2023-510084-35-00招募中2 期
Tocilizumab for Painful Chronic Pancreatitis: A Randomised, Placebo-controlled, Double-blinded, Investigator-initiated Trial (TOPAC trial)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
We hypothesise that treatment with tocilizumab, compared with a placebo, will reduce symptom burden (CP-related pain) and improve physical functioning and quality of life in patients with CP.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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 (specific details for definitive (New ID 3) and for probable (New ID 4))
- •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.
- •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
- •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 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
- •≥ 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
排除标准
- •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).
- •Pregnancy, fertile women (<55 years) must provide a urine sample for pregnancy test upon inclusion.
- •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.
- •Severe liver disease, indicated by ALT with >5 upper normal limit.
- •Thrombocytopenia (platelet count < 50 x 109/L).
- •Neutropenia (neutrophil count <2 x 109/L).
结局指标
主要结局
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.
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.
次要结局
- 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.
- The Brief Pain Inventory Short Form (mBPI-SF) pain severity and interference scores between treatment groups (tocilizumab vs. placebo) at weeks 12 and 24.
- The average daily pain score (registered in the mBPI-SF) between treatment groups (tocilizumab vs. placebo) at week 24.
- The Patient Global Impression of Change (PGIC) questionnaire between treatment groups (tocilizumab vs. placebo) at week 24.
- The CP prognosis score (COPPS)-score between treatment groups (tocilizumab vs. placebo) at week 24.
- Use of analgesics, including opioid-based therapies (type and dose).
- Adherence to treatment and frequency of adverse events.
研究者
Søren Schou Olesen
Scientific
Aalborg University Hospital
研究点 (1)
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