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

NCT04879966 | Unknown FDA Drug

• 1 other identifier: 2021ZSLYEC-102
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

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.

Conditions

Moderate to Severe Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• clinical response in induction phase

  week 14

• mucosal healing in induction phase

  week 14

• histological healing in induction phase

  week 14

• clinical response in maintenance phase

  week 52

• mucosal healing in maintenance phase

  week 52

Study Arms (1)

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; Drug: Corticosteroid

Interventions

Infliximab DRUG

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

Also known as: IFX

UC cohort

Corticosteroid DRUG

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

Also known as: CS

UC cohort

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults patinets of moderately to severely active ulcerative colitis who will initiate IFX or CS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead

Study Sites (1)

The Sixth Affiliated Hospital, Sun Yat-sen University

Guandong, China

RECRUITING

MeSH Terms

Interventions

Infliximab; Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 10, 2021
• Study Start: May 17, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: November 25, 2022

Record last verified: 2022-11

Locations

CN (1)