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 : 175 / 薬物数 : 161 - (DrugBank : 41) / 標的遺伝子数 : 13 - 標的パスウェイ数 : 24
| 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 | NCT05405361 (ClinicalTrials.gov) | January 18, 2023 | 17/5/2022 | A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy | A Long-term Extension of the ARGX-117-2002 Trial to Evaluate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy | Multifocal Motor Neuropathy (MMN) | Biological: ARGX-117;Other: Placebo | argenx | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 2 | United States |
| 2 | NCT05581199 (ClinicalTrials.gov) | December 15, 2022 | 12/10/2022 | To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP | A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants With Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy | Drug: Batoclimab 680 milligrams (mg) subcutaneous (SC) weekly;Drug: Batoclimab 340 mg SC weekly;Drug: Placebo | Immunovant Sciences GmbH | NULL | Recruiting | 18 Years | N/A | All | 240 | Phase 2 | United States |
| 3 | NCT05327114 (ClinicalTrials.gov) | September 23, 2022 | 7/4/2022 | Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Nipocalimab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 2/Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;China;Colombia;Czechia;Denmark;France;Germany;Greece;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Slovakia;Spain;Taiwan;United Kingdom;Romania;South Africa |
| 4 | JPRN-jRCT2041220037 | 10/09/2022 | 23/06/2022 | Efficacy and Safety Study of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Nipocalimab : Nipocalimab will be administered intravenously. Participants in Stage A (Open-label) will receive a loading dose of nipocalimab (Dose 1) intravenous (IV) infusion on Day 1, followed by nipocalimab (Dose 2) IV infusion once every 2 weeks (q2w) from Week 2 to Week 12. Participants who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive nipocalimab (Dose 2) IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant s local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first. Placebo : Placebo will be administered intravenously. Participants receiving nipocalimab in Stage A and who demonstrate evidence of clinical improvement in Stage A (responders) will enter Stage B (Double-blind) and receive placebo IV infusion q2w starting on Day 1 up to Week 52. After completion of Stage B or discontinuation from Stage B due to relapse, participants will have the option to enter the open label extension (OLE) phase and receive nipocalimab (Dose 2) IV infusion q2w starting on OLE Day 1 until 2 years after marketing authorization in a participant s local country or until nipocalimab becomes available commercially or via other continued access program, whichever comes first. | Nakano Masayoshi | NULL | Pending | >= 18age old | Not applicable | Both | 300 | Phase 2-3 | Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;UnitedKingdomOf GreatBritainAndNorthernIreland;Greece;Italy;Korea,RepublicOf;Mexico;Poland;Portugal;Slovakia;Taiwan,ProvinceOf China;UnitedStates OfAmerica;Japan |
| 5 | EUCTR2021-003302-50-AT (EUCTR) | 22/04/2022 | 20/12/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Belgium;Spain;Poland;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 6 | NCT05225675 (ClinicalTrials.gov) | March 31, 2022 | 5/11/2021 | A Clinical Trial to Investigate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy | Multifocal Motor Neuropathy | Biological: ARGX-117;Other: Placebo | argenx | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 2 | United States;Austria;Belgium;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom |
| 7 | EUCTR2021-003302-50-ES (EUCTR) | 08/03/2022 | 02/11/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy | ||
| 8 | EUCTR2021-003302-50-IT (EUCTR) | 17/02/2022 | 26/11/2021 | A clinical trial to investigate the safety and tolerability, efficacy pharmacokinetics, pharmacodynamics, and immunogenicity of 2 dose regimens of ARGX-117 in adults with multifocal motor neuropathy | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel- Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy,Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: [ARGX-117 IV] Trade Name: Act-HiB Product Name: Haemophilus type b vaccine (conjugated) Product Code: [.] Other descriptive name: HAEMOPHILUS TYPE B CONJUGATE VACCINE (TETANUS TOXOID CONJUGATE) Trade Name: Intratect Product Name: Human normal immunoglobulin (IVIg) Product Code: [-] INN or Proposed INN: Human normal immunoglobulin (IVIg) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Trade Name: Menjugate Product Name: Group C meningococcal conjugate vaccine Product Code: [J07AH07] INN or Proposed INN: Group C meningococcal conjugate vaccine Other descriptive name: N. MENINGITIDIS GROUP C POLYSACCHARIDE Trade Name: Prevenar 13 sospensione per iniezione Product Name: pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed) Product Code: [NA] INN or Proposed INN: VACCINO PNEUMOCOCCICO SACCARIDICO | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy | ||
