Ocr    (DrugBank: -)

1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎173

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.
173 / 3,050 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04650321
(ClinicalTrials.gov)
January 1, 202116/11/2020Home Based Infusions for OcrelizumabEvaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based InfusionsMultiple SclerosisDrug: Ocrelizumab at homeUniversity of Colorado, DenverGenentech, Inc.Not yet recruiting18 Years55 YearsAll110Phase 4NULL
2EUCTR2019-003919-53-GB
(EUCTR)
17/12/202026/11/2020FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple SclerosisA PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH OCRELIZUMAB IN ADULT PATIENTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary Progressive multiple sclerosis
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] - Immune System Diseases [C20]
Product Name: fenebrutinib
Product Code: RO7010939
INN or Proposed INN: FENEBRUTINIB
Other descriptive name: GDC-0853 RO7010939
Trade Name: Ocrevus
Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
946Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Denmark;Australia;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand
3NCT04544436
(ClinicalTrials.gov)
December 15, 20204/9/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: Antihistamine;Drug: MethylprednisoloneHoffmann-La RocheNULLRecruiting18 Years55 YearsAll786Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
4NCT04548999
(ClinicalTrials.gov)
December 3, 20209/9/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)A Phase IIIB Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: Antihistamine;Drug: MethylprednisoloneHoffmann-La RocheNULLRecruiting18 Years55 YearsAll699Phase 3United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
5NCT04387734
(ClinicalTrials.gov)
December 202011/5/2020Effects of Ocrevus in Relapsing Multiple SclerosisEffects and Mechanisms of Ocrevus on Ambulatory Functions in People With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Ocrelizumab;Drug: PlatformGeorgia State UniversityMultiple Sclerosis Center of AtlantaNot yet recruiting18 Years55 YearsAll60Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04640818
(ClinicalTrials.gov)
November 30, 202018/11/2020Safety and Efficacy of Cladribine Therapy After Anti CD20 TherapySafety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot StudyMultiple SclerosisDrug: Cladribine Oral Tablet;Drug: Rituximab;Drug: OcrelizumabClaudio GobbiMerck AG SwitzerlandNot yet recruiting18 Years80 YearsAll45Switzerland
7EUCTR2019-001967-58-FR
(EUCTR)
20/11/202027/05/2020Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS Relapsing Multiple Sclerosis
MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Dapirolizumab Pegol
Product Code: BIIB133
INN or Proposed INN: DAPIROLIZUMAB PEGOL
Trade Name: Ocrevus
Product Name: OCREVUS
INN or Proposed INN: OCRELIZUMAB
Other descriptive name: OCRELIZUMAB
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 2United States;Serbia;France;Spain;Poland;Belgium;Germany;Switzerland;Italy
8NCT04578639
(ClinicalTrials.gov)
November 2, 202022/9/2020Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS DiseaseOcrelizumab VErsus Rituximab Off-Label at the Onset of RelapsingRelapsing Remitting Multiple SclerosisDrug: Rituximab;Drug: OcrelizumabHaukeland University HospitalUniversity Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North NorwayRecruiting18 Years60 YearsAll211Phase 3Norway
9EUCTR2020-000893-69-PL
(EUCTR)
28/10/202009/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
10NCT04544449
(ClinicalTrials.gov)
October 26, 20204/9/2020A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple SclerosisA Phase III Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Patients With Primary Progressive Multiple Sclerosis.Multiple Sclerosis, Primary ProgressiveDrug: fenebrutinib;Drug: ocrelizumab;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years65 YearsAll946Phase 3United States;Canada;France;Argentina;Australia;Austria;Belgium;Brazil;Czechia;Denmark;Germany;Greece;Hungary;Israel;Italy;Mexico;New Zealand;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2020-000893-69-BE
(EUCTR)
23/10/202023/10/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
12EUCTR2020-000894-26-PT
(EUCTR)
12/10/202013/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary Progressive Multiple Sclerosis (MS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
699Phase 3Portugal;United States;Greece;Spain;Ukraine;Turkey;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
13EUCTR2020-000893-69-PT
(EUCTR)
12/10/202009/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
14EUCTR2020-000893-69-HU
(EUCTR)
09/10/202006/08/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
15EUCTR2020-000894-26-FR
(EUCTR)
08/10/202011/08/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary Progressive Multiple Sclerosis (MS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
699Phase 3United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;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
16NCT04448977
(ClinicalTrials.gov)
October 202015/6/2020Examining Effects of Ocrevus on Cognitive Fatigue Using fMRIA Biomarker for Cognitive Fatigue Using Functional Imaging in MSMultiple Sclerosis, Relapsing-RemittingDrug: OcrevusKessler FoundationHackensack Meridian HealthNot yet recruiting18 Years64 YearsAll60United States
17EUCTR2020-000894-26-GB
(EUCTR)
25/09/202030/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a HigherDose of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - BN42083 Study to evaluate high dose Ocrelizumab in PPMS Relapsing Multiple Sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
18EUCTR2020-000893-69-GB
(EUCTR)
25/09/202029/07/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS - BN42082 Study to evaluate high dose Ocrelizumab in RMS Relapsing Multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
786Phase 3United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Peru;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand
19EUCTR2020-000894-26-HU
(EUCTR)
22/09/202006/08/2020A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary Progressive Multiple Sclerosis (MS)
MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
699Phase 3United States;Portugal;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Germany;New Zealand
20NCT04466150
(ClinicalTrials.gov)
August 30, 20207/7/2020Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis OnsetImpact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis OnsetRelapsing Multiple Sclerosis;Clinically Isolated SyndromeDrug: OcrelizumabUniversity of California, San FranciscoGenentech, Inc.;Valhalla Charitable FoundationRecruiting18 Years50 YearsAll30Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT04387110
(ClinicalTrials.gov)
August 7, 20204/5/2020Ocrelizumab in BreastmilkMonoclonal Antibodies in Mothers' Milk and Infants: Ocrelizumab in BreastmilkMultiple Sclerosis;Clinically Isolated SyndromeDrug: OcrelizumabUniversity of California, San FranciscoGenentech, Inc.Recruiting18 Years64 YearsFemale20United States
22NCT04261790
(ClinicalTrials.gov)
August 1, 20206/2/2020Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple SclerosisEvaluating the Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: OcrelizumabJohns Hopkins UniversityGenentech, Inc.Recruiting18 Years99 YearsAll10Phase 4United States
23NCT04377555
(ClinicalTrials.gov)
July 30, 20201/5/2020Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) Before and During Treatment With OcrelizumabAn Open-Label, Multicenter Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With OcrelizumabMultiple Sclerosis, RelapsingDrug: OcrelizumabGenentech, Inc.NULLRecruiting18 Years65 YearsAll150Phase 4United States;Puerto Rico
24NCT04459988
(ClinicalTrials.gov)
July 1, 202030/6/2020Mechanistic Study of OcrevusEnhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple SclerosisMultiple SclerosisDrug: OcrelizumabUniversity of MichiganNULLRecruiting18 Years65 YearsAll35United States
25NCT04458688
(ClinicalTrials.gov)
July 202030/6/2020Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple SclerosisInvestigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) StudyMultiple Sclerosis, Relapsing-RemittingOther: Observation of Ocrelizumab as Treatment in RRMS PatientsWayne State UniversityNULLNot yet recruiting18 Years60 YearsAll80NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2019-003127-38-NL
(EUCTR)
09/04/202009/04/2020Research on the effect of add-on high dosage simvastatin treatment on progression in MS patients treated with ocrelizumab and natalizumab.Efficacy of add-on high dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial. - SIMSON trial Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Simvastatin
INN or Proposed INN: SIMVASTATIN
Other descriptive name: Simvastatine
VUmc Neurology DepartmentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Netherlands
27EUCTR2019-001549-42-GB
(EUCTR)
27/03/202003/02/2020Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MSA multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS Highly active relapsing remitting multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cyclophosphamide
INN or Proposed INN: Cyclophosphamide monohydrate
INN or Proposed INN: Cyclophosphamide monohydrate
Product Name: Filgrastim
INN or Proposed INN: Filgrastim
Trade Name: Thymoglobuline
Product Name: Thymoglobuline
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin
Trade Name: Alemtuzumab
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Product Name: Lenograstim
INN or Proposed INN: Lenograstim
Trade Name: Ocrelizumab
Product Name: Ocrelizumab
Sheffield Teaching HospitalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
198Phase 3United Kingdom
28EUCTR2017-001313-93-DE
(EUCTR)
27/03/202012/02/2020A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10053395;Term: Progressive 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
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria
29EUCTR2016-001166-29-DE
(EUCTR)
18/03/202012/08/2019A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST)A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) - COAST 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] - Immune System Diseases [C20]
Trade Name: Lemtrada
Product Name: alemtuzumab
INN or Proposed INN: alemtuzumab
Other descriptive name: ALEMTUZUMAB
Trade Name: Ocrevus
Product Name: ocrelizumab
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
Product Name: autologous hematopoietic stem cells
Product Code: aHSC
University Medical Centre Hamburg-EppendorfNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
50Phase 2Germany
30EUCTR2018-001511-73-DE
(EUCTR)
17/03/202017/06/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS 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]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;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
31EUCTR2018-001511-73-IE
(EUCTR)
16/03/202008/05/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS 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]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
32EUCTR2016-002667-34-PL
(EUCTR)
06/03/202014/11/2019A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple SclerosisAN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS Relapsing-remitting multiple sclerosis (MS)
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2United States;Poland;Italy
33EUCTR2018-001511-73-PT
(EUCTR)
02/03/202030/04/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 20.1;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]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
