| Interventions |
The interventional arm will receive subcutaneous (SC) infliximab and the dosing will be stratified according to prior intravenous (IV) infliximab dosing regimen. 120 mg SC infliximab 2-weekly - patients previously receiving IV infliximab at doses of 5-7.5 mg/kg 4- or 6-weekly and 7.5-10 mg/kg 6- or 8-weekly 240 mg SC infliximab 2-weekly - patients previously receiving IV infliximab 10 mg/kg 4-weekly The duration of administration will be 48 weeks. Patients receiving a dose of 120 mg SC infliximab 2-weekly that meet relapse criteria at weeks 12, 24, 36, or at any time point during the study, will be escalated to a maximum of SC infliximab 240 mg 2-weekly. Criteria for dose-escalation include one of the following three: - Modified Harvey Bradshaw Index (HBI) >/=5 in Crohn's disease (CD) patients, partial Mayo Score >/=2 in ulcerative colitis (UC) patients AND objective evidence of active disease (defined as C-reactive protein [CRP] >5mg/L OR faecal calprotectin [FCP] > 250 mg/g) - Need for corticosteroids, new immunomodulator or switch in biologic therapy - IBD-related hospitalisation or surgery Self-reported adherence with prescribed medications will be surveyed 12-weekly throughout the 48-week study. |