Infliximab for Ulcerative colitis | Crohn's disease | Inflammatory bowel disease (IBDU)

Stratification factors

• Use of concomitant immunomodulatory (yes or no)
• Average intravenous infliximab per eight weeks based on two most recent IV administrations (less than 12 mg/kg per eight weeks or between 12 and 22 mg/kg per eight weeks)

Inclusion criteria

• {"criterion_text":"- Patients with a previously documented CD, UC, IBDU diagnosis confirmed by clinical , endoscopic, histological, and/or radiological criteria.\n- Males and females ≥18 years old\n- Patients must be in steroid-free clinical remission at Screening defined as a rectal bleeding score of 0 and a stool frequency score of ≤1 for patients with UC / IBDU, or an average daily abdominal pain score ≤1 and a liquid stool frequency score ≤2.8 for patients with CD (based on the 3 days before the screening visit, excluding the day of or the day before an eventual endoscopy with bowel preparation) and this without the need for any type of steroids in the previous eight weeks.\n- Patients must be in biological remission at screening defined as a CRP <10 mg/L and a fecal calprotectin <250 µg/g.\n- Patients receiving IV infliximab for at least 26 consecutive weeks.\n- Patients receiving a stable IV dosing schedule for at least 20 weeks.\n- Patients receiving an average IV infliximab per eight weeks based on the two most recent IV administrations of more than 8 mg/kg, but not more than 22 mg/kg.\n- Patients who speak and read fluently Dutch, French or English.\n- Patients who is able to voluntary give their written informed consent."}

Exclusion criteria

• {"criterion_text":"- Male or female < 18 years\n- Patients with an ileorectal anastomosis, an ileal pouch-anal anastomosis or an ostomy (transient or permanent)\n- Patients participating in an interventional clinical trial with an Investigational Medicinal Product (IMP) or device.\n- Patients previously treated with subcutaneous infliximab.\n- Patients with active perianal fistulizing disease.\n- Patients with microscopic colitis."}

Primary endpoints

• {"endpoint_text":"- The proportion of patients that maintain steroid-free clinical and biological remission by week 52 without treatment optimization after switch to subcutaneous infliximab.","definition_or_measurement_approach":"Clinical remission defined in inclusion criteria: for UC/IBDU rectal bleeding score of 0 and stool frequency score ≤1; for CD average daily abdominal pain score ≤1 and liquid stool frequency score ≤2.8 (based on 3 days before screening, excluding day of/before bowel prep). Biological remission defined as CRP <10 mg/L and fecal calprotectin <250 µg/g. Endpoint measured as proportion of patients meeting both clinical and biological remission criteria at week 52 without treatment optimization."}

Secondary endpoints

• {"endpoint_text":"- The proportion of patients that maintain steroid-free clinical and biological remission by week 52 with treatment optimization.","definition_or_measurement_approach":"Proportion at week 52 meeting clinical and biological remission criteria (as defined for primary endpoint) allowing for treatment optimization."}
• {"endpoint_text":"- The proportion of patients that maintain steroid-free clinical and biological remission by week 52 (with or without treatment optimization).","definition_or_measurement_approach":"Proportion at week 52 meeting clinical and biological remission criteria regardless of treatment optimization."}
• {"endpoint_text":"- The proportion of patients that maintain steroid-free clinical and biological remission by week 8, by week 24 (without treatment optimization).","definition_or_measurement_approach":"Proportions at weeks 8 and 24 meeting clinical and biological remission criteria without treatment optimization."}
• {"endpoint_text":"- The proportion of patients that maintain steroid-free clinical remission by week 8, by week 24, by week 52 (without treatment optimization).","definition_or_measurement_approach":"Proportions at weeks 8, 24 and 52 meeting clinical remission criteria without treatment optimization."}
• {"endpoint_text":"- The proportion of patients that maintain steroid-free biological remission by week 8, by week 24, by week 52 (without treatment optimization).","definition_or_measurement_approach":"Proportions at weeks 8, 24 and 52 meeting biological remission thresholds (CRP <10 mg/L and fecal calprotectin <250 µg/g) without treatment optimization."}
• {"endpoint_text":"- The proportion of patients switching back to IV infliximab by week 8, by week 24, by week 52.","definition_or_measurement_approach":"Proportion of participants who revert to IV infliximab at specified timepoints."}
• {"endpoint_text":"- Time to (objectified) clinical relapse (or treatment optimization or treatment discontinuation).","definition_or_measurement_approach":"Time-to-event analysis measuring time from switch to objective clinical relapse or to treatment optimization or discontinuation."}
• {"endpoint_text":"- Time to objectified clinical relapse (or treatment optimization or treatment discontinuation).","definition_or_measurement_approach":"Time-to-event for objectively defined clinical relapse; patients who have treatment optimization/discontinuation without objective relapse are censored/lost to follow-up from that timepoint."}
• {"endpoint_text":"- Time to treatment optimization (or treatment discontinuation).","definition_or_measurement_approach":"Time-to-first treatment optimization or treatment discontinuation."}
• {"endpoint_text":"- Time to treatment discontinuation.","definition_or_measurement_approach":"Time-to-treatment discontinuation."}
• {"endpoint_text":"- Time to clinical relapse (patients that undergo treatment optimization or treatment discontinuation without clinical relapse will be regarded as lost to follow-up from that timepoint).","definition_or_measurement_approach":"Time-to-clinical relapse with prespecified censoring rules for optimization/discontinuation without relapse."}
• {"endpoint_text":"- Time to objective clinical relapse (patients that undergo treatment optimization or treatment discontinuation without objective clinical relapse will be regarded as lost to follow-up from that timepoint).","definition_or_measurement_approach":"Time-to-objective clinical relapse with censoring rules as above."}
• {"endpoint_text":"- Patients experience and satisfaction with switching to SC therapy by week 8, week 24, by week 52.","definition_or_measurement_approach":"Patient-reported experience and satisfaction measured at weeks 8, 24 and 52 using questionnaires (several satisfaction and registration forms listed in documents)."}
• {"endpoint_text":"- The proportion of eligible patients willing to switch and effectively switching to SC therapy.","definition_or_measurement_approach":"Proportion of eligible patients who indicate willingness and who actually switch to SC therapy."}
• {"endpoint_text":"- Baseline characteristics linked to willingness of switching and effectively switching to SC therapy.","definition_or_measurement_approach":"Association analyses between baseline characteristics and switching willingness/behavior."}
• {"endpoint_text":"- Reasons for willing or not willing to switch to SC therapy.","definition_or_measurement_approach":"Descriptive listing/coding of reasons provided by patients for (not) switching."}
• {"endpoint_text":"- Reasons for treatment optimization (clinical disease activity, biological disease activity, endoscopic disease activity, radiological disease activity, and/or other).","definition_or_measurement_approach":"Categorisation of primary reasons for treatment optimization."}
• {"endpoint_text":"- Reasons for treatment discontinuation (clinical disease activity, biological disease activity, endoscopic disease activity, radiological disease activity, adverse events, pregnancy, patient's request, and/or other).","definition_or_measurement_approach":"Categorisation of reasons for treatment discontinuation including pregnancy."}
• {"endpoint_text":"- The number and type of (serious) adverse events by week 52.","definition_or_measurement_approach":"Counting and classification of (serious) adverse events up to week 52."}

Belgium

Earliest CTIS Part Ii Submission Date

22-03-2024

Latest Decision Or Authorization Date

03-03-2025

Processing Time Days

346

Number Of Sites

21

Number Of Participants

275

Primary sponsor

Full Name

Belgian IBD Research and Development

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Belgium

Third parties

• {"country":"","full_name":"Celltrion","duties_or_roles":"Source of monetary support","organisation_type":""}