[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microscopic-polyangiitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microscopic-polyangiitis":38},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,62,102,125],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":41,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":61},"100599701","phase-4-safety-and-immunogenicity-of-the-live-attenuated-tetravalent-butantan-dengue-vaccine-in-autoimmune-rheumatic-diseases-100599701",false,"NCT07087912","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine (Butantan-DV) in Patients With Autoimmune Rheumatic Diseases Living in Dengue-Endemic Areas","BTNDV-ARD","Inclusion Criteria:\n\n* Age between 12 and 59 years\n* Male or female\n* Clinical diagnosis of an autoimmune rheumatic disease (ARD) based on internationally accepted criteria (e.g., rheumatoid arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, Sjögren's syndrome, vasculitis)\n* Healthy control matched by age and sex\n* ARD patients with clinically stable disease for at least 3 months\n* ARD patients under low-grade immunosuppression or no immunosuppression\n* Acceptable immunosuppressive treatments include:\n\nHydroxychloroquine Sulfasalazine Prednisone ≤ 20 mg\u002Fday Methotrexate ≤ 0.4 mg\u002Fkg\u002Fweek (maximum 20 mg\u002Fweek) Leflunomide 20 mg\u002Fday Azathioprine \\\u003C 3 mg\u002Fkg\u002Fday Combination therapy with low-dose prednisone (≤ 7.5 mg\u002Fday), hydroxychloroquine, or sulfasalazine\n\n* Healthy controls with no history of autoimmune or chronic infectious diseases\n* Healthy controls not taking immunosuppressive medications Willing and able to comply with study procedures and follow-up\n* Female participants of reproductive potential with negative pregnancy test at baseline\n* Female participants of reproductive potential agreeing to use effective contraception for at least 90 days after vaccination\n\nExclusion Criteria:\n\n* Prior receipt of any dengue vaccine\n* Receipt of a live attenuated vaccine within 4 weeks prior to enrollment\n* Receipt of an inactivated vaccine within 2 weeks prior to enrollment\n* Known allergy to any component of the vaccine\n* Febrile illness (≥ 37.8°C) within 72 hours prior to vaccination\n* History of immunodeficiency syndromes\n* History of asplenia\n* History of cancer\n* History of HIV infection\n* History of primary immunodeficiencies\n* Immunosuppression due to organ transplant\n* Chronic uncontrolled comorbidities (e.g., heart failure, renal failure, hepatic insufficiency, diabetes mellitus)\n* Hospitalization or acute illness at screening\n* Receipt of blood transfusion within 3 months prior to enrollment\n* Current pregnancy or breastfeeding\n* Intention to become pregnant within 90 days post-vaccination\n* Participation in another clinical trial within 30 days prior to enrollment",true,"ALL","12 Years","59 Years",{"count":22,"type":23},477,"ESTIMATED","INTERVENTIONAL",[26],"PHASE4","The goal of this clinical trial is to evaluate whether the live attenuated tetravalent Butantan-Dengue vaccine (Butantan-DV) is safe and capable of inducing an immune response in patients aged 12 to 59 years with autoimmune rheumatic diseases (ARDs) who are clinically stable and under low-grade or no immunosuppression, as well as in healthy volunteers matched by sex and age.\n\nThe main questions it aims to answer are:\n\nDoes the vaccine induce adequate seroconversion in patients with ARDs compared to healthy controls? What is the frequency and intensity of common adverse events after vaccination in ARDs patients? Does physical activity levels and nutritional status influence vaccine-induced immune response in patients with ARDs?\n\nResearchers will compare patients with ARDs to healthy controls to evaluate if the vaccine elicits similar immune responses and safety profiles.