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 | EUCTR2018-004701-11-BG (EUCTR) | 10/01/2020 | 09/01/2020 | Evobrutinib compared to Avonex in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION MS1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Evobrutinib 10mg Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Product Name: Evobrutinib 25mg Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Avonex Product Name: Interferon beta 1-a INN or Proposed INN: INTERFERON BETA-1A | Merck Healthcare KGaA | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Georgia;Germany;Bulgaria;Croatia;Poland;Belgium;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Montenegro;Austria;Korea, Republic of;Bosnia and Herzegovina;France;Italy;Russian Federation;Israel;Ukraine;Spain;Estonia;Taiwan;United States;Serbia | ||
| 2 | EUCTR2018-004700-19-BG (EUCTR) | 10/01/2020 | 08/01/2020 | Evobrutinib compared to Avonex in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION MS2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Evobrutinib 10mg Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Product Name: Evobrutinib 25mg Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Avonex Product Name: Interferon beta 1-a INN or Proposed INN: INTERFERON BETA-1A | Merck Healthcare KGaA | NULL | Not Recruiting | Female: yes Male: yes | 950 | Phase 3 | Belarus;United States;Portugal;Slovakia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;South Africa;Tunisia;Kuwait;Moldova, Republic of;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 3 | EUCTR2016-004819-12-IT (EUCTR) | 10/01/2018 | 20/01/2022 | Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients | Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders | Relapsing-Remitting multiple sclerosis (RR-MS), 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: BETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 ML Product Name: Interferone Beta-1B Product Code: [032166011] INN or Proposed INN: INTERFERONE BETA 1B Other descriptive name: Interferon Beta-1B Trade Name: AVONEX - 30 MCG (6 MILIONI UI) POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 4 FLACONI CON DISPOSITIVO BIOSET + 4 SIRINGHE PRERIEMPITE USO INTRAMUSCOLARE Product Name: Inteferone Beta-1A Product Code: [033283045] INN or Proposed INN: INTERFERON BETA - 1A Other descriptive name: Interferon Beta 1-A Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO Product Name: Glatiramer acetato Product Code: [035418060] INN or Proposed INN: GLATIRAMER ACETATO Other descriptive name: Glatiramer acetate Trade Name: REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML)12 PENNE PRERIEMPITE Product Name: Interferon Beta-1a Product Code: [034091165] INN or Proposed INN: INTERFERON BETA - 1A Other descriptive name: Interferon Beta-1a | OSPEDALE SAN RAFFAELE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 4 | Italy | ||
| 4 | EUCTR2016-002180-33-PL (EUCTR) | 16/11/2016 | 14/07/2016 | Multiple sclerosis therapy with transdermal myelin peptide stimulation. | Multiple sclerosis therapy with transdermal myelin peptide stimulation. | relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: SMderpept INN or Proposed INN: PLP peptide INN or Proposed INN: MBP peptide INN or Proposed INN: MOG peptide Product Name: Avonex INN or Proposed INN: Interferon beta 1-A Other descriptive name: INTERFERON BETA-1A | Centrum Neurologii Krzysztof Selmaj | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 2 | Poland | ||
| 5 | NCT01071083 (ClinicalTrials.gov) | March 2010 | 17/2/2010 | Treatment Interruption of Natalizumab | Randomized Treatment Interruption of Natalizumab | Relapsing Remitting Multiple Sclerosis | Drug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetate | Biogen | Elan Pharmaceuticals | Completed | 18 Years | 60 Years | All | 175 | Phase 2 | United States;Germany;Spain |
| 6 | NCT00771043 (ClinicalTrials.gov) | November 2008 | 7/10/2008 | A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a | Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a | Relapsing-Remitting Multiple Sclerosis | Drug: TYSABRI and AVONEX | Biogen Idec | NULL | Withdrawn | 18 Years | 55 Years | Both | 50 | Phase 4 | United States |
| 7 | NCT00784836 (ClinicalTrials.gov) | October 2008 | 29/10/2008 | Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients | A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: BG9418 (interferon beta 1-a) | Biogen | NULL | Terminated | 18 Years | 60 Years | All | 3 | Phase 3 | United States |
| 8 | NCT00211887 (ClinicalTrials.gov) | January 2005 | 13/9/2005 | Combination Therapy in Patients With Relapsing-Remitting Multiple Sclerosis (MS)CombiRx | A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis (CombiRx) | Relapsing Remitting Multiple Sclerosis | Drug: Interferon beta 1-a;Drug: glatiramer acetate;Other: placebo | Fred Lublin | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | 18 Years | 60 Years | All | 1008 | Phase 3 | United States;Canada |