Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 13 February 2023
• Main ID: NCT03765450
• Date of registration: 04/12/2018
• Prospective Registration: Yes
• Primary sponsor: Alimentiv 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: 18
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT03765450
• Study type: Observational

Countries of recruitment

Canada, United States

Contacts

• 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

Intervention(s)

Drug: Infliximab

Primary Outcome(s)

Inter-compartmental Difference in Infliximab Concentration [Time Frame: 22 weeks]

Secondary Outcome(s)

Change in Robarts Histopathologic Index [Time Frame: 22 weeks]

Change in Proteome [Time Frame: 22 weeks]

Change in Mayo Clinic Endoscopic Score [Time Frame: 22 weeks]

Change in Transcriptome [Time Frame: 22 weeks]

Secondary ID(s)

RP1713

Source(s) of Monetary Support

Please refer to primary and secondary sponsors