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

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

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
974 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04660539
(ClinicalTrials.gov)
January 11, 202124/11/2020A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)A Multicenter, Single Arm, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Satralizumab in Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica Spectrum DisorderDrug: satralizumab;Drug: azathioprine (AZA);Drug: mycophenolate mofetil (MMF);Drug: oral corticosteroidsHoffmann-La RocheNULLNot yet recruiting18 YearsN/AAll127Phase 3United States;Bulgaria;Canada;Croatia;Germany;Hungary;Italy;Japan;Korea, Republic of;Malaysia;Poland;Puerto Rico;Romania;Spain;Taiwan;Turkey;Ukraine;United Kingdom
2NCT03807973
(ClinicalTrials.gov)
December 30, 202014/1/2019Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.Tracking Peripheral Immune Cell Infiltration of the Brain in Central Inflammatory Disorders Using [Zr-89]Oxinate-4-labeled Leukocytes.Fibromyalgia;Chronic Fatigue Syndrome;Multiple Sclerosis;HealthyDrug: [Zr-89]Oxine-labeled leukocytes PET/MRUniversity of Alabama at BirminghamNULLNot yet recruiting18 Years65 YearsAll120Phase 1NULL
3NCT04586023
(ClinicalTrials.gov)
December 26, 20208/10/2020Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: teriflunomide;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years55 YearsAll734Phase 3United States
4NCT04586010
(ClinicalTrials.gov)
December 18, 20208/10/2020A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS)A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: teriflunomide;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years55 YearsAll734Phase 3United States
5NCT04667117
(ClinicalTrials.gov)
December 17, 20208/12/2020A Multicenter Study to Assess Response to Influenza Vaccine in Multiple Sclerosis Participants Treated With OfatumumabAn Open-label Multicenter Study to Assess Response to Influenza Vaccine in Participants With Multiple Sclerosis Treated With Ofatumumab 20 mg SubcutaneouslyRelapsing Multiple SclerosisBiological: Quadrivalent influenza vaccine;Drug: OfatumumabNovartis PharmaceuticalsNULLNot yet recruiting18 Years55 YearsAll66Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2019-003919-53-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
7NCT04544436
(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
8NCT04548999
(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
9NCT04578639
(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
10NCT04150549
(ClinicalTrials.gov)
November 202011/10/2019FMT for MS PatientsFecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized TrialMultiple SclerosisBiological: Fecal Microbial TransplantsLawson Health Research InstituteNULLNot yet recruiting18 Years55 YearsAll34Phase 2NULL
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-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
12NCT04544449
(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
13EUCTR2020-000893-69-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
14NCT04626921
(ClinicalTrials.gov)
October 22, 202030/10/2020A Multi-Center, Open-Label Long-Term Extension Study of CNM-Au8 In Patients With Stable Relapsing Multiple SclerosisVISIONARY-MS LTE: A Multi-Center, Open-Label Long-Term Extension Study Assessing the Safety, Efficacy, Tolerability, and Pharmacokinetics of CNM-Au8 In Patients With Stable Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: CNM-Au8Clene NanomedicineGeorge ClinicalEnrolling by invitation18 Years55 YearsAll150Phase 2/Phase 3Australia
15EUCTR2019-001829-26-DE
(EUCTR)
19/10/202008/01/2020A Trial to Evaluate the Safety and Activity of Eculizumab in PediatricPatients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Soliris
Product Name: Soliris
Product Code: Soliris
INN or Proposed INN: ECULIZUMAB
Other descriptive name: h5G1.1-mAb
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Phase 2;Phase 3United States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2020-000893-69-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
17EUCTR2020-000894-26-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
18EUCTR2020-000893-69-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
19EUCTR2020-000894-26-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
20EUCTR2020-000894-26-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2020-000893-69-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
22NCT04561557
(ClinicalTrials.gov)
September 22, 202010/9/2020Safety and Efficacy of CT103A Cells for Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous SystemAn Open Label Clinical Trial to Evaluate the Safety and Efficacy of CT103A Cells for the Treatment of Relapsed/Refractory Antibody-associated Idiopathic Inflammatory Diseases of the Nervous SystemAutoimmune Diseases;Autoimmune Diseases of the Nervous System;Neuromyelitis Optica Spectrum DisorderBiological: CT103A cells;Drug: Cyclophosphamide and fludarabineTongji HospitalNULLRecruiting18 Years65 YearsAll12Early Phase 1China
23EUCTR2020-000894-26-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
24NCT04528121
(ClinicalTrials.gov)
