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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 11 January 2021
Main ID:  NCT03765450
Date of registration: 04/12/2018
Prospective Registration: Yes
Primary sponsor: Robarts Clinical Trials Inc.
Public title: Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis PROTOS
Scientific title: Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis
Date of first enrolment: December 21, 2018
Target sample size: 30
Recruitment status: Recruiting
Study type:  Observational
Study design:   
Countries of recruitment
Canada United States
Name:     Lee Williamson
Telephone: 226-270-7674
Name:     Niels Vande Casteele
Affiliation:  UCSD
Key inclusion & exclusion criteria

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.

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.

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Drug: Infliximab
Primary Outcome(s)
Inter-compartmental Difference in Infliximab Concentration [Time Frame: 22 weeks]
Secondary Outcome(s)
Change in Mayo Clinic Endoscopic Score [Time Frame: 22 weeks]
Change in Proteome [Time Frame: 22 weeks]
Change in Robarts Histopathologic Index [Time Frame: 22 weeks]
Change in Transcriptome [Time Frame: 22 weeks]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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