Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)
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.
3 other identifiers
interventional
290
1 country
13
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
Longer than P75 for phase_2
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
September 4, 2025
August 1, 2025
7.3 years
July 4, 2018
August 27, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in mean serum CRP measured on days 2, 4 and 14
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.
Days 2, 4 (+/- 1 day), and 14 (+/- 2 days)
Secondary Outcomes (16)
Pain scores
First 14 Days
Opiate requirements
First 14 days
Nutritional deficit
First 14 days
Decline in serum albumen
First 14 days
Rise in neutrophils
First 14 days
- +11 more secondary outcomes
Study Arms (3)
Infusion of 5 mg/kg Infliximab
ACTIVE COMPARATORInfliximab (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 COMPARATORInfliximab (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 COMPARATOR250 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.
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
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Liverpoollead
- Bangor Universitycollaborator
- Liverpool University Hospitals NHS Foundation Trustcollaborator
- Medical Research Councilcollaborator
- National Institute for Health Research, United Kingdomcollaborator
- Merck Sharp & Dohme LLCcollaborator
Study Sites (13)
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom
University Hospital of Wales
Cardiff, Cardiff, CF14 4XW, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW, United Kingdom
University College London Hospital
London, Greater London, NW1 2BU, United Kingdom
St Mary's Hospital
London, Greater London, W2 1NY, United Kingdom
Charing Cross Hospital
London, Greater London, W6 8RF, United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP, United Kingdom
Aintree University Hospital
Liverpool, Merseyside, L9 7AL, United Kingdom
Whiston Hospital
Whiston, Merseyside, L35 5DR, United Kingdom
Queen's Medical Centre
Nottingham, Nottinghamshire, NG7 2UH, United Kingdom
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Sutton, DPhil, FRCS
University of Liverpool
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Once the delegated research team member performs randomisation and the staff member responsible for preparation of trial medication is provided with the allocation to either Arm A, B or C, that latter staff member will prepare the infusion, which will be covered by an opaque sleeve and labelled for blinding.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2018
First Posted
September 25, 2018
Study Start
May 1, 2019
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
September 4, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share