[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659938":3},{"organization":4,"outcomesModule":7,"designInfo":67,"detailedDescription":80,"studyPopulation":66,"armGroups":81,"interventions":94,"overallOfficials":103,"centralContacts":107,"locations":117,"responsibleParty":205,"collaborators":208,"id":216,"slug":217,"hasResults":218,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":222,"eligibilityCriteria":223,"healthyVolunteers":218,"sex":224,"minAge":225,"maxAge":66,"enrollmentInfo":226,"targetDuration":66,"studyType":229,"phases":230,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":239,"whyStopped":66,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"fullName":5,"class":6},"Oslo University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":66},[9],{"measure":10,"description":11,"timeFrame":12},"Infarct growth on brain MRI (mL)","Infarct growth is defined as the change in DWI lesion volume from baseline to 72 hours after completion of EVT. DWI lesion volume will be measured on brain MRI at baseline and 72 hours after completion of EVT. Infarct growth will be calculated as the DWI lesion volume at 72 hours minus the baseline DWI lesion volume.","Within 8 hours after completion of EVT and at 72 hours after completion of EVT",[14,18,21,24,28,32,36,40,44,48,51,55,58,62],{"measure":15,"description":16,"timeFrame":17},"Infarct volume on brain MRI at 72 hours after EVT (mL)","DWI lesion volume measured on brain MRI at 72 hours after completion of EVT.","At 72 hours after completion of EVT",{"measure":19,"description":20,"timeFrame":12},"Change in FLAIR lesion volume from baseline to 72 hours after EVT","Change in FLAIR lesion volume from the first post-EVT brain MRI to the brain MRI at 72 hours after EVT. The first post-EVT MRI will be performed within 8 hours after completion of EVT. Change in FLAIR lesion volume will be calculated as lesion volume at 72 hours minus lesion volume on the first post-EVT MRI.",{"measure":22,"description":23,"timeFrame":17},"Effect of tocilizumab given before\u002Fduring EVT on FLAIR lesion volume at 72 hours after EVT in patients with acute ischemic stroke","FLAIR lesion volume measured on brain MRI at 72 hours after completion of EVT",{"measure":25,"description":26,"timeFrame":27},"Change in high-sensitivity C-reactive protein (hsCRP) levels","Change in high-sensitivity C-reactive protein (hsCRP) levels from baseline to 72 hours and 90 days after completion of EVT","At baseline, 72 hours, and 90 days after completion of EVT",{"measure":29,"description":30,"timeFrame":31},"National Institutes of Health Stroke Scale (NIHSS) score","National Institute of Health Stroke Scale (NIHSS) score, min 0, max 42","At 24 hours, 72 hours, hospital discharge, and 90 days after completion of EVT",{"measure":33,"description":34,"timeFrame":35},"Modified Rankin Scale (mRS) score","Modified Rankin Scale (mRS) score measured at hospital discharge, 30 days, 90 days, and 12 months after completion of EVT. mRS range 0-6.","At hospital discharge, 30 days, 90 days, and 12 months after completion of EVT",{"measure":37,"description":38,"timeFrame":39},"EuroQol 5-Dimension 5-Level (EQ-5D-5L) Visual Analogue Scale (EQ VAS) score (0-100)","The EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ VAS) records the participant's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state).","At 90 days and 12 months after completion of EVT",{"measure":41,"description":42,"timeFrame":43},"All-cause mortality","Occurrence of death (all-cause and stroke-related)","At hospital discharge, 30 days, and 90 days after completion of EVT",{"measure":45,"description":46,"timeFrame":47},"Symptomatic intracranial haemorrhage","Occurrence of symptomatic intracranial haemorrhage during the first 72 hours after completion of EVT","Through 72 hours after completion of EVT",{"measure":49,"description":50,"timeFrame":17},"Any intracranial haemorrhage","Occurrence of any intracranial haemorrhage during the first 72 hours after completion of EVT",{"measure":52,"description":53,"timeFrame":54},"Any infection","Occurrence of any infection during hospitalization, based on clinical assessment, blood samples, and relevant investigations for infection","At hospital discharge upto 6 weeks",{"measure":56,"description":57,"timeFrame":54},"Stroke-associated pneumonia","Occurrence of stroke-associated pneumonia during hospitalization, based on clinical assessment and relevant diagnostic investigations",{"measure":59,"description":60,"timeFrame":61},"Serious adverse events","Occurrence of serious adverse events from completion of EVT through 90 days after completion of EVT.","Through 90 days after completion of EVT",{"measure":63,"description":64,"timeFrame":65},"Adverse events","Occurrence of adverse events from completion of EVT through 30 days after completion of EVT.","Through 30 days after completion of EVT",null,{"allocation":68,"interventionModel":69,"interventionModelDescription":70,"primaryPurpose":71,"observationalModel":66,"timePerspective":66,"maskingInfo":72},"RANDOMIZED","PARALLEL","This is a randomized, double-blind, placebo-controlled, parallel-group interventional study. Participants will be randomly assigned to receive either tocilizumab or matching placebo in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Study treatment will be administered before or during EVT. Participants, investigators, treating clinicians, outcome assessors, and other study personnel will remain blinded to treatment allocation, except where unblinding is required for participant safety.","TREATMENT",{"masking":73,"maskingDescription":74,"whoMasked":75},"QUADRUPLE","The participants, investigators, treating clinicians, outcome assessors, imaging assessors, study coordinators, and other study personnel involved in the conduct or assessment of the trial will be masked to treatment allocation. Personnel responsible for the preparation and administration of the study medication may be unmasked when necessary to ensure correct preparation and administration. Personnel performing the primary imaging analysis will remain masked to treatment allocation",[76,77,78,79],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Acute ischemic stroke is a major cause of death and long-term disability. Although endovascular therapy (EVT) can effectively restore blood flow in patients with large-vessel occlusion, brain tissue injury may continue to develop after reperfusion. Infarct growth after successful reperfusion is associated with worse functional outcomes and may be influenced by inflammatory processes triggered by ischemia and reperfusion.\n\nInterleukin-6 (IL-6) is an important mediator of the inflammatory response following acute ischemic stroke. Tocilizumab is a monoclonal antibody that blocks the IL-6 receptor and is an established treatment for several inflammatory conditions. Experimental and clinical evidence suggests that modulation of the IL-6 pathway may reduce inflammation and tissue injury following ischemic stroke.\n\nThe Illuminate study is a phase II, randomized, double-blind, placebo-controlled clinical trial designed to investigate whether early treatment with tocilizumab can reduce infarct growth in adults with acute ischemic stroke undergoing EVT. Participants will be randomly assigned to receive a single intravenous dose of tocilizumab or matching placebo before or during EVT, in addition to standard stroke treatment.\n\nThe primary objective is to determine whether treatment with tocilizumab reduces infarct growth assessed by brain magnetic resonance imaging (MRI) approximately 72 hours after EVT, compared with placebo. Secondary and exploratory assessments will evaluate clinical outcomes, imaging findings, safety, and biological markers of inflammation.\n\nThe study will provide clinical data on whether early inhibition of the IL-6 pathway may limit brain tissue injury after reperfusion and inform the design of future clinical trials of anti-inflammatory treatment in acute ischemic stroke.",[82,88],{"label":83,"type":84,"description":85,"interventionNames":86},"Placebo","PLACEBO_COMPARATOR","Participants randomized to this arm will receive a single intravenous dose of matching placebo in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Placebo will be administered before or during EVT, according to the study protocol.",[87],"Drug: Placebo",{"label":89,"type":90,"description":91,"interventionNames":92},"Tocilizumab","ACTIVE_COMPARATOR","Participants randomized to this arm will receive a single intravenous dose of tocilizumab in addition to standard endovascular therapy (EVT) for acute ischemic stroke. Tocilizumab will be administered before or during EVT, according to the study protocol.",[93],"Drug: Tociliuzumab",[95,101],{"type":96,"name":97,"description":91,"armGroupLabels":98,"otherNames":99},"DRUG","Tociliuzumab",[89],[100],"RoActemra",{"type":96,"name":83,"description":85,"armGroupLabels":102,"otherNames":66},[83],[104],{"name":105,"affiliation":5,"role":106},"Anne Hege Aamodt","STUDY_CHAIR",[108,113],{"name":109,"role":110,"phone":111,"phoneExt":66,"email":112},"Anne Hege Aamodt, MD, PhD","CONTACT","+47 95867270","a.h.aamodt@medisin.uio.no",{"name":114,"role":110,"phone":115,"phoneExt":66,"email":116},"Lars Hansen Tveit, MD","+4792203202","latvei@ous-hf.no",[118,134,147,164,177,187],{"facility":119,"status":66,"city":120,"state":66,"zip":66,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"Aalborg University Hospital","Aalborg","Denmark","DK",{"type":124,"coordinates":125},"Point",[126,127],9.9187,57.048,{"lat":127,"lon":126},[130],{"name":131,"role":110,"phone":132,"phoneExt":66,"email":133},"Boris Modrau, MD PhD","+4551159170","boris.modrau@rn.dk",{"facility":135,"status":66,"city":136,"state":66,"zip":66,"country":121,"countryCode":122,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Aarhus University Hospital","Aarhus",{"type":124,"coordinates":138},[139,140],10.21076,56.15674,{"lat":140,"lon":139},[143],{"name":144,"role":110,"phone":145,"phoneExt":66,"email":146},"Rolf Blauenfeldt, MD PhD","+45 78 45 00 00","rolfblau@rm.dk",{"facility":148,"status":66,"city":149,"state":66,"zip":66,"country":121,"countryCode":122,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Rigshospitalet","Copenhagen",{"type":124,"coordinates":151},[152,153],12.56553,55.67594,{"lat":153,"lon":152},[156,160],{"name":157,"role":110,"phone":158,"phoneExt":66,"email":159},"Thomas C Truelsen, MD PhD","+4521810068","thomas.clement.truelsen@regionh.dk",{"name":161,"role":110,"phone":162,"phoneExt":66,"email":163},"Rikke Puggaard, MD","+45 35 45 35 45","rikke.puggaard@regionh.dk",{"facility":165,"status":66,"city":166,"state":66,"zip":66,"country":121,"countryCode":122,"cosmosGeoPoint":167,"geoPoint":171,"contacts":172},"Odense University Hospital","Odense",{"type":124,"coordinates":168},[169,170],10.38831,55.39594,{"lat":170,"lon":169},[173],{"name":174,"role":110,"phone":175,"phoneExt":66,"email":176},"Karen L Ægidius, MD PhD","+4560891960","Karen.Lehrmann.AEgidius@rsyd.dk",{"facility":178,"status":66,"city":179,"state":66,"zip":66,"country":180,"countryCode":181,"cosmosGeoPoint":66,"geoPoint":66,"contacts":182},"Akershus University Hospital","Lørenskog","Norway","NO",[183],{"name":184,"role":110,"phone":185,"phoneExt":66,"email":186},"Marianne Altmann, MD PhD","+4792253294","marianne.altmann@ahus.no",{"facility":5,"status":66,"city":188,"state":66,"zip":189,"country":180,"countryCode":181,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Oslo","0424",{"type":124,"coordinates":191},[192,193],10.74609,59.91273,{"lat":193,"lon":192},[196,199,200,203],{"name":197,"role":110,"phone":198,"phoneExt":66,"email":112},"Anne Hege Aamodt, MD PhD","95867270",{"name":114,"role":110,"phone":115,"phoneExt":66,"email":116},{"name":201,"role":202,"phone":66,"phoneExt":66,"email":66},"Mona Skjelland, MD PhD","SUB_INVESTIGATOR",{"name":204,"role":202,"phone":66,"phoneExt":66,"email":66},"Jesper Sømark, MD",{"type":206,"investigatorFullName":105,"investigatorTitle":207,"investigatorAffiliation":5,"oldNameTitle":66,"oldOrganization":66},"PRINCIPAL_INVESTIGATOR","Coordinating Investigator",[209,211,213,214,215],{"name":210,"class":6},"Copenhagen University Hospital, Rigshospitalet",{"name":212,"class":6},"University Hospital, Akershus",{"name":135,"class":6},{"name":119,"class":6},{"name":165,"class":6},"100659938","phase-2-infarct-growth-after-intravenous-tocilizumab-in-adults-with-acute-ischemic-stroke-undergoing-endovascular-thrombectomy---illuminate-100659938",false,"NCT07870681","Infarct Growth After Intravenous Tocilizumab in Adults With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy - ILLUMINATE","A Randomized Placebo-controlled Double-blind Trial Phase II Two-arm Study to Investigate Infarct Growth Over 72 Hours Assessed With Diffusion Weighted Imaging on MRI After Treatment With Intravenous Tocilizumab or Placebo in Patients Above 18 Years of Age With Acute Ischemic Stroke Undergoing Endovascular Thrombectomy.","Illuminate","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\nAge\n\n1. Participant must be above 18 years of age at the time of signing the informed consent.