[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100563623":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":45,"responsibleParty":64,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":26,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Universitas Padjadjaran","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","ACTIVE_COMPARATOR","SLE patient at the Hasan Sadikin Rheumatology Outpatient Clinic and registered as Lupus Registry with remission or mild SLE disease activity. The diagnosis of SLE is based on ACR 1997 criteria or SLE SLICC 2012 criteria. Screening will include history review, physical examinations, chest X-Ray, laboratory test such as CBC, ALT\u002FAST, HbsAg, total anti-HCV, complement (C3), dsDNA, creatinine serum, urinalysis (proteinuria, ACR, RBC, WBC, casts), IGRA, to assess if any subject has no active TB and no chronic liver disease.\n\nTreatment group receiving Isoniazid 5 mg\u002Fkg\u002Fday (maximum 300 mg\u002Fday) with pyridoxine 10 mg\u002Fday.\n\nMonitor ALT\u002FAST and SLE disease activity after two weeks, continued monthly for the first three months (1st, 2nd, 3rd) then every three months for up to a year (6th, 9th, 12th months). Routine SLE medication is continued and routinely recorded at every visit.",[13],"Drug: Isoniazid\u002FPyridoxine",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group","PLACEBO_COMPARATOR","SLE patient at the Hasan Sadikin Rheumatology Outpatient Clinic and registered as Lupus Registry with remission or mild SLE disease activity. The diagnosis of SLE is based on ACR 1997 criteria or SLE SLICC 2012 criteria. Screening will include history review, physical examinations, chest X-ray, laboratory test such as CBC, ALT\u002FAST, HbsAg, total anti-HCV, complement (C3), dsDNA, creatinine serum, urinalysis (proteinuria, ACR, RBC, WBC, casts) IGRA, to assess if any subject has no active TB and no chronic liver disease.\n\nControl group receiving placebo.\n\nMonitor ALT\u002FAST and SLE disease activity after two weeks, continued monthly for the first three months (1st, 2nd, 3rd) then every three months for up to a year (6th, 9th, 12th months). Routine SLE medication is continued and routinely recorded at every visit.",[19],"Drug: Saccharum Lactis",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Isoniazid\u002FPyridoxine","Treatment group received isoniazid 300mg and pyridoxine 10mg\u002Fday",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Saccharum Lactis","Control group received placebo",[15],[32],"Placebo",[34],{"name":35,"affiliation":5,"role":36},"Laniyati Hamijoyo, MD, PhD","PRINCIPAL_INVESTIGATOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+62222040151","laniyati.hamijoyo@unpad.ac.id",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Edhyana Sahiratmadja, MD, PhD","e.sahiratmadja@unpad.ac.id",[46],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Rumah Sakit Dr Hasan Sadikin, Universitas Padjadjaran","RECRUITING","Bandung","West Java","40161","Indonesia","ID",{"type":55,"coordinates":56},"Point",[57,58],107.60694,-6.92222,{"lat":58,"lon":57},[61],{"name":62,"role":39,"phone":63,"phoneExt":26,"email":41},"Laniyati Hamijoyo","62222040151",{"type":65,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100563623","phase-2-safety-of-administering-isoniazid-to-sle-patients-to-prevent-tb-100563623",false,"NCT06618573","Safety of Administering Isoniazid to SLE Patients to Prevent TB","Study on the Safety of Administering Isoniazid to Systemic Lupus Erythematosus Patients to Prevent Tuberculosis","Inclusion Criteria:\n\nSLE patients with conditions of :\n\n* No signs and symptoms of active TB\n* Not under TB treatment\n* No History of TB, malignancy, HIV, liver function test abnormality\n* Not in pregnancy\u002Flactation\n* No other active infections\n* Remission or low to moderate disease activity state\n* Consented to join the study completely\n\nExclusion Criteria:\n\nSLE patients with conditions of :\n\n* History of allergy to Isoniazid\n* Chronic liver disease, including chronic hepatitis B or C virus\n* Malignancy\n* Pregnancy","FEMALE","18 Years","55 Years",{"count":77,"type":78},60,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE2","PHASE3","Systemic Lupus Erythematosus (SLE) is a prototypical systemic autoimmune disease characterized by heterogeneity, multisystem involvement, and production of multiple autoantibodies. Clinical features can vary, from mild skin and joint involvement to severe and life-threatening conditions.\n\nPatients with lupus are more susceptible to infections, in addition to being immunocompromised, and due to the administration of corticosteroid and cytotoxic drugs. The presence of these infections is a cause of death in lupus disease in addition to the activity of the disease itself, especially in Asia-Pacific countries. One infection that often occurs in lupus is Tuberculosis (TB).\n\nEfforts have been made to prevent TB infection in vulnerable populations, including isoniazid (INH) prophylaxis. In 2010, World Heatlh Organization issued guidelines for HIV patients to receive INH prophylaxis to prevent TB infection. The implementation of Isoniazid Preventive Therapy (IPT) is quite cheap using INH with mild side effects.18 A meta-analysis study of INH prophylaxis in patients with HIV found that the efficacy of this prophylaxis significantly reduced TB incidence by 35% with an RR of 0.65%. In addition, INH was found to be safe, with no significant increase in drug reactions, according to a meta-analysis of prophylaxis studies in HIV patients.\n\nHowever, there is no guideline for INH prophylaxis for SLE patients, as there is for HIV patients, due to lack of data on this issue.\n\nStudies on the effectiveness of INH prophylaxis on the prevention of TB infection for SLE patients should be conducted, but before that, studies on the safety of INH therapy in SLE patients should be conducted.",[85,86],"Tuberculosis","Systemic Lupus Erythematosus",[85,86],"2024-09-26",{"date":90,"type":91},"2024-10-01","ACTUAL",{"date":93,"type":91},"2022-08-15",{"date":95,"type":78},"2025-12-01",{"name":5,"class":6},1]