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 | EUCTR2010-020315-36-IT (EUCTR) | 05/10/2011 | 27/12/2011 | A study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-Blind, Double Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 14.1;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] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: OCRELIZUMAB Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | ROCHE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 469 | Colombia;Turkey;Ireland;Italy;Sweden;Brazil;United Kingdom;Russian Federation;Canada;Ukraine;Belarus;Peru;Belgium;Argentina;Mexico;Spain;Bosnia and Herzegovina;United States;Croatia | |||
| 2 | NCT01412333 (ClinicalTrials.gov) | September 20, 2011 | 8/8/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 835 | Phase 3 | United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic;Morocco |
| 3 | NCT01247324 (ClinicalTrials.gov) | August 31, 2011 | 23/11/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 821 | Phase 3 | Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;United States;Czech Republic;Morocco;New Zealand;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France |
| 4 | NCT01285401 (ClinicalTrials.gov) | February 2011 | 26/1/2011 | Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® Treatment | A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif® | Relapsing-Remitting Multiple Sclerosis | Drug: VigantOL oil plus interferon beta-1a (Rebif);Drug: Placebo plus interferon beta-1a (Rebif);Biological: Interferon beta-1a (Rebif®) alone | Merck KGaA | NULL | Completed | 18 Years | 55 Years | All | 260 | Phase 2 | Austria;Denmark;Estonia;Finland;Germany;Italy;Latvia;Lithuania;Netherlands;Norway;Portugal;Switzerland;Belgium;Hungary |
| 5 | NCT01101776 (ClinicalTrials.gov) | January 2010 | 8/4/2010 | Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting. | Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting | Multiple Sclerosis | Drug: Interferon beta-1a (Rebif) | Merck KGaA | Merck Serono Australia Pty Ltd | Completed | 18 Years | N/A | Both | 49 | N/A | Australia |
| 6 | EUCTR2007-001162-32-IT (EUCTR) | 06/08/2008 | 14/07/2008 | A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II | A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab Trade Name: REBIF INN or Proposed INN: Interferon beta-1a | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Phase 3 | France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 7 | NCT01142466 (ClinicalTrials.gov) | December 2005 | 10/6/2010 | A Phase IV Study of Rebif ® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone | Phase IV, Multicenter, Open Label, Randomized Study of Rebif® 44mcg Administered Three Times Per Week by Subcutaneous Injection Compared With no Treatment in the Therapy of Relapsing Multiple Sclerosis After Mitoxantrone | Multiple Sclerosis, Relapsing-Remitting | Drug: Interferon beta-1a (Rebif) | Merck KGaA | Gesellschaft für Therapieforschung mbH | Completed | 18 Years | 60 Years | All | 30 | Phase 4 | NULL |
| 8 | NCT01142557 (ClinicalTrials.gov) | June 2004 | 10/6/2010 | An Observational Study to Document the Effectiveness and Compatibility of Rebif 44 or 22 µg in the Therapy of the Chronic Multiple Sclerosis | Therapy of the Chronic Multiple Sclerosis With Interferon-beta 1a (Rebif®) | Multiple Sclerosis | Drug: Interferon beta-1a (Rebif) | Merck KGaA | Gesellschaft für Therapieforschung mbH | Completed | N/A | N/A | Both | 522 | N/A | Germany |