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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

290 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2027-03-31

Brief Summary

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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.

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Detailed Description

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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 trial will determine size of any effect and safety of this treatment.

Conditions

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Acute Pancreatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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. 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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Study Groups

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Infusion of 5 mg/kg Infliximab

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.

Group Type ACTIVE_COMPARATOR

Infusion of 5 mg/kg Infliximab

Intervention Type DRUG

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 Infliximab

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.

Group Type ACTIVE_COMPARATOR

Infusion of 10 mg/kg Infliximab

Intervention Type DRUG

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)

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.

Group Type PLACEBO_COMPARATOR

0.9% Sodium Chloride (Placebo)

Intervention Type OTHER

250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride

Interventions

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Infusion of 5 mg/kg Infliximab

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).

Intervention Type DRUG

Infusion of 10 mg/kg Infliximab

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).

Intervention Type DRUG

0.9% Sodium Chloride (Placebo)

250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride

Intervention Type OTHER

Other Intervention Names

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Remicade Remicade

Eligibility Criteria

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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 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No