13. 多発性硬化症/視神経脊髄炎
[臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228

Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
41 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-002820-10-DE
(EUCTR)
26/06/201708/11/2016Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Canada;Germany;Italy;United Kingdom
2NCT02881567
(ClinicalTrials.gov)
April 18, 201724/8/2016Efficacy and Safety of Daclizumab in Participants With RRMS Switching From NatalizumabA 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: DaclizumabBiogenAbbVieTerminated18 Years55 YearsAll41Phase 3United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom
3EUCTR2016-002820-10-GB
(EUCTR)
13/03/201708/11/2016Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Canada;Denmark;Germany;Italy;United Kingdom
4EUCTR2012-003176-39-DK
(EUCTR)
30/10/201325/10/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3Argentina;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
5EUCTR2012-003176-39-IE
(EUCTR)
01/08/201311/04/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2012-003176-39-GB
(EUCTR)
31/07/201312/04/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301A 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]
Biogen Idec Research LimitedNULLNot Recruiting Female: yes
Male: yes
1600Phase 3Serbia;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
7EUCTR2012-003176-39-GR
(EUCTR)
14/07/201322/05/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1841Phase 3United 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
8EUCTR2012-003176-39-FI
(EUCTR)
11/06/201314/05/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1841United 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
9EUCTR2012-003176-39-DE
(EUCTR)
31/05/201314/12/2012Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3Serbia;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
10EUCTR2012-003176-39-FR
(EUCTR)
28/05/201320/06/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1841Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2012-003176-39-ES
(EUCTR)
24/05/201321/03/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301A 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 LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1841United 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;Brazil;Poland;Romania;Georgia;Germany;Sweden
12EUCTR2012-003176-39-SE
(EUCTR)
07/05/201314/03/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3Serbia;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
13EUCTR2012-003176-39-HU
(EUCTR)
23/04/201328/02/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301A 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)
BiogenNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3Serbia;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
14EUCTR2012-003176-39-PL
(EUCTR)
17/04/201304/03/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 203MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3United 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
15EUCTR2012-003176-39-CZ
(EUCTR)
16/04/201307/02/2013Daclizumab HYP Extension Study for Subjects with Multiple Sclerosis Who Have Completed 205MS301A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3Serbia;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2012-003176-39-IT
(EUCTR)
14/03/201311/01/2013Daclizumab 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 LTDNULLNot RecruitingFemale: yes
Male: yes
1841Phase 3United 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
17NCT01797965
(ClinicalTrials.gov)
February 15, 201315/2/2013Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019A 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 205MS301Relapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: BIIB019 (Daclizumab)BiogenAbbVieTerminated18 YearsN/AAll1501Phase 3United 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
18EUCTR2009-012500-11-SI
(EUCTR)
27/01/201210/01/2012Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1800Germany;France;Ireland;Australia;Sweden;Brazil;Czech Republic;Serbia;Canada;United States;Greece;Poland;Hungary;Switzerland;Italy;Israel;Finland;India;United Kingdom;Russian Federation;Ukraine;Mexico;Argentina;Slovenia;Denmark;Romania;Spain
19NCT01462318
(ClinicalTrials.gov)
November 201114/7/2011An Open-Label Immunogenicity and Pharmacokinetics Study of Daclizumab High Yield Process Prefilled Syringe in Relapsing Remitting Multiple SclerosisA 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 SclerosisRelapsing-Remitting Multiple SclerosisDrug: Midazolam;Other: Caffeine;Drug: S-warfarin;Other: Vitamin K;Drug: Omeprazole;Drug: Dextromethorphan;Biological: BIIB019 (Daclizumab)BiogenNULLCompleted18 Years65 YearsAll133Phase 3United States;Czech Republic;Hungary;Poland;Russian Federation
20EUCTR2010-023856-97-CZ
(EUCTR)
13/10/201109/08/2011Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled SyringeA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
120United States;Hungary;Czech Republic;Poland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2010-023856-97-PL
(EUCTR)
12/10/201126/08/2011Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled SyringeA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
