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

Last updated: November 22, 2022
Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT04879966
2021ZSLYEC-102
  • Ages 18-70
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • moderately to severely active ulcerative colitis, defined as a total score of 6 to 12on the Mayo scale (scores range from 0 to 12, with higher scores indicating moresevere disease) and a subscore of at least 2 on the endoscopic component of the Mayoscale (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 beforescreening and confirmed by Pathology

Exclusion

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 Design

Total Participants: 342
Study Start date:
May 17, 2021
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guandong,
    China

    Active - Recruiting

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