34NCT04175834
(ClinicalTrials.gov)
February 5, 202022/11/2019Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to OcrelizumabComparing the Risk and Severity of Infusion-Related Reactions in Patients Premedicated With Cetirizine Versus Diphenhydramine Prior to Ocrelizumab InfusionsMultiple Sclerosis;Infusion ReactionDrug: antihistamineProvidence Health & ServicesGenentech, Inc.Recruiting18 Years70 YearsAll52Phase 3United States
35NCT04230174
(ClinicalTrials.gov)
February 202013/1/2020Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia ActivationEffect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia ActivationMultiple SclerosisDrug: 11C-PBR28Massachusetts General HospitalGenentech, Inc.Not yet recruiting18 Years65 YearsAll24Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT04075266
(ClinicalTrials.gov)
January 9, 202014/8/2019A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple SclerosisAn Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple SclerosisMultiple SclerosisDrug: OcrelizumabHoffmann-La RocheNULLRecruiting10 Years18 YearsAll12Phase 2United States;Italy;Poland
37EUCTR2018-001511-73-GB
(EUCTR)
23/12/201909/04/2019A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HANDA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - ORATORIO HAND Trade Name: Ocrevus
Product Name: Ocrevus
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: no
1000Phase 3Portugal;Hungary;Poland;Spain;Ireland;Croatia;Bulgaria;Germany;United Kingdom
38EUCTR2018-001511-73-HU
(EUCTR)
18/12/201908/11/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS 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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 3Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
39EUCTR2018-001511-73-HR
(EUCTR)
16/12/201917/01/2020A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS 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]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
40EUCTR2018-001511-73-BG
(EUCTR)
02/10/201919/06/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS 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]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;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
41EUCTR2018-001511-73-PL
(EUCTR)
30/09/201906/08/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple SclerosisA PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OFOCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS 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]
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Belarus;Portugal;Serbia;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand
42EUCTR2017-001362-25-NL
(EUCTR)
30/09/201910/09/2019 Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS 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]
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100Phase 3Denmark;Netherlands
43EUCTR2018-001511-73-ES
(EUCTR)
21/08/201904/07/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS Primary progressive multiple sclerosis (PPMS)
MedDRA version: 20.1;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]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1000Phase 3Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand
44NCT03972306
(ClinicalTrials.gov)
August 12, 201929/5/2019A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple SclerosisA Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple SclerosisMultiple Sclerosis (MS)Drug: Ocrelizumab;Drug: rHuPH20Hoffmann-La RocheNULLRecruiting18 Years65 YearsAll135Phase 1United States
45NCT04035005
(ClinicalTrials.gov)
August 12, 201917/7/2019A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisA Phase IIIb Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Drug: PlaceboHoffmann-La RocheNULLRecruiting18 Years65 YearsAll1000Phase 3United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Colombia;Croatia;Egypt;France;Georgia;Germany;Hungary;Ireland;Italy;Mexico;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46NCT03873389
(ClinicalTrials.gov)
June 12, 201912/3/2019Ocrelizumab Effects on the Metabolome in MSEvaluating the Effects of Ocrelizumab on the Circulating Metabolome in Multiple Sclerosis (MS)Multiple SclerosisDrug: OcrelizumabJohns Hopkins UniversityGenentech, Inc.Recruiting18 Years75 YearsAll50United States
47NCT03025269
(ClinicalTrials.gov)
April 2, 201916/1/2017Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple SclerosisEffect of Ocrelizumab on Gray Matter Pathology, Leptomeningeal Inflammation and Cognitive Dysfunction in Multiple SclerosisMultiple SclerosisDrug: OcrelizumabUniversity at BuffaloNULLEnrolling by invitation18 Years60 YearsAll30United States
48NCT03853746
(ClinicalTrials.gov)
April 1, 201922/2/2019Short-term B-cell Depletion in Relapsing Multiple SclerosisEvaluating the Effects of Short-term B-cell Depletion on Long-term Disease Activity and Immune Tolerance in Relapsing Multiple SclerosisMultiple SclerosisDrug: OcrelizumabJohns Hopkins UniversityNational Multiple Sclerosis SocietyActive, not recruiting18 Years99 YearsAll10Phase 4United States
49NCT03784547
(ClinicalTrials.gov)
February 1, 201913/12/2018Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAMReal-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin AmericaMultiple SclerosisDrug: OcrelizumabHospital Italiano de Buenos AiresNULLRecruitingN/AN/AAll100Argentina
50EUCTR2017-004886-29-IE
(EUCTR)
11/01/201909/05/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT03691077
(ClinicalTrials.gov)
November 11, 201828/9/2018Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714A Prospective Study Evaluating the Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in Multiple Sclerosis Using PET-MRI With 18F-DPA714Multiple Sclerosis;Relapse;Primary Progressive Multiple SclerosisDrug: OcrelizumabAssistance Publique - Hôpitaux de ParisRoche Pharma AG;Institut du Cerveau et de la Moelle épinièreRecruiting18 Years60 YearsAll51Phase 3France
52NCT03593590
(ClinicalTrials.gov)
November 2, 201811/7/2018Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple SclerosisA Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDYMultiple SclerosisDrug: OcrelizumabHoffmann-La RocheNULLRecruiting18 YearsN/AAll1250Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Dominican Republic;Egypt;Italy;Kuwait;Montenegro;Netherlands;Panama;Paraguay;Poland;Portugal;Qatar;Romania;Russian Federation;Saudi Arabia;Slovakia;Spain;Turkey;United Arab Emirates;United Kingdom;Israel
53NCT03396822
(ClinicalTrials.gov)
September 24, 20184/1/2018Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple SclerosisMeningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple SclerosisMultiple SclerosisDrug: GadoteridolUniversity of Maryland, BaltimoreGenentech, Inc.Recruiting18 Years65 YearsAll22United States
54NCT03606460
(ClinicalTrials.gov)
September 14, 201823/7/2018A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)A Phase IIIb, Open-Label Study To Evaluate The Safety And Tolerability Of Shorter Infusions Of Ocrelizumab In Patients With Primary Progressive And Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab Dose 1;Drug: Ocrelizumab Dose 2 and Dose 3Genentech, Inc.NULLCompleted18 Years55 YearsAll141Phase 3United States
55EUCTR2017-004158-40-FR
(EUCTR)
11/09/201804/07/2018NAA Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714 - INN-MS Patients with Relapsing MS or primary progressive MS
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
71Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2017-004886-29-NL
(EUCTR)
05/09/201827/06/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
57EUCTR2017-004886-29-CZ
(EUCTR)
08/08/201810/05/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
58NCT03589105
(ClinicalTrials.gov)
August 6, 20185/7/2018A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic SettingAn Open-Label, Single-Arm Phase IV Study To Assess Ocrelizumab Efficacy, Safety, And Impact On Patient Reported Outcomes (PROS) In Patients With Active Relapsing Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mgHoffmann-La RocheNULLActive, not recruiting18 YearsN/AAll423Phase 4France
59NCT03562975
(ClinicalTrials.gov)
July 23, 201823/5/2018Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With OcrevusA Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™Multiple Sclerosis;Pathologic Processes;Demyelinating Diseases;Nervous System Diseases;Autoimmune Diseases;Immune System Diseases;Primary Progressive Multiple Sclerosis;Relapsing Remitting Multiple SclerosisDrug: OcrelizumabUniversity of South FloridaGenentech, Inc.Active, not recruiting18 Years70 YearsAll18United States
60EUCTR2017-004886-29-SE
(EUCTR)
23/07/201805/06/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1224Phase 3Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03599245
(ClinicalTrials.gov)
July 12, 201825/6/2018This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical TrialsMultiple SclerosisDrug: OcrelizumabHoffmann-La RocheNULLRecruiting18 Years65 YearsAll1500Phase 4Czechia;Denmark;Estonia;Finland;France;Ireland;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom
62EUCTR2017-001313-93-CZ
(EUCTR)
09/07/201826/03/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
900Phase 3Panama;United Arab Emirates;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;Bosnia and Herzegovina
63EUCTR2017-004886-29-FR
(EUCTR)
05/07/201817/05/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
64EUCTR2017-004886-29-GB
(EUCTR)
03/07/201802/07/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1224Phase 3France;Czech Republic;Estonia;Finland;Spain;Ireland;Denmark;Netherlands;United Kingdom;Sweden
65EUCTR2017-001362-25-DK
(EUCTR)
27/06/201821/03/2018 Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS 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]
Helse Bergen HF, Haukeland University HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
100Phase 3Denmark;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2017-001313-93-HU
(EUCTR)
21/06/201825/04/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
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 10053395;Term: Progressive 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
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
67EUCTR2017-004886-29-DK
(EUCTR)
21/06/201818/05/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1224Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
68EUCTR2017-004886-29-FI
(EUCTR)
19/06/201815/06/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
69EUCTR2017-001313-93-PL
(EUCTR)
08/06/201815/03/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
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 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
70EUCTR2017-004886-29-EE
(EUCTR)
31/05/201818/04/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical TrialA SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT03523858
(ClinicalTrials.gov)
May 28, 201816/4/2018A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple SclerosisAn Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple SclerosisProgressive Multiple Sclerosis (PMS)Drug: OcrelizumabHoffmann-La RocheNULLRecruiting18 Years65 YearsAll900Phase 3United States;Bosnia and Herzegovina;Brazil;Canada;Colombia;Costa Rica;Czechia;Denmark;Egypt;France;Germany;Guatemala;Hungary;Ireland;Italy;Lebanon;Mexico;Morocco;Netherlands;Panama;Poland;Russian Federation;Saudi Arabia;Spain;United Arab Emirates;Algeria
72EUCTR2017-004886-29-ES
(EUCTR)
22/05/201809/04/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL Multiple sclerosis (MS)
