Switching from Dose-Intensified intravenous to SubCutaneoUS infliximab in Inflammatory Bowel Disease: a randomised controlled trial - DISCUS-IBD

Phase 3

Recruiting

• Conditions: Inflammatory bowel disease; Crohn's disease; Ulcerative colitis; Oral and Gastrointestinal - Inflammatory bowel disease; Oral and Gastrointestinal - Crohn's disease; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12622001458729
• Lead Sponsor: The Alfred Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-17
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Adult luminal CD or UC patients on maintenance escalated IV infliximab in clinical steroid-free remission for at least 6 months and biochemical remission at study entry, defined as:
- Modified HBI <5 for CD and partial Mayo score <2 for UC) AND
- CRP <5 mg/L AND FCP <250 µg/g

Exclusion Criteria

- Patients with recent IV infliximab dose change (within 3 months)
- Patients with perianal CD in the absence of luminal CD
- Pregnancy or planning pregnancy within 12 months
- Actively breastfeeding
- Weight <40 kg or >120 kg

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of disease relapse in each group, defined as one of: 1. Clinical (either modified HBI >/=5 in CD or partial Mayo Score >/=2 in UC) AND objective evidence of active disease (either CRP >5mg/L, or FCP >250 µg/g) 2. Need for corticosteroids, immunomodulator or switch in biologic therapy. 3. Need for IBD-related hospitalisation or surgery.<br><br>Patients meeting any of the relapse criteria are permitted one dose-escalation in their subcutaneous or intravenous infliximab. The maximum subcutaneous dose is 240 mg 2-weekly and the maximum IV dose is 10 mg/kg 4-weekly.<br><br>Patients receiving escalation will be recorded as meeting the primary endpoint (relapse) whilst still remaining in the study to 48 weeks to measure response to dose-intensification. The above criteria will be measured using 12-weekly blood tests, faecal tests and clinical surveys to inform primary and secondary outcomes.[ Week 48 from the time of receiving their first dose of either IV or SC infliximab within the study]