Tocilizumab for Painful Chronic Pancreatitis
ConditionPancreatitis, Chronic
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSoren Schou Olesen
About this trial
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.
Eligibility criteria
Qualifiers
Signed informed consent.
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Tocilizumab 20 MG/ML [Actemra]
- Sodium Chloride 0.9% Inj
Treatment groups
36 Participants
are divided into 2 treatment groupsSponsors and collaborators
Soren Schou Olesen
Lead sponsor
Aalborg University Hospital
Sponsor institution
Aarhus University Hospital
Collaborator
University of Aarhus
Collaborator
Viborg Regional Hospital
Collaborator
Stanford University
Collaborator
Haukeland University Hospital
Collaborator
Source ClinicalTrials.gov