September 15, 202022/8/2020Effect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple SclerosisEffect of CoDuSe Balance Training and Step Square Exercises on Risk of Fall in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingOther: CoDuSe balance training and step square exercises;Other: conventional balance trainingLama Saad El-Din MahmoudNULLRecruiting20 Years40 YearsAll52N/AEgypt
25EUCTR2019-001341-40-AT
(EUCTR)
10/09/202007/07/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2019-003625-16-HR
(EUCTR)
26/08/202012/11/2020An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple SclerosisAn Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis 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: Ublituximab
Product Code: TG-1101
INN or Proposed INN: UBLITUXIMAB
Other descriptive name: LFB-R603, TGTX1101
TG Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Belarus;Poland;Ukraine;Romania;Croatia;Russian Federation;Georgia
27NCT04510220
(ClinicalTrials.gov)
August 202031/7/20209-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple SclerosisOpen-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: Ofatumumab;Drug: [F-18]PBR06Brigham and Women's HospitalNovartisNot yet recruiting18 Years60 YearsAll10Phase 3United States
28NCT04377555
(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
29NCT04353492
(ClinicalTrials.gov)
July 14, 202016/4/2020An Open-label Study Evaluating Ofatumumab Treatment Effectiveness and PROs in Subjects With RMS Transitioning From Dimethyl Fumarate or Fingolimod to OfatumumabA Single-arm, Prospective, Multicentre, Open-label Study to Evaluate Ofatumumab Treatment Effectiveness and Patient Reported Outcomes in Patients With Relapsing Multiple Sclerosis Transitioning From Dimethyl Fumarate or Fingolimod TherapyRelapsing Multiple SclerosisBiological: OfatumumabNovartis PharmaceuticalsNULLRecruiting18 Years60 YearsAll550Phase 3United States;Australia;Belgium;Bulgaria;Czechia;Germany;Greece;Hungary;Portugal;Russian Federation;Slovakia;Spain;Turkey
30EUCTR2019-001341-40-PT
(EUCTR)
15/06/202031/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Austria;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2019-001341-40-BG
(EUCTR)
12/06/202007/05/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
32EUCTR2019-003352-37-NL
(EUCTR)
11/06/202024/02/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
33EUCTR2019-001341-40-GR
(EUCTR)
20/05/202010/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
34EUCTR2019-003352-37-DE
(EUCTR)
11/05/202006/01/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of
35EUCTR2019-001341-40-CZ
(EUCTR)
07/05/202011/02/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2019-001341-40-BE
(EUCTR)
29/04/202017/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
37EUCTR2019-001341-40-HU
(EUCTR)
29/04/202011/03/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
38EUCTR2019-001341-40-ES
(EUCTR)
24/04/202007/05/2020An open-label study evaluating ofatumumab treatment effectiveness and PROs in subjects with RMS transitioning from dimethyl fumarate or fingolimod to ofatumumabA single-arm, prospective, multicentre, open-label study to evaluate ofatumumab treatment effectiveness and patient-reported outcomes in patients with relapsing multiple sclerosis transitioning from dimethyl fumarate or fingolimod therapy - ARTIOS Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Farmacéutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Bulgaria;Germany;Norway
39EUCTR2019-003352-37-AT
(EUCTR)
27/03/202013/02/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Australia;Denmark;Germany;Netherlands;Japan;Korea, Republic of
40EUCTR2017-001313-93-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
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-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
42EUCTR2018-001511-73-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
43EUCTR2018-003008-38-DE
(EUCTR)
10/03/202006/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
44EUCTR2016-002667-34-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
45EUCTR2018-001511-73-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2019-003352-37-ES
(EUCTR)
25/02/202014/01/2020Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
47NCT04291456
(ClinicalTrials.gov)
January 31, 202018/11/2019Minocycline in MS: Confirmation of BenefitOpen-Label Trial of Minocycline in Early Multiple Sclerosis: Confirmation of Treatment BenefitMultiple Sclerosis;Clinically Isolated SyndromeDrug: Minocycline 100mgUniversity of CalgaryHotchkiss Brain Institute, University of CalgaryRecruiting18 Years60 YearsAll148Phase 3Canada
48NCT04140305
(ClinicalTrials.gov)
January 16, 202024/10/2019Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)A Multicenter, Longitudinal, Open-Label, Single-Arm Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)Multiple SclerosisDrug: RPC-1063CelgeneNULLRecruiting18 Years65 YearsAll250Phase 3United States;Canada;Puerto Rico
49EUCTR2019-003352-37-DK
(EUCTR)
15/01/202019/12/2019Clinical study testing the efficacy and safety of Ravulizumab in adults with NMOSD.A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients with Neuromyelitis Optica Spectrum Disorder (NMOSD) - A Phase 3 Efficacy and Safety Study of Ravulizumab in Adult Patients with NMOSD Neuromyelitis Optica Spectrum Disorder
