51. 全身性強皮症 Scleroderma Clinical trials / Disease details
臨床試験数 : 523 / 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
| 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 | NCT04380831 (ClinicalTrials.gov) | February 24, 2022 | 30/4/2020 | TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis | Pilot Study of Total Body Irradiation Using Intensity Modulated Radiation Therapy (IMRT) and Cyclophosphamide Conditioning Regimen Prior to Autologous Hematopoietic Cell Transplantation in Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Radiation: Intensity-Modulated Radiation Therapy;Procedure: Total-Body Irradiation | City of Hope Medical Center | National Cancer Institute (NCI) | Recruiting | 18 Years | 65 Years | All | 15 | Early Phase 1 | United States |
| 2 | 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 | Recruiting | >= 16age old | < 65age old | Both | 12 | Phase 2 | Japan |
| 3 | 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 | Paul Szabolcs | NULL | Recruiting | 16 Years | 70 Years | All | 8 | Phase 2 | United States |
| 4 | NCT03593902 (ClinicalTrials.gov) | May 17, 2018 | 28/6/2018 | Cardiac Safe Transplants for Systemic Sclerosis | Autologous Hematopoietic Stem Cell Transplant for Patients With Systemic Sclerosis and Cardiac Dysfunction | Systemic Sclerosis;Scleroderma | Drug: Rituximab;Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Terminated | 18 Years | 65 Years | All | 9 | Phase 2/Phase 3 | United States |
| 5 | NCT01862926 (ClinicalTrials.gov) | November 2014 | 22/5/2013 | Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD | A Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung Disease | Interstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue Disease | Drug: Rituximab;Drug: Cyclophosphamide | Royal Brompton & Harefield NHS Foundation Trust | Imperial College London;University of East Anglia;University College London Hospitals | Completed | 18 Years | 80 Years | All | 104 | Phase 2/Phase 3 | United Kingdom |
| 6 | EUCTR2012-003633-42-GB (EUCTR) | 18/10/2013 | 22/08/2013 | A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases | A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD | A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Cyclophosphamide Injection 1g Product Name: Cyclophosphamide Injection 1g INN or Proposed INN: Cyclophosphamide | Royal Brompton and Harefield NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 7 | NCT01570764 (ClinicalTrials.gov) | January 14, 2013 | 2/4/2012 | Cyclophosphamide Systemic Sclerosis Associated Interstitial Lung Disease | Intravenous Cyclophosphamide for the Treatment of Systemic Sclerosis Associated Interstitial Lung Disease | Systemic Sclerosis;Scleroderma;Interstitial Lung Disease;Lung Fibrosis | Drug: Cyclophosphamide;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Hôpital Claude-Huriez | Completed | 18 Years | N/A | All | 40 | Phase 3 | France |
| 8 | NCT01445821 (ClinicalTrials.gov) | September 15, 2011 | 29/9/2011 | Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial | Randomized Study of Different Non-myeloablative Conditioning Regimens With Hematopoietic Stem Cell Support in Patients With Scleroderma (Autologous Systemic Sclerosis Immune Suppression Trial - II ASSIST-IIb) | Scleroderma, Systemic | Biological: Peripheral Blood Stem Cells;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: Filgrastim;Drug: Fludarabine | Northwestern University | NULL | Terminated | 17 Years | 60 Years | All | 44 | Phase 3 | United States |
| 9 | NCT01413100 (ClinicalTrials.gov) | September 15, 2011 | 8/8/2011 | Scleroderma Treatment With Autologous Transplant (STAT) Study | A Phase II Multi-center Study of High-Dose Cyclophosphamide and Antithymocyte Globulin Followed by Autologous Hematopoietic Cell Transplantation With Post Transplant Maintenance for the Treatment of Systemic Sclerosis | Systemic Scleroderma | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Cyclophosphamide;Biological: Filgrastim;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Plerixafor;Other: Quality-of-Life Assessment;Other: Questionnaire Administration | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) | Active, not recruiting | N/A | 70 Years | All | 21 | Phase 2 | United States;Canada |
| 10 | JPRN-UMIN000031940 | 2010/09/07 | 28/03/2018 | Phase 2 trial of autologous hematopoietic stem cell transplantation for severe systemic sclerosis | Systemic sclerosis | Cyclophosphamide 2g/m2, 2 days Harvest of autologous hematopoietic stem cells Cyclophosphamide 50mg/kg, 4 days Transplantation of autologous hematopoietic stem cells | Kyushu University | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 24 | Phase 2 | Japan | |
| 11 | NCT02339441 (ClinicalTrials.gov) | June 2010 | 22/12/2014 | Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis | Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis | Early Diffuse Cutaneous Systemic Sclerosis | Drug: Methotrexate;Drug: Mycophenolate mofetil;Drug: Cyclophosphamide | University of Manchester | NULL | Completed | 18 Years | N/A | Both | 320 | N/A | NULL |
| 12 | NCT01047072 (ClinicalTrials.gov) | January 2010 | 11/1/2010 | Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis | Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | National Cancer Institute (NCI) | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 2 | United States |
| 13 | NCT00883129 (ClinicalTrials.gov) | September 2009 | 16/4/2009 | Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II) | Mycophenolate vs. Oral Cyclophosphamide in Scleroderma Interstitial Lung Disease (Scleroderma Lung Study II) | Scleroderma;Interstitial Lung Disease | Drug: Mycophenolate mofetil;Drug: Cyclophosphamide;Drug: Placebo | Michael Roth | National Heart, Lung, and Blood Institute (NHLBI);Hoffmann-La Roche | Completed | 18 Years | N/A | All | 142 | Phase 2 | United States |
| 14 | EUCTR2006-004598-83-GB (EUCTR) | 22/10/2008 | 24/10/2008 | High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS | High dose immunoablation and autologous hematopoietic stem cell transplantation versus monthly intravenous pulse therapy cyclophosphamide in severe systemic sclerosis ( ‘ASTIS’-TRIAL: Autologous Stem Cell Transplantation International Scleroderma Trial) - ASTIS | Severe systemic sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Neupogen Product Name: Filgrastim INN or Proposed INN: FILGRASTIM Trade Name: Thymoglobuline Product Name: Thymoglobuline Product Code: rbATG INN or Proposed INN: Anti-Thymocyte Globulin, Rabbit Other descriptive name: ANTI-HUMAN T-LYMPHOCYTE IMMUNOGLOBULIN FROM RABBITS Trade Name: Solu-Medrone Product Name: Methylprednisolone INN or Proposed INN: METHYLPREDNISOLONE Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Mesna Product Name: Mesna INN or Proposed INN: MESNA Trade Name: Mesna Product Name: Mesna INN or Proposed INN: MESNA | EBMT (European group for Blood and Marrow Transplantation) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | United Kingdom | |||
| 15 | EUCTR2008-000224-27-GB (EUCTR) | 15/10/2008 | 07/08/2008 | Systemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung disease | Systemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung disease | Systemic Sclerosis associated interstitial lung disease MedDRA version: 9.1;Level: LLT;Classification code 10042953;Term: Systemic sclerosis | Trade Name: Solu-medrone Product Name: methylprednisolone INN or Proposed INN: METHYLPREDNISOLONE Product Name: cyclophosphamide Product Code: cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE | Newcastle upon Tyne NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | United Kingdom | ||
| 16 | NCT00278525 (ClinicalTrials.gov) | September 2005 | 15/1/2006 | Cyclophosphamide and rATG With Hematopoietic Stem Cell Support in Systemic Scleroderma | Trial of High Dose Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG) With Hematopoietic Stem Cell Support in Patients With Systemic Scleroderma: A Randomized Trial | SYSTEMIC SCLERODERMA | Drug: standard of care;Procedure: stem cell transplantation | Northwestern University | NULL | Completed | N/A | 60 Years | All | 19 | Phase 2 | United States |
| 17 | NCT00860548 (ClinicalTrials.gov) | June 2005 | 11/3/2009 | SCOT Scleroderma Treatment Alternative Registry (STAR Registry) | An Observational, Long-term Follow-up Study of Eligible Individuals Declining To Participate in the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study (SCSSc-02) | Scleroderma, Systemic;Sclerosis | Drug: currently available therapy in the community | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 18 Years | 69 Years | All | 19 | N/A | United States |
| 18 | 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 |
| 19 | NCT00040651 (ClinicalTrials.gov) | July 2002 | 5/7/2002 | Safety and Value of Self Bone Marrow Transplants Following Chemotherapy in Scleroderma Patients | Transplantation With T-Cell Depleted Autologous Peripheral Stem Cells for Severe Systemic Sclerosis: A Phase I Dose Escalation Study | Scleroderma;Systemic Sclerosis | Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Thymoglobulin;Procedure: Leukapheresis;Procedure: Self bone marrow transplant | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | University of Pittsburgh;Amgen;Genzyme, a Sanofi Company | Terminated | 18 Years | 70 Years | Both | 15 | Phase 1 | United States |
| 20 | NCT00501995 (ClinicalTrials.gov) | February 2001 | 13/7/2007 | High Dose Cyclophosphamide for Treatment of Scleroderma | High Dose Cyclophosphamide for Treatment of Systemic Sclerosis (Scleroderma) | Scleroderma | Drug: IV Cyclophosphamide | Johns Hopkins University | NULL | Completed | 18 Years | 70 Years | All | 6 | Phase 3 | United States |
| 21 | NCT00016458 (ClinicalTrials.gov) | June 2000 | 6/5/2001 | Phase II Pilot Study of Cyclophosphamide and Rabbit Anti-Thymocyte Globulin as Salvage Therapy in Patients With Diffuse Systemic Sclerosis | Systemic Sclerosis | Drug: anti-thymocyte globulin;Drug: cyclophosphamide | Fred Hutchinson Cancer Research Center | NULL | Completed | N/A | 64 Years | Both | 20 | Phase 2 | United States | |
| 22 | NCT00004563 (ClinicalTrials.gov) | August 1999 | 9/2/2000 | Scleroderma Lung Disease | Cyclophosphamide Versus Placebo in Scleroderma Lung Study | Lung Diseases;Pulmonary Fibrosis;Systemic Scleroderma;Scleroderma, Systemic | Drug: Cyclophosphamide;Drug: Placebo | The University of Texas Health Science Center, Houston | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 18 Years | N/A | All | 158 | Phase 3 | NULL |
| 23 | NCT00058578 (ClinicalTrials.gov) | June 1999 | 8/4/2003 | Stem Cell Transplant to Treat Patients With Systemic Sclerosis | Autologous T-Cell Depleted Peripheral Blood Stem Cell Transplantation for the Treatment of Selected Patients With Systemic Sclerosis | Systemic Sclerosis | Drug: Cyclophosphamide;Drug: Mesna;Drug: G-CSF;Procedure: Leukopheresis;Procedure: Total Body Irradiation | Baylor College of Medicine | The Methodist Hospital System;Center for Cell and Gene Therapy, Baylor College of Medicine | Completed | 18 Years | 65 Years | All | 24 | Phase 1 | United States |