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"
34 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-004616-37-DE
(EUCTR)
24/11/201605/08/2016A Study to Explore the Mechanism of Action of Ocrelizumab and B-cell Biology in Patients with Relapsing Multiple Sclerosis or Primary Progressive Multiple Sclerosis.An open-label, multicenter, biomarker study to explore the mechanism of action of ocrelizumab and B-cell biology in patients with relapsing multiple sclerosis or primary progressive multiple sclerosis. - Relapsing multiple sclerosis (RMS)/Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
GENENTECH Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
99Phase 3United States;Germany;Switzerland;Sweden
2EUCTR2010-020315-36-CZ
(EUCTR)
18/10/201222/08/2012A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
3EUCTR2010-020315-36-BG
(EUCTR)
28/11/201119/08/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
4EUCTR2010-020315-36-IE
(EUCTR)
04/11/201108/09/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 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]
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
5EUCTR2010-020337-99-GB
(EUCTR)
20/10/201105/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2010-020315-36-GB
(EUCTR)
20/10/201116/08/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
7EUCTR2010-020315-36-SK
(EUCTR)
18/10/201128/06/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
8EUCTR2010-020315-36-DE
(EUCTR)
22/09/201108/07/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
9EUCTR2010-020337-99-DE
(EUCTR)
05/09/201111/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
10EUCTR2010-020315-36-SE
(EUCTR)
31/08/201105/07/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2010-020337-99-SK
(EUCTR)
23/06/201114/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
12EUCTR2010-020338-25-DE
(EUCTR)
08/06/201106/10/2010A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10 ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10 ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand
13EUCTR2010-020338-25-BE
(EUCTR)
26/05/201122/09/2010A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand
14EUCTR2010-020337-99-BG
(EUCTR)
07/03/201117/12/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
15EUCTR2010-020337-99-BE
(EUCTR)
23/02/201112/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2010-020337-99-CZ
(EUCTR)
21/02/201111/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
17EUCTR2010-020337-99-PT
(EUCTR)
04/02/201129/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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]
Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Serbia;Portugal;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
18EUCTR2010-020338-25-AT
(EUCTR)
26/01/201118/10/2010A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand
19EUCTR2010-020338-25-GR
(EUCTR)
21/01/201117/01/2011A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand
20EUCTR2010-020338-25-CZ
(EUCTR)
20/01/201105/10/2010A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2010-020337-99-AT
(EUCTR)
20/01/201118/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
22EUCTR2010-020337-99-LT
(EUCTR)
17/01/201127/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
23EUCTR2010-020338-25-PT
(EUCTR)
12/01/201114/10/2010A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: OCREVUS
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3United States;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand
24EUCTR2010-020337-99-LV
(EUCTR)
29/12/201011/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
25EUCTR2010-020338-25-GB
(EUCTR)
29/12/201005/10/2010A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2010-020338-25-FI
(EUCTR)
15/12/201015/12/2010A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand
27EUCTR2010-020337-99-EE
(EUCTR)
26/11/201027/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
28EUCTR2010-020338-25-LT
(EUCTR)
02/11/201002/09/2010A Study of Ocrelizumab in Patients With Primary Progressive Multiple SclerosisA Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: Ro 496-4913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand
29EUCTR2007-006338-32-BG
(EUCTR)
07/10/200831/07/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis Multiple sclerosis is a disabling disease of brain and spinal cord thatdisrupts flow of information within brain, characterized by flare-ups withperiods of remission in between (relapsing remitting)
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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: oclelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
30EUCTR2007-006338-32-BE
(EUCTR)
15/09/200817/04/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Netherlands;Germany;Serbia;United States;Slovakia;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2007-006338-32-GB
(EUCTR)
28/07/200807/03/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis Relapsing remitting 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
32EUCTR2007-006338-32-DK
(EUCTR)
09/07/200809/04/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis Relapsing remitting 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Hoffman La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
33EUCTR2007-006338-32-SK
(EUCTR)
16/06/200809/04/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis Relapsing remitting 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
34EUCTR2007-006338-32-CZ
(EUCTR)
28/05/200801/04/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis Relapsing remitting 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany