Nctid:
NCT06234852
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04", "submissionTracking"=>{"submissionInfos"=>[{"resetDate"=>"2024-09-17", "releaseDate"=>"2024-04-29"}], "estimatedResultsFirstSubmitDate"=>"2024-04-29"}}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008180", "term"=>"Lupus Erythematosus, Systemic"}], "ancestors"=>[{"id"=>"D000003240", "term"=>"Connective Tissue Diseases"}, {"id"=>"D000001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D000007154", "term"=>"Immune System Diseases"}], "browseLeaves"=>[{"id"=>"M11177", "name"=>"Lupus Erythematosus, Systemic", "asFound"=>"Systemic Lupus Erythematosus", "relevance"=>"HIGH"}, {"id"=>"M6464", "name"=>"Connective Tissue Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Skin and Connective Tissue Diseases", "abbrev"=>"BC17"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000005938", "term"=>"Glucocorticoids"}], "ancestors"=>[{"id"=>"D000006728", "term"=>"Hormones"}, {"id"=>"D000006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M14120", "name"=>"Prednisolone", "relevance"=>"LOW"}, {"id"=>"M11749", "name"=>"Methylprednisolone", "relevance"=>"LOW"}, {"id"=>"M1833", "name"=>"Methylprednisolone Acetate", "relevance"=>"LOW"}, {"id"=>"M11750", "name"=>"Methylprednisolone Hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M229449", "name"=>"Prednisolone acetate", "relevance"=>"LOW"}, {"id"=>"M211887", "name"=>"Prednisolone hemisuccinate", "relevance"=>"LOW"}, {"id"=>"M248881", "name"=>"Prednisolone phosphate", "relevance"=>"LOW"}, {"id"=>"M9047", "name"=>"Glucocorticoids", "asFound"=>"G/kg", "relevance"=>"HIGH"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Inflammatory Agents", "abbrev"=>"Infl"}, {"name"=>"Antineoplastic Agents", "abbrev"=>"ANeo"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Antiemetics", "abbrev"=>"AnEm"}, {"name"=>"Neuroprotective Agents", "abbrev"=>"NeuroAg"}, {"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"QUADRUPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR", "OUTCOMES_ASSESSOR"]}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>20}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-01-24", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-04-17", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-04-17", "studyFirstSubmitDate"=>"2024-01-14", "studyFirstSubmitQcDate"=>"2024-01-30", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-19", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-31", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-12-26", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Any flare according any of 3 definitions", "timeFrame"=>"24 weeks", "description"=>"Flare definition: 1. Clinical SLEDAI 2K (excluding serology) ≥ 4, 2. Increase in SLE-DAS ≥ 1.72, 3. Increase in clinical SLEDAI-2K plus treatment escalation (including with NSAIDS, glucocorticoids (topical or oral), antimalarials, or immunosuppressants."}], "secondaryOutcomes"=>[{"measure"=>"Any increase in clinical SLEDAI-2K", "timeFrame"=>"24 weeks", "description"=>"Percentage of participants with any increase in clinical SLEDAI-2K"}, {"measure"=>"Any changes in immunology", "timeFrame"=>"24 weeks", "description"=>"Percentage of participants with the decrease of C3 or C4 by 50% and/or the increase of anti-dsDNA by 25% as compared with baseline"}, {"measure"=>"Any increase in damage accrual", "timeFrame"=>"24 weeks", "description"=>"Percentage of participants with any increase in Systemic Lupus International Collaborating Clinic/American College of Rheumatology Damage Index (SDI) Score."}, {"measure"=>"Changes in quality of life", "timeFrame"=>"24 weeks", "description"=>"Changes in Score of Systemic Lupus Erythematosus Quality Of Life (SLEQoL) Questionnaire (mean difference)"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Systemic Lupus Erythematosus", "Glucocorticosteroid", "Flare"], "conditions"=>["Systemic Lupus Erythematosus, SLE"]}, "descriptionModule"=>{"briefSummary"=>"This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.", "detailedDescription"=>"Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (\\< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"20 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Aged; 20 years\n* Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria, 2012.\n* Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.\n* Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.\n\nExclusion Criteria:\n\n* Pregnant or pregnancy planning\n* Unable to follow the schedules\n* Overlap with other autoimmune disease, except secondary SjS and APS\n* Co-morbid with any other condition which required prednisolone treatment\n* Documented adrenal insufficiency"}, "identificationModule"=>{"nctId"=>"NCT06234852", "briefTitle"=>"Gradual Withdrawal of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus.", "organization"=>{"class"=>"OTHER", "fullName"=>"Phramongkutklao College of Medicine and Hospital"}, "officialTitle"=>"The Effect of Gradual Withdrawal Versus Maintenance of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Randomized Placebo Controlled Trial.", "orgStudyIdInfo"=>{"id"=>"LUCRA001"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"ACTIVE_COMPARATOR", "label"=>"Glucocorticoid maintenance group", "description"=>"Maintenance of 5-mg of prednisolone daily over 24 weeks", "interventionNames"=>["Behavioral: Glucocorticoid maintenance group"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Glucocorticoid withdrawal group", "description"=>"Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks", "interventionNames"=>["Behavioral: Glucocorticoid withdrawal group"]}], "interventions"=>[{"name"=>"Glucocorticoid withdrawal group", "type"=>"BEHAVIORAL", "description"=>"Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks", "armGroupLabels"=>["Glucocorticoid withdrawal group"]}, {"name"=>"Glucocorticoid maintenance group", "type"=>"BEHAVIORAL", "description"=>"Daily 5-mg prednisolone over 24 weeks", "armGroupLabels"=>["Glucocorticoid maintenance group"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"10400", "city"=>"Bangkok", "country"=>"Thailand", "facility"=>"Rheumatic Disease Unit, Department of Internal Medicine, Phramongkutklao Hospital and College of Medicine", "geoPoint"=>{"lat"=>13.75398, "lon"=>100.50144}}], "overallOfficials"=>[{"name"=>"Rattapol Pakchotanon, M.D.", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Phramongkutklao College of Medicine and Hospital"}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "timeFrame"=>"Mid 2025", "ipdSharing"=>"YES", "description"=>"Study Protocol is to be shared with others. Full data would become available by mid 2025.", "accessCriteria"=>"IPD Sharing Access Criteria has not been decided."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Phramongkutklao College of Medicine and Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}, "annotationSection"=>{"annotationModule"=>{"unpostedAnnotation"=>{"unpostedEvents"=>[{"date"=>"2024-04-29", "type"=>"RELEASE"}, {"date"=>"2024-09-17", "type"=>"RESET"}], "unpostedResponsibleParty"=>"Phramongkutklao College of Medicine and Hospital"}}}}
