Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis

Completed

• Conditions: Inflammatory Bowel Disease; Colitis, Ulcerative; IBD

• Registration Number: NCT02438410
• Lead Sponsor: Mayo Clinic

Brief Summary

To assess if infliximab drug levels in subjects with Ulcerative Colitis predict risk of colectomy rate. Additionally, the investigators will estimate an optimal day 4 infliximab level based on the study results.

Detailed Description

Infliximab is approved for induction and maintenance of clinical remission and mucosal healing in patients with moderate to severe active ulcerative colitis, in those who have an inadequate response to conventional therapy such as IV steroids. It is typically dosed at 5 mg/kg at 0, 2, and 6 weeks, followed by 5 mg/kg every 8 weeks thereafter. The alternative to rescue medical therapy with infliximab is proctocolectomy with ileal pouch anastomosis, which carries risks including pouchitis, fecal incontinence, pouch failure requiring further surgical procedures and female infertility, or proctocolectomy with permanent end-ileostomy, which many patients wish to avoid. The induction regimen of 3 doses of Infliximab followed by a maintenance dose every 8 weeks is used to achieve response in hopes of avoiding colectomy. Unfortunately, a large proportion of patients are unable to achieve or sustain a clinical response over time and end up getting a colectomy.

Potential implicated pathways in non-responders include fecal wasting of infliximab and factors that accelerate drug clearance such as a large TNF (tumor necrosis factor) or CRP (C reactive protein) burden, anti-infliximab antibodies (ATI), low serum albumin, male sex and larger body size. Patients with severe ulcerative colitis who fail corticosteroids and standard dosing with infliximab usually proceed to proctocolectomy. Optimizing early infliximab blood levels in patients with moderate-severe ulcerative colitis by administering the second dose of infliximab before week 2 could improve the efficacy and further reduce the need for colectomy. However, there is a paucity in the literature as this is a relatively new school of thought. Our study will address this deficit by evaluating the relationship between early drug levels of infliximab in ulcerative colitis and colectomy rates at one and three months.

Study Timeline

• Study First Submitted: 2015-04-29
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-05
• Study First Posted: 2015-05-08
• Primary Completion: 2019-12-04
• Study Completion: 2019-12-04
• Results First Submitted: 2021-10-14
• Results First Submitted QC: 2021-12-13
• Results First Posted: 2022-03-03
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants to be Colectomy Free at 3 Months	3 month	Total number of participants to be colectomy free at 3 months
Number of Participants With the Need for Colectomy Assessed by Biomarker Levels	3 months	Biomarkers markers ESR, CRP, TNF levels, and hemoglobin will be collected to assess relationships between colectomy an other potential biomarkers

Secondary Outcome Measures

Name	Time	Method
Number of Participants to be Colectomy Free at 1 Month	1 month	Total number of participants to be colectomy free at 1 month

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States