Trial Details
Not RecruitingBasic Information
| Clinical ID | c3029 |
|---|---|
| Identifier | NL-OMON42154 |
| Trial Title | Precision dosing of infliximab (IFX): the efficacy and economic effect of *precision dosing* of maintenance treatment with IFX in comparison with standard IFX maintenance treatment in inflammatory bowel disease. - Precision dosing of infliximab |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | IBD Inflammatory Bowel disease;10017969 |
| Interventions | Patients in the intervention arm will receive individualized treatment with variable IFX dosing AND/OR intervals guided by a Bayesian pharmacokinetic model, aiming to achieve an IFX TL of 3 mg/ml. Patients in the control group will continue to receive the same IFX treatment regimen that was given prior to inclusion without dose adaptation. In the control group, treatment adjustments will only be made in case of signs of active disease, in accordance to current routine care but these patients will be considered as failures to their treatment. |
Participant Information
| Sponsor | Academisch Medisch Centrum |
|---|---|
| City | - |
| Country/Region | Netherlands |
Enrollment Criteria
| Sex Requirement | NOT SPECIFIED |
|---|---|
| Age Requirement | ADULT, ELDER, OLDER_ADULT |
Study Design
| Study Type | Interventional |
|---|---|
| Phase | Not Available |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |