Acute PancreatitisPhase 2RAPID-INCT03684278
Randomised Treatment of Acute Pancreatitis With Infliximab: Double-blind, Placebo-controlled, Multi-centre Trial (RAPID-I)
A Phase 2 study testing Infusion of 5 mg/kg Infliximab and Infusion of 10 mg/kg Infliximab in people with Acute Pancreatitis, run by University of Liverpool at 14 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Pancreatitis
- What is being tested?
- Infusion of 5 mg/kg Infliximab and Infusion of 10 mg/kg Infliximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 14 sitesUnited Kingdom
- Study dates
- 1 May 2019to 6 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 22Show fewer
- Severe respiratory conditions including cystic fibrosis, severe asthma and severe chronic obstructive pulmonary disease (COPD)
- On home oxygen or home mechanical ventilation
- Jaundice (serum bilirubin >50 µmol/L), and/or known advanced liver disease, on waiting list for liver transplantation or considered unsuitable for transplantation
- Known cancer for which chemotherapy and/or radiotherapy ongoing/completed in last 6 months
- Known haematological malignancy
- Known end-stage cancer requiring 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.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
United Kingdom14 sites, 8 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire, AB25 2ZN
Jamie Cooper, MD, jamie.cooper2@nhs.scot
- Recruiting
University Hospital of Wales
Cardiff, Cardiff, CF14 4XW
David O'Reilly, MD, FRCS, David.O'reilly@wales.nhs.uk
- Recruiting
Royal Devon and Exeter Hospital
Exeter, Devon, EX2 5DW
Antonio Manzelli, MD, BSc, PhD, antonio.manzelli@nhs.net
- Recruiting
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
Andrew M Smith, MB, BS, MD, FRCS, andrewmsmith@nhs.net
- Recruiting
Royal Liverpool University Hospital
Liverpool, Merseyside, L7 8XP
Robert Sutton, DPhil, FRCS, r.sutton@liverpool.ac.uk
- Recruiting
Aintree University Hospital
Liverpool, Merseyside, L9 7AL
Rajarshi Mukherjee, MB, BChir, FRCS (Gen), PhD, rishim@liverpool.ac.uk
- Recruiting
University College London Hospital
London, Greater London, NW1 2BU
Samer Elkhodair, MD, samer.elkhodair@nhs.net
- Terminated
St Mary's Hospital
London, Greater London, W2 1NY
- Terminated
Charing Cross Hospital
London, Greater London, W6 8RF
- Terminated
Queen's Medical Centre
Nottingham, Nottinghamshire, NG7 2UH
- Recruiting
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Giles Bond-Smith, MB, BS, BSc, FRCS, Giles.Bond-smith@ouh.nhs.uk
- Withdrawn
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
- Withdrawn
Arrowe Park Hospital
Upton, Wirral, CH49 5PE
- Terminated
Whiston Hospital
Whiston, Merseyside, L35 5DR
About this study
Official title: Phase IIb, Randomised, Double-blind, Placebo-controlled, Multi-centre Trial of Infliximab With Transcriptomic Biomarker and Mechanism Evaluation in Patients With Acute Pancreatitis.
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.
Read the detailed description
Acute pancreatitis (AP) is an inflammatory disorder of the pancreas causing excruciating pain, gastrointestinal dysfunction and pronounced systemic inflammatory responses with circulatory and respiratory disturbances that can lead to organ failure and death.
Tumour necrosis factor alpha (TNFα) has a major role in the pathogenesis and severity of acute pancreatitis. TNFα levels rise early and remain elevated for days in human AP, proportional to severity, presenting a suitable drug target to inhibit the amplified immune responses that further damage the pancreas and drive widespread organ dysfunction.
Infliximab is a chimeric monoclonal antibody biologic drug that blocks the actions of tumor necrosis factor alpha (TNF-α) and is normally used to treat autoimmune diseases. Infliximab has been selected as it is given via intravenous infusion, which will ensure rapid bioavailability to treat AP. This is different from most other biologics, which are given subcutaneously.
This trial will determine the efficacy of early initiation of anti-TNF treatment in AP, setting new standards for trials in AP. Using a randomised, double-blind, placebo-controlled adaptive design, with two doses of a single intravenous infusion of infliximab at 5 mg/kg or 10 mg/kg (the higher dose arm was dropped on 19th May 2026, see Study Design), the trial will determine size of any effect and safety of this treatment.
- Conditions
- Acute Pancreatitis
- Being tested
- Infusion of 5 mg/kg Infliximab, Infusion of 10 mg/kg Infliximab, 0.9% Sodium Chloride (Placebo)
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion of 5 mg/kg InfliximabDrug
Also called Remicade
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 InfliximabDrug
Also called Remicade
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Infusion of 5 mg/kg Infliximab |
| 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. Receives: Drug: Infusion of 10 mg/kg Infliximab |
| 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. Receives: Other: 0.9% Sodium Chloride (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 2, 4 (+/- 1 day), and 14 (+/- 2 days)
Secondary outcomes (16)
Pain scores
Patient will complete a Numerical Rating Scale.The scale is from 0-10 (0= no pain and 10 = worst pain possible)
Measured: First 14 Days
Opiate requirements
Recording of daily morphine equivalents by research team
Measured: First 14 days
Nutritional deficit
Number of days without solid food for first 14 days
Measured: First 14 days
Decline in serum albumen
Albumen measured via blood samples
Measured: First 14 days
Rise in neutrophils
Neutrophils measured in blood samples
Measured: First 14 days
Sequential organ failure assessment (SOFA) score
Summed respiratory (0-4), cardiovascular (0-4) and renal (0-4) SOFA scores on each of the first 28 days after hospital admission
Measured: First 14 days
Local pancreatic injury
Contrast-enhanced CT scan assessed by a central panel
Measured: Day 14 +/- 7 days
Revised Atlanta Classification (RAC)
RAC severity classification (mild, moderate or severe)
Measured: 90 days after admission
Infective complications
Infective complications reported
Measured: First 90 days
Length of hospital stay
Length of time patient remains within hospital as an inpatient
Measured: Up to 90 days
Mortality
Patient death
Measured: Within the first 90 days
Patient reported outcome
EuroQol EQ-5D-5L
Measured: Day 4, Day 14 and Day 90
Potential safety signals
Adverse events relating to infliximab including infusion reactions and delayed serum sickness reactions
Measured: Up to 90 days
Anti-infliximab antibody concentration
Blood sample analysis to determine the concentration of anti-infliximab antibodies
Measured: Day 14
Incremental cost per quality adjusted life years (QALY) gained by trial treatment
QALYs using data from the EQ-5D-5L questionnaire
Measured: Days 4, 14 and 90
Infliximab concentration
Infliximab measured in blood samples
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 May 2019
- Primary completion15 Dec 2026 (estimated)
- Study completion6 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute PancreatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RAPID-I is a randomised, placebo-controlled, double-blind, multi-centre, three-arm, phase IIb efficacy trial of infliximab in patients with AP. Patients will be randomised (1:1:1 allocation ratio) to receive an intravenous infusion of either 5 mg/kg or 10 mg/kg infliximab or placebo, initiated within 36 hours of admission to hospital with acute pancreatitis. Following the second interim analysis, the Independent Data Monitoring and Safety Committee on 22nd April 2026 advised discontinuation of the higher dose arm, accepted by the Trial Steering Committee on 11th May 2026 and effected on 19th May 2026. From that date further randomisation will be to receive either 5 mg/kg infliximab or placebo (1:1 allocation ratio). Treatment allocation will only be revealed to those responsible for trial treatment preparation (Pharmacy or an independent research team not administering the trial medication) to ensure the research team administering the treatment remains blinded.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liverpool
- Sponsor type
- University, hospital or other
- Collaborators
- Bangor University, Liverpool University Hospitals NHS Foundation Trust, Medical Research Council, National Institute for Health Research, United Kingdom, Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Robert Sutton, DPhil, FRCS, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684278
- Sponsor's protocol ID
- UoL001326
- Other IDs
- 2017-003840-19, 15/20/01, 2017
- Acronym
- RAPID-I
- Status last verified
- Jun 2026
- First submitted
- 4 Jul 2018
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To ensure negotiations with Pharma and Regulatory Authorities for further trial(s) of infliximab for this indication will not be impeded.
Publications
Lin J, Smyth M, Spowart C, Brown M, Powell I, Latawiec D, Wu D, Huang W, Mukherjee R, Szatmary P, Baron R, Dunne D, Evans J, Srinivas S, Bond-Smith G, Cooper J, Smith A, Manzelli A, Elkhodair S, O'Reilly D, Mitra V, Body R, Siriwardena AK, Subramanian S, Plumpton C, Hughes DA, Mclaren T, Lucas A, Gamble C, Jaki T, Sutton R. Randomised treatment of acute pancreatitis with infliximab: protocol for a double-blind, placebo-controlled, multi-centre, adaptive, phase 2 superiority trial (RAPID-I). BMJ Open. 2026 Sep 18;16(9):e118729. doi: 10.1136/bmjopen-2026-118729.
PubMed 42760074
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIb, Randomised, Double-blind, Placebo-controlled, Multi-centre Trial of Infliximab With Transcriptomic Biomarker and Mechanism Evaluation in Patients With Acute Pancreatitis.
- ClinicalTrials.gov ID
- NCT03684278
- Acronym / sponsor ID
- RAPID-I / UoL001326
- Conditions
- Acute Pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- University of LiverpoolUniversity, hospital or other
- Collaborators
- Bangor University, Liverpool University Hospitals NHS Foundation Trust, Medical Research Council, National Institute for Health Research, United Kingdom, Merck Sharp & Dohme LLC
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 6 Mar 2027 (estimated)
- First posted
- 25 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute pancreatitis (AP) is an inflammatory disorder of the pancreas causing excruciating pain, gastrointestinal dysfunction and pronounced systemic inflammatory responses with circulatory and respiratory disturbances that can lead to organ failure and death.
Tumour necrosis factor alpha (TNFα) has a major role in the pathogenesis and severity of acute pancreatitis. TNFα levels rise early and remain elevated for days in human AP, proportional to severity, presenting a suitable drug target to inhibit the amplified immune responses that further damage the pancreas and drive widespread organ dysfunction.
Infliximab is a chimeric monoclonal antibody biologic drug that blocks the actions of tumor necrosis factor alpha (TNF-α) and is normally used to treat autoimmune diseases. Infliximab has been selected as it is given via intravenous infusion, which will ensure rapid bioavailability to treat AP. This is different from most other biologics, which are given subcutaneously.
This trial will determine the efficacy of early initiation of anti-TNF treatment in AP, setting new standards for trials in AP. Using a randomised, double-blind, placebo-controlled adaptive design, with two doses of a single intravenous infusion of infliximab at 5 mg/kg or 10 mg/kg (the higher dose arm was dropped on 19th May 2026, see Study Design), the trial will determine size of any effect and safety of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- RAPID-I is a randomised, placebo-controlled, double-blind, multi-centre, three-arm, phase IIb efficacy trial of infliximab in patients with AP. Patients will be randomised (1:1:1 allocation ratio) to receive an intravenous infusion of either 5 mg/kg or 10 mg/kg infliximab or placebo, initiated within 36 hours of admission to hospital with acute pancreatitis. Following the second interim analysis, the Independent Data Monitoring and Safety Committee on 22nd April 2026 advised discontinuation of the higher dose arm, accepted by the Trial Steering Committee on 11th May 2026 and effected on 19th May 2026. From that date further randomisation will be to receive either 5 mg/kg infliximab or placebo (1:1 allocation ratio). Treatment allocation will only be revealed to those responsible for trial treatment preparation (Pharmacy or an independent research team not administering the trial medication) to ensure the research team administering the treatment remains blinded.
| Arm | Type | Receives |
|---|---|---|
| Infusion of 5 mg/kg Infliximab | Active comparator | Drug: Infusion of 5 mg/kg InfliximabInfliximab (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 | Drug: Infusion of 10 mg/kg InfliximabInfliximab (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 | Other: 0.9% Sodium Chloride (Placebo)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion of 5 mg/kg InfliximabAlso: RemicadeInfliximab 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). | Drug | Infusion of 5 mg/kg Infliximab |
| Infusion of 10 mg/kg InfliximabAlso: RemicadeInfliximab 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). | Drug | Infusion of 10 mg/kg Infliximab |
| 0.9% Sodium Chloride (Placebo)250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride | Other | 0.9% Sodium Chloride (Placebo) |
Primary outcome
Difference in mean serum CRP measured on days 2, 4 and 14
Time frame: Days 2, 4 (+/- 1 day), and 14 (+/- 2 days)
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.
16 secondary outcomes
Pain scores
Time frame: First 14 Days
Opiate requirements
Time frame: First 14 days
Nutritional deficit
Time frame: First 14 days
Decline in serum albumen
Time frame: First 14 days
Rise in neutrophils
Time frame: First 14 days
Sequential organ failure assessment (SOFA) score
Time frame: First 14 days
Local pancreatic injury
Time frame: Day 14 +/- 7 days
Revised Atlanta Classification (RAC)
Time frame: 90 days after admission
Infective complications
Time frame: First 90 days
Length of hospital stay
Time frame: Up to 90 days
Mortality
Time frame: Within the first 90 days
Patient reported outcome
Time frame: Day 4, Day 14 and Day 90
Potential safety signals
Time frame: Up to 90 days
Anti-infliximab antibody concentration
Time frame: Day 14
Incremental cost per quality adjusted life years (QALY) gained by trial treatment
Time frame: Days 4, 14 and 90
Infliximab concentration
Time frame: Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 42760074Lin J, Smyth M, Spowart C, Brown M, Powell I, Latawiec D, Wu D, Huang W, Mukherjee R, Szatmary P, Baron R, Dunne D, Evans J, Srinivas S, Bond-Smith G, Cooper J, Smith A, Manzelli A, Elkhodair S, O'Reilly D, Mitra V, Body R, Siriwardena AK, Subramanian S, Plumpton C, Hughes DA, Mclaren T, Lucas A, Gamble C, Jaki T, Sutton R. Randomised treatment of acute pancreatitis with infliximab: protocol for a double-blind, placebo-controlled, multi-centre, adaptive, phase 2 superiority trial (RAPID-I). BMJ Open. 2026 Sep 18;16(9):e118729. doi: 10.1136/bmjopen-2026-118729.
- Individual participant dataSharing planned: No. To ensure negotiations with Pharma and Regulatory Authorities for further trial(s) of infliximab for this indication will not be impeded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Sutton, DPhil, FRCS principal investigator
University of Liverpool
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infusion of 5 mg/kg Infliximab and Infusion of 10 mg/kg Infliximab in people with Acute Pancreatitis, run by University of Liverpool at 14 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matt Smyth, BSc ((0) 151 794 9774, rapid.one@liverpool.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in mean serum CRP measured on days 2, 4 and 14 (time frame: Days 2, 4 (+/- 1 day), and 14 (+/- 2 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684278, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.