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

Sixth Affiliated Hospital, Sun Yat-sen University342 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

342

Conditions

Moderate to Severe Ulcerative Colitis

Interventions

InfliximabDRUG

Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher

CorticosteroidDRUG

Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guandong, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: week 14

Secondary Outcomes

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

Time frame: week 14

mucosal healing in induction phase

defined as a subscore of 0 or 1 on the Mayo endoscopic component

Time frame: week 14

histological healing in induction phase

defined as Nancy index score of 0

Time frame: week 14

clinical response in maintenance phase

Time frame: week 52

mucosal healing in maintenance phase

defined as a subscore of 0 or 1 on the Mayo endoscopic component

Time frame: week 52

histological healing in maintenance phase

defined as Nancy index score of 0

Time frame: week 52

Data from ClinicalTrials.gov

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