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Could an arthritis drug tame pancreatitis inflammation?

NCT ID NCT03684278

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jul 07, 2026 · Updated 2 times

Summary

This study tests whether a single infusion of infliximab, a drug used for arthritis and Crohn's disease, can reduce inflammation in adults with acute pancreatitis. About 290 participants will receive either a low dose, a high dose, or a placebo. The main goal is to see if infliximab lowers C-reactive protein levels, a marker of inflammation, over two weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Infliximab (Remicade), an anti-inflammatory drug given as a single infusion
What this could lead to
If it works, this could point toward a new treatment to reduce severe inflammation in acute pancreatitis, potentially preventing complications.
What could go wrong
This is a mid-stage trial with only 290 people, so results may not apply to everyone. Infliximab can increase infection risk, and it's being tested for a new use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 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 Criteria: * 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 (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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aberdeen Royal Infirmary

    RECRUITING

    Aberdeen, Aberdeenshire, AB25 2ZN, United Kingdom

  • Aintree University Hospital

    RECRUITING

    Liverpool, Merseyside, L9 7AL, United Kingdom

  • Arrowe Park Hospital

    WITHDRAWN

    Upton, Wirral, CH49 5PE, United Kingdom

  • Charing Cross Hospital

    TERMINATED

    London, Greater London, W6 8RF, United Kingdom

  • John Radcliffe Hospital

    RECRUITING

    Oxford, Oxfordshire, OX3 9DU, United Kingdom

  • Queen's Medical Centre

    TERMINATED

    Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

  • Royal Cornwall Hospital

    WITHDRAWN

    Truro, Cornwall, TR1 3LJ, United Kingdom

  • Royal Devon and Exeter Hospital

    RECRUITING

    Exeter, Devon, EX2 5DW, United Kingdom

  • Royal Liverpool University Hospital

    RECRUITING

    Liverpool, Merseyside, L7 8XP, United Kingdom

  • St James's University Hospital

    RECRUITING

    Leeds, West Yorkshire, LS9 7TF, United Kingdom

  • St Mary's Hospital

    TERMINATED

    London, Greater London, W2 1NY, United Kingdom

  • University College London Hospital

    RECRUITING

    London, Greater London, NW1 2BU, United Kingdom

  • University Hospital of Wales

    RECRUITING

    Cardiff, Cardiff, CF14 4XW, United Kingdom

  • Whiston Hospital

    TERMINATED

    Whiston, Merseyside, L35 5DR, United Kingdom

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Other studies related to the condition(s) this trial covers.