Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind Multi-centre Trial (RAPID-I)

• Status: Suspended
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the effectiveness and safety of infliximab in the treatment of acute pancreatitis in adults. A third of participants will receive one single dose of infliximab via infusion, another third will receive a higher dose of infliximab via infusion and the final third of participants will receive a placebo infusion.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Professor Robert Sutton
• Collaborators: Bangor University; Clinical Trials Research Centre; Liverpool Clinical Trials Centre; Liverpool University Hospitals NHS Foundation Trust; Medical Research Council; Merck Sharp & Dohme Corp.; National Institute for Health Research, United Kingdom; Royal Liverpool and Broadgreen University Hospitals NHS Trust; University of Liverpool
• Treatments: Infliximab

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.