Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06426160

Tocilizumab for Painful Chronic Pancreatitis

Led by Soren Schou Olesen · Updated on 2024-06-25

36

Participants Needed

1

Research Sites

105 weeks

Total Duration

On this page

Sponsors

S

Soren Schou Olesen

Lead Sponsor

A

Aarhus University Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

This placebo-controlled study will investigate the effect of tocilizumab (an anti-interleukin-6 receptor antibody) on symptom burden, physical functioning, and quality of life in patients with chronic pancreatitis.

CONDITIONS

Official Title

Tocilizumab for Painful Chronic Pancreatitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent.
  • Probable or definitive diagnosis of chronic pancreatitis (CP) according to M-ANNHEIM criteria, including typical clinical history such as recurrent pancreatitis or abdominal pain.
  • Definitive diagnosis includes pancreatic calcification, moderate or marked ductal lesions, exocrine pancreatic insufficiency, or histological verification.
  • Probable diagnosis includes mild ductal alterations, recurrent or persistent pseudocysts, pathological pancreatic exocrine function tests, or diabetes mellitus.
  • Abdominal pain of presumed pancreatic origin (upper abdominal pain radiating to the back).
  • Evidence of ongoing pancreatic inflammatory activity with an inflammatory flare occurring one or more times within the past six months.
  • Flare defined by increased pancreatic pain plus elevated plasma amylase (2-fold or more), elevated CRP (2-fold upper normal level) without other infection sources, or signs of pancreatic inflammation on imaging.
  • At least 18 years old.
  • Ability to read and understand informed consent forms.
  • Willingness and ability to comply with scheduled visits, treatment, and trial procedures.
Not Eligible

You will not qualify if you...

  • End-stage CP with severe pancreatic atrophy (pancreas volume less than 20 ml on recent CT or MRI).
  • Pancreatic duct obstruction by stricture or stone treatable by endoscopy or surgery (previous decompression allowed).
  • Ongoing alcohol or substance abuse; must have abstained for six months prior to enrollment; recreational alcohol within safety limits allowed.
  • Active or recurrent infections.
  • Untreated gastrointestinal ulcers (treated and stable patients allowed).
  • Known allergy to tocilizumab.
  • Positive tuberculosis or hepatitis test during screening.
  • Severe liver disease (ALT more than 5 times upper normal limit).
  • Low platelet count (less than 50 x 10^9/L).
  • Low neutrophil count (less than 2 x 10^9/L).
  • Pregnancy without contraception; fertile women under 55 must have a negative pregnancy test at inclusion.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Centre for Pancreatic Diseases and Mech-Sense research laboratory, Aalborg University Hospital

Aalborg, North Denmark, Denmark, 9000

Actively Recruiting

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Research Team

R

Rasmus Hagn-Meincke, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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