INFLIXIMAB for Acute severe ulcerative colitis|Acute ulcerative colitis

Inclusion criteria

• {"criterion_text":"- The subject or, when applicable, the subject's legally acceptable representative signs and dates a written informed consent form and any required privacy authorisation prior to or within 48 hours after the initiation of any study procedures."}
• {"criterion_text":"- The subject will receive a first dose of infliximab, or already received a first dose of 10 mg/kg infliximab within 48 hours before screening and signing the patient consent form (must have blood samples during each day), as rescue therapy for this episode of ASUC."}
• {"criterion_text":"- The subject is known with ulcerative colitis and diagnosis confirmed on pathology."}
• {"criterion_text":"- The subject is aged 18 years to 75 years (inclusive) at the first infliximab infusion."}
• {"criterion_text":"- The subject has a good understanding of the Dutch and/or English language."}
• {"criterion_text":"- The subject is admitted with a diagnosis of ASUC defined according to the Truelove and Witts’ criteria."}
• {"criterion_text":"- The subject is hospitalised."}
• {"criterion_text":"- The subject failed intravenous steroid treatment as defined by the Oxford criteria (more than 8 stools/d or 3-8 stools/d and CRP ≥45) and a Lichtiger score ≥ 10 on day 3 (± 2 days) after starting intravenous steroid treatment."}
• {"criterion_text":"- The subject did not receive anti-tumour necrosis factor therapy before."}
• {"criterion_text":"- The subject will receive infliximab as rescue therapy for this episode of acute severe ulcerative colitis."}

Exclusion criteria

• {"criterion_text":"- The subject has an ostomy or an ileal pouch anal anastomosis."}
• {"criterion_text":"- The subject received ciclosporin prior to infliximab as rescue therapy during the same hospitalisation."}
• {"criterion_text":"- The subject is participating in another interventional clinical trial."}

Primary endpoints

• {"endpoint_text":"- A description of the workload experienced by the healthcare personnel involved in the MIPD process, using the National Aeronautics and Space Association task load index (NASA-TLX, cf. Appendix 1). [feasibility]","definition_or_measurement_approach":"Measured using the NASA-TLX (National Aeronautics and Space Administration task load index) as specified in protocol appendix."}
• {"endpoint_text":"- A relative bias (rBias) within 20% between observation and model prediction, with a 95% confidence interval including zero. [performance]","definition_or_measurement_approach":"Relative bias (rBias) between observed and model-predicted infliximab concentrations; target is rBias within 20% with 95% CI including zero."}

Secondary endpoints

• {"endpoint_text":"- colectomy-free survival at 12 weeks (± one week) after start of infliximab therapy (short- term);","definition_or_measurement_approach":"Measured as colectomy-free survival assessed at 12 weeks (± 1 week) after start of infliximab therapy."}
• {"endpoint_text":"- colectomy-free survival at 24 weeks (± one week) (i.e., the end of the safety follow-up) ;","definition_or_measurement_approach":"Measured as colectomy-free survival assessed at 24 weeks (± 1 week) after start of infliximab therapy (end of safety follow-up)."}
• {"endpoint_text":"- (steroid-free) clinical response at 12 weeks (± one week) after start of infliximab therapy (short-term);","definition_or_measurement_approach":"Assessed at 12 weeks (±1 week) after start of infliximab therapy; steroid-free clinical response as defined in protocol."}
• {"endpoint_text":"- (steroid-free) clinical remission at 12 weeks (± one week) after start of infliximab therapy (short-term);","definition_or_measurement_approach":"Assessed at 12 weeks (±1 week) after start of infliximab therapy; steroid-free clinical remission as defined in protocol."}
• {"endpoint_text":"- biological response at 12 weeks (± one week) after start of infliximab therapy (short-term);","definition_or_measurement_approach":"Assessed at 12 weeks (±1 week) after start of infliximab therapy; biological response definitions per protocol (e.g., biomarkers)."}
• {"endpoint_text":"- biological remission at 12 weeks (± one week) after start of infliximab therapy (short-term);","definition_or_measurement_approach":"Assessed at 12 weeks (±1 week) after start of infliximab therapy; biological remission definitions per protocol."}
• {"endpoint_text":"- endoscopic response at 12 weeks (± one week) after start of infliximab therapy (short-term);","definition_or_measurement_approach":"Assessed by endoscopy at 12 weeks (±1 week) after start of infliximab therapy."}
• {"endpoint_text":"- endoscopic remission at 12 weeks (± one week) after start of infliximab therapy (short- term);","definition_or_measurement_approach":"Assessed by endoscopy at 12 weeks (±1 week) after start of infliximab therapy."}
• {"endpoint_text":"- minimal histological disease activity at 12 weeks (± one week) after start of infliximab therapy (short-term);","definition_or_measurement_approach":"Assessed by histology at 12 weeks (±1 week) after start of therapy."}
• {"endpoint_text":"- intestinal ultrasound (IUS) based disease activity during the first 12 weeks after the start of infliximab therapy (short-term)","definition_or_measurement_approach":"IUS assessments of disease activity during the first 12 weeks after start of infliximab therapy."}
• {"endpoint_text":"- histological remission at 12 weeks (± one week) after start of infliximab therapy (short-term)","definition_or_measurement_approach":"Assessed by histology at 12 weeks (±1 week) after start of therapy."}
• {"endpoint_text":"- percentage of target concentration attainment during the first 12 weeks;","definition_or_measurement_approach":"Proportion of patients achieving predefined infliximab trough concentration targets during the first 12 weeks."}
• {"endpoint_text":"- length of hospital admission after start of infliximab therapy;","definition_or_measurement_approach":"Measured as duration (days) of hospital admission after initiation of infliximab therapy."}
• {"endpoint_text":"- mortality;","definition_or_measurement_approach":"All-cause mortality during study follow-up."}
• {"endpoint_text":"- relapse-free survival in patients achieving clinical remission;","definition_or_measurement_approach":"Time to relapse among patients achieving clinical remission, per protocol definitions."}
• {"endpoint_text":"- need for rescue therapy other than infliximab;","definition_or_measurement_approach":"Occurrence of requirement for rescue therapy other than infliximab during follow-up."}
• {"endpoint_text":"- postoperative complications;","definition_or_measurement_approach":"Postoperative complication rates as recorded in surgical cases during follow-up."}
• {"endpoint_text":"- the total infliximab dose, the number of infliximab infusions, and the direct cost of infliximab therapy during the first 12 weeks (± one week) of the model-guided infliximab rescue therapy.","definition_or_measurement_approach":"Total infliximab dose, infusion count, and direct cost calculated for first 12 weeks (±1 week) of therapy."}
• {"endpoint_text":"- the ratio of the direct cost to the proportion of patients achieving colectomy-free survival at week 12 (± one week) after the start of model-guided infliximab rescue therapy","definition_or_measurement_approach":"Economic endpoint: direct cost divided by proportion achieving colectomy-free survival at week 12 (±1 week)."}

Belgium

Latest Decision Or Authorization Date

18-12-2024

Number Of Sites

1

Number Of Participants

13

Primary sponsor

Full Name

UZ Leuven

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"R-Biopharm","duties_or_roles":"Source of monetary support","organisation_type":""}