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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Moderate to Severe Ulcerative Colitis
• Intervention / Treatment: Drug: Infliximab; Drug: Corticosteroid

• Study Type: Observational
• Enrollment (Anticipated): 342

Contacts and Locations

Study Locations

• China
  • Guandong, China
    • Recruiting
    • The Sixth Affiliated hospital, Sun Yat-sen University
    • Contact: Jian Tang; Phone Number: 13751879964; Email: tangjiansys@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults patinets of moderately to severely active ulcerative colitis who will initiate IFX or CS

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UC cohort; the patiente of Moderate to Severe Ulcerative Colitis who recieved infliximab(IFX) or corticosteroids(CS) as induction therapy would be enrolled in this cohort	Drug: Infliximab; Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher; Other Names: IFX; Drug: Corticosteroid; Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher; Other Names: CS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
mucosal healing in induction phase	defined as a subscore of 0 or 1 on the Mayo endoscopic component	week 14
histological healing in induction phase	defined as Nancy index score of 0	week 14
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
mucosal healing in maintenance phase	defined as a subscore of 0 or 1 on the Mayo endoscopic component	week 52
histological healing in maintenance phase	defined as Nancy index score of 0	week 52
quality of life in induction phase	defined as an increase of ≥16 points in IBDQ score	week 14
quality of life in maintenance phase	defined as an increase of ≥16 points in IBDQ score	week 52
adverse events	as assessed by the incidence of adverse events	week 52

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 17, 2021
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 6, 2021
• First Posted (ACTUAL): May 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 22, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Antirheumatic Agents; Gastrointestinal Agents; Dermatologic Agents; Infliximab
• Other Study ID Numbers: 2021ZSLYEC-102

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No