Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind Multi-centre Trial (RAPID-I) (RAPID-I)
Acute Pancreatitis
About this trial
This is an interventional treatment trial for Acute Pancreatitis
Eligibility Criteria
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 upper limit of normal; (3) characteristic findings on abdominal imaging (if undertaken urgently by CT or MRI)
- Patients in whom trial treatment can be started within 36 hours of the onset of abdominal pain allowing 120 min for preparation of trial medication
- Patients from whom appropriate consent is obtained (from the patient or their legal representative).
Exclusion Criteria:
- Age <18 or >85
- Patients with a bodyweight over 200 kg
- Onset of abdominal pain over 24 h before admission
- Previous AP or chronic pancreatitis
- Multiple sclerosis, systemic vasculitis, Guillain-Barré syndrome or other demyelinating disorder
- Known epilepsy
- Moderate to severe heart failure and/or coronary disease (NYHA III/IV)
- Severe respiratory conditions including cystic fibrosis, severe asthma and severe chronic obstructive pulmonary disease (COPD)
- On home oxygen or home mechanical ventilation
- Known advanced liver disease
- Known cancer for which chemotherapy and/or radiotherapy ongoing/completed in last 6 months
- Known haematological malignancy
- Known cancer with palliative care
- Known established infection prior to or suspected infection, including COVID-19, at the time of AP onset
- Known history of tuberculosis, or household contact with those with tuberculosis or opportunistic infection
- Known history of infective hepatitis
- Rare diseases or inborn errors of metabolism that significantly increase the risk of infections, including severe combined immunodeficiency (SCID) and homozygous sickle cell disease
- Known live vaccine or infectious agent within one month of admission
- Known immunosuppressive or biologic therapy within one month of admission
- Known hypersensitivity to infliximab or to inactive components of REMICADE® or to any murine proteins
- Known pregnancy or lactation at admission
- Females of childbearing potential who do not agree to use adequate contraception up to 6 months after infliximab infusion
- Known participation in investigational medicinal product study within last three months.
Sites / Locations
- Royal Liverpool University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Placebo Comparator
Infusion of 5 mg/kg Infliximab
Infusion of 10 mg/kg Infliximab
0.9% Sodium Chloride (Placebo)
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.
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.
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.