Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)
Phase IIb, Randomised, Double-blind, Placebo-controlled, Multi-centre Trial of Infliximab With Transcriptomic Biomarker and Mechanism Evaluation in Patients With Acute Pancreatitis.
University of Liverpool
290 participants
May 1, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 admission to hospital with a new diagnosis of acute pancreatitis allowing 120 min for preparation of trial medication
- Patients from whom appropriate consent is obtained (from the patient or their legal representative).
Exclusion Criteria22
- Age <18 or >85
- Patients with a bodyweight over 200 kg
- Known previous AP within the last 30 days 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
- Jaundice and/or 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.
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Interventions
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).
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).
250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride
Locations(13)
View Full Details on ClinicalTrials.gov
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NCT03684278