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IGNITE: Model-informed precision dosing of infliximab in steroid-refractory acute severe ulcerative colitis
2023-503509-12-00Phase 4Authorised
- Sponsor
- UZ Leuven
- Start
- Dec 2024
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Countries
- 1
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Overview
Phase 4, open-label, single-arm trial of infliximab in autoimmune colitis, sponsored by UZ Leuven. Primary endpoints: Healthcare personnel workload in MIPD process and Relative bias between observed and model-predicted infliximab concentrations. Planned start Dec 2024; status: authorised.
02
Drugs
infliximab
03
Conditions
autoimmune colitis
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