Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis
NCT ID: NCT03765450
Last Updated: 2025-05-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
18 participants
Study Classification
OBSERVATIONAL
Study Start Date
2018-12-21
Study Completion Date
2026-03-02
Brief Summary
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This is an open-label, prospective, observational study with the primary objective to characterize the pharmacokinetics of infliximab in patients with Acute Severe Ulcerative Colitis.
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Detailed Description
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In Acute Severe Ulcerative Colitis (ASUC), drug exposure may be affected by intestinal protein loss leading to hypoalbuminemia and rapid clearance of infliximab (IFX). Importantly, 2 studies have associated the loss of IFX in stool with poor outcomes. Multiple observational studies have identified that patients with faster IFX clearance have worse clinical outcomes and higher rates of antidrug antibody formation. To better understand optimal dosing of IFX in ASUC, the pharmacokinetics of IFX in association with outcomes must be better defined in this setting.
Conditions
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Ulcerative Colitis
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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Single Group Study
Patients with Acute Severe Ulcerative Colitis who are either a) biologic-naïve or b) biologic-experienced without a known history of anti-infliximab antibodies requiring infliximab infusion therapy as a part of standard of care.
Infliximab
Intervention Type
DRUG
Patients will receive infliximab at the discretion of their physician as part of standard of care.
Interventions
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Infliximab
Patients will receive infliximab at the discretion of their physician as part of standard of care.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* Present to hospital with ASUC based on Truelove and Witts criteria,33 defined as the presence of more than 6 bloody stools per day along with any 1 of the following: tachycardia \> 90 beats per minute, fever \> 37.8 °C, hemoglobin \< 10.5 g/dL, and erythrocyte sedimentation rate (ESR) \> 30 mm/h (or CRP \> 30 mg/L \[high-sensitivity CRP \> 300 mg/L\]) is a suitable surrogate if ESR is not available1).
* Have a partial MCS \> 7.
* Have a Mayo Clinic ES ≥ 2 with disease extending 15 cm or more beyond the anal verge.
* Require rescue inpatient IFX infusion as part of routine care. Note, the IFX treatment regimen is not defined by this protocol and any dosage regimen is acceptable for the purposes of this study, such as standard or accelerated induction regimens.
* Be able to speak English and participate fully in all aspects of this clinical trial.
* Provide written informed consent.
* Have a partial MCS \> 7.
* Have a Mayo Clinic ES ≥ 2 with disease extending 15 cm or more beyond the anal verge.
* Require rescue inpatient IFX infusion as part of routine care. Note, the IFX treatment regimen is not defined by this protocol and any dosage regimen is acceptable for the purposes of this study, such as standard or accelerated induction regimens.
* Be able to speak English and participate fully in all aspects of this clinical trial.
* Provide written informed consent.
Exclusion Criteria
* A known history of being positive for anti-IFX antibodies.
* Have a serious active infection, active malignancy, or any other known condition contraindicated with infliximab therapy, according to current prescribing information.
* Serious underlying disease other than ASUC, or other physical or psychosocial condition that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
* Prior enrollment in the current study.
* Have a serious active infection, active malignancy, or any other known condition contraindicated with infliximab therapy, according to current prescribing information.
* Serious underlying disease other than ASUC, or other physical or psychosocial condition that, in the opinion of the investigator, may interfere with the subject's ability to participate fully in the study.
* Prior enrollment in the current study.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Alimentiv Inc.
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Niels Vande Casteele
Role: STUDY_DIRECTOR
UCSD
Locations
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UCSD
San Diego, California, United States
Site Status
Cornell University
New York, New York, United States
Site Status
Mount Sinai Hospital
Toronto, Ontario, Canada
Site Status
Countries
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United States
Canada
References
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Other Identifiers
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RP1713
Identifier Type: -
Identifier Source: org_study_id
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