MedDRA version: 21.1;Level: PT;Classification code 10077875;Term: Neuromyelitis optica spectrum disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Trade Name: Ultomiris
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 3United States;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
50NCT04155424
(ClinicalTrials.gov)
January 14, 20205/11/2019A Study of the Safety and Activity of Eculizumab in Pediatric Participants With Relapsing Neuromyelitis Optica Spectrum DisorderA Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients With Relapsing Neuromyelitis Optica Spectrum DisorderNeuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: EculizumabAlexion PharmaceuticalsNULLRecruiting2 Years17 YearsAll15Phase 2/Phase 3United States;Japan;Korea, Republic of;Spain;Canada;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT04075266
(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
52EUCTR2018-001511-73-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
53NCT03993171
(ClinicalTrials.gov)
December 19, 201931/5/201931P-MRS Imaging to Assess the Effects of CNM-Au8 on Impaired Neuronal Redox State in Multiple Sclerosis.A Phase 2, Open-Label, Sequential Group, Investigator Blinded Study of Magnetic Resonance Spectroscopy (31P-MRS) to Assess the Effects of CNM-Au8 for the Bioenergetic Improvement of Impaired Neuronal Redox State in Multiple Sclerosis.Relapsing Remitting Multiple SclerosisDrug: gold nanocrystalsClene NanomedicineUniversity of Texas Southwestern Medical CenterRecruiting18 Years55 YearsAll30Phase 2United States
54EUCTR2018-001511-73-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
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;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
55EUCTR2019-001829-26-ES
(EUCTR)
18/12/201906/11/2019 A Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder (NMOSD)A Phase 2/3 Open-Label, Single-Arm Trial to Evaluate the Safety and Activity of Eculizumab in Pediatric Patients with Relapsing Neuromyelitis Optica Spectrum Disorder Neuromyelitis Optica Spectrum Disorder (NMOSD)
MedDRA version: 21.1;Level: LLT;Classification code 10077879;Term: Neuromyelitis optica spectrum disorder relapse;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Alexion Pharmaceuticals Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Spain;Germany;Japan;Italy;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2018-001511-73-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
57NCT04201262
(ClinicalTrials.gov)
December 13, 201911/12/2019An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSDA Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderBiological: RavulizumabAlexion PharmaceuticalsNULLRecruiting18 YearsN/AAll55Phase 3United States;Australia;Austria;Canada;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Poland;Spain
58EUCTR2018-003008-38-HR
(EUCTR)
10/12/201917/01/2020A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
59NCT04130997
(ClinicalTrials.gov)
November 18, 201916/10/2019An Open Label Extension Study of Ublituximab in Subjects With Relapsing Multiple SclerosisTG1101-RMS303 is an Open-label, Single-arm Extension Study Designed to Evaluate Long-term Safety and Efficacy of Ublituximab in Subjects With Relapsing Multiple Sclerosis. Subjects Who Complete the 96-week, Double-blind Treatment Period o TG1101-RMS301 or TG1101-RMS302 Are Eligible for Participation in This Open Label Extension (OLE) Study.Relapsing Multiple Sclerosis (RMS)Biological: UblituximabTG Therapeutics, Inc.NULLEnrolling by invitation18 YearsN/AAll1000Phase 3United States;Belarus;Croatia;Georgia;Poland;Russian Federation;Serbia;Ukraine
60NCT04171310
(ClinicalTrials.gov)
November 13, 201919/11/2019Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male SubjectsAn Open-label Study of Excretion Balance and Pharmacokinetics Following a Single Oral Dose of [14C]-SAR442168 (Not More Than 3.7 MBq) in Healthy Male SubjectsMultiple SclerosisDrug: SAR442168SanofiNULLCompleted30 Years65 YearsMale6Phase 1United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT03958877
(ClinicalTrials.gov)
October 18, 201920/5/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label ExtensionMultiple Sclerosis, Relapsing-RemittingDrug: BIIB017 (peginterferon beta-1a);Drug: Interferon beta type 1aBiogenNULLRecruiting10 Years18 YearsAll142Phase 3United States;Argentina;Australia;Belgium;Bulgaria;Croatia;Czechia;France;Germany;Greece;Hungary;Israel;Italy;Kuwait;Portugal;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Tunisia;Turkey
62NCT04121403
(ClinicalTrials.gov)
October 16, 201923/9/2019Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS)Norwegian Study of Oral Cladribine and Rituximab in Multiple Sclerosis (NOR-MS) A Prospective Randomized Open-label Blinded Endpoint (PROBE) Multicenter Non-inferiority StudyRelapsing Multiple Sclerosis;Multiple SclerosisBiological: Rituximab;Drug: CladribineOslo University HospitalUniversity of Oslo;Göteborg University;Sykehuset Ostfold;Sykehuset Telemark;Vestre Viken Hospital Trust;Sorlandet Hospital HF;Helse Stavanger HF;Sykehuset Innlandet HF;Sykehuset i Vestfold HF;Helse Forde;University Hospital of North Norway;St. Olavs HospitalRecruiting18 Years65 YearsAll264Phase 3Norway