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 10048393;Term: Multiple sclerosis relapse;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
750Phase 3Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
73EUCTR2017-001313-93-ES
(EUCTR)
11/05/201802/03/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
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 10053395;Term: Progressive 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
Other descriptive name: OCRELIZUMAB
Roche Farma S.A(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F. Hoffmann-La Roche LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
74EUCTR2017-001313-93-IE
(EUCTR)
03/05/201806/02/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
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 10053395;Term: Progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01 (development)
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01 (commercial)
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United Arab Emirates;Saudi Arabia;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Kuwait;Netherlands;Bosnia and Herzegovina;Panama;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Algeria
75EUCTR2017-001313-93-DK
(EUCTR)
04/04/201823/02/2018A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple SclerosisAN OPEN-LABEL, SINGLE-ARM 4-YEAR STUDY TO EVALUATE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB TREATMENT IN PATIENTS WITH PROGRESSIVE MULTIPLE SCLEROSIS Progressive multiple sclerosis (PMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10053395;Term: Progressive 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
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Phase 3United Arab Emirates;Panama;Morocco;Spain;Costa Rica;Guatemala;Lebanon;Ireland;Russian Federation;Colombia;Italy;Egypt;France;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Netherlands;Germany;Algeria;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
76EUCTR2016-002937-31-HR
(EUCTR)
29/11/201713/04/2018A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
77NCT03344094
(ClinicalTrials.gov)
October 12, 201713/10/2017Mechanism of Action of Ocrelizumab in Multiple SclerosisMechanism of Action of Ocrelizumab in Multiple SclerosisMultiple Sclerosis;Immune System DiseasesDrug: ocrelizumabUniversity of ChicagoNULLRecruiting18 Years65 YearsAll30N/AUnited States
78EUCTR2016-002937-31-NO
(EUCTR)
12/09/201718/04/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
79EUCTR2016-002937-31-DE
(EUCTR)
11/09/201702/05/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
80EUCTR2016-002937-31-GB
(EUCTR)
06/09/201705/09/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2016-002937-31-NL
(EUCTR)
21/08/201715/06/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1228Phase 3Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Netherlands;Kuwait;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Bulgaria;Norway;Germany;Sweden
82EUCTR2016-002937-31-BG
(EUCTR)
02/08/201730/05/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
83EUCTR2016-002937-31-ES
(EUCTR)
31/07/201729/05/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;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;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Roche Farma S.A. (Soc.unipersonal)que realiza el ensayo en España y que actúa como representante de F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
84EUCTR2016-002937-31-FR
(EUCTR)
26/07/201730/10/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;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;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3United States;Portugal;Slovakia;Spain;Switzerland;Italy;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
85EUCTR2016-002937-31-PT
(EUCTR)
24/07/201704/05/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2016-002937-31-BE
(EUCTR)
10/07/201705/05/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
87EUCTR2016-002937-31-HU
(EUCTR)
29/06/201708/05/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Portugal;United States;Slovakia;Slovenia;Finland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Mexico;Poland;Belgium;Brazil;Romania;Croatia;Denmark;Bulgaria;Norway;Netherlands;Germany;Sweden
88EUCTR2016-002937-31-PL
(EUCTR)
26/06/201710/05/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
89EUCTR2016-002937-31-AT
(EUCTR)
19/06/201720/04/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
90EUCTR2016-002937-31-SE
(EUCTR)
19/06/201720/04/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2016-002937-31-SI
(EUCTR)
16/06/201713/06/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1228Phase 3Portugal;United States;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Norway;Germany;Sweden
92EUCTR2016-002937-31-SK
(EUCTR)
16/06/201711/05/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
93EUCTR2016-002937-31-DK
(EUCTR)
08/06/201728/04/2017A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple SclerosisAn Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
Trade Name: Ocrevus
Product Name: Ocrelizumab
Product Code: RO4964913/F07-01
INN or Proposed INN: Ocrelizumab
Other descriptive name: OCRELIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1225Phase 3United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden
94NCT03085810
(ClinicalTrials.gov)
April 4, 201716/3/2017Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: OcrelizumabHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll1225Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Croatia;Denmark;France;Germany;Hungary;Italy;Kuwait;Lebanon;Mexico;Netherlands;Norway;Poland;Portugal;Romania;Slovakia;Slovenia;Spain;Sweden;Switzerland;Turkey;United Kingdom;Finland
95NCT02980042
(ClinicalTrials.gov)
