An exploratory analysis of markers in blood, faeces and the colonic mucosa regarding response to treatment with infliximab for acute severe ulcerative colitis

An exploratory analysis of markers in blood, faeces and the colonic mucosa regarding response to treatment with infliximab for acute severe ulcerative colitis - Mechanisms for Infliximab (non)response in acute severe ulcerative colitis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50664

Enrollment

Registered

2018-08-16

Start date

2019-04-18

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory bowel disease ulcerative colitis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. At least 16 years of age. 2. A documented diagnosis of UC prior to entry into the study, based on clinical, biochemical, endoscopic and histological findings(14). 3. ASUC as defined by the Truelove and Witts criteria as six or more stools a day with either large amounts of blood per stool, a temperature over 37.8 °C, a heart rate above 90 bpm, hemoglobin levels of less than 10.5 g/dL, or an erythrocyte sedimentation rate over 30 mm/h(1). 4. Patients not responding to intravenous corticosteroid treatment and receiving IFX as rescue therapy 5. Patients who are not yet candidates for emergency colectomy. 6. Signed and dated informed consent.

Exclusion criteria

Exclusion criteria: 1.Other cause of colitis: indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn*s disease. 2.Positive stool examinations for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin. 3.Contra-indications to anti-TNFa treatment (TBC, severe infections or congestive heart failure) 4.IFX or any other anti-TNFa therapy in the past six months. 5. Pregnant or lactating females.

Design outcomes

Primary

Measure	Time frame
Main study parameters are 1) the inflammatory protein levels and 2) the IFX induced macrophage levels measured in blood and mucosal tissue, compared between responders and non-responders at baseline and post IFX.	—

Secondary

Measure	Time frame
i. IFX levels measured in blood, feces, and mucosal tissue, compared between responders and non-responders. ii. MMP activity measured in blood, feces, and mucosal tissue, compared between responders and non-responders at baseline and post IFX. iii. Anti-drug antibodies measured in blood, compared between responders and non-responders. iv. Changes in inflammatory protein levels measured in blood and mucosal tissue, compared between baseline and post IFX.	—

Measure

Time frame

i. IFX levels measured in blood, feces, and mucosal tissue, compared between responders and non-responders. ii. MMP activity measured in blood, feces, and mucosal tissue, compared between responders and non-responders at baseline and post IFX. iii. Anti-drug antibodies measured in blood, compared between responders and non-responders. iv. Changes in inflammatory protein levels measured in blood and mucosal tissue, compared between baseline and post IFX.

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Countries

Netherlands

Outcome results