Tocilizumab for Chronic pancreatitis

Inclusion criteria

• {"criterion_text":"- Signed informed consent"}
• {"criterion_text":"- 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 (specific details for definitive (New ID 3) and for probable (New ID 4))"}
• {"criterion_text":"- 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, and/or (iv) Histological verification of CP."}
• {"criterion_text":"- 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), and/or (iv) Diabetes mellitus"}
• {"criterion_text":"- Abdominal pain of presumed pancreatic origin (i.e., upper abdominal pain radiating to the back)."}
• {"criterion_text":"- 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 of 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, and/or (iii) Signs of pancreatic inflammation on cross-sectional imaging"}
• {"criterion_text":"- ≥ 18 years of age"}
• {"criterion_text":"- The participant must be able to read and understand the informed consent forms"}
• {"criterion_text":"- The participant is willing and able to comply with the scheduled visits, treatment plan, and other trial procedures"}

Exclusion criteria

• {"criterion_text":"- 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 or MRI)."}
• {"criterion_text":"- Pregnancy, fertile women (<55 years) must provide a urine sample for pregnancy test upon inclusion."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Active or recurrent infections."}
• {"criterion_text":"- 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)."}
• {"criterion_text":"- Known hypersensitivity to Tocilizumab."}
• {"criterion_text":"- Severe liver disease, indicated by ALT with >5 upper normal limit."}
• {"criterion_text":"- Thrombocytopenia (platelet count < 50 x 109/L)."}
• {"criterion_text":"- Neutropenia (neutrophil count <2 x 109/L)."}

Primary endpoints

• {"endpoint_text":"- The primary outcome assessment parameter is the total score of the COMPAT-SF questionnaire (31). The primary endpoint is the difference between the tocilizumab and placebo-treated groups in the COMPAT-SF score after 24 weeks.","definition_or_measurement_approach":"Total score of the COMPAT-SF questionnaire; the endpoint is the between-group difference (tocilizumab vs placebo) in COMPAT-SF score at 24 weeks."}

Secondary endpoints

• {"endpoint_text":"- The European Organization for Research and Treatment of Cancer Quality of Life (EORTC-QLQ-C30) questionnaire between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24.","definition_or_measurement_approach":"EORTC-QLQ-C30 scores compared between treatment groups at weeks 12 and 24."}
• {"endpoint_text":"- The Brief Pain Inventory Short Form (mBPI-SF) pain severity and interference scores between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24.","definition_or_measurement_approach":"mBPI-SF pain severity and interference scores compared between treatment groups at weeks 12 and 24."}
• {"endpoint_text":"- The average daily pain score (registered in the mBPI-SF) between treatment groups (tocilizumab vs. placebo) at week 24.","definition_or_measurement_approach":"Average daily pain score from mBPI-SF compared between groups at week 24."}
• {"endpoint_text":"- The Patient Global Impression of Change (PGIC) questionnaire between treatment groups (tocilizumab vs. placebo) at week 24.","definition_or_measurement_approach":"PGIC responses compared between treatment groups at week 24."}
• {"endpoint_text":"- The CP prognosis score (COPPS)-score between treatment groups (tocilizumab vs. placebo) at week 24.","definition_or_measurement_approach":"COPPS-score compared between groups at week 24."}
• {"endpoint_text":"- Use of analgesics, including opioid-based therapies (type and dose).","definition_or_measurement_approach":"Assessment of analgesic use (type and dose) between treatment groups (timepoints not further specified beyond general follow-up)."}
• {"endpoint_text":"- Adherence to treatment and frequency of adverse events.","definition_or_measurement_approach":"Assessment of treatment adherence and adverse event frequency between groups."}

Denmark

Earliest CTIS Part Ii Submission Date

23-03-2024

Latest Decision Or Authorization Date

25-03-2024

Processing Time Days

2

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

Aalborg University Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Aalborg University Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}