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 | NCT04660539 (ClinicalTrials.gov) | March 2, 2021 | 24/11/2020 | A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD) | A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD) | Neuromyelitis Optica Spectrum Disorder | Drug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroids | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 127 | Phase 3 | United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 2 | ChiCTR1900025744 | 2019-09-01 | 2019-09-07 | Clinical effectiveness and safety of Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial | Clinical effectiveness and safety Rituximab (Henlius) for optic neuritis secondary to neuromyelitis optica spectrum disorder: a pilot clinical trial | neuromyelitis optica spectrum disorder (NMOSD) | 1:Intravenous 200mg Rituximab, 1/week*2, if the proportion of CD19+ B lymphocytes in peripheral blood is above 1% then repeat administration (200mg);2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (750~3000mg/day); | The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital | NULL | Recruiting | 18 | 70 | Both | 1:30;2:30; | Phase 4 | China |
| 3 | NCT03350633 (ClinicalTrials.gov) | November 1, 2017 | 10/11/2017 | Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders | Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial | Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica | Drug: Tocilizumab Injection;Drug: Azathioprine | Tianjin Medical University General Hospital | NULL | Completed | 18 Years | N/A | All | 118 | Phase 2/Phase 3 | China |
| 4 | NCT03002038 (ClinicalTrials.gov) | September 2015 | 21/12/2016 | Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients | Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders | Neuromyelitis Optica Spectrum Disorder | Drug: Azathioprine;Drug: Rituximab | Isfahan University of Medical Sciences | NULL | Completed | 18 Years | 50 Years | All | 86 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 5 | ChiCTR-ICR-15007177 | 2014-08-30 | 2014-05-30 | A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis | A Prospective Study on the Efficacy andSafety of Rituximab in Treatment for Neuromyelitis Optica associated Optic Neuritis | Neuromyelitis Optica associated Optic Neuritis | 1:Intravenous 100mg Rituximab, 1/week*4 ;2:Oral azathioprine (2.5-3 mg/kg bodyweight/day) or mycophenolate mofetil (1000-1500mg/day); | The Ophthalmology Department of the Chinese Peoples Liberation Army Hospital | NULL | Recruiting | 18 | 70 | Both | 1:30;2:30; | China | |
| 6 | EUCTR2006-004937-13-IT (EUCTR) | 17/08/2006 | 04/07/2007 | multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trial | multicentee randomized controlled study of azathioprine versus iterferon beta in relapsing remitting multiple sclerosis - M.A.I.N. trial | patients with relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Trade Name: AZATIOPRINA HEX. 50CPR 50MG BL INN or Proposed INN: Azathioprine Trade Name: REBIF SC 12SIR 6000000UI 22MCG INN or Proposed INN: Interferon beta-1a Trade Name: BETAFERON SC 15F 0,25MG 15SIR INN or Proposed INN: Interferon beta-1b Trade Name: REBIF SC 12SIR 12000000UI44MCG INN or Proposed INN: Interferon beta-1a Trade Name: AVONEX IM 4SIR 30MCG/0,5ML 4AG INN or Proposed INN: Interferon beta-1a | Universita di Firenze | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy |