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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

342 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-17

Study Completion Date

2023-12-31

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.

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Detailed Description

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Conditions

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Moderate to Severe Ulcerative Colitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Infliximab

Intervention Type DRUG

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

Corticosteroid

Intervention Type DRUG

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

Interventions

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Infliximab

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

Intervention Type DRUG

Corticosteroid

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

Intervention Type DRUG

Other Intervention Names

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IFX CS

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No