13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,342 / 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
| 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 | EUCTR2019-001549-42-GB (EUCTR) | 27/03/2020 | 03/02/2020 | Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MS | A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS | Highly active relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide monohydrate INN or Proposed INN: Cyclophosphamide monohydrate Product Name: Filgrastim INN or Proposed INN: Filgrastim Trade Name: Thymoglobuline Product Name: Thymoglobuline INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin Trade Name: Alemtuzumab Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Product Name: Lenograstim INN or Proposed INN: Lenograstim Trade Name: Ocrelizumab Product Name: Ocrelizumab | Sheffield Teaching Hospitals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 198 | Phase 3 | United Kingdom | ||
| 2 | NCT03829566 (ClinicalTrials.gov) | November 2019 | 1/2/2019 | Autologous Transplant To End NMO Spectrum Disorder | Autologous Hematopoietic Stem Cell Transplant for Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica;Devic's Disease;NMO Spectrum Disorder | Drug: Rituximab;Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | Phase 2/Phase 3 | United States |
| 3 | EUCTR2017-001362-25-NL (EUCTR) | 30/09/2019 | 10/09/2019 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Thymoglobuline® Product Name: Thymoglobuline® INN or Proposed INN: ANTITHYMOCYTE IMMUNOGLOBULIN Other descriptive name: ANTITHYMOCYTE IMMUNOGLOBULIN Trade Name: Lemtrada INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB Trade Name: Mavenclad Product Name: Cladribine INN or Proposed INN: CLADRIBINE Trade Name: Ocrevus Product Name: Ocrelizumab INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Denmark;Netherlands | ||
| 4 | EUCTR2017-001362-25-DK (EUCTR) | 27/06/2018 | 21/03/2018 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Sendoxane Product Name: Cyclophosphamide Trade Name: Thymoglobuline® Product Name: Thymoglobuline® Trade Name: Lemtrada Product Name: alemtuzumab Trade Name: Sendoxane Product Name: Cyclophosphamide Trade Name: Mavenclad Product Name: Cladribine Trade Name: Ocrevus Product Name: Ocrelizumab | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Denmark;Netherlands | ||
| 5 | NCT03342638 (ClinicalTrials.gov) | November 8, 2017 | 9/11/2017 | Maximizing Outcome of Multiple Sclerosis Transplantation | Maximizing Outcome of Multiple Sclerosis Transplantation: MOST Trial | Multiple Sclerosis, Relapsing-Remitting | Drug: Cyclophosphamide;Drug: Mesna;Drug: rATG;Drug: Methylprednisolone;Drug: G-CSF;Biological: IVIg;Biological: Autologous Stem Cells | Northwestern University | NULL | Terminated | 18 Years | 58 Years | All | 66 | Phase 3 | United States |
| 6 | EUCTR2010-023560-40-SE (EUCTR) | 23/03/2011 | 21/12/2010 | Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed. | Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST | Relapsing-remitting multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: Tysabri INN or Proposed INN: NATALIZUMAB Trade Name: Sendoxan Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE Trade Name: Thymoglobuline Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN Trade Name: Neupogen Trade Name: Solu-Medrol | Uppsala l?ns landsting | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | United States;Canada;Brazil;Sweden | |||
| 7 | NCT00716066 (ClinicalTrials.gov) | June 2008 | 15/7/2008 | Autologous Peripheral Blood Stem Cell Transplant for Neurologic Autoimmune Diseases | High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, and Melphalan (BEAM) + Thymoglobulin Followed by Syngeneic or Autologous Hematopoietic Cell Transplantation for Patients With Autoimmune Neurologic Diseases | Autoimmune Disease;Neurologic Autoimmune Disease;Autologous Transplant Autoimmune;Multiple Sclerosis Transplant;MS Stem Cell Transplant;Multiple Sclerosis Stem Cell Transplant;Stiff Person Syndrome;HCT for Neurologic Autoimmune Disorders;CIDP Transplant;Myasthenia Gravis Transplant;Autoimmune Nervous System Disorder;Central Nervous System Vasculitis;Cerebellar Degeneration;Chronic Inflammatory Demyelinating Polyneuropathy;Lambert Eaton Myasthenic Syndrome;Myasthenia Gravis;Neuromyelitis Optica;Opsoclonus Myoclonus Syndrome;Rasmussen Subacute Encephalitis | Biological: Anti-Thymocyte Globulin;Procedure: Autologous Hematopoietic Stem Cell Transplantation;Drug: Carmustine;Drug: Cytarabine;Drug: Etoposide;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Drug: Prednisone;Procedure: Syngeneic Bone Marrow Transplantation | Fred Hutchinson Cancer Research Center | NULL | Recruiting | N/A | 71 Years | All | 40 | Phase 2 | United States |
| 8 | NCT00288626 (ClinicalTrials.gov) | July 2006 | 7/2/2006 | High-Dose Immunosuppression and Autologous Transplantation for Multiple Sclerosis (HALT MS) Study | A Phase II Study of High-Dose Immunosuppressive Therapy Using Carmustine, Etoposide, Cytarabine, Melphalan, Thymoglobulin and Autologous CD34+ Hematopoietic Stem Cell Transplant for the Treatment of Poor Prognosis Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Granulocyte-colony stimulating factor (G-CSF) and prednisone;Drug: Carmustine, etoposide, cytarabine, and melphalan (BEAM);Procedure: Autologous hematopoietic stem cell transplant | National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) | Completed | 18 Years | 60 Years | All | 25 | Phase 2 | United States |
| 9 | EUCTR2006-002562-19-IT (EUCTR) | 21/04/2006 | 24/01/2007 | Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT | Immunoablation with Cyclophosphamide at high dosage and Rabbit antithymoglobulin followed by autologous hematopoietic stem cell transplantation in severe multiple sclerosis - LIGHT | VERIFICARE Patients with multiple sclerosis, age between 18 and 50 MedDRA version: 6.1;Level: PT;Classification code 10028245 | Trade Name: L04AA04 - IMMUNOGLOBULINA ANTITIMOCITARIA (DI CONIGLIO) IMMUNOGLOBULINA DI CONIGLIO ANTITIMOCITI UMANI THYMOGLOBULINE Product Name: Thymoglobuline INN or Proposed INN: Antithymocyte Trade Name: Endoxan - ciclofosfamide Product Name: Endoxan INN or Proposed INN: Cyclophosfamide | Dipartimento di Neuroscienze Oftalmologia e Genetica DINOG - Universita di Genova | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Italy | |||
| 10 | EUCTR2008-005773-35-IT (EUCTR) | 15/01/2013 | AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM | AUTOLOUGUS STEM CELLS TRANSPLANTATION AFTER LINFOCYTE DEPLETION AS A NEW THERAPY FOR THE AGGRESSIVE AND DRUG RESISTANT FORMS OF MULTIPLE SLEROSIS IN THE ADULTS AND CHILDREN. - AUTOLOUGUS STEM CELLS TRANSPLANTATION IN SM | MULTIPLE SCLEROSIS MedDRA version: 15.1;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: ENDOXAN BAXTER INN or Proposed INN: Cyclophosphamide Trade Name: FLUDARA INN or Proposed INN: Fludarabine Trade Name: THYMOGLOBULINE INN or Proposed INN: Antithymocyte immunoglobulin (rabbit) Trade Name: MABTHERA INN or Proposed INN: Rituximab | AZIENDA OSPEDALIERA DI PADOVA | NULL | NA | Female: yes Male: yes | Phase 1 | Italy |