Clinical trial · Observational
Pharmacokinetics of IFX and TNF Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis
Pharmacokinetics of Infliximab and Tumor Necrosis Factor Concentrations in Serum, Stool, and Colonic Mucosa in Acute Severe Ulcerative Colitis
NCT03765450CI-TRIAL-00113358PROTOSactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ulcerative Colitis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Infliximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Single Group Study
- description
- 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.
- interventionNames
- Drug: Infliximab
Primary outcomes (1)
- measure
- Inter-compartmental Difference in Infliximab Concentration
- timeFrame
- 22 weeks
- description
- Infliximab population pharmacokinetics
Secondary outcomes (4)
- measure
- Change in Proteome
- timeFrame
- 22 weeks
- description
- Change in Proteomics before and after therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (38)
- BACKGROUNDDinesen LC, Walsh AJ, Protic MN, Heap G, Cummings F, Warren BF, George B, Mortensen NJ, Travis SP. The pattern and outcome of acute severe colitis. J Crohns Colitis. 2010 Oct;4(4):431-7. doi: 10.1016/j.crohns.2010.02.001. Epub 2010 Feb 19. PMID 21122540
- BACKGROUNDWilliams JG, Alam MF, Alrubaiy L, Clement C, Cohen D, Grey M, Hilton M, Hutchings HA, Longo M, Morgan JM, Rapport FL, Seagrove AC, Watkins A. Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT). Health Technol Assess. 2016 Jun;20(44):1-320. doi: 10.3310/hta20440. PMID 27329657
- BACKGROUNDSeah D, De Cruz P. Review article: the practical management of acute severe ulcerative colitis. Aliment Pharmacol Ther. 2016 Feb;43(4):482-513. doi: 10.1111/apt.13491. Epub 2016 Jan 4. PMID 26725569
- BACKGROUNDRutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. doi: 10.1056/NEJMoa050516. PMID 16339095
- BACKGROUNDSandborn WJ, Rutgeerts P, Feagan BG, Reinisch W, Olson A, Johanns J, Lu J, Horgan K, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Colectomy rate comparison after treatment of ulcerative colitis with placebo or infliximab. Gastroenterology. 2009 Oct;137(4):1250-60; quiz 1520. doi: 10.1053/j.gastro.2009.06.061. Epub 2009 Jul 28. PMID 19596014
- BACKGROUNDJarnerot G, Hertervig E, Friis-Liby I, Blomquist L, Karlen P, Granno C, Vilien M, Strom M, Danielsson A, Verbaan H, Hellstrom PM, Magnuson A, Curman B. Infliximab as rescue therapy in severe to moderately severe ulcerative colitis: a randomized, placebo-controlled study. Gastroenterology. 2005 Jun;128(7):1805-11. doi: 10.1053/j.gastro.2005.03.003.