Tocilizumab for Painful Chronic Pancreatitis

Launched by SOREN SCHOU OLESEN · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called tocilizumab on individuals suffering from chronic pancreatitis, a condition that causes ongoing abdominal pain and discomfort due to inflammation of the pancreas. The trial aims to determine if tocilizumab can help reduce pain and improve the overall quality of life for patients with this condition. Participants in the study will be compared to a control group receiving a placebo, which looks like the real medication but has no active ingredients.

To join the study, participants must be adults aged 18 or older who have been diagnosed with chronic pancreatitis and are experiencing ongoing pain. They should have evidence of recent pancreatic inflammation, like elevated pain levels and specific lab results. However, those with certain severe conditions, previous treatments that might interfere, or active infections cannot participate. If you join, you’ll receive regular check-ups and assessments to monitor your health and how well the medication is working. This trial is currently recruiting participants, so there is an opportunity to contribute to important research that may help others with chronic pancreatitis in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Signed informed consent.
• * Probable or definitive diagnosis of CP according to the M-ANNHEIM criteria. This entails a typical clinical history of CP, including recurrent pancreatitis or abdominal pain in combination with the following additional criteria:
• * A definitive diagnosis of CP is established by one or more of the following additional criteria:
• • i) Pancreatic calcification
• • ii) Moderate or marked ductal lesions (according to the Cambridge classification)
• • iii) Exocrine pancreatic insufficiency, defined as pancreatic steatorrhea markedly reduced by enzyme supplementation
• • iv) Histological verification of CP
• * A probable diagnosis of CP is established by one or more of the following additional criteria:
• • i) Mild ductal alterations (according to the Cambridge classification)
• • ii) Recurrent or persistent pseudocysts
• • iii) Pathological test of pancreatic exocrine function (such as faecal elastase-1 test, secretin test, secretin-pancreozymin test)
• • iv) Diabetes mellitus
• • Abdominal pain of presumed pancreatic origin (i.e., upper abdominal pain radiating to the back).
• * Evidence of ongoing pancreatic inflammatory activity, with an inflammatory pancreatic flare occurring one or more times within the past six months. An inflammatory pancreatic flare is defined as an exacerbation of pancreatic pain in combination with one or more of the following criteria:
• • i) Plasma amylase levels elevated 2-fold or more than the participant's usual amylase level.
• • ii) Elevated plasma levels of CRP 2-fold the upper normal level without suspicion of other sources such as infection.
• • iii) Signs of pancreatic inflammation on cross-sectional imaging.
• • ≥ 18 years of age
• • The participant must be able to read and understand the informed consent forms.
• • The participant is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures.
• Exclusion Criteria:
• • End-stage CP indicated by severe pancreatic atrophy defined as segmented pancreas volume \<20 ml on the latest available cross-sectional imaging examination (Computed Tomography (CT) or MRI).
• • Pancreatic duct obstruction by a stricture and/or stone amendable to endoscopic or surgical treatment. Patients with previous pancreatic duct decompression procedures are allowed to participate.
• • Ongoing alcohol or substance abuse. The patient must document abstinence from alcohol and substance abuse for the preceding six months prior to study enrolment. Recreational alcohol consumption within the safety limits recommended by the National Danish Health Authorities (i.e., max. ten units of alcohol per week) is allowed.
• • Active or recurrent infections.
• • Untreated ulcers in the gastrointestinal tract (however, those who have undergone proper treatment and one month has elapsed with no recurrence of symptoms will not be excluded).
• • Known hypersensitivity to Tocilizumab.
• • Positive test for Tuberculosis during screening
• • Positive test for Hepatitis during screening
• • Severe liver disease, indicated by ALT with \>5 upper normal limits.
• • Thrombocytopenia (platelet count \< 50 x 109/L).
• • Neutropenia (neutrophil count \<2 x 109/L).
• • Pregnancy and no contraception use, fertile women (\<55 years) must provide a urine sample for pregnancy test upon inclusion.

Trial Officials