102
• Status: Recruiting
• Start date: May 17, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Sixth Affiliated Hospital, Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 342
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Moderate to Severe Ulcerative Colitis
• Ulcer

Intervention

Drug:
• Infliximab
Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher
• Corticosteroid
Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher

Locations

Country	Name	City	State
China	The Sixth Affiliated Hospital, Sun Yat-sen University	Guandong

Sponsors (1)

Lead Sponsor	Collaborator
Sixth Affiliated Hospital, Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical remission	defined as a total score of =2 on the Mayo scale and no subscore >1; partial Mayo score = 2, no individual subscore > 1	week 14
Secondary	clinical response in induction phase	defined as a reduction in the partial Mayo score [stool frequency, rectal bleeding, and physician's global assessment] of =2 points and of =25% from baseline, with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point	week 14
Secondary	mucosal healing in induction phase	defined as a subscore of 0 or 1 on the Mayo endoscopic component	week 14
Secondary	histological healing in induction phase	defined as Nancy index score of 0	week 14
Secondary	clinical response in maintenance phase	defined as a reduction in the partial Mayo score [stool frequency, rectal bleeding, and physician's global assessment] of =2 points and of =25% from baseline, with an accompanying decrease in rectal bleeding subscore of =1 point or absolute rectal bleeding subscore of =1 point	week 52
Secondary	mucosal healing in maintenance phase	defined as a subscore of 0 or 1 on the Mayo endoscopic component	week 52
Secondary	histological healing in maintenance phase	defined as Nancy index score of 0	week 52
Secondary	quality of life in induction phase	defined as an increase of =16 points in IBDQ score	week 14
Secondary	quality of life in maintenance phase	defined as an increase of =16 points in IBDQ score	week 52
Secondary	adverse events	as assessed by the incidence of adverse events	week 52