[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576344":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":15,"centralContacts":20,"locations":7,"responsibleParty":26,"collaborators":7,"id":28,"slug":29,"hasResults":30,"nctId":31,"briefTitle":32,"officialTitle":32,"acronym":33,"eligibilityCriteria":34,"healthyVolunteers":30,"sex":35,"minAge":36,"maxAge":37,"enrollmentInfo":38,"targetDuration":7,"studyType":41,"phases":7,"briefSummary":42,"conditions":43,"keywords":7,"overallStatus":45,"whyStopped":7,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":7},{"fullName":5,"class":6},"NHS Greater Glasgow and Clyde","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":13},"DRUG","Anifrolumab","Anifrolumab 300mg intravenous infusions administered as described in the EU SmPC",[14],"N\u002FA (Not applicable)",[16],{"name":17,"affiliation":18,"role":19},"Neil Basu, MD, PhD","neil.basu@glasgow.ac.uk","PRINCIPAL_INVESTIGATOR",[21],{"name":22,"role":23,"phone":24,"phoneExt":7,"email":25},"Maxine Arnott, BSc","CONTACT","07890 059695","maxine.arnott@glasgow.ac.uk",{"type":27,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100576344","establishing-the-salience-of-type-1-interferon-pathway-blockade-in-the-central-mechanisms-of-sle-related-fatigue-100576344",false,"NCT06784076","Establishing the Salience of Type 1 Interferon Pathway Blockade in the Central Mechanisms of SLE Related Fatigue","EPIC","Inclusion Criteria:\n\n* Adults ≥ 18 years \\\u003C 65 years\n* Fulfilment of the 2019 ACR (American College of Rheumatology)\u002FEULAR (European Alliance of Associations for Rheumatology) classification criteria for SLE\n* Persistent (\\>3 months) and clinically significant fatigue (≥6 on numerical rating 0-10 scale measuring average level of fatigue during the past 7 days)\n* Attainment of Lupus low disease activity state (LLDAS)\n\nExclusion Criteria:\n\n* Inability to provide informed written consent\n* Moderate or severe active SLE\n* Severe active CNS (Central Nervous System) Lupus and Lupus Nephritis\n* Contra-indications to anifrolumab\n* History of malignancy\n* History of recurrent infections or known risk factors for infection\n* Active or chronic infection\n* Concomitant biological therapies\n* Hypersensitivity to anifrolumab or excipients\n* Current treatment with a biologic medicine or monoclonal antibody (including B cell depleting therapies in the previous 52 weeks)\n* Previous exposure to anifrolumab\n* Contra-indications to MRI\n* Pregnant or breast-feeding\n* Females of child-bearing potential who do not agree to use an effective method of birth control until 12 weeks after the final study visit (See appendix 1).)\n* Severe physical impairment (e.g. blindness, paraplegia)\n* Medical or psychiatric conditions that in the judgement of the study personnel would preclude participation in the study","ALL","18 Years","64 Years",{"count":39,"type":40},20,"ESTIMATED","OBSERVATIONAL","Systemic Lupus Erythematosus (SLE) is a multi-system autoimmune disorder, characterised by activation of the interferon system. Of the multiple domains of this disease, patients identify fatigue as the most pervasive and disabling aspect. As many as 90% report significant levels of fatigue, a prevalence far in excess of that observed in the general population and most other chronic disorders. Moreover, its impact permeates all aspects of living as reflected by fatigue's strong relationship with impaired quality of life3 and work disability. Despite these substantial consequences, relatively little is known about this symptom and so the current dearth of accepted therapies is unsurprising. A better understanding of the underlying mechanisms of fatigue will be vital if efficacious interventions are to be developed in the future.\n\nThe investigators will recruit 25 SLE patients to achieve 20 full data sets. They will attend for a baseline 7T brain scan to primarily measure basal ganglia glutamate and then receive 5 months of a pharmacological blocker that antagonises type 1 interferon receptors before completing the study with a final 7T brain scan to undertake repeat measure of basal ganglia glutamate.",[44],"Systemic Lupus Erythematosus","NOT_YET_RECRUITING","2025-01-27",{"date":48,"type":49},"2025-01-29","ACTUAL",{"date":51,"type":40},"2025-03-17",{"date":53,"type":40},"2027-03-15",{"name":5,"class":6}]