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 | EUCTR2016-002820-10-DE (EUCTR) | 26/06/2017 | 08/11/2016 | Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) | Remitting-Relapsing Multiple Sclerosis MedDRA version: 20.0;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: Zinbryta Product Name: Daclizumab Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: DAC HYP | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Canada;Germany;Italy;United Kingdom | ||
| 2 | NCT02881567 (ClinicalTrials.gov) | April 18, 2017 | 24/8/2016 | Efficacy and Safety of Daclizumab in Participants With RRMS Switching From Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN) | Relapsing-Remitting Multiple Sclerosis (RRMS) | Drug: Daclizumab | Biogen | AbbVie | Terminated | 18 Years | 55 Years | All | 41 | Phase 3 | United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom |
| 3 | EUCTR2016-002820-10-IT (EUCTR) | 31/03/2017 | 13/01/2021 | Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | Remitting-Relapsing Multiple Sclerosis 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: Zinbryta Product Name: Daclizumab Product Code: BIIB019 INN or Proposed INN: DACLIZUMAB Other descriptive name: DAC HYP | BIOGEN IDEC RESEARCH LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;United States;Canada;Denmark;Germany;United Kingdom;Italy | ||
| 4 | EUCTR2016-002820-10-GB (EUCTR) | 13/03/2017 | 08/11/2016 | Efficacy and Safety of Daclizumab in Participants with RRMS Switching from Natalizumab | A Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - 205MS305_Biogen | Remitting-Relapsing Multiple Sclerosis MedDRA version: 20.0;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: Zinbryta Product Name: Zinbryta Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: DAC HYP | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United Kingdom;Italy;Germany;Denmark;Canada;United States;France | ||
| 5 | EUCTR2012-003176-39-DK (EUCTR) | 30/10/2013 | 25/10/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 20.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden;Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada | ||
| 6 | EUCTR2012-003176-39-IE (EUCTR) | 01/08/2013 | 11/04/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 20.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 7 | EUCTR2012-003176-39-GB (EUCTR) | 31/07/2013 | 12/04/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 20.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 8 | EUCTR2012-003176-39-GR (EUCTR) | 14/07/2013 | 22/05/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 16.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1841 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | ||
| 9 | EUCTR2012-003176-39-FI (EUCTR) | 11/06/2013 | 14/05/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1841 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 10 | EUCTR2012-003176-39-DE (EUCTR) | 31/05/2013 | 14/12/2012 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 20.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 11 | EUCTR2012-003176-39-FR (EUCTR) | 28/05/2013 | 20/06/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1841 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | ||
| 12 | EUCTR2012-003176-39-ES (EUCTR) | 24/05/2013 | 21/03/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 15.1;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1841 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 13 | EUCTR2012-003176-39-SE (EUCTR) | 07/05/2013 | 14/03/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.1;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 14 | EUCTR2012-003176-39-HU (EUCTR) | 23/04/2013 | 28/02/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 15 | EUCTR2012-003176-39-PL (EUCTR) | 17/04/2013 | 04/03/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 20.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden;Serbia | ||
| 16 | EUCTR2012-003176-39-CZ (EUCTR) | 16/04/2013 | 07/02/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 - EXTEND | Relapsing-remitting Multiple Sclerosis MedDRA version: 20.0;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: Zinbryta Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | ||
| 17 | EUCTR2012-003176-39-IT (EUCTR) | 14/03/2013 | 11/01/2013 | Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis WhoHave Completed 203MS301. | A Multicenter, Open-Label, Extension Study to Evaluate the Long TermSafety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have CompletedStudy 205MS301. - EXTEND | Relapsing-remitting 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: Daclizumab HYP Product Code: BIIB019 INN or Proposed INN: DACLIZUMAB Other descriptive name: Daclizumab HYP (DAC HYP | BIOGEN IDEC RESEARCH LTD | NULL | Not Recruiting | Female: yes Male: yes | 1841 | Phase 3 | United States;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;Australia;Denmark;Moldova, Republic of;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Georgia;Germany;Sweden | ||
| 18 | NCT01797965 (ClinicalTrials.gov) | February 15, 2013 | 15/2/2013 | Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019 | A Multicenter, Open-Label, Extension Study to Evaluate the Long Term Safety and Efficacy of BIIB019, Daclizumab High Yield Process (DAC HYP), Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Study 205MS301 | Relapsing-Remitting Multiple Sclerosis;Multiple Sclerosis | Drug: BIIB019 (Daclizumab) | Biogen | AbbVie | Terminated | 18 Years | N/A | All | 1501 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Czechia;Denmark;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;China;Czech Republic;Finland |