January 1, 20179/11/2016Tolerability and Safety of Switching From Rituximab to Ocrelizumab in Patients With Relapsing Forms of Multiple SclerosisEvaluating the Tolerability and Safety Profile of Switching From Rituximab to Ocrelizumab: A Real World Evaluation of Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: Ocrelizumab;Drug: RituximabUniversity of Colorado, DenverNULLCompleted18 Years65 YearsAll200Phase 3United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2015-004616-37-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
97EUCTR2015-005597-38-CZ
(EUCTR)
07/10/201617/06/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
98NCT02807285
(ClinicalTrials.gov)
October 201616/6/2016Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple SclerosisAn Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple SclerosisMultiple SclerosisDrug: OcrelizumabGenentech, Inc.NULLNo longer available18 Years55 YearsAllN/AUnited States
99EUCTR2015-005597-38-FI
(EUCTR)
12/09/201621/06/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
100NCT02861014
(ClinicalTrials.gov)
September 9, 20165/8/2016A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying TreatmentMultiple Sclerosis, Relapsing-RemittingBiological: OcrelizumabHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll681Phase 3Australia;Belgium;Czechia;Denmark;Estonia;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Hong Kong
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2015-005597-38-BE
(EUCTR)
14/07/201616/06/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
102EUCTR2015-005597-38-NL
(EUCTR)
11/07/201601/06/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
103EUCTR2015-005597-38-DE
(EUCTR)
29/06/201607/04/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
104EUCTR2015-005597-38-DK
(EUCTR)
02/06/201606/04/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
105EUCTR2015-005597-38-SE
(EUCTR)
25/05/201615/03/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2015-005597-38-EE
(EUCTR)
25/05/201606/04/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
107EUCTR2015-005597-38-FR
(EUCTR)
23/05/201615/02/2018A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
600Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
108EUCTR2015-005597-38-GB
(EUCTR)
19/05/201609/03/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
109EUCTR2015-005597-38-IE
(EUCTR)
13/05/201610/03/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
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;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
110NCT02688985
(ClinicalTrials.gov)
April 29, 201618/2/2016Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)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 SclerosisRelapsing Multiple Sclerorsis;Multiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: AntihistamineGenentech, Inc.NULLActive, not recruiting18 Years55 YearsAll127Phase 3United States;Canada;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2015-005597-38-ES
(EUCTR)
26/04/201618/03/2016A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple SclerosisAn open-label study to evaluate the efficacy and safety of ocrelizumab in patients with relapsing remitting multiple sclerosis who have a suboptimal response to an adequate course of disease-modifying treatment - CASTING Relapsing remitting multiple sclerosis (RRMS)
MedDRA version: 18.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;Classification code 10048393;Term: Multiple sclerosis relapse;Level: LLT;Classification code 10039720;Term: Sclerosis multiple;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
Roche Farma S.A. que representa en España a F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
600Phase 3Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
112NCT02637856
(ClinicalTrials.gov)
February 11, 201618/12/2015A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying TreatmentMultiple Sclerosis, Relapsing-RemittingDrug: OcrelizumabGenentech, Inc.NULLCompleted18 Years55 YearsAll608Phase 3United States;Canada
113NCT02545868
(ClinicalTrials.gov)
October 27, 20158/9/2015A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple SclerosisA Phase IIIB, Multicenter, Randomized, Parallel-Group, Open-Label Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Patients With Relapsing Forms of Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: 23-PPV;Biological: 13-PCV Booster;Biological: Influenza Vaccine;Biological: KLH;Drug: OCR;Biological: TT VaccineHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll102Phase 3United States;Canada
114EUCTR2010-020338-25-NL
(EUCTR)
02/03/201330/09/2010A 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]
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finished Female: 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
115EUCTR2010-020315-36-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2010-020337-99-NL
(EUCTR)
13/04/201219/10/2010 A 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]
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Netherlands;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
117EUCTR2010-020315-36-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
118EUCTR2010-020315-36-BE
(EUCTR)
14/11/201130/06/2011 A 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]
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finished Female: 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
119EUCTR2010-020315-36-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
120EUCTR2010-020337-99-PL
(EUCTR)
25/10/201113/09/2011 A 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]
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finished Female: 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;Brazil;Poland;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
121EUCTR2010-020337-99-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
