Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis
![]() |
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: NCT02438410 |
Recruitment Status :
Recruiting
First Posted : May 8, 2015
Last Update Posted : November 12, 2018
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Submitted Date | April 29, 2015 | ||||||||
First Posted Date | May 8, 2015 | ||||||||
Last Update Posted Date | November 12, 2018 | ||||||||
Study Start Date | May 2015 | ||||||||
Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
colectomy free survival [ Time Frame: 3 month ] The primary aim of this study is to analyze the relationship between daily infliximab levels in the first week after infusion and colectomy free survival at 3 months
|
||||||||
Original Primary Outcome Measures | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT02438410 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures |
|
||||||||
Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title | Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis | ||||||||
Official Title | Correlation of Infliximab Levels With Outcomes in Ulcerative Colitis | ||||||||
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 Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Retention: Samples Without DNA Description: Stool and blood laboratory data such as CBC with differential, creatinine, TNF levels, albumin, fecal calprotectin, ESR, CRP, infliximab and antibodies to infliximab levels will be obtained.
|
||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients must be scheduled to receive clinically indicated infliximab at the discretion of their treating physician during an acute hospitalization with a flare of moderate to severe UC. These will be inpatients at Mayo Clinic Rochester campus or be admitted in Mayo Clinic Health Systems. Endoscopic findings will be noted and those deemed to have moderate to severe disease activity based on the Mayo Scoring System for Assessment of Ulcerative Colitis Activity will be considered. | ||||||||
Condition |
|
||||||||
Intervention | Not Provided | ||||||||
Study Groups/Cohorts | Not Provided | ||||||||
Publications * |
|
||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status | Recruiting | ||||||||
Estimated Enrollment |
25 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 2020 | ||||||||
Estimated Primary Completion Date | May 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria | Inclusion Criteria
Exclusion Criteria
|
||||||||
Sex/Gender |
|
||||||||
Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
|
||||||||
Listed Location Countries | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT02438410 | ||||||||
Other Study ID Numbers | 14-005723 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product | Not Provided | ||||||||
IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | Darrell S. Pardi, M.D., Mayo Clinic | ||||||||
Study Sponsor | Mayo Clinic | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
|
||||||||
PRS Account | Mayo Clinic | ||||||||
Verification Date | November 2018 |