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Tocilizumab · 1 trial · 2 indications
ProBNP plasma concentration being assessed at multiple time points (including the primary endpoint) will be analyzed by application of a linear mixed model of covariance. As the biomarker will be measured prior to initiation of the study drug, the models will be baseline corrected (i.e., constrained linear mixed models, CLMM). The main result of these analyses will be the treatment-by-time interaction as a marker of whether the proBNP levels change differently over time in the treatment versus the placebo arm.
| Arm | Type | Description |
|---|---|---|
| Tocilizumab + Dobutamine | ACTIVE_COMPARATOR | Tocilizumab IV 280 mg (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours) |
| Tocilizumab + Placebo | ACTIVE_COMPARATOR | Tocilizumab IV 280 mg (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours) |
| Placebo + Dobutamine | ACTIVE_COMPARATOR | NaCl 0,9% IV (100mL/hour, 1 hour) Dobutamine IV 5 micrograms/kg/minute (5mL/hour, 24 hours) |
| Placebo + Placebo | PLACEBO_COMPARATOR | NaCl 0,9% IV (100mL/hour, 1 hour) NaCl 0,9% IV (5mL/hour, 24 hours) |
| Name | Type | Description |
|---|---|---|
| Tocilizumab | DRUG | Single bolus |
| Dobutamine | DRUG | Continous weight-adjusted infusion |
| NaCl 0.9% | DRUG | Placebo comparator and diluent |
Inclusion Criteria: * Acute myocardial infarction * Revascularization with PCI * Presentation within 24 hours of chest pain * ORBI risk score ≥ 10 * Age ≥ 18 Exclusion Criteria: * Unwilling to give informed consent to study participation * Unable to give consent due to language barrier * Comatose...
Tocilizumab is being studied for use in acute myocardial infarction, specifically in patients with high risk of cardiogenic shock. It is administered as a single dose in combination with low-dose dobutamine. The drug is currently in Phase 2 clinical development and is not yet approved for this indication.
Tocilizumab is a monoclonal antibody that targets the interleukin-6 receptor. By binding to this receptor, it modulates inflammatory pathways that are relevant in the setting of acute myocardial infarction. This mechanism is being evaluated in a Phase 2 trial for patients at high risk of cardiogenic shock.
Tocilizumab is being developed by Novo Nordisk A/S, a company traded under the ticker NVO. The drug is currently in Phase 2 clinical development for acute myocardial infarction. Novo Nordisk is conducting a randomized, double-blind, placebo-controlled trial to evaluate its safety and efficacy in this patient population.
Tocilizumab is in Phase 2 clinical development for acute myocardial infarction. It is an investigational drug and has not been approved by regulatory authorities for this use. The ongoing Phase 2 trial is active but not recruiting, with an enrollment target of 100 participants in Denmark.
Tocilizumab is being evaluated in a Phase 2 clinical trial with the identifier NCT05350592. The trial is titled 'Low-Dose Dobutamine and Single-Dose Tocilizumab in Acute Myocardial Infarction With High Risk of Cardiogenic Shock.' It is a randomized, double-blind, placebo-controlled study enrolling 100 adults aged 18 years and older in Denmark.
Tocilizumab is the same drug as Actemra, which is a brand name for tocilizumab. However, in the context of this Phase 2 trial for acute myocardial infarction, it is being investigated by Novo Nordisk. The drug is a monoclonal antibody targeting the interleukin-6 receptor.