Status:
ACTIVE_NOT_RECRUITING
Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis
Lead Sponsor:
Alimentiv Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
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 asso...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 2 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03765450
Start Date
December 21 2018
End Date
March 2 2026
Last Update
May 16 2025
Active Locations (3)
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1
UCSD
San Diego, California, United States, 92037
2
Cornell University
New York, New York, United States, 10065
3
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5