| 19 | EUCTR2009-012500-11-SI (EUCTR) | 27/01/2012 | 10/01/2012 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab wih Greek suffix Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Denmark;Australia;Slovenia;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;Sweden | ||
| 20 | NCT01462318 (ClinicalTrials.gov) | November 2011 | 14/7/2011 | An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple Sclerosis | A Multicenter, Single-Arm, Open-Label Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Midazolam;Other: Caffeine;Drug: S-warfarin;Other: Vitamin K;Drug: Omeprazole;Drug: Dextromethorphan;Biological: BIIB019 (Daclizumab) | Biogen | NULL | Completed | 18 Years | 65 Years | All | 133 | Phase 3 | United States;Czech Republic;Hungary;Poland;Russian Federation |
| 21 | EUCTR2010-023856-97-CZ (EUCTR) | 13/10/2011 | 09/08/2011 | Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe | A Multicenter, Single-Arm, Open-Label, Study to Evaluate the Immunogenicity and Pharmacokinetics of BIIB019, Daclizumab High Yield Process (DAC HYP), Prefilled Syringe Administered by Subcutaneous Injection in Subjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;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: Daclizumab HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Hungary;Czech Republic;Poland | |||
| 22 | EUCTR2010-023856-97-PL (EUCTR) | 12/10/2011 | 26/08/2011 | Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe | A Multicenter, Single-Arm, Open-Label, Study to Evaluatethe Immunogenicity and Pharmacokinetics of BIIB019,Daclizumab High Yield Process (DAC HYP), PrefilledSyringe Administered by Subcutaneous Injection inSubjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE | Relapsing-remitting Multiple Sclerosis MedDRA version: 16.1;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: Daclizumab HYP Product Code: BIIB019 INN or Proposed INN: - Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Hungary;Czech Republic;Poland;Russian Federation | |||
| 23 | EUCTR2010-023856-97-HU (EUCTR) | 22/09/2011 | 15/07/2011 | Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled Syringe | A Multicenter, Single-Arm, Open-Label, Study to Evaluatethe Immunogenicity and Pharmacokinetics of BIIB019,Daclizumab High Yield Process (DAC HYP), PrefilledSyringe Administered by Subcutaneous Injection inSubjects With Relapsing-Remitting Multiple Sclerosis - OBSERVE | Relapsing-remitting 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: Daclizumab HYP Product Code: BIIB019 Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Limited | NULL | Not Recruiting | Female: yes Male: yes | 120 | United States;Czech Republic;Hungary;Poland;Russian Federation | |||
| 24 | EUCTR2009-015318-23-DE (EUCTR) | 09/06/2011 | 08/06/2010 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;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: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 25 | EUCTR2009-012500-11-DK (EUCTR) | 08/09/2010 | 04/06/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 26 | EUCTR2009-015318-23-HU (EUCTR) | 31/08/2010 | 14/06/2010 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;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: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Czech Republic;Hungary;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 27 | EUCTR2009-012500-11-FR (EUCTR) | 25/08/2010 | 11/01/2010 | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden | ||
| 28 | EUCTR2009-012500-11-CZ (EUCTR) | 19/08/2010 | 20/01/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 29 | EUCTR2009-012500-11-GR (EUCTR) | 13/07/2010 | 17/05/2010 | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis | Relapsing-remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden | |||
| 30 | EUCTR2009-012500-11-DE (EUCTR) | 13/07/2010 | 20/01/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 31 | EUCTR2009-012500-11-FI (EUCTR) | 29/06/2010 | 22/03/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 16.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | ||
| 32 | EUCTR2009-012500-11-ES (EUCTR) | 24/06/2010 | 12/04/2010 | Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) | Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) | Esclerosis Múltiple recidivante-remitente MedDRA version: 11;Level: PT;Classification code 10063399;Term: Esclerosis múltiple remitente-recurrente | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden | ||
| 33 | EUCTR2009-012500-11-IT (EUCTR) | 18/06/2010 | 21/05/2010 | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon ß-1a) in Patients with Relapsing Remitting Multiple Sclerosis - ND | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex (Interferon ß-1a) in Patients with Relapsing Remitting Multiple Sclerosis - ND | Relapsing Remitting Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Daclizumab HYP Other descriptive name: Daclizumab HYP Trade Name: AVONEX INN or Proposed INN: Interferon beta-1a | BIOGEN IDEC LTD | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Slovenia;Greece;Finland;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden | |||
| 34 | EUCTR2009-012500-11-SE (EUCTR) | 07/06/2010 | 09/04/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 15.1;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1800 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Slovenia;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden | |||
| 35 | EUCTR2009-012500-11-GB (EUCTR) | 03/06/2010 | 16/04/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 16.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab HYP Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Phase 3 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | ||
| 36 | NCT01064401 (ClinicalTrials.gov) | May 2010 | 26/1/2010 | Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ß 1a in Participants With Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon ß 1a) in Patients With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Interferon beta-1a Placebo;Biological: Interferon beta-1a;Drug: Daclizumab High Yield Process Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 1841 | Phase 3 | United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Bulgaria;Egypt;Slovenia |
| 37 | EUCTR2009-012500-11-IE (EUCTR) | 12/04/2010 | 07/01/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting Multiple Sclerosis MedDRA version: 17.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 38 | NCT01051349 (ClinicalTrials.gov) | March 31, 2010 | 15/1/2010 | Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis | A Multicenter, Open-label, Extension Study to Evaluate the Long Term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab);Biological: trivalent seasonal influenza vaccine | Biogen | AbbVie | Completed | 18 Years | 60 Years | All | 410 | Phase 2 | Czechia;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Czech Republic |
| 39 | EUCTR2009-015318-23-GB (EUCTR) | 31/03/2010 | 17/03/2010 | A study designed to determine safety and efficacy of Daclizumab High Yield Process (DAC HYP) in patients with Multiple Sclerosis Who Have Completed Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) - SELECTED | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen | NULL | Not Recruiting | Female: yes Male: yes | 450 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 40 | EUCTR2009-012500-11-HU (EUCTR) | 31/03/2010 | 24/02/2010 | Comparison of Daclizumab HYP and Avonex® in Multiple Sclerosis | Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE | Relapsing-remitting 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) Trade Name: AVONEX Other descriptive name: INTERFERON BETA-1A | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1800 | United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden | |||
| 41 | EUCTR2009-015318-23-CZ (EUCTR) | 21/01/2010 | 03/12/2009 | A study designed to determine safety and efficacy of Daclizumab HighYield Process (DAC HYP) in patients with Multiple Sclerosis Who HaveCompleted Treatment in a previous study, 205MS202 (SELECTION) | A Multicenter, Open-label, Extension Study to Evaluate the Long-term Safety and Efficacy of Daclizumab High Yield Process (DAC HYP) Monotherapy in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS202 (SELECTION) | Relapsing-remitting Multiple Sclerosis MedDRA version: 19.0;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: Daclizumab High Yield Process Product Code: BIIB019 INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 450 | Phase 2 | Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 42 | EUCTR2008-005559-46-DE (EUCTR) | 08/12/2009 | 26/06/2009 | An Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis who have completed Treatment in the study 205MS201 (SELECT) | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) - SELECTION | Relapsing-remitting 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India | |||
| 43 | EUCTR2008-005559-46-HU (EUCTR) | 04/08/2009 | 05/06/2009 | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) - SELECTION | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) - SELECTION | Relapsing-remitting Multiple Sclerosis/1 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Czech Republic;Hungary;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India | |||
| 44 | EUCTR2008-005559-46-GB (EUCTR) | 18/05/2009 | 27/07/2010 | An Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis who have completed Treatment in the study 205MS201 (SELECT) | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) - SELECTION | Relapsing-remitting 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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 2 | Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India | ||
| 45 | NCT00870740 (ClinicalTrials.gov) | February 2009 | 26/3/2009 | Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) in Participants With Multiple Sclerosis Who Have Completed Study 205MS201 (NCT00390221) to Treat Relapsing-Remitting Multiple Sclerosis | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects With Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 517 | Phase 2 | Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom |
| 46 | EUCTR2008-005559-46-CZ (EUCTR) | 23/01/2009 | 28/11/2008 | An Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis who have completed Treatment in the study 205MS201 (SELECT) | A Double-Blind, Multicenter, Extension Study to Evaluate the Safety and Efficacy of DAC HYP in Subjects with Multiple Sclerosis Who Have Completed Treatment in Study 205MS201 (SELECT) - SELECTION | Relapsing-remitting Multiple Sclerosis MedDRA version: 14.0;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: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) Product Name: DACLIZUMAB HYP Product Code: BIIB019 INN or Proposed INN: Daclizumab with Greek suufix Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India | |||
| 47 | EUCTR2006-001161-42-HU (EUCTR) | 21/05/2008 | 18/08/2006 | Multicentre, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis. - SELECT | Multicentre, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects with Relapsing-Remitting Multiple Sclerosis. - SELECT | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Germany;United Kingdom;Sweden | |||
| 48 | EUCTR2006-001161-42-DE (EUCTR) | 08/05/2008 | 31/05/2006 | A study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Relapsing Remitting 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: DACLIZUMAB HYP INN or Proposed INN: Daclizumab Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;Sweden;India | |||
| 49 | NCT00390221 (ClinicalTrials.gov) | February 2008 | 17/10/2006 | Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple Sclerosis | Multicenter, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Determine the Safety and Efficacy of Daclizumab HYP (DAC HYP) as a Monotherapy Treatment in Subjects With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Biological: BIIB019 (Daclizumab High Yield Process);Drug: Placebo | Biogen | AbbVie | Completed | 18 Years | 55 Years | All | 621 | Phase 2 | Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Australia;Former Serbia and Montenegro;Sweden;Turkey |
| 50 | EUCTR2006-001161-42-CZ (EUCTR) | 30/11/2006 | 25/08/2006 | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Czech Republic;Germany;United Kingdom;Sweden | |||
| 51 | EUCTR2006-001161-42-SE (EUCTR) | 17/10/2006 | 29/05/2006 | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - Not applicable | Multiple sclerosis (MS) | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 232 | Hungary;Germany;United Kingdom;Sweden | |||
| 52 | EUCTR2006-001161-42-GB (EUCTR) | 29/08/2006 | 15/05/2006 | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multicentre, double-blind, placebo-controlled, dose-ranging study to determine the safety and efficacy of daclizumab HYP (DAC HYP) as a monotherapy treatment in subjects with relapsing-remitting multiple sclerosis. - SELECT | Multiple sclerosis (MS) MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: DACLIZUMAB HYP Other descriptive name: Daclizumab HYP (DAC HYP) | Biogen Idec Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 2 | Czech Republic;Hungary;Germany;United Kingdom;Sweden | ||
| 53 | EUCTR2005-001567-55-DE (EUCTR) | 23/06/2006 | 29/07/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | United Kingdom;Germany;Spain | ||
| 54 | EUCTR2005-001567-55-GB (EUCTR) | 14/12/2005 | 24/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 55 | EUCTR2005-001567-55-ES (EUCTR) | 18/10/2005 | 05/09/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis Estudio de fase II, aleatorizado, doble ciego, controlado con placebo, multicéntrico del daclizumab subcutáneo en pacientes con formas activas recidivantes de esclerosis múltiple | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 2 | United Kingdom;Germany;Spain | ||
| 56 | EUCTR2005-001567-55-AT (EUCTR) | 27/09/2005 | 23/08/2005 | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | A Phase II, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients with Active, Relapsing Forms of Multiple Sclerosis | This study is performed in patients with relapsing forms of Multiple Sclerosis. Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the central nervous system (CNS), thought to be mediated by autoreactive T cells. Daclizumab is a genetically engineered humanized IgG1 monoclonal antibody that binds specifically to CD25 (alpha chain of the IL-2 receptor) and achieves immunosuppression at least in part by competitive antagonism of IL-2-induced T cell proliferation. | Product Name: Daclizumab INN or Proposed INN: Daclizumab Other descriptive name: Anti-CD25 Humanized Monoclonal Antibody | Protein Design Labs, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 2 | Spain;Austria;Germany;United Kingdom | ||
| 57 | NCT00109161 (ClinicalTrials.gov) | April 2005 | 22/4/2005 | Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | A Phase II Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study of Subcutaneous Daclizumab in Patients With Active, Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Daclizumab (Anti-CD25 Humanized Monoclonal Antibody) | PDL BioPharma, Inc. | NULL | Completed | 18 Years | 55 Years | Both | 270 | Phase 2 | United States;Canada |
| 58 | NCT00071838 (ClinicalTrials.gov) | October 30, 2003 | 31/10/2003 | Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis | Zenapax (Daclizumab) Admin to Pts With Multiple Sclerosis (ZAP MS): Effect of Intravenously Admin Humanized Monoclonal Antibody Against the Interleukin-2 Receptor Alpha Subunit (Daclizumab) on Inflammatory Activity in the Central Nervous System | Multiple Sclerosis, Relapsing-Remitting | Drug: Daclizumab | National Institute of Neurological Disorders and Stroke (NINDS) | NULL | Completed | 18 Years | 65 Years | All | 16 | Phase 2 | United States |