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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Tocilizumab 20 MG/ML [Actemra]
DrugTocilizumab 8 mg/kg every four weeks for 24 weeks.
Sodium Chloride 0.9% Inj
DrugPlacebo (Sodium chloride) every four weeks for 24 weeks.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: TocilizumabActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The Comprehensive Pain Assessment Tool Short Form (COMPAT-SF) Questionnaire
The between-group difference (tocilizumab vs. placebo) of the change from baseline in the COMPAT-SF score at 24 weeks. The COMPAT-SF score is noramlized on a 0-100 score. Higher scores indicate a higher degree of pain.
Time frame
The intervention period is 24 weeks (assessed every 4 weeks from baseline to finalization)Secondary outcomes
1
Global Quality of Life Score (EORTC-QLQ-C30)
The between-group difference in the Global Quality of Life Score from baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 (EORTC-QLQ-C30) questionnaire at 24 weeks. The global quality of life score range from 0 to 100. A high score on the Global Quality of Life score represents a high level of life quality.
Time frame
The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)2
Physical Functional Score (EORTC-QLQ-C30)
The between-group difference in Physical Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The physical functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning.
Time frame
The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)3
Role Functional Score (EORTC-QLQ-C30)
The between-group difference in Role Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The role functional score ranges from 0 to 100 A high score on the functional scales represents a high level of daily functioning.
Time frame
The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)4
Cognitive Functional Score (EORTC-QLQ-C30)
The between-group difference in Cognitive Functional Score from baseline in the EORTC-QLQ-C30 questionnaire at 24 weeks. The cognitive functional score ranges from 0 to 100. A high score on the functional scales represents a high level of daily functioning.
Time frame
The intervention period is 24 weeks (assessed at weeks 0, 12, and 24)Other outcomes
1
Levels of soluble inflammation biomarker
The investigators plan to use an O-link multiplex platform to examine changes in soluble inflammatory biomarker levels, including several cytokines and chemokines.
Time frame
The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24)2
Levels of soluble fibrosis biomarker
The investigators plan to use an O-link multiplex platform to examine changes in soluble fibrosis biomarker levels, from baseline at 24 weeks.
Time frame
The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24)3
Levels of soluble Biomarker of Macrophage Activation
Macrophage activation biomarkers will be analyzed using enzyme-linked immunosorbent assays (ELISAs) levels, from baseline at 24 weeks.
Time frame
The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24)4
Levels of key Inflammatory Mediator
For the key inflammatory mediator, found in above mentioned analysis, the investigators will confirm the analyses using ELISAs levels from baseline at 24 weeks.
Time frame
The intervention period is 24 weeks (samples drawn at weeks 0, 4, 8, 16, and 24)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
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