drugset / Trial / NCT05660746
Precise Infliximab Exposure and Pharmacodynamic Control
Phase 2/3
Recruiting
180 enrolled
Children's Hospital Medical Center, Cincinnati
Janssen Scientific Affairs, LLC · collabNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab
Non-randomizedParallel-groupOpen-labelTreatment
Summary
Approximately 3 million people in the United States are living with inflammatory bowel disease, which includes Crohn's Disease (CD). There are limited treatment options approved for use in children and adults with Crohn's disease. Physicians need better ways to inform decisions on treatment. The main reason for this research study is to determine if a computer program that calculates an individualized dose based on a patient's blood testing results (precision dosing) can better achieve the best possible response to infliximab compared to standard dosing (conventional dosing).
Timeline
- Start
- 2023-07-01
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 7.5 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 10 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 12.5 mg/kg | — |
| Subject | Infliximab | Monoclonal antibody | 15 mg/kg | — |