Status:
UNKNOWN
A Cohort Study Comparing IFX to CS for Moderate to Severe UC
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Moderate to Severe Ulcerative Colitis
Eligibility:
All Genders
18-70 years
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 17 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
342 Patients enrolled
Trial Details
Trial ID
NCT04879966
Start Date
May 17 2021
End Date
December 31 2023
Last Update
November 25 2022
Active Locations (1)
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1
The Sixth Affiliated Hospital, Sun Yat-sen University
Guandong, China