63JPRN-JapicCTI-205119
15/10/201920/01/2020A compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patientsA compassionate use study of satralizumab in neuromyelitis optica spectrum disorders.(NMOSD) patients neuromyelitis optica(NMO), neuromyelitis optica spectrum disorders (NMOSD)Intervention name : SA237
INN of the intervention : satralizumab
Dosage And administration of the intervention : 120 mg subcutaneously at Weeks 0, 2 and 4 and every 4 weeks thereafter
Control intervention name : -
INN of the control intervention : -
Dosage And administration of the control intervention : -
Chugai Pharmaceutical Co., Ltd.F. Hoffmann-La Roche Ltdcomplete1274BOTH30NAJapan
64EUCTR2018-001511-73-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
65EUCTR2018-001511-73-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2018-003008-38-PT
(EUCTR)
02/09/201902/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Kuwait;Germany
67EUCTR2018-001511-73-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
1000 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;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
68NCT04035005
(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
69NCT03972306
(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
70EUCTR2019-001505-24-NO
(EUCTR)
25/07/201928/05/2019A Clinical Study Comparing Rituximab and Cladribine for Relapsing Multiple SclerosisNorwegian study of Oral cladribine versus Rituximab in Multiple Sclerosis (NOR-MS). A prospective randomized open-label blinded endpoint (PROBE) multicenter non-inferiority study. - NOR-MS Relapsing Multiple Sclerosis (RMS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Department of Neurology, Division of Clinical Neuroscience, Oslo University HospitalNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
264 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noNorway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2018-003008-38-BE
(EUCTR)
17/07/201919/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
72EUCTR2018-003008-38-BG
(EUCTR)
10/07/201905/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a, 30 µg/0.5 ml
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a, 30 µg/0.5 ml
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
73EUCTR2018-003008-38-GR
(EUCTR)
27/06/201903/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
74EUCTR2018-003008-38-SK
(EUCTR)
24/06/201926/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
75EUCTR2017-004703-51-GB
(EUCTR)
18/06/201915/10/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2017-004703-51-BE
(EUCTR)
17/06/201915/01/2019Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
77EUCTR2018-003008-38-HU
(EUCTR)
30/05/201908/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Germany;Tunisia
78EUCTR2017-004703-51-HR
(EUCTR)
06/05/201903/06/2019 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
79EUCTR2017-004703-51-GR
(EUCTR)
24/04/201927/03/2019 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
80EUCTR2018-003008-38-ES
(EUCTR)
02/04/201917/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Kuwait;Tunisia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2017-004703-51-NL
(EUCTR)
29/03/201916/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
82EUCTR2017-004703-51-LV
(EUCTR)
28/03/201924/01/2019 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
83EUCTR2018-002145-11-GB
(EUCTR)
21/03/201911/10/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329 Relapsing-remitting multiple sclerosis (RRMS)
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: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom
84EUCTR2017-004703-51-PT
(EUCTR)
18/03/201924/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
85EUCTR2018-002145-11-NL
(EUCTR)
14/03/201905/11/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration Relapsing-remitting multiple sclerosis (RRMS)
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: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT03799718
(ClinicalTrials.gov)
March 13, 20197/1/2019Safety and Efficacy of Repeated Administration of NurOwn (MSC-NTF Cells) in Participants With Progressive MSA Phase 2 Open-label Multicenter Study to Evaluate the Safety and Efficacy of Repeated Administration of NurOwn® [Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors (NTF), MSC-NTF] Cells in Participants With Progressive MSMultiple Sclerosis, Chronic ProgressiveBiological: NurOwn (MSC-NTF cells)Brainstorm-Cell TherapeuticsNULLActive, not recruiting18 Years65 YearsAll20Phase 2United States
87EUCTR2018-002145-11-FR
(EUCTR)
08/03/201931/10/2018 A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID TreatmentA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - NOVA Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
88EUCTR2017-004703-51-LT
(EUCTR)
19/02/201903/12/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
89EUCTR2018-002145-11-DE
(EUCTR)
15/02/201917/10/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration Relapsing-remitting multiple sclerosis (RRMS)
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: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;New Zealand;Italy
90NCT03623243
(ClinicalTrials.gov)
February 14, 20197/8/2018Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Advