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A Cohort Study Comparing IFX to CS for Moderate to Severe UC (INSURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04879966
Recruitment Status : Recruiting
First Posted : May 10, 2021
Last Update Posted : November 25, 2022
Sponsor:
Information provided by (Responsible Party):
Sixth Affiliated Hospital, Sun Yat-sen University

Study Description
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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 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.

Condition or disease Intervention/treatment
Moderate to Severe Ulcerative Colitis Drug: Infliximab Drug: Corticosteroid

Study Design
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Study Type : Observational
Estimated Enrollment : 342 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis
Actual Study Start Date : May 17, 2021
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
 Drug: Infliximab
Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher
Other Name: IFX

Drug: Corticosteroid
Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher
Other Name: CS


Outcome Measures
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Primary Outcome Measures :
  1. clinical remission [ Time Frame: week 14 ]
    defined as a total score of ≤2 on the Mayo scale and no subscore >1; partial Mayo score ≤ 2, no individual subscore > 1


Secondary Outcome Measures :
  1. clinical response in induction phase [ Time Frame: week 14 ]
    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

  2. mucosal healing in induction phase [ Time Frame: week 14 ]
    defined as a subscore of 0 or 1 on the Mayo endoscopic component

  3. histological healing in induction phase [ Time Frame: week 14 ]
    defined as Nancy index score of 0

  4. clinical response in maintenance phase [ Time Frame: week 52 ]
    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

  5. mucosal healing in maintenance phase [ Time Frame: week 52 ]
    defined as a subscore of 0 or 1 on the Mayo endoscopic component

  6. histological healing in maintenance phase [ Time Frame: week 52 ]
    defined as Nancy index score of 0

  7. quality of life in induction phase [ Time Frame: week 14 ]
    defined as an increase of ≥16 points in IBDQ score

  8. quality of life in maintenance phase [ Time Frame: week 52 ]
    defined as an increase of ≥16 points in IBDQ score

  9. adverse events [ Time Frame: week 52 ]
    as assessed by the incidence of adverse events


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults patinets of moderately to severely active ulcerative colitis who will initiate IFX or CS
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04879966


Locations
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China
The Sixth Affiliated Hospital, Sun Yat-sen University Recruiting
Guandong, China
Contact: Jian Tang    13751879964    tangjiansys@163.com   
Sponsors and Collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
More Information
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Responsible Party: Sixth Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04879966    
Other Study ID Numbers: 2021ZSLYEC-102
First Posted: May 10, 2021    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
 Pathologic Processes
Inflammatory Bowel Diseases
Infliximab
Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents