14. 慢性炎症性脱髄性多発神経炎／多巣性運動ニューロパチー Chronic inflammatory demyelinating polyneuropathy Clinical trials / Disease details
臨床試験数 : 167 / 薬物数 : 158 - (DrugBank : 38) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 23
| 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 | NCT04480450 (ClinicalTrials.gov) | July 2022 | 16/7/2020 | Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy | Rituximab in Chronic Inflammatory Demyelinating Polyneuropathy: A Phase II Study | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Rituximab | University of Kansas Medical Center | NULL | Not yet recruiting | 18 Years | N/A | All | 48 | Phase 2 | NULL |
| 2 | JPRN-jRCTs041210046 | 12/08/2021 | 03/08/2021 | The Evaluation of Efficacy and Safety of Additional Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the 2nd Exploratory Clinical Study in Patients Requested Medical Care | The Evaluation of Efficacy and Safety of Additional Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the 2nd Exploratory Clinical Study in Patients Requested Medical Care - RECIPE-2 Study | Refractory Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Chronicity, Demyelination, Peripheral Neuropathy;G618 | Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. | Iijima Masahiro | NULL | Not Recruiting | >= 20age old | Not applicable | Both | 5 | Phase 2 | Japan |
| 3 | JPRN-jRCT2041180037 | 28/03/2019 | 31/01/2019 | RECIPE Trial | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial | Chronic Inflammatory Demyelinating Polyneuropathy Chronic Inflammatory Demyelinating Polyneuropathy | CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) or placebo IV infusion once weekly for 4 doses. CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. | Iijima Masahiro | NULL | Not Recruiting | >= 12age old | Not applicable | Both | 25 | Phase 2 | Japan |
| 4 | JPRN-UMIN000035753 | 2019/03/28 | 02/02/2019 | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients with Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial - RECIPE Trial | Chronic Inflammatory Demyelinating Polyneuropathy | CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. CIDP patients with positive IgG4 autoantibody (CNTN-1 or NF-155): Administer placebo IV infusion once weekly for 4 doses. CIDP patients with negative IgG4 autoantibody (CNTN-1 and NF-155): Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses. | Nagoya University Hospital | Zenyaku Kogyo Co., Ltd. | Complete: follow-up continuing | 12years-old | Not applicable | Male and Female | 25 | Phase 2 | Japan |
| 5 | NCT03864185 (ClinicalTrials.gov) | March 28, 2019 | 19/2/2019 | The Evaluation of Efficacy and Safety of Rituximab in Refractory CIDP Patients With IgG4 Autoantibodies | The Evaluation of Efficacy and Safety of Rituximab (Genetical Recombination) in Refractory Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Patients With Immunoglobulin G4 (IgG4) Autoantibodies in the Exploratory Clinical Trial | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Biological: Rituximab (genetical recombination);Other: Placebo | Nagoya University | Japan Agency for Medical Research and Development;Zenyaku Kogyo Co., Ltd. | Completed | 12 Years | N/A | All | 25 | Phase 2 | Japan |
| 6 | EUCTR2018-001347-31-IT (EUCTR) | 30/07/2018 | 13/01/2021 | Pilot study with rituximab in patients with CIDP not responding to conventional immune therapy | Anti-nerve reactivity as predictor of response to immune therapy in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP): A proof of concept study with rituximab in patients with CIDP not responding to conventional immune therapy - RF-2016-02361887 | Chronic inflammatory demyelinating polyradiculoneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10072650;Term: CIDP;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: Rituximab INN or Proposed INN: RITUXIMAB | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Italy | ||
| 7 | EUCTR2017-005034-36-IT (EUCTR) | 22/05/2018 | 04/11/2020 | Study evaluating the effect of rituximab in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | An Italian database-based randomized controlled trial with Rituximab in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) - A randomized controlled trial of rituximab in CIDP (CIDPRIT) | Chronic inflammatory demyelinating polyradiculoneuropathy MedDRA version: 20.0;Level: LLT;Classification code 10072650;Term: CIDP;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: Rituximab Product Code: [Rituximab] INN or Proposed INN: RITUXIMAB Trade Name: TACHIPIRINA - 1000 MG COMPRESSE 8 COMPRESSE Product Name: Paracetamolo Product Code: [Paracetamolo] INN or Proposed INN: PARACETAMOLO Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: Metilprednisolone sodio succinato Product Code: [Metilprednisolone sodio succinato] INN or Proposed INN: METILPREDNISOLONE SODIO SUCCINATO Trade Name: TRIMETON - 10 MG/1 ML SOLUZIONE INIETTABILE 5 FIALE 1 ML Product Name: Clorfenamina maleato Product Code: [Clorfenamina maleato] INN or Proposed INN: CLORFENAMINA MALEATO | IRCCS ISTITUTO CLINICO HUMANITAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | Italy |