122EUCTR2010-020315-36-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
123EUCTR2010-020315-36-ES
(EUCTR)
18/10/201121/07/2011A 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: 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: 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
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Colombia;Turkey;Ireland;Italy;Sweden;Brazil;United Kingdom;Russian Federation;Ukraine;Canada;Peru;Belarus;Belgium;Mexico;Argentina;Spain;Bosnia and Herzegovina;United States;Croatia
124EUCTR2010-020315-36-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
125EUCTR2010-020315-36-FR
(EUCTR)
07/10/201102/09/2011A 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: 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: 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
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
126EUCTR2010-020315-36-IT
(EUCTR)
05/10/201127/12/2011A study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis.A Randomized, Double-Blind, Double Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: OCRELIZUMAB
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
ROCHENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
469Colombia;Turkey;Ireland;Italy;Sweden;Brazil;United Kingdom;Russian Federation;Canada;Ukraine;Belarus;Peru;Belgium;Argentina;Mexico;Spain;Bosnia and Herzegovina;United States;Croatia
127EUCTR2010-020315-36-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
128EUCTR2010-020337-99-ES
(EUCTR)
21/09/201120/07/2011A 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 I Relapsing 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: 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
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;Serbia;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain
129NCT01412333
(ClinicalTrials.gov)
September 20, 20118/8/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants 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 SclerosisRelapsing Multiple SclerosisDrug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placeboHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll835Phase 3United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic;Morocco
130EUCTR2010-020337-99-IT
(EUCTR)
19/09/201129/03/2012A Study of Ocrelizumab in Comparison With Interferon Beta-1a inPatients With Relapsing Multiple Sclerosis.A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study ToEvaluate The Efficacy And Safety Of Ocrelizumab In Comparison ToInterferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA I Relapsing Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: OCRELIZUMAB
Other descriptive name: NA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: NA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: NA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: NA
ROCHENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2010-020337-99-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
132EUCTR2010-020315-36-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
133NCT01247324
(ClinicalTrials.gov)
August 31, 201123/11/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants 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 SclerosisRelapsing Multiple SclerosisDrug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placeboHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll821Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France;Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;Czech Republic;Morocco;New Zealand
134EUCTR2010-020337-99-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
135EUCTR2010-020338-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2010-020338-25-PL
(EUCTR)
04/06/201114/05/2011A 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: 20.1;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]
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finished Female: 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;Brazil;Belgium;Poland;Bulgaria;Norway;Germany;New Zealand
137EUCTR2010-020338-25-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
138EUCTR2010-020338-25-BG
(EUCTR)
11/05/201119/01/2011A 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: 18.0;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
Product Code: Ro 496-4913/F03
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLNot RecruitingFemale: 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
139EUCTR2010-020337-99-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
140NCT01194570
(ClinicalTrials.gov)
March 2, 201128/8/2010A Study of Ocrelizumab in Participants With Primary Progressive Multiple SclerosisA Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple SclerosisMultiple Sclerosis, Primary ProgressiveDrug: Ocrelizumab;Other: PlaceboHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll732Phase 3United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czechia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Lithuania;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Uruguay;Czech Republic;Denmark;Turkey
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2010-020338-25-DK
(EUCTR)
02/03/201107/02/2011A 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 - OratorioA 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: 15.1;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
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Netherlands;Germany
142EUCTR2010-020337-99-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
143EUCTR2010-020337-99-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
144EUCTR2010-020337-99-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
145EUCTR2010-020338-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2010-020338-25-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
147EUCTR2010-020338-25-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
148EUCTR2010-020337-99-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
149EUCTR2010-020337-99-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
150EUCTR2010-020338-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2010-020337-99-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
152EUCTR2010-020338-25-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
153EUCTR2010-020338-25-ES
(EUCTR)
20/12/201017/09/2010Estudio de fase III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ocrelizumab en adultos con esclerosis múltiple progresiva primaria A 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 - OratorioEstudio de fase III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ocrelizumab en adultos con esclerosis múltiple progresiva primaria A 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 Esclerosis múltiple progresiva primaria (EMPP)
MedDRA version: 12.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis
Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: -
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
630Phase 3Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria
154EUCTR2010-020337-99-FI
(EUCTR)
15/12/201011/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, 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: 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: 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
F.Hoffmann-La RocheNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
155EUCTR2010-020338-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2010-020338-25-IT
(EUCTR)
07/12/201024/12/2010A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adultswith Primary Progressive Multiple Sclerosis. - ORATORIOA Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adultswith Primary Progressive Multiple Sclerosis. - ORATORIO Primary Progressive Multiple Sclerosis (PPMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063401
Product Name: ocrelizumabF. Hoffmann - La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
650Phase 3Portugal;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria
157EUCTR2010-020337-99-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
158EUCTR2010-020338-25-HU
(EUCTR)
17/11/201029/09/2010A 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: 18.0;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
Product Code: Ro 496-4913/F03
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;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand
159EUCTR2010-020337-99-HU
(EUCTR)
17/11/201011/10/2010A 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: 17.1;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
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Portugal;United States;Serbia;Estonia;Morocco;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
160EUCTR2010-020338-25-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2007-006338-32-FI
(EUCTR)
08/10/200830/06/2008Phase 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 sclerosisPhase 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: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy
162EUCTR2007-006338-32-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
163EUCTR2007-006338-32-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
164EUCTR2007-006338-32-IT
(EUCTR)
11/09/200802/10/2008A 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 MRI.Phase 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 RRMS. Relapsing-Remitting Multiple Sclerosis (RRMS).
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
F.Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Denmark;Bulgaria;Netherlands;Germany
165NCT00676715
(ClinicalTrials.gov)
July 31, 20089/5/2008A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple SclerosisPhase 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 RRMSMultiple Sclerosis, Relapsing-RemittingDrug: Placebo;Drug: Ocrelizumab;Drug: AvonexGenentech, Inc.Roche Pharma AGActive, not recruiting18 Years55 YearsAll220Phase 2United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Italy;Mexico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2007-006338-32-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
167EUCTR2007-006338-32-ES
(EUCTR)
16/07/200828/03/2008Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase 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 sclerosisEstudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase 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 Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Hoffman La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy
168EUCTR2007-006338-32-DE
(EUCTR)
09/07/200817/03/2008A 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: Ocrrelizumab 300 mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrrelizumab 300 mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F. 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
169EUCTR2007-006338-32-NL
(EUCTR)
09/07/200829/05/2008Phase 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 sclerosisPhase 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: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy
170EUCTR2007-006338-32-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2007-006338-32-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
172EUCTR2007-006338-32-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
173EUCTR2007-006338-32-FR
(EUCTR)
06/05/200826/02/2008Phase 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 sclerosisPhase 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: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913/F03
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Hoffman La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
200Phase 2Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy