InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease
Summary
Study Design: A Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators during Induction treatment in Moderate to Severe Crohn's Disease. Primary endpoint: The proportion of patients in corticosteroid-free clinical remission (as defined by a Crohn's disease activity index (CDAI)\<150) and endoscopic response (as defined by a simple endoscopic score for Crohn's disease (SES-CD) drop of at least 50%) at week 26. Accrual and feasibility: This study will enroll 158 subjects at approximately 20 sites in the Netherlands (peripheral and academic hospitals). The estimated enrollment is 0.5 patient/centre/month leading to an inclusion duration of 16 months once all centres are open. The first enrolment is anticipated in Q1 2021. Treatment, dosage and administration: Eligible patients will be randomized to receive SC IFX monotherapy (240mg at week 0 and week 2 and then 120mg every other week (EOW) OR SC IFX (240mg at week 0 and week 2 and then 120mg EOW) in combination with immunosuppression.
Timeline
- Start
- 2021-11-25
- Primary completion
- 2025-06
- Completion
- 2025-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 120 mg | Subcutaneous |
| Background | Azathioprine | Small molecule | 2 mg/kg | Oral |
| Background | Azathioprine | Small molecule | 2.5 mg/kg | Oral |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | 1 mg/kg | Oral |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | 1.5 mg/kg | Oral |
| Background | Methotrexate | Small molecule | 15 mg | — |
| Background | Thioguanine | Small molecule | 20 mg | Oral |
| Background | folic acid | Other / unclassified | 5 mg | Oral |