100United States;Hungary;Czech Republic;Poland;Russian Federation
22EUCTR2010-023856-97-HU
(EUCTR)
22/09/201115/07/2011Study to Evaluate BIIB019, Daclizumab High Yield Process (DAC HYP), when administered by Pre-filled SyringeA 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
120United States;Czech Republic;Hungary;Poland;Russian Federation
23EUCTR2009-015318-23-DE
(EUCTR)
09/06/201108/06/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
450Phase 2Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India
24EUCTR2009-012500-11-DK
(EUCTR)
08/09/201004/06/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1800Serbia;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
25EUCTR2009-015318-23-HU
(EUCTR)
31/08/201014/06/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
450Phase 2Czech Republic;Hungary;Ukraine;Russian Federation;Germany;United Kingdom;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2009-012500-11-CZ
(EUCTR)
19/08/201020/01/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1800United 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
27EUCTR2009-012500-11-DE
(EUCTR)
13/07/201020/01/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1800Serbia;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
28EUCTR2009-012500-11-FI
(EUCTR)
29/06/201022/03/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United 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
29EUCTR2009-012500-11-SE
(EUCTR)
07/06/201009/04/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1800United 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
30EUCTR2009-012500-11-GB
(EUCTR)
03/06/201016/04/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT01064401
(ClinicalTrials.gov)
May 201026/1/2010Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ß 1a in Participants With Relapsing-Remitting Multiple SclerosisMulticenter, 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 SclerosisRelapsing-Remitting Multiple SclerosisBiological: BIIB019 (Daclizumab High Yield Process);Drug: Interferon beta-1a Placebo;Biological: Interferon beta-1a;Drug: Daclizumab High Yield Process PlaceboBiogenAbbVieCompleted18 Years55 YearsAll1841Phase 3United 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
32EUCTR2009-012500-11-IE
(EUCTR)
12/04/201007/01/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1800Serbia;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
33EUCTR2009-012500-11-HU
(EUCTR)
31/03/201024/02/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1800United 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
34NCT01051349
(ClinicalTrials.gov)
March 31, 201015/1/2010Safety 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 SclerosisA 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 SclerosisBiological: BIIB019 (Daclizumab);Biological: trivalent seasonal influenza vaccineBiogenAbbVieCompleted18 Years60 YearsAll410Phase 2Czechia;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Czech Republic
35EUCTR2009-015318-23-CZ
(EUCTR)
21/01/201003/12/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
450Phase 2Hungary;Czech Republic;Ukraine;Russian Federation;Germany;United Kingdom;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2008-005559-46-DE
(EUCTR)
08/12/200926/06/2009An 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.NULLNot RecruitingFemale: yes
Male: yes
600Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India
37EUCTR2008-005559-46-HU
(EUCTR)
04/08/200905/06/2009A 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) - SELECTIONA 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.NULLNot RecruitingFemale: yes
Male: yes
600Czech Republic;Hungary;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India
38EUCTR2008-005559-46-GB
(EUCTR)
18/05/200927/07/2010An 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.NULLNot RecruitingFemale: yes
Male: yes
600Phase 2Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India
39NCT00870740
(ClinicalTrials.gov)
February 200926/3/2009Safety 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 SclerosisA 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 SclerosisBiological: BIIB019 (Daclizumab High Yield Process);Drug: PlaceboBiogenAbbVieCompleted18 Years55 YearsAll517Phase 2Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom
40EUCTR2008-005559-46-CZ
(EUCTR)
23/01/200928/11/2008An 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.NULLNot RecruitingFemale: yes
Male: yes
600Hungary;Czech Republic;Poland;Ukraine;Russian Federation;Germany;United Kingdom;India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT00390221
(ClinicalTrials.gov)
February 200817/10/2006Safety and Efficacy Study of Daclizumab High Yield Process (DAC HYP) to Treat Relapsing-Remitting Multiple SclerosisMulticenter, 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 SclerosisRelapsing-Remitting Multiple SclerosisBiological: BIIB019 (Daclizumab High Yield Process);Drug: PlaceboBiogenAbbVieCompleted18 Years55 YearsAll621Phase 2Czech Republic;Germany;Hungary;India;Poland;Russian Federation;Ukraine;United Kingdom;Australia;Former Serbia and Montenegro;Sweden;Turkey