| 9 | EUCTR2021-003302-50-NL (EUCTR) | 14/02/2022 | 27/12/2021 | A study for adult patients with Multifocal Motor Neuropathy comparing 2 doses of ARGX-117 | A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety and Tolerability, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of 2 Dose Regimens of ARGX-117 in Adults With Multifocal Motor Neuropathy - ARDA | Multifocal Motor Neuropathy MedDRA version: 21.1;Level: PT;Classification code 10065579;Term: Multifocal motor neuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ARGX-117 IV Product Code: ARGX-117 IV INN or Proposed INN: not defined Other descriptive name: ARGX-117 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 2 | France;United States;Canada;Spain;Poland;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy | ||
| 10 | NCT04281472 (ClinicalTrials.gov) | April 15, 2020 | 20/2/2020 | A Study to Assess the Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP, an Autoimmune Disorder That Affects the Peripheral Nerves) | A Phase 2 Trial to Investigate the Efficacy, Safety, and Tolerability of Efgartigimod PH20 SC in Adult Patients With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Biological: efgartigimod PH20 SC in stage B;Other: placebo in stage B | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 360 | Phase 2 | United States;Austria;Belgium;Bulgaria;China;Czechia;Denmark;France;Georgia;Germany;Hungary;Israel;Italy;Japan;Latvia;Netherlands;Poland;Romania;Russian Federation;Serbia;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 11 | EUCTR2016-002411-17-GB (EUCTR) | 23/07/2019 | 14/08/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) 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] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 34 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2016-002411-17-FR (EUCTR) | 02/07/2019 | 19/07/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom | ||
| 13 | EUCTR2016-002411-17-NL (EUCTR) | 13/06/2019 | 02/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) 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] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 14 | EUCTR2016-002411-17-DE (EUCTR) | 23/05/2019 | 04/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) 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] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | France;United States;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 15 | EUCTR2016-002411-17-ES (EUCTR) | 09/05/2019 | 11/04/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom | ||
| 16 | EUCTR2016-002411-17-BE (EUCTR) | 29/04/2019 | 08/02/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) 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] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 17 | EUCTR2016-002411-17-DK (EUCTR) | 11/04/2019 | 20/02/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) - My CIDP choice | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) 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] - Immune System Diseases [C20] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab Other descriptive name: ROZANOLIXIZUMAB | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 34 | Phase 2 | United States;France;Canada;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 18 | 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 complete | 12years-old | Not applicable | Male and Female | 25 | Phase 2 | Japan |
| 19 | 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 | Complete | >= 12age old | Not applicable | Both | 25 | Phase 2 | Japan |
| 20 | 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 |
| 21 | NCT03861481 (ClinicalTrials.gov) | March 26, 2019 | 1/3/2019 | A Study to Assess the Efficacy, Safety and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy | A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma S.P.R.L. | NULL | Completed | 18 Years | N/A | All | 34 | Phase 2 | United States;Belgium;Denmark;France;Germany;Netherlands;Spain;United Kingdom;Canada |
| 22 | EUCTR2011-003448-28-PL (EUCTR) | 07/07/2015 | 06/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 23 | EUCTR2011-003448-28-EE (EUCTR) | 11/06/2015 | 14/05/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 24 | EUCTR2011-003448-28-LT (EUCTR) | 09/06/2015 | 21/04/2015 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 25 | EUCTR2011-005280-24-CZ (EUCTR) | 19/05/2015 | 24/11/2014 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 17.1;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] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | Serbia;United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 26 | NCT02372149 (ClinicalTrials.gov) | February 2015 | 12/2/2015 | IVIg for Demyelination in Diabetes Mellitus | Treatment With Gamunex 10% Intravenous Immunoglobulin (IVIg) for Patients With Demyelination and Diabetes Mellitus: A Blinded, Placebo-Controlled Crossover Pilot Study | Peripheral Neuropathy;Diabetes Mellitus;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: 10% intravenous immunoglobulin (IVIg);Drug: 0.9% sodium chloride | University of Toronto | University Health Network, Toronto | Recruiting | 18 Years | N/A | Both | 25 | Phase 4 | Canada |
| 27 | EUCTR2011-005280-24-NL (EUCTR) | 30/01/2013 | 19/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 18.0;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] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 28 | EUCTR2011-005280-24-PL (EUCTR) | 11/01/2013 | 11/12/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 18.0;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] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 29 | EUCTR2011-005280-24-GR (EUCTR) | 17/10/2012 | 24/09/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 15.0;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: Gilenya Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Australia;Germany;Netherlands;Norway;Japan | ||
| 30 | EUCTR2011-005280-24-BE (EUCTR) | 08/10/2012 | 04/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 18.0;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] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 31 | EUCTR2011-003448-28-BE (EUCTR) | 27/09/2012 | 02/04/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 32 | EUCTR2011-005280-24-GB (EUCTR) | 25/09/2012 | 09/08/2012 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 18.0;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] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 33 | EUCTR2011-005280-24-ES (EUCTR) | 19/09/2012 | 07/08/2012 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 14.1;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: GILENYA 0,5 mg cápsulas duras Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: HIDROCLORURO DE FINGOLIMOD | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Norway;Germany;Japan | ||
| 34 | EUCTR2011-005280-24-IT (EUCTR) | 17/09/2012 | 13/09/2012 | Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating polyradiculoneuropathy. | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 14.1;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] | Product Name: Fingolimod Product Code: FTY720I INN or Proposed INN: FINGOLIMOD HYDROCHLORIDE | NOVARTIS PHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Australia;Netherlands;Germany;Japan | ||
| 35 | JPRN-JapicCTI-121961 | 01/9/2012 | A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | A Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Fingolimod 0.5 mg Administered Orally Once Daily Versus Placebo in Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) | Intervention name : FTY720 INN of the intervention : fingolimod Dosage And administration of the intervention : oral daily, 0.5 mg Control intervention name : placebo Dosage And administration of the control intervention : oral daily | Mitsubishi Tanabe Pharma Corporation, Novartis Pharma K.K. | NULL | 18 | BOTH | 156 | Phase 3 | NULL | |||
| 36 | EUCTR2011-005280-24-DE (EUCTR) | 29/08/2012 | 30/07/2012 | Evaluate efficacy and safety of fingolimod 0.5 mgorally once daily versus placebo in chronicinflammatory demyelinatingpolyradiculoneuropathy | A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) | Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) MedDRA version: 19.0;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] | Product Name: fingolimod Product Code: FTY720I INN or Proposed INN: fingolimod Other descriptive name: FINGOLIMOD HYDROCHLORIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 2;Phase 3 | United States;Greece;Spain;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Norway;Netherlands;Germany;Japan | ||
| 37 | EUCTR2011-003448-28-IT (EUCTR) | 23/08/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallelgroup phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN | CSL BEHRING GMBH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Switzerland;Czech Republic;Canada;Argentina;Poland;Belgium;Australia;Germany;Netherlands;Korea, Republic of | ||
| 38 | EUCTR2011-003448-28-GB (EUCTR) | 23/05/2012 | 29/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 39 | EUCTR2011-003448-28-AT (EUCTR) | 18/05/2012 | 16/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Argentina;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 40 | EUCTR2011-003448-28-NL (EUCTR) | 11/05/2012 | 14/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 17.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 41 | EUCTR2011-003448-28-CZ (EUCTR) | 09/05/2012 | 23/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 42 | EUCTR2011-003448-28-ES (EUCTR) | 24/04/2012 | 29/02/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)-the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 14.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Australia;Netherlands;Germany;Korea, Republic of | ||
| 43 | EUCTR2011-003448-28-DE (EUCTR) | 20/04/2012 | 31/01/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 19.0;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Australia;Netherlands;Germany;Japan | ||
