[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"scleroderma-systemic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:scleroderma-systemic":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,46,78,106,140,166,198,223,245],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100630878","phase-2-phase-iia-trial-of-anti-cd19-car-t-cells-in-systemic-sclerosis-resistant-to-immunosuppressive-therapy-100630878",false,"NCT07493395","Phase IIa Trial of Anti-CD19 CAR T-Cells in Systemic Sclerosis Resistant to Immunosuppressive Therapy","SCLEROCAR: A Phase IIa Trial Evaluating the Efficacy of Anti-CD19 Chimeric Antigen Receptor Engineered T-Cells in Patients With Systemic Sclerosis (SSc) Resistant to Immunosuppressive Drugs","SCLEROCAR","Pre-Inclusion criteria:\n\n1. Diagnosis of systemic sclerosis according to ACR\u002FEULAR 2013 classification (15).we include in the critera the fulfilling of 2013 EULAR\u002FACR criteria and specify disease duration (less than 2 years), score\u002Fclinical evidence for active disease :\n2. Severe and resistant to low dose steroids and at least 2 immunosuppressive treatment including csDMARDs (methotrexate, azathioprine, mycophenolate mofetil) and at least one bDMARDs (Tocilizumab)\n3. Early onset (less than 2 years).\n4. Severity \\& progression of disease be defined by :\n\n   1. .mRSS \\>15 with at least one organ involvement (lung: FVC \\\u003C80%, renal involvement, cardiac involvement, Creatinine \\\u003C 1.5 mg\u002Fdl within 6 months).\n   2. mRSS \\\u003C15 and lung fibrosis progression (FVC -10% DLCO -15% within 6 months)\n5. patients with active disease (as defined by EUSTAR ≥2.5) and to patients with a worsening disease despite 6 months of at least 2 immunosuppressive treatments including one DMARDs (methotrexate, azathioprine, mycophenolate mofetil), and one biological DMARD rituximab or tocilizumab.\n6. Estimated survival time \\> 24 weeks\n7. Age: ≥18 ≤64 years old voluntary to participate in the study and sign the informed consent\n8. Adequate organ functions assessed :\n\n   1. serum Creatinine clearance \\> 40ml\u002Fmi\n   2. adequate bone marrow function (Hemoglobin ≥9g\u002FdL ; PMN ≥ 1 G\u002FL ; Platelets ≥ 100 G\u002FL)\n   3. Alanine aminotransferase (ALT) ≤ 3 x ULN and total bilirubin \\\u003C 2.0 mg\u002FdL (34 μmol\u002FL) (or \\\u003C 3.0 mg\u002FdL \\[51 μmol\u002FL\\] for subjects with Gilbert's syndrome)\n   4. Adequate respiratory function: no dyspnea or grade I dyspnea (Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0) and oxygen saturation \\>\u002F= 92% on room air\n9. Highly effective contraception methods\n\nInclusion criteria:\n\n1. Adequate organ functions assessed:\n\n   1. serum Creatinine clearance \\> 40ml\u002Fmi\n   2. adequate bone marrow function (Hemoglobin ≥9g\u002FdL ; PMN ≥ 1 G\u002FL ; Platelets ≥ 100 G\u002FL)\n   3. Alanine aminotransferase (ALT) ≤ 3 x ULN and total bilirubin \\\u003C 2.0 mg\u002FdL (34 μmol\u002FL) (or \\\u003C 3.0 mg\u002FdL \\[51 μmol\u002FL\\] for subjects with Gilbert's syndrome)\n   4. Adequate respiratory function: no dyspnea or grade I dyspnea (Common Terminology Criteria for Adverse Events (NCI CTCAE v 5.0) and oxygen saturation \\>\u002F= 92% on room air\n2. Adequate venous access for apheresis\n3. Leucapheresis : a wash-out period of 6 weeks for conventional immunosuppressants (i.e. methotrexate, mycophenolate mofetil)\n4. Leucapheresis : at least 12 weeks after biotherapy (i.e. tocilizumab, 6 months for rituximab),\n\nExclusion Criteria:\n\n1. Craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia or cerebrovascular hemorrhagic diseases\n2. ECG showing prolonged QT interval or history of severe heart diseases or FEVG \\\u003C 40%\n3. Lung and \u002F or heart severe dysfunction defined by CVF\\\u003C50% and\u002For DLCO \\\u003C40%\n4. Pulmonary arterial hypertension defined by catheterism (mean AP \\> 25mmHg at rest or \\> 30mmHg after exercise, PAOP \\\u003C 15mmHG)\n5. Clinically significant active, opportunistic, chronic or recurrent infection (including but not limited to: hepatitis B or C virus or HIV) or covid-19 \\\u003C 1 months including active or latent tuberculosis (TB) infection\n6. Contra indication for autologous hematopoietic stem cell transplantation (AHSCT ) or relapsing at least one year after AHSCT\n7. Active hematological or solid neoplasm\n8. Concurrent therapy with systemic steroids (\\>10 mg\u002Fd prednisone equivalent) within 2 weeks prior to inclusion, except inhaled steroids\n9. Methylprednisolone or prednisone (maximum dose 20 mg) instead of immunosuppressive agents\n10. T cell targeting drugs (e.g. mycophenolate mofetil, azathioprine, calcineurin inhibitors) within 6 weeks prior to leukapheresis\n11. Previous adoptive T cell therapy or any gene therapy including CAR T cell therapy\n12. Live vaccines within 6 weeks prior to leukapheresis\n13. Hypersensitivity against any drug or its ingredients\u002Fimpurities that is scheduled or likely to be given during trial participation, e.g. as part of the mandatory preparative chemotherapy or rescue medication\u002Fsalvage therapies for treatment related toxicities\n14. patients without social security coverage;\n15. patients under guardianship;\n16. Male or female patients seeking to conceive a child\n17. Women of childbearing potential unless they are using a highly effective method of contraception starting from the time of enrolment and for at least 12 months following LD chemotherapy and until clearance of CAR-T cells, and sexually active male participants unwilling to use a condom. Female partners of sexually active male participants must be on a highly effective form of birth control from the time of enrolment and for at least 12 months following LD chemotherapy and until clearance of CAR-T cells.\n18. pregnant or breastfeeding women;\n19. patients with advanced cognitive disorders or any other cause preventing their informed consent;\n20. active, clinically significant CNS pathology : If signs or symptoms exist which present diagnostic uncertainty, neurologist consultation will be obtained to confirm the diagnosis of any neurological condition\n21. any comorbidity, whatever it may be, which may, in the opinion of the investigator, place the patient at additional risk or interfere with the monitoring of the study.\n22. Concurrent participation in any other interventional trial and Contraindication to the lymphodepleting chemotherapy","ALL","18 Years","64 Years",{"count":21,"type":22},6,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to evaluate whether anti-CD19 CAR T-cell therapy can improve disease activity in adults with severe, treatment-resistant systemic sclerosis (SSc). The study will also assess the safety of this therapy and how CAR T-cells behave in the body.\n\nThe main questions are:\n\nDoes CAR T-cell therapy reduce skin thickening and other signs of SSc? What side effects occur after receiving CAR T-cells? How do CAR T-cells expand, persist, and affect B-cells and autoantibodies?\n\nParticipants will:\n\nUndergo leukapheresis Receive short lymphodepleting chemotherapy Receive one infusion of anti-CD19 CAR T-cells Stay in the hospital for about 10 days Attend follow-up visits for 24 months with clinical exams, blood tests, and organ-function assessments\n\nOptional skin or lymph-node biopsies may be performed in participants who consent to these procedures.\n\nThis study aims to provide early evidence on whether CAR T-cell therapy could become a promising treatment option for systemic sclerosis.",[28],"Scleroderma, Systemic",[30,31,32],"Systemic Sclerosis","Anti-CD19 CAR T-cells","Autologous CAR T-cell therapy","RECRUITING","2026-06-17",{"date":36,"type":37},"2026-06-22","ACTUAL",{"date":39,"type":37},"2026-06-11",{"date":41,"type":22},"2028-06-11",{"name":43,"class":44},"University Hospital, Montpellier","OTHER",4,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100641434","phase-1-a-phase-12-study-of-pro-203-in-healthy-volunteers-and-participants-with-systemic-sclerosis-100641434","NCT07641634","A Phase 1\u002F2 Study of PRO-203 in Healthy Volunteers and Participants With Systemic Sclerosis.","A Two-part, Phase 1\u002F2, Randomized, Double-blind, Placebo-controlled, Single-ascending-dose Study of PRO-203 in Healthy Adult Volunteers Followed by an Open-label, Single-ascending-dose With Priming Study of PRO-203 in Participants With Systemic Sclerosis","Key Inclusion Criteria (All Participants)\n\n* Is male or female, age 18 to 65 years, inclusive, at Screening.\n* Able to provide Informed Consent.\n* Absolute B cell count \\> 25 cells\u002FuL.\n\nAdditional Inclusion for Part 1 (Closed to Enrollment)\n\n* In good general health, determined by no clinically significant findings in the of the investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1 (participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment).\n* Up to date vaccination status per local guidelines (including but not limited to influenza vaccine, COVID booster and hepatitis B vaccine).\n\nAdditional Inclusion for Part 2\n\n* Fulfill 2013 ACR\u002F EULAR criteria for classification of SSc with a total score of ≥ 9.\n* Active disease defined as at least two of the following at screening:\n* Disease duration ≤ 2 years (since onset of first-non-Raynaud-symptom), or\n* Elevated acute phase reactant levels (CRP ≥ 6 mg\u002FL, erythrocytes sedimentation rate \\[ESR\\] ≥ 28 mm\u002F1h, or platelet count ≥ 330,000\u002FµL), or\n* Baseline mRSS ≥10 with evidence of progression, defined as mRSS increase at least 3 units, or involvement of 1 new body area and mRSS increase at least 2 units, or involvement of 2 new body areas (each within the previous 6 months), or\n* ≥ 1 tendon friction rub, or\n* Elevation of CK or aldolase \\> 2 × the upper limit of normal (ULN) consistent with SSc-related myopathy, or\n* Progressive fibrosing interstitial lung disease (ILD) as defined by at least one of the following criteria at any time within the prior 2 years:\n\n  1. relative decline in forced vital capacity (FVC) % predicted ≥ 10%, or\n  2. relative decline in FVC % predicted ≥ 5% to \\\u003C10% and worsened respiratory symptoms, or\n  3. relative decline in FVC % predicted ≥ 5% to \\\u003C10% and increased extent of fibrosis on high-resolution computed tomography (HRCT), or\n  4. worsened respiratory symptoms and increased extent of fibrosis on HRCT\n* Intolerant or refractory to at least 1 line of standard therapy, including methotrexate, azathioprine, IVIG, mycophenolic acid derivatives, cyclophosphamide, TNF-inhibitors, rituximab, or tocilizumab.\n\nKey Exclusion Criteria (All Participants)\n\n* Any clinically significant underlying illness in the opinion of the investigator.\n* Active infection within 4 weeks prior to screening. Participants receiving IV antibiotics or having received IV antibiotics within 14 days prior to enrollment are excluded.\n* Positive QuantiFERON-Gold TB test at screening.\n* Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, such as the flu vaccine, are allowed).\n* Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except for treated local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that had been excised and cured).\n* Currently enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives of the prior investigational agent (whichever is longer) have passed since ending another investigational device or drug study or plans to enroll in another investigational device or drug study during the course of this study.\n* Social smokers e.g. up to 10 cigarettes per week (or equivalent amounts of nicotine containing products) and willing to abstain during inpatient stay, are allowed\n\nAdditional Exclusion Criteria for Part 1 (Closed to Enrollment)\n\n* Use of any prescription medication within 14 days and OTC medications, vitamins, herbal medications (e.g., St. John's wort), or cannabis, except for contraceptive medications and as needed (prn) acetaminophen\u002Fparacetamol (not exceeding 2 grams\u002Fday) within 7 days prior to administration of the study drug and throughout the study.\n\nAdditional Exclusion Criteria for Part 2\n\n* Rheumatic autoimmune disease other than SSc.\n* Positive anti-centromere antibodies.\n* Pulmonary disease with FVC ≤ 45% of predicted, or DLCO ≤ 35% of predicted.\n* Class 2 or higher pulmonary arterial hypertension or evidence of other moderately severe pulmonary disease.\n* Renal crisis within 6 months prior to Screening.\n* Prior treatment with cellular immunotherapy (eg, CAR-T) or gene therapy product directed at any target.\n* Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation.\n* Previous treatment with thalidomide, anti-thymocyte globulin, plasmapheresis, or extracorporeal photopheresis.\n* Unable to washout current immunosuppressive therapy within 2 months\n* Has received anti-CD19 or CD20 therapies, within 6 months prior to start of therapy\n* Plan to receive live or live-attenuated vaccines within 8 weeks prior to first dose of study drug and during treatment until B cell reconstitution to 80% of baseline (inactive vaccines, such as the flu vaccine, are allowed)","65 Years",{"count":55,"type":22},44,[57,25],"PHASE1","A two-part study of PRO-203 administered subcutaneously in healthy adult volunteers and participants with Systemic Sclerosis (SSc).",[60,61,28,62],"Healthy Volunteers","Systemic Sclerosis (SSc)","Scleroderma",[64,65,62,66],"Systemic sclerosis","SSc","B cell depletion","2026-06-16",{"date":69,"type":37},"2026-06-18",{"date":71,"type":37},"2025-10-27",{"date":73,"type":22},"2028-01",{"name":75,"class":76},"Prolium Bioscience, Inc","INDUSTRY",3,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100424287","trichoscopy-and-systemic-scleroderma-100424287","NCT04804930","Trichoscopy and Systemic Scleroderma","Prognostic Value of Trichoscopy in Patients With Systemic Scleroderma","TRICHLOSCLERO","Inclusion Criteria:\n\n* Patient who fulfils the Systemic scleroderma ACR-EULAR 2013 criteria\n* Signed informed consent\n* Being social insured\n\nExclusion Criteria:\n\n* Patients aged less than 18 years old\n* patients under legal protection\n* patients deprived of their liberty\n* patients in emergency situations\n* patients who refused or unable to give informed consent\n* For the control group: sclap inflammatory disease active the day of the examination",{"count":87,"type":22},200,"OBSERVATIONAL","* Few data are available on scalp involvement in systemic scleroderma.\n* Few data are available on the association between scalp abnormalities and features of systemic scleroderma\n* Trichoscopy is a simple, reproducible, noninvasive examination that is part of the examination of hairy areas in routine dermatologic practice\n* There is a lack of simple, noninvasive examinations to evaluate patients with systemic scleroderma\n\nThe objective will be to evaluate the contribution of trichoscopy in the evaluation of patients with systemic scleroderma",[28],[92,93,94,95],"Trichoscopy","Dermoscopy","Systemic Scleroderma","Scalp","2026-04-21",{"date":98,"type":37},"2026-04-22",{"date":100,"type":37},"2021-11-08",{"date":102,"type":22},"2026-05",{"name":104,"class":44},"University Hospital, Lille",1,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100506771","phase-2-a-study-of-the-efficacy-and-safety-of-belimumab-in-adults-with-systemic-sclerosis-associated-interstitial-lung-disease-100506771","NCT05878717","A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease","A Phase 2\u002F3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD)","BLISSc-ILD","Inclusion Criteria:\n\n1. Participant is 18 years of age inclusive, or older at the time of signing the informed consent.\n2. Documented diagnosis of SSc as defined by the American College of Rheumatology \u002F European League Against Rheumatism 2013 SSc classification criteria.\n3. Diffuse cutaneous disease, defined as presence of thickened skin with mRSS \\>0 over at least one skin area proximal to elbows and\u002For knees in addition to distal areas involvement on Day 1.\n4. Total mRSS ≥15 on Day 1.\n5. Evidence of interstitial lung disease on centrally read screening HRCT.\n6. Anticentromere antibody negative on central test at screening.\n7. Evidence for active or progressive disease\n8. Participant has an area of uninvolved or mildly thickened skin that, in the opinion of the investigator, would allow SC injection at the abdomen or the front, middle region of the thigh.\n9. Participant is capable and willing to self-administer the study medication or has a caregiver who is capable and willing to administer the study medication throughout the study.\n10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:\n\n    Is a Woman of Non-Childbearing Potential (WONCBP) OR Is a Woman of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective.\n11. Capable of giving signed informed consent.\n\nExclusion Criteria:\n\n1. Systemic sclerosis-like illness, including but not limited to localized scleroderma (morphoea), eosinophilic fasciitis, sclerodermoid graft-versus-host disease, fibro mucinous conditions (scleroedema, scleromyxoedema), scleroderma-like conditions that are associated with environmental chemical and drug exposure (e.g., toxic rapeseed oil, vinyl chloride, bleomycin, gadolinium-based contrast agents \\[nephrogenic systemic fibrosis\\], or due to metabolic disease).\n2. Primary diagnosis of a rheumatic autoimmune disease other than dcSSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, polymyositis, dermatomyositis, systemic vasculitis, Sjogren's syndrome, antisynthetase syndrome, or mixed connective tissue disease, as determined by the investigator.\n3. FVC ≤45% of predicted, or a DLco (corrected for hemoglobin) ≤40% of predicted or requiring supplemental oxygen at screening.\n4. Pulmonary arterial hypertension, as determined by the investigator at, or prior to first day of dosing (Day 1).\n5. SSc renal crisis within 6 months prior to the first day of dosing (Day 1).\n6. History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.\n7. Obstructive pulmonary disease (pre-bronchodilator FEV1\u002FFVC \\\u003C0.7).\n8. Significant emphysema on screening HRCT (extent of emphysema exceeds extent of ILD).\n9. Previous or planned major organ transplant (e.g., heart, lung, kidney, liver) or bone marrow transplant (e.g., autologous stem cell transplant).\n10. Treatment with biologic agents, such as intravenous immunoglobulin or monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives (whichever is longer) prior to dosing.\n11. Treatment with rituximab within 6 months prior to Day 1.\n12. Treatment with non-biologic systemic immunosuppressive medication, other than mycophenolate, methotrexate or azathioprine (including, but not limited to cyclosporine A, tacrolimus, leflunomide, oral or parenteral gold, Janus kinase (JAK) inhibitors) within 3 months prior to Day 1.\n13. Treatment with cyclophosphamide (oral or intravenous) within 6 months prior to Day 1.\n14. Use of anti-fibrotic agents including colchicine, D-penicillamine, pirfenidone or tyrosine kinase inhibitors (e.g., nintedanib, nilotinib, imatinib, dasatinib) within 4 weeks prior to Day 1.\n15. Cytotoxic drugs such as, chlorambucil, nitrogen mustard, or other alkylating agents within 6 months of Day 1.\n16. Treatment with IM or IV corticosteroids within 1 month prior to Day 1.",{"count":115,"type":22},300,[25,117],"PHASE3","This study investigates the efficacy and safety of belimumab compared to placebo, in addition to standard therapy, for the treatment of participants with systemic sclerosis associated interstitial lung disease (SSc-ILD). The study will evaluate the effect of belimumab treatment on lung function as well as on extra-pulmonary disease manifestations, including skin thickening and general symptoms, such as fatigue, that impact quality of life (QoL).",[120,28],"Systemic Sclerosis Associated Interstitial Lung Disease",[122,123,124,125,126,127,128,129],"Monoclonal antibody","Autoimmune connective tissue disease","Skin","lung","systemic sclerosis","scleroderma","interstitial lung disease","belimumab","2026-01-09",{"date":132,"type":37},"2026-01-12",{"date":134,"type":37},"2023-09-13",{"date":136,"type":22},"2029-07-12",{"name":138,"class":76},"GlaxoSmithKline",131,{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":148,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":151,"studyType":88,"phases":4,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":105},"100619471","western-sweden-systemic-sclerosis-project-100619471","NCT07345052","Western Sweden Systemic Sclerosis Project","Western Sweden Systemic Sclerosis Project - A Study on Underlying Mechanisms for Disease Development and Predictors of Disease Activity and Treatment Response in Patients With Systemic Sclerosis","WESST","Inclusion Criteria:\n\n* Participants diagnosed with SSc according to the ACR and EULAR classification criteria\n\nExclusion Criteria:\n\n* Diagnosis of Mixed connective tissue disease\n* Not speaking or reading Swedish\n* With severe cognitive impairment\n* With blood count below specified limits\n* Allergy to local anaesthetic (for subjects who will provide a skin biopsy)",true,{"count":150,"type":22},150,"5 Years","The main aim of the project is to identify key-factors involved in the development and progression of Systemic Sclerosis (SSc), a chronic invalidating rheumatic disease characterized by high mortality and insufficient treatment options. A cohort of patients with SSc will be collected at the Sahlgrenska University Hospital in Gothenburg, Skaraborg Hospital in Skövde, and Södra Älvsborg Hospital in Borås (Sweden). Thanks to a holistic approach including integrated analysis of blood, and skin samples as well as DNA, and with the use of state-of-the-art methods, this project aims to identify factors (e.g. genes, proteins, metabolites, and immune cell types) associated with the development of SSc and with the progression to a more aggressive phenotype. Functional studies using in vitro model systems and patient specimens will be also implemented. The findings of the current project could lead to the identification of possible diagnostic and prognostic markers for the disease as well as potential drug targets. This cohort will be also linked to the European Scleroderma Trial and Research (EUSTAR), which is an international SSc research network aiming to coordinate research activities on SSc from groups all over Europe in order to improve treatment, quality of life and mortality of patients with SSc.",[28,154,155,156],"Fibrosis; Skin","Fibrosis Lung","Interstitial Lung Disease Due to Systemic Disease","2026-01-07",{"date":159,"type":37},"2026-01-15",{"date":161,"type":37},"2022-06-20",{"date":163,"type":22},"2030-12-31",{"name":165,"class":44},"Sahlgrenska University Hospital",{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":173,"maxAge":4,"enrollmentInfo":174,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":178,"conditions":179,"keywords":185,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":105},"100615465","investigating-the-effectiveness-of-the-biopsychosocial-model-based-exercise-approach-in-children-and-adults-diagnosed-with-scleroderma-100615465","NCT07292961","Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach in Children and Adults Diagnosed With Scleroderma","Investigating the Effectiveness of the Biopsychosocial Model-Based Exercise Approach (BETY) in Children and Adults Diagnosed With Scleroderma: A Single-Blind Randomized Controlled Trial","\\*For a child diagnosed with scleroderma\\*\n\nInclusion Criteria:\n\n* Cases diagnosed with scleroderma,\n* Cases aged 7-18 years will be included.\n\nExclusion Criteria:\n\n* Advanced heart\u002Flung\u002Fliver\u002Fkidney disease, neurological disease, and malignancies\n* Cases that are not willing to participate in the study will be excluded.\n* History of developmental delay\n* Having participated in a regular exercise program for the past 3 months\n* Individuals who are not willing to participate in the study\n\n\\*For adults diagnosed with scleroderma\\*\n\nInclusion Criteria:\n\n* Individuals diagnosed with scleroderma,\n* Individuals over the age of 18 will be included.\n\nExclusion Criteria:\n\n* Advanced heart\u002Flung\u002Fliver\u002Fkidney disease, neurological disease, and malignancies\n* Individuals who are not willing to participate in the study will be excluded.\n* Having participated in a regular exercise program for the past 3 months\n* Individuals who are not willing to participate in the study","7 Years",{"count":175,"type":22},48,[177],"NA","This study aims to investigate the effectiveness of BETY, an exercise approach based on the biopsychosocial model, in children and adults diagnosed with scleroderma.",[62,180,181,182,61,183,184],"Scleroderma, Localized","Scleroderma Systemic","Scleroderma (Limited and Diffuse)","Systemic Sclerosis - 2013 ACR\u002FEULAR Classification Criteria","Juvenile Systemic Sclerosis",[186,187,127,188],"biopsychosocial model","exercise","juvenile scleroderma","2025-12-06",{"date":191,"type":37},"2025-12-18",{"date":193,"type":37},"2025-12-04",{"date":195,"type":22},"2027-12-04",{"name":197,"class":44},"Hacettepe University",{"id":199,"slug":200,"hasResults":11,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":205,"targetDuration":4,"studyType":23,"phases":207,"briefSummary":208,"conditions":209,"keywords":211,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":222},"100535803","study-of-diosmin-for-the-treatment-of-digital-ulcers-in-systemic-sclerosis-100535803","NCT06256575","Study of Diosmin for the Treatment of Digital Ulcers in Systemic Sclerosis","Treatment of Digital Ulcers in Systemic Sclerosis With Diosmin: A Randomized, Double-blind, Placebo-controlled Multi-centre Pilot Study","Inclusion Criteria:\n\n* Diagnosis of systemic sclerosis (scleroderma)\n* At least one \"active\" digital ulcer\n* Medication for systemic sclerosis unchanged for 30 days\n\nExclusion Criteria:\n\n* Infection or gangrene in ulcer\n* Citrus allergy\n* Unstable heart, kidney, or liver disease\n* Active infection of any type\n* Current cancer treatment or uncured cancer\n* Pregnancy or breast feeding",{"count":206,"type":22},45,[177],"This study is performed to consider the safety and healing ability of diosmin in patients with systemic sclerosis (scleroderma) and open sores on their fingers (digital ulcers). Two (2) out of three (3) participants will receive active product. The participants will have four (4) visits over eight (8) weeks. Physical exams and photos will be performed. A variety of questions will be asked describing level of pain and lifestyle changes.",[28,210],"Digital Ulcer",[65,212,213,62],"Digital Ulcers","Sclerosis","2025-12-02",{"date":193,"type":37},{"date":217,"type":37},"2025-05-02",{"date":219,"type":22},"2027-08-15",{"name":221,"class":76},"Primus Pharmaceuticals",5,{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":229,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":23,"phases":233,"briefSummary":234,"conditions":235,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"locationsCount":105},"100530093","periodontal-microbiota-in-systemic-sclerosis-100530093","NCT06182293","Periodontal Microbiota in Systemic Sclerosis","Impact of Systemic Sclerosis on the Periodontal Microbiota: a Pilot Study","Periomicross","Inclusion Criteria:\n\nCommon inclusion criteria\n\n* Men or women over 18 (adults)\n* Affiliation to a social health insurance plan\n* Subject able to understand the aims and risks of the research and to give signed informed consent form prior to the inclusion in the study\n* More than 12 teeth suitable for evaluation\n\nInclusion criteria for systemic sclerosis patients\n\n* Systemic sclerosis patient with a diagnosis based on the American College of Rheumatology\u002FEuropean League Against Rheumatism criteria (LeRoy et al., 1988 ; van den Hoogen et al., 2013)\n* Diagnosis made during the 2 years preceding study inclusion (early form of the disease)\n\nInclusion criteria for controls\n\n\\- Patient attending the Oral Medicine and Surgery Department from the University Hospital of Strasbourg for a routine dental consultation\n\nExclusion Criteria:\n\n* \\- Subject under court protection\n* Subject under guardianship or curatorship\n* Pregnancy or breastfeeding\n* Impossibility to provide accurate information (emergency situation, comprehension difficulties…)\n* Subject currently involved in another clinical trial or in an exclusion period following participation in another clinical trial\n* Smoking (≥ 10 cigarettes per day)\n* Other associated systemic auto-immune disease (Sjögren syndrome with positive serum anti-SSA and\u002For anti-SSB auto-antibodies, systemic lupus erythematosus…)\n* Progressive chronic illness other than systemic sclerosis\n* Acute infection at inclusion\n* Progressive cancer or cancer diagnosed within 2 years prior to the study\n* Ongoing antibiotic and\u002For antifungal treatment or within 3 months prior to inclusion\n* Probiotics and\u002For prebiotics intake within 3 months prior to inclusion\n* Oral antiseptics within the week before inclusion (chlorhexidin mouthwashes…)\n* Risk of infective endocarditis\n* Corticosteroids ≥10 mg\u002Fday and\u002For proton pump inhibitors within 3 months prior to inclusion\n* Previous hematopoietic stem cell transplantation\n* Another cause of skin sclerosis (radiotherapy of the orofacial area…)\n* Periodontal specialized treatments, root and\u002For periodontal surgical treatment and\u002For subgingival instrumentation within the year before inclusion",{"count":232,"type":22},30,[177],"Systemic sclerosis (SSc) is a rare and complex autoimmune disease. Although its etiology remains unknown, various environmental factors, including certain microorganisms, can represent potential triggers of SSc in individuals with a permissive genetic background. Patients show a wide spectrum of clinical features including periodontitis, which is an inflammatory disease of the tooth-supporting tissues resulting from dysbiosis of the periodontal microbiota guided by inflammophilic bacteria.\n\nThe microbiota plays a fundamental role in the induction, training, and function of the host immune system. Numerous studies have highlighted the impact of an altered microbiota, i.e. dysbiosis, on the pathogenesis of immune-mediated diseases. Indeed, commensals are important to maintain immune homeostasis and changes in the microbial composition can be responsible for a loss of tolerance. SSc has been shown to be associated with gut dysbiosis and a depletion of commensals. However, although the oral cavity is one of the two largest microbial habitats, only one study (only focusing on Lactobacillus species) has investigated the oral microbiota in SSc. As periodontal dysbiosis is known to induce low-grade systemic inflammation and represents a risk factor for the development of various autoimmune diseases, the relationship between periodontal microbiota composition and SSc merits further exploration.\n\nThe aim of this pilot study is to characterize the taxonomic composition and metabolic pathways of the periodontal microbiota in SSc patients and age and sex-matched controls.",[181],"2025-08-01",{"date":238,"type":37},"2025-08-06",{"date":240,"type":37},"2024-10-24",{"date":242,"type":22},"2025-10-24",{"name":244,"class":44},"University Hospital, Strasbourg, France",{"id":246,"slug":247,"hasResults":11,"nctId":248,"briefTitle":249,"officialTitle":249,"acronym":250,"eligibilityCriteria":251,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":105},"100410695","effect-of-the-use-of-specific-oral-hygiene-devices-on-gingival-health-among-patients-with-systemic-sclerosis-100410695","NCT04627857","Effect of the Use of Specific Oral Hygiene Devices on Gingival Health Among Patients With Systemic Sclerosis","ScleroBross","Inclusion Criteria:\n\n* Adult male or female ≥ 18 years (18th birthday completed)\n* Affiliation to a social welfare system\n* Signed informed consent form\n* More than 12 natural teeth suitable for evaluation\n* Systemic sclerosis with cutaneous involvement with a diagnosis based on American College of Rheumatology (ACR) and LeRoy and Metzger criteria\n\nExclusion Criteria:\n\n* Localized scleroderma or systemic sclerosis without cutaneous involvement (\"sine scleroderma\" limited form)\n* Less than 12 natural teeth suitable for evaluation and\u002For mandibular\u002Fmaxillary complete denture(s)\n* Other progressive chronic illness \u002Fautoimmune disease other than systemic sclerosis (e.g. diabetes)\n* Another cause of mucocutaneous sclerosis (e.g. radiotherapy involving the oro-facial region)\n* Current use of sonic toothbrush and\u002For dental water flosser\n* Severe manual handicap preventing the patient from holding a toothbrush with a large handle\n* Oral antiseptics (e.g. chlorhexidin mouthwashes)\n* Ongoing medical treatment inducing a significant modification of the gingival state (e.g. anti-epileptic drugs)\n* Smoking (≥ 10 cigarettes per day)\n* Impossibility to provide accurate information (e.g. emergency situation, comprehension difficulties)\n* Individual under guardianship, curatorship or judicial protection",{"count":253,"type":22},100,[177],"Systemic sclerosis is a rare multisystem connective-tissue disorder characterized by three major pathological hallmarks: widespread fibrosis, vasculopathy and immunological abnormalities. This condition has multiple effects on the orofacial region that is involved in approximately 80% of the patients with a significant impact on the quality of life.\n\nThe aim of this randomized single-blind study is to evaluate the impact of the use of a specific oral hygiene instrumentation (sonic toothbrush and water flosser with a large handle) compared to \"standard\" toothbrushing with a manual toothbrush on the gingival health among patients with systemic sclerosis.",[181],"2024-08-16",{"date":259,"type":37},"2024-08-19",{"date":261,"type":37},"2021-07-01",{"date":263,"type":22},"2025-03-01",{"name":244,"class":44}]