\n\nAll participants will:\n\n* receive a single 0.5 mL dose of the Butantan-DV vaccine via subcutaneous injection;\n* undergo blood sample collection before and after vaccination (baseline, Day 42, and Day 400) to assess antibody and cellular responses;\n* attend follow-up visits on Days 7, 14, and 42 for safety monitoring and laboratory tests;\n* report any symptoms or adverse events using a standardized diary for 42 days;\n* be followed for up to one year for long-term safety and immunogenicity assessments.\n* wear a device for 14 consecutive days to assess current and habitual physical activity levels.\n* answer three non-consecutive 24-hour dietary recalls, including at least one weekend day to assess nutritional status.\n* collect blood samples one-year after vaccination to access immunogenicity and cellular response.\n\nResearcher will also perform subgroups analysis in:\n\nA viremia subgroup (50 patients and 50 healthy controls) will provide additional samples on Days 1, 7, 14, 28, 42, and-if viremia is detected-Day 68, to evaluate post-vaccination viremia and its duration.\n\nAn immunogenicity subgroup (\\~20% of participants, n=96) will undergo cellular immune response testing via flow cytometry to evaluate T-cell responses.",[29,30,31,32,33,34,35,36,37,38,39,40],"Rheumatoid Arthritis (RA)","Juvenile Idiopathic Arthritis (JIA)","Systemic Lupus Erythematosus (SLE)","Juvenile Systemic Lupus Erythematosus","Systemic Sclerosis (SSc)","Idiopathic Inflammatory Myopathies (IIMs)","Axial Spondyloarthritis","Psoriatic Arthritis (PsA)","Granulomatosis With Polyangiitis","Microscopic Polyangiitis","Antiphospholipid Syndrome","Takayasu Arteritis",[42,43,44,45,46,47,48],"Tetravalent Vaccine","Butantan-Dengue Vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","Vaccine","RECRUITING","2026-04-14",{"date":52,"type":53},"2026-04-15","ACTUAL",{"date":55,"type":23},"2026-03-16",{"date":57,"type":23},"2028-12-30",{"name":59,"class":60},"University of Sao Paulo General Hospital","OTHER",2,{"id":63,"slug":64,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":83,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100283245","vcrc-tissue-repository-100283245","NCT02967068","VCRC Tissue Repository","VCRC Tissue Biorepository Collection Protocol","Inclusion Criteria:\n\n* A participant will be deemed eligible for this study if the participant is\u002Fwas enrolled in another one of the VCRC observational\u002Flongitudinal protocols (5502, 5503, 5504, 5505, 5506, 5507, 5563) and\u002For one of the VCRC interventional studies (5522, 5523, 5526, 5527, or 5562).\n\nExclusion Criteria:\n\n* Inability to give informed consent (or their guardians in the case of children) and to sign the consent form.\n* Unwilling to allow the use of their tissue for research.",{"count":70,"type":23},1000,"OBSERVATIONAL","The purpose of this study is to collect existing tissue specimens from subjects enrolled in Vasculitis Clinical Research Consortium (VCRC) studies. Analysis of these tissue specimens and linked clinical data collected through VCRC studies may lead to the identification and development of a series of translational research projects. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.",[74,75,76,77,78,79,80,38,81,40,82],"Aortitis","Cutaneous Vasculitis","Eosinophilic Granulomatosis With Polyangiitis","Giant Cell Arteritis","Granulomatosis With Polyangiitis (Wegener's)","Henoch-Schonlein Purpura","IgA Vasculitis","Polyarteritis Nodosa","Churg-Strauss Syndrome",[84,85,86,87,88,89,90,91],"CSS","EGPA","GCA","GPA","MPA","PAN","TAK","HSP","2026-01-21",{"date":94,"type":53},"2026-01-22",{"date":96,"type":53},"2016-11",{"date":98,"type":23},"2028-12",{"name":100,"class":60},"University of Pennsylvania",8,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":18,"minAge":109,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100151303","one-time-dna-study-for-vasculitis-100151303","NCT01241305","One-Time DNA Study for Vasculitis","VCRC Genetic Repository One-Time DNA Protocol","Inclusion Criteria:\n\n1\\. Diagnostic criteria for Giant Cell Arteritis Age at disease onset \\>50 years (required)\n\n1. New onset or new type of localized pain in the head\n2. Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased pulsation, unrelated to arteriosclerosis of cervical arteries)\n3. ESR of \\>40mm in the first hour by the Westergren method\n4. Abnormal artery biopsy (i.e. temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells)\n5. Large Vessel Vasculitis (LVV) by angiogram or biopsy not explained by something else\n\nInclusion Criteria:\n\n2\\. Diagnostic criteria for Takayasu's Arteritis\n\n1. Age at disease onset \\\u003C50 years\n2. Claudication of extremities\n3. Decreased brachial artery pulse (one or both arteries)\n4. Blood pressure difference of \\>10mm Hg between the arms\n5. Bruit over subclavian arteries or aorta\n6. Arteriogram abnormalities compatible with TAK (includes conventional dye angiography or MR angiography or CT angiography)\n\nInclusion Criteria:\n\n3\\. Diagnostic criteria for Polyarteritis Nodosa Major criteria (not explained by other causes) felt by investigator to be due to vasculitis\n\n1. Arteriographic abnormality\n2. Presence of granulocyte or mixed leukocyte infiltrate in an arterial wall on biopsy\n3. Mononeuropathy or polyneuropathy\n\nMinor criteria (not explained by other causes) felt by investigator to be due to vasculitis\n\n1. Weight loss \\> 4 kg\n2. Livedo reticularis, cutaneous ulcerations, or skin nodules\n3. Testicular pain or tenderness\n4. Myalgias\n5. Diastolic blood pressure \\> 90 mm Hg\n6. Elevated BUN or serum creatinine levels\n7. Ischemic abdominal pain\n\nIsolated cutaneous Polyarteritis Nodosa 1. Biopsy-proven cutaneous PAN\n\nInclusion Criteria:\n\n4\\. Diagnostic criteria for Granulomatosis with Polyangiitis (Wegener's) (GPA) and Microscopic Polyangitis (MPA)\n\n* Diagnosis of GPA or MPA. Widely accepted diagnostic criteria, as opposed to classification criteria or definitions, have not been developed for GPA \\& MPA.\n* For diagnosis of GPA meets at least 2 of the following 5 modified ACR criteria:\n\n  1. Nasal or oral inflammation with oral ulcers or nasal discharge with pus or blood\n  2. Abnormal chest radiograph with nodules, fixed infiltrates, or cavities\n  3. Urinary sediment with microhematuria or red cell casts\n  4. Granulomatous inflammation within the wall of an artery or in the perivascular area on biopsy\n  5. Antineutrophil cytoplasmic antibody (ANCA) positive by enzyme immunoassay for either PR3- or MPO-ANCA\n* For diagnosis of MPA, meets the Chapel Hill Consensus Conference Definition for MPA:\n\n  1. Necrotizing vasculitis, with few or no immune deposits, that affects small vessels (i.e., capillaries, venules, arterioles)\n  2. Necrotizing arteritis involving small- and medium-sized arteries may be present\n  3. Necrotizing glomerulonephritis is very common\n  4. Pulmonary capillaritis often occurs\n\n     Inclusion Criteria:\n\n     5\\. Diagnostic criteria for Eosinophilic Granulomatosis with Polyangiitis (Churg-Strauss)\n     1. Asthma\n     2. Peak peripheral blood eosinophilia of \\>10% of total WBC\n     3. Peripheral neuropathy attributable to vasculitis\n     4. Transient pulmonary infiltrates on chest imaging studies\n     5. Paranasal sinus abnormalities or nasal polyposis\n     6. Eosinophilic inflammation on tissue biopsy\n\n     If patients have 4 of the above 6 criteria but lack clearcut documentation of small vessel vasculitis, they are also eligible for enrollment.