51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05029336 (ClinicalTrials.gov) | September 2023 | 24/8/2021 | Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | Autologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune Diseases | Systemic Lupus Erythematosus;Systemic Sclerosis | Biological: Depletion of CD3/CD19 in an autologous stem cell transplant | Stephan Grupp MD PhD | NULL | Recruiting | 8 Years | 25 Years | All | 20 | Phase 2 | United States |
| 2 | EUCTR2022-001484-27-NL (EUCTR) | 24/01/2023 | 29/10/2022 | Basta 2 | B cell Activation in Sjögren's Syndrome, Cutaneous Lupus Erythematodus and Systemic Sclerosis TissuesAnalysis 2 - Basta 2 | Systemic Sclerosis Sjögren's SyndromeCutaneous Lupus Erythematodus;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: [89Zr]Zr-Df-crefmirlimab berdoxam Product Code: IND 127861 INN or Proposed INN: [89Zr]Zr-Df-crefmirlimab berdoxam Other descriptive name: Minibody against CD8 conjugated to desferrioxamine labeled with zirconium Zr 89 | radboudumc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | Netherlands | ||
| 3 | NCT05270668 (ClinicalTrials.gov) | February 22, 2022 | 27/2/2022 | Phase 2 Safety and Efficacy Study of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) | A Double Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PRA023 in Subjects With Systemic Sclerosis Associated With Interstitial Lung Disease (SSc-ILD) | Diffuse Cutaneous Systemic Sclerosis;Interstitial Lung Disease | Drug: PRA023 IV;Device: Companion diagnostic ( CDx);Drug: Placebo | Prometheus Biosciences, Inc. | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | United States;Australia;Belgium;Canada;France;Germany;Hungary;Israel;Italy;Netherlands;Norway;Poland;Spain;Switzerland;United Kingdom |
| 4 | NCT05085444 (ClinicalTrials.gov) | October 8, 2021 | 11/10/2021 | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Scleroderma | Scleroderma;Autoimmune Diseases | Biological: Assigned Interventions CD19/BCMA CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 9 | Early Phase 1 | China |
| 5 | JPRN-jRCTc071190041 | 04/01/2019 | 09/01/2020 | A clinical trial of autologous stem cell transplantation for severe systemic sclerosis | A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis - A single-arm, open-label, phase 2 study of autologous CD34+ stem cells-selected transplantation for severe systemic sclerosis | systemic sclerosis | After peripheral blood stem cell mobilization and aphereisi with cyclophosphamide 4 g/m2 and G-CSF, CD34+ cells were enriched by using anti-CD34 immunomagnetic beads. Conditioning was performed using high-dose cyclophosphamide (50 mg/kg) for 4 days, and freeze-thawed CD34+ cells were transplanted. | Akashi Koichi | NULL | Not Recruiting | >= 16age old | < 65age old | Both | 12 | Phase 2 | Japan |
| 6 | NCT03630211 (ClinicalTrials.gov) | July 31, 2018 | 7/8/2018 | Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Autologous Stem Cell Transplantation With CD34-Selected Peripheral Blood Stem Cells (PBSC) in Patients With Treatment Resistant Systemic Sclerosis (SSc) | Systemic Sclerosis;Diffuse Sclerosis Systemic;Interstitial Lung Disease;Pulmonary Hypertension | Drug: Cyclophosphamide;Drug: Mesna;Drug: Rituximab;Drug: Alemtuzumab;Drug: Thiotepa;Drug: GM-CSF;Drug: Intravenous immunoglobulin;Radiation: Total Body Irradiation;Drug: Anti Thymocyte Globulin | Paul Szabolcs | NULL | Recruiting | 8 Years | 60 Years | All | 8 | Phase 2 | United States |
| 7 | NCT01895244 (ClinicalTrials.gov) | September 2012 | 1/7/2013 | Autologous Stem Cell Transplantation for Progressive Systemic Sclerosis | Highdose Chemotherapy and Transplantation of 34+ Selected Stem Cell for Progressive Systemic Sclerosis - Modification According to Manifestation | Scleroderma;Cardiac Involvement;Autologous Stem Cell Transplantation | Drug: Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells | University Hospital Tuebingen | NULL | Active, not recruiting | 18 Years | 65 Years | All | 44 | Phase 2 | Germany |
| 8 | EUCTR2011-002434-40-DE (EUCTR) | 23/03/2012 | 18/08/2011 | Transplantation of stem cells for the treatment of svere systemic sclerosis with a protocol which is adapted to individual manifestatons of the disease | Highdose Chemotherapy and transplantation of 34+ selected stem cell for progressive systemic sclerosisModification according to manifestation - AST-MOMA | Systemic sclerosis MedDRA version: 14.1;Level: LLT;Classification code 10059040;Term: Autologous peripheral haematopoietic stem cell transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: CD34 selected autologous hematopoietic cells Product Code: CD34+SC | University Hospital Tuebingen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Germany | ||||
| 9 | NCT01086540 (ClinicalTrials.gov) | June 24, 2011 | 11/3/2010 | Rituximab for Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | A Randomized, Double-Blind, Placebo-Controlled, Phase II Multicenter Trial of a Monoclonal Antibody to CD20 (Rituximab) for the Treatment of Systemic Sclerosis-Associated Pulmonary Arterial Hypertension (SSc-PAH) | Systemic Sclerosis-Associated PAH | Biological: Rituximab;Other: Placebo;Diagnostic Test: CMRI;Drug: prednisone;Drug: methylprednisolone;Drug: diphenhydramine;Drug: acetaminophen | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Rho Federal Systems Division, Inc. | Completed | 18 Years | 75 Years | All | 57 | Phase 2 | United States |
| 10 | NCT00936546 (ClinicalTrials.gov) | June 2009 | 9/7/2009 | A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy | A Protocol Based Treatment for Debilitating Fibrosing Skin Disorders With (Anti-CD 20), Rituximab, Evaluating Safety and Efficacy | Debilitating Fibrosing Skin Disorders (Localised Scleroderma, Eosinophilic Fasciitis) | Drug: Rituximab | University Hospital, Ghent | NULL | Completed | 18 Years | N/A | All | 3 | Phase 2 | Belgium |
| 11 | EUCTR2008-007180-16-NL (EUCTR) | 13/05/2009 | 24/11/2008 | INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS) | INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA - RItuximab In Scleroderma ( RITIS) | systemic sclerosis MedDRA version: 9.1;Level: PT;Classification code 10039710;Term: Scleroderma | Trade Name: Rituximab Product Name: Mabthera | LUMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 12 | NCT00379431 (ClinicalTrials.gov) | November 27, 2006 | 20/9/2006 | A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab | A Protocol Based Treatment for Early and Severe Systemic Sclerosis With (Anti-CD20), Rituximab | Early and Severe Systemic Sclerosis | Drug: Administration of rituximab and methylprednisolone | University Hospital, Ghent | NULL | Completed | 18 Years | N/A | All | 9 | Phase 2 | Belgium |
| 13 | EUCTR2006-003836-31-BE (EUCTR) | 06/09/2006 | 02/08/2006 | A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab | A protocol based treatment for early and severe systemic sclerosis with (anti-CD-20) rituximab | systemic sclerosis MedDRA version: 8.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab | University Hospital Gent | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 14 | NCT00114530 (ClinicalTrials.gov) | June 2005 | 15/6/2005 | Scleroderma: Cyclophosphamide or Transplantation (SCOT) | A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01) | Scleroderma, Systemic;Sclerosis;Autoimmune Disease | Biological: mHSCT;Drug: cyclophosphamide | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 69 Years | All | 75 | Phase 2/Phase 3 | United States;Canada |