[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tocilizumab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tocilizumab":34},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,55],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":35,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100564074","phase-4-immunomodulatory-effects-of-dexamethasone-tocilizumab-and-anakinra-during-experimental-human-endotoxemia-100564074",false,"NCT06624436","Immunomodulatory Effects of Dexamethasone, Tocilizumab and Anakinra During Experimental Human Endotoxemia","DEDICATE-LPS","Inclusion Criteria:\n\n* Male subjects aged ≥18 and ≤35 years\n* Body mass index (BMI) ≥18 and ≤30 kg\u002Fm2\n* Healthy (as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine clinical laboratory parameters)\n* Able to comprehend and sign the Information letter and Informed Consent (IC) prior to enrolment in the study.\n\nExclusion Criteria:\n\n* Use of any prescription medication or over-the-counter non-steroidal anti-inflammatory drugs\n* Known anaphylaxis or hypersensitivity to any (non-)investigational products or their excipients\n* History of chronic headache or previous post-dural puncture headache (PDPH)\n* History or signs of severe atopic syndrome (asthma, rhinitis with medication and\u002For eczema)\n* History of any disease associated with immune deficiency\n* History of cancer in the last 5 years (excluding localised skin cancer or carcinoma in situ)\n* History or signs of haematological disease\n* History or signs of thromboembolic disorders\n* History of peptic \u002F gastric ulcer disease\n* History of psychiatric disorders\n* Thrombocytopenia (\\<150\\*109\u002FmL) or anaemia (\\<8.0 mmol\u002FL)\n* History, signs or symptoms of cardiovascular disease, in particular:\n\n  * Prone to vagal collapse\n  * History of atrial or ventricular arrhythmia\n  * Cardiac conduction abnormalities on the ECG consisting of a 2nd degree atrio-ventricular block or a complete left bundle branch block\n  * Hypertension (defined as RR systolic \\> 160 or RR diastolic \\> 90 mmHg)\n  * Hypotension (defined as RR systolic \\< 100 or RR diastolic \\< 50 mmHg)\n* Renal impairment (defined as plasma creatinine \\>120 μmol\u002FL)\n* Liver enzyme abnormalities (above 2x the upper limit of normal)\n* Signs of infection (CRP \\> 20 mg\u002FL, white blood cells \\> 12x109\u002FL or\n\n  * lt; 4x109\u002FL)\n* Clinically significant acute illness, including infections or trauma, within 1 month prior to the first LPS challenge\n* Previous (participation in a study with) endotoxin (LPS) administration\n* Participation in an experimental intervention or drug trial within 3 months prior to the first LPS challenge\n* Any vaccination or blood donation within 1 month prior to the first LPS challenge\n* Recent hospital admission or surgery with general anaesthesia within 3 months prior to the first LPS challenge\n* Use of recreational drugs within 2 weeks prior to the first LPS challenge\n* Suspected of not being able to comply with the trial protocol\n* Inability to personally provide written informed consent (e.g. for linguistic or mental reasons) and\u002For take part in the study",true,"MALE","18 Years","35 Years",{"count":21,"type":22},52,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","The goal of this clinical trial is to investigate the immunomodulatory effects of the drugs dexamethasone, tocilizumab and anakinra in healthy male subjects aged 18 to 35 undergoing experimental endotoxemia. The main questions it aims to answer are:\n\n* What are the effects of these drugs on the development of immunoparalysis in a repeated human endotoxemia model?\n* What is the extent of the neuroinflammatory response and how do these drugs affect neuroinflammation in a repeated human endotoxemia model?\n\nResearchers will compare these drugs to a placebo (a look-alike substance that contains no drug).\n\nParticipants will visit the Intensive Care research department on two or five occasions (screening included):\n\n* The intervention group will receive an LPS challenge twice, with a week in between. Before the first LPS challenge, one of the described drugs will be administered. Blood, saliva and tear fluid will be collected regularly during the LPS challenge. Cerebrospinal fluid will also be collected through a catheter in the spinal cord.\n* The control group will not receive an LPS challenge or drug administration and will have only one study day. During this day, blood, saliva, tear fluid and cerebrospinal fluid will be collected as regularly as during the LPS challenge of the intervention group.\n\nDuring an LPS challenge, the investigators mimic blood poisoning by giving an endotoxin, also called LPS. This is a small part of the cell wall of a bacteria. This will cause transient flu-like symptoms for 3-4 hours.",[28,29,30,31,32,33,34],"Sepsis","Neuroinflammatory Response","Immunosuppresion","Endotoxemia","Anakinra","Dexamethasone","Tocilizumab",[28,36,37,38,32,33,34,39,40,41],"Immunosuppression","Systemic inflammation","Neuroinflammation","Human endotoxemia","Immunoparalysis","Hyperinflammatory response","RECRUITING","2025-04-01",{"date":45,"type":46},"2025-04-04","ACTUAL",{"date":48,"type":46},"2024-10-24",{"date":50,"type":22},"2025-12",{"name":52,"class":53},"Radboud University Medical Center","OTHER",1,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":54},"100385590","phase-4-a-pilot-study-in-severe-patients-with-takayasu-arteritis-100385590","NCT04300686","A Pilot Study in Severe Patients With Takayasu Arteritis.","A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort","Inclusion Criteria:\n\n1. age≥14 years old;\n2. active: Kerr score≥ 2;\n3. severe:\n\n   1. Blood pressure \\> 180\u002F110mmHg;\n   2. ≥ 3 branches with the stenotic rate \\> 70% involved;\n   3. high degree of organ insufficiency: NYHF III\\~IV; eGFR (MRDR) 15\\~ 60ml\u002Fmin;\n\nExclusion Criteria:\n\n1. Severe organ insufficiency;\n2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;\n3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;\n4. malignant tumors;\n5. history of severe drug allergy;\n6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)","ALL","14 Years","100 Years",{"count":66,"type":22},40,[25],"Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. We classify TAK patients into 3 levels, including mild, moderate, and severe. And the biological agents tocilizumab and adalimumab are randomly prescribed in severe patients, to find out the relatively better treatment strategy, facilitating better intervention strategy in severe TAK patients.",[70,34,71,72],"Takayasu Arteritis","Adalimumab","Treatment",[70,34,71,74],"treatment","2021-08-07",{"date":77,"type":46},"2021-08-10",{"date":79,"type":46},"2020-03-01",{"date":81,"type":22},"2023-12-31",{"name":83,"class":53},"Shanghai Zhongshan Hospital"]