\n\n   Type of Participant and Disease Characteristics\n2. Participants who have acute ischemic stroke selected for emergency endovascular treatment according to treatment guidelines.\n3. Onset of stroke symptoms (last-known-well) time to randomization time within 12 hours.\n4. Large vessel occlusion in the anterior circulation (terminal internal carotid artery, M1 or M2 segment of MCA). Tandem extracranial carotid and intracranial occlusions are permitted.\n\n   Sex and Contraceptive\u002FBarrier Requirements\n5. Women of childbearing potential (WOCBP) can only be included if they use a highly effective contraception method as defined in Appendix 3 of the protocol.\n\n   Informed Consent\n6. Participants must be capable of giving signed informed consent or consent must be given by legal representative as described in Section 10.1.2., including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nMedical Conditions\n\n1. Any intracranial haemorrhage during the qualifying imaging.\n2. Malignancies, immunodeficiency, ongoing infection or any suspicion of acute infection.\n3. Clinical history, prior imaging or clinical judgment suggesting that the intracranial occlusion is chronic, or there is a suspected intracranial dissection such that there is a predicted lack of success with endovascular intervention.\n4. Systolic blood pressure \\> 185 mmHg or diastolic blood pressure \\> 110 mmHg at baseline, despite appropriate medical management.\n5. Known thrombocytopenia (platelet count \\\u003C100 × 10³\u002FµL), neutropenia (neutrophil count \\\u003C2.5 × 10⁹\u002FL), or elevated liver enzymes (ALT or AST \\>1.5 × the upper limit of normal \\[ULN\\]).\n6. Known hypersensitivity to tocilizumab or any of the excipients listed in section 6.1 of the SmPC: sucrose, polysorbate 80 (E 433), disodium phosphate dodecahydrate (for pH adjustment), sodium dihydrogen phosphate dihydrate (for pH adjustment) and water for injections. Prior\u002FConcomitant Therapy\n7. Endovascular thrombectomy procedure is completed as defined by the presence of TICI 2c\u002F3 reperfusion or completion of groin \u002F arterial closure.\n8. Patients receiving immunosuppressive drugs other than prednisolone ≤ 10 mg\u002Fday. Prior\u002FConcurrent Clinical Study Experience\n9. Known prior receipt of tocilizumab for any reason, including prior enrolment in this trial.\n\n   Diagnostic Assessments\n10. Contraindications to MRI.\n11. Large core of established infarction (ASPECTS 0-2). Other Exclusion Criteria\n12. Pregnancy\u002FLactation; female, with positive urine or serum beta human chorionic gonadotropin (β-hCG) test, or breastfeeding.","ALL","18 Years",{"count":227,"type":228},156,"ESTIMATED","INTERVENTIONAL",[231,232],"PHASE2","PHASE3","The goal of this phase II, placebo-controlled intervention study is to investigate whether tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, may have a neuroprotective effect by reducing infarct growth in adults with acute ischemic stroke.\n\nThe main question it aims to answer is:\n\nDoes treatment with tocilizumab given before or during endovascular therapy (EVT) reduce infarct growth 72 hours after EVT compared with placebo in adults with acute ischemic stroke?\n\nResearchers will compare tocilizumab with placebo to determine whether infarct growth is smaller in participants receiving tocilizumab.\n\nParticipants will:\n\nReceive either a single dose of tocilizumab or placebo before or during EVT. Undergo standard endovascular treatment for acute ischemic stroke. Undergo brain MRI approximately 72 hours after EVT to assess infarct growth. Have clinical assessments and other study-related examinations and follow-up according to the study protocol.",[235],"Acute Ischemic Stroke",[237,238],"neuroprotection","endovascular therapy","NOT_YET_RECRUITING","2026-10-09",{"date":242,"type":243},"2026-10-13","ACTUAL",{"date":245,"type":228},"2026-09-21",{"date":247,"type":228},"2030-01-31",{"name":5,"class":6},6]