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

Study Overview
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Brief Summary
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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.

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

Conditions
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Moderate to Severe Ulcerative Colitis

Intervention / Treatment
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* Drug: Infliximab
* Drug: Corticosteroid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UC cohort<br>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<br>* Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher<br>* Other names: IFX;Drug: Corticosteroid<br>* Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher<br>* Other names: CS;|

What is the study measuring?
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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 |