Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Infusion of/kg Infliximab · 1 trial · 1 indication
Difference in mean serum CRP measured on (summated as AUC) in the active arms (5 mg/kg or 10 mg/kg) versus the placebo arm. CRP assays will be undertaken on blood samples centrally to ensure standardised measurement, and when central measurements of CRP at specific time points are not available for any patient, CRP measures from that patient's specific recruiting centre will be sought.
| Arm | Type | Description |
|---|---|---|
| Infusion of 5 mg/kg Infliximab | ACTIVE_COMPARATOR | Infliximab (Remicade) to be administered as a one time intravenous infusion in 250 ml (500 ml if patient weighs over 100 kg) 0.9% sodium chloride solution over a period of 2 hours. Dosage calculated at 5 mg of Infliximab, per kg of patient body weight. |
| Infusion of 10 mg/kg Infliximab | ACTIVE_COMPARATOR | Infliximab (Remicade) to be administered as a one time intravenous infusion in 250 ml (500 ml if patient weighs over 100 kg) 0.9% sodium chloride solution over a period of 2 hours. Dosage calculated at 10 mg of Infliximab, per kg of patient body weight. |
| 0.9% Sodium Chloride (Placebo) | PLACEBO_COMPARATOR | 250 ml (500 ml if patient weighs over 100 kg) 0.9% Sodium Chloride to be administered as a one time intravenous infusion over a period of 2 hours. |
| Name | Type | Description |
|---|---|---|
| Infusion of 5 mg/kg Infliximab | DRUG | Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP). |
| Infusion of 10 mg/kg Infliximab | DRUG | Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP). |
| 0.9% Sodium Chloride (Placebo) | OTHER | 250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride |
Inclusion Criteria: * Adult patients attending Accident and Emergency (A\&E) at or admitted to recruiting hospitals via a GP with a new diagnosis of AP established by two of the following three criteria: (1) typical continuous upper abdominal pain; (2) amylase and/or lipase three or more times the ...
Infusion of/kg Infliximab is an investigational small molecule being studied for the treatment of acute pancreatitis. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is administered as an infusion and is being evaluated in a randomized, double-blind, placebo-controlled trial.
Infusion of/kg Infliximab is a small molecule that targets tumor necrosis factor-alpha (TNF-alpha), a key inflammatory cytokine involved in the systemic inflammatory response seen in acute pancreatitis. By inhibiting TNF-alpha, the drug aims to reduce pancreatic inflammation and associated organ damage during acute episodes.
Infusion of/kg Infliximab is being developed by Merck & Company, Inc., a global biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting a Phase 2 clinical trial to evaluate the drug's safety and efficacy in patients with acute pancreatitis.
Infusion of/kg Infliximab is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is recruiting participants to assess the treatment's effect on acute pancreatitis outcomes.
Infusion of/kg Infliximab is being studied in a single Phase 2 trial with the identifier NCT03684278, titled "Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)." This randomized, double-blind, placebo-controlled study is recruiting 240 participants in the United Kingdom.
Yes, Infusion of/kg Infliximab is also known as Infusion of 5 mg/kg Infliximab. The alternative name specifies the dose being evaluated in the clinical trial. Both names refer to the same investigational drug being developed by Merck & Company, Inc. for acute pancreatitis.