\n\n     General Exclusion Criteria:\n* Inability to give informed consent and to sign the consent form\n* Enrolled in VCRC protocols 5502, 5503, 5504, 5505, 5506, 5522, or 5523\n* Unwilling to provide blood for DNA collection","7 Years",{"count":70,"type":23},"The purpose of this study is to identify genes that increase the risk of developing vasculitis, a group of severe diseases that feature inflammation of blood vessels. Results of these studies will provide vasculitis researchers with insight into the causes of these diseases and generate new ideas for diagnostic tests and therapies, and will be of great interest to the larger communities of researchers investigating vasculitis and other autoimmune, inflammatory, and vascular diseases.",[113,77,78,38,81,114],"Eosinophilic Granulomatosis With Polyangiitis (Churg-Strauss)","Takayasu's Arteritis",[116,84,85,86,87,117,88,89,90],"Vasculitis","WG",{"date":94,"type":53},{"date":120,"type":4},"2010-10",{"date":122,"type":23},"2028-08",{"name":100,"class":60},14,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":18,"minAge":133,"maxAge":134,"enrollmentInfo":135,"targetDuration":4,"studyType":24,"phases":137,"briefSummary":140,"conditions":141,"keywords":150,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":161},"100542995","phase-1-fourth-gen-car-t-cells-targeting-bcmacd19-for-refractory-systemic-lupus-erythematosus-sle-100542995","NCT06350110","Fourth-gen CAR T Cells Targeting BCMA\u002FCD19 for Refractory Systemic Lupus Erythematosus (SLE)","T-cell Infusion Targeting BCMA and CD19 for Refractory\u002FRelapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement","BAH242","Inclusion Criteria:\n\n* 18-90 years old;\n* Total score ≥ 10 on the EULAR\u002FACR 2019 SLE classification criteria.\n* SELENA-SLEDAI≥8.\n* Patients with CD19+ B-cell.\n* Hemoglobin≥85 g\u002FL.\n* WBC≥2.5×10\\^9\u002FL.\n* NEUT≥1×10\\^9\u002FL.\n* BPC≥50×10\\^9\u002FL.\n* AST\u002FALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL\u002Fmin; blood bilirubin ≤2.0 mg\u002Fdl; echocardiography indicates that the ejection fraction is ≥50%.\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis.\n* Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline.\n* Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.\n* Agree to attend follow-up visits as required.\n* Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n\nExclusion Criteria:\n\n* Renal disease: severe lupus nephritis (serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL) within 8 weeks --Prior to leukapheresis, or subjects who need hemodialysis.\n* CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \\[CVA\\], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.\n* Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.\n* Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;\n* Received immunosuppressive therapy within 1 week prior to leukapheresis.\n* Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus.\n* Patients with syphilis infection.\n* The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening.\n* Received live vaccine treatment within 4 weeks prior to screening.\n* Severe allergies or hypersensitivity.\n* Contraindication to cyclophosphamide in combination with fludarabine.\n* Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion.\n* Cannula or drainage tubes other than central venous catheters.\n* Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;\n* Subjects with prior CD19 or BCMA-targeted therapy.\n* Participated in any clinical study within 3 months prior to enrollment.\n* Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.","18 Years","90 Years",{"count":136,"type":23},75,[138,139],"PHASE1","PHASE2","This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.",[142,143,144,145,146,38,147,148,149],"Systemic Lupus Erythematosus","Lupus Nephritis","Autoimmune Diseases","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Granulomatous Polyangiitis","Systemic Sclerosis","Idiopathic Inflammatory Myopathies","Sjogren's Syndrome",[151],"CAR-T Cell Therapy","2024-10-11",{"date":154,"type":53},"2024-10-15",{"date":156,"type":53},"2024-07-10",{"date":158,"type":23},"2025-12-28",{"name":160,"class":60},"Essen Biotech",1]