| 44 | EUCTR2011-003448-28-FI (EUCTR) | 05/04/2012 | 05/03/2012 | Chronic inflammatory demyelinating polyneuropathy (CIDP) and treatment with subcutaneous immunoglobulin (IgPro20) | Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) MedDRA version: 18.1;Level: PT;Classification code 10061811;Term: Demyelinating polyneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Hizentra® Product Name: Hizentra® Product Code: IgPro20 INN or Proposed INN: Human normal immunoglobulin (SCIg) | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 350 | Phase 3 | United States;Estonia;Finland;Spain;Lithuania;Austria;Israel;Italy;United Kingdom;Czech Republic;European Union;Canada;Poland;Belgium;Australia;Germany;Netherlands;Japan | ||
| 45 | NCT01545076 (ClinicalTrials.gov) | March 2012 | 1/3/2012 | Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) and Treatment With Subcutaneous Immunoglobulin (IgPro20) | Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Phase III Study to Investigate the Efficacy, Safety, and Tolerability of 2 Different Doses of IgPro20 (Subcutaneous Immunoglobulin) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) - the PATH Study | Chronic Inflammatory Demyelinating Polyneuropathy;Polyradiculoneuropathy | Biological: IgPro20 (low dose);Biological: Placebo;Biological: IgPro10;Biological: IgPro20 (high dose) | CSL Behring | ICON Clinical Research | Completed | 18 Years | N/A | All | 208 | Phase 3 | United States;Australia;Belgium;Canada;Czechia;Estonia;Finland;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Spain;United Kingdom;Austria;Czech Republic |
| 46 | EUCTR2009-017805-13-CZ (EUCTR) | 14/07/2011 | 22/04/2010 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | Czech Republic;Bulgaria | ||
| 47 | EUCTR2009-017805-13-BG (EUCTR) | 27/01/2011 | 13/12/2010 | Study to evaluate efficacy of human immune globulin in patients with CIDP-chronic neuropathy. | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;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] | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2/3 | India;Serbia;Czech Republic;Mexico;Poland;Ukraine;Romania;Bulgaria | ||
| 48 | EUCTR2009-017805-13-RO (EUCTR) | 08/09/2010 | 15/07/2010 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03 | Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 12.1;Level: LLT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy | Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 172 | Phase 2;Phase 3 | Czech Republic;Romania;Bulgaria | ||
| 49 | EUCTR2009-013841-27-DK (EUCTR) | 17/12/2009 | 27/10/2009 | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multofocl Motor Neuropathy - IGIV, 10% MMN Trial | Multifocal motor neuropathy MedDRA version: 12.0;Level: LLT;Classification code 10065579;Term: Multifocal motor neuropathy | Trade Name: KIOVIG 100 mg/ml solution for infusion Product Name: IGIV, 10% Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Baxter Innovations GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Denmark | |||
| 50 | NCT00962429 (ClinicalTrials.gov) | February 2009 | 19/8/2009 | Lipoic Acid to Treat Chronic Inflammatory Demyelinating Polyneuropathy | Lipoic Acid for Chronic Inflammatory Demyelinating Polyneuropathy-A Randomized, Double-Blind, Placebo Controlled Pilot Study | CIDP;Chronic Inflammatory Demyelinating Polyneuropathy | Drug: lipoic acid | Oregon Health and Science University | Collins Medical Trust | Completed | 18 Years | 80 Years | All | 7 | Phase 2 | United States |
| 51 | NCT00666263 (ClinicalTrials.gov) | August 2008 | 23/4/2008 | Study of the Effectiveness of Intravenous Immune Globulin (10%) for the Treatment of Multifocal Motor Neuropathy | A Randomized, Double-Blind, Placebo Controlled, Cross-over Study of the Effectiveness of Immune Globulin Intravenous (Human), 10% (IGIV, 10%) for the Treatment of Multifocal Motor Neuropathy | Multifocal Motor Neuropathy | Biological: Immune Globulin Intravenous (human), 10%;Biological: 0.25% human albumin solution (Placebo) | Baxalta now part of Shire | NULL | Completed | 18 Years | N/A | All | 50 | Phase 3 | United States;Canada;Denmark;Netherlands;Poland |
| 52 | NCT00220740 (ClinicalTrials.gov) | April 2004 | 13/9/2005 | Immune Globulin Intravenous (IGIV) For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) | Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of IGIV-Chromatography (IGIV-C), 10% Treatment in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified;Drug: Albumin (Human) 25%, United States Pharmacopeia (USP) | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | N/A | All | 117 | Phase 3 | United States;Argentina;Canada;Czech Republic;Germany;Israel;Italy;Mexico;Poland;Serbia;Former Serbia and Montenegro |
| 53 | NCT00004772 (ClinicalTrials.gov) | September 1992 | 24/2/2000 | Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Chronic Inflammatory Demyelinating Polyneuropathy | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: Immune globulin | National Center for Research Resources (NCRR) | Ohio State University | Completed | 15 Years | N/A | Both | 90 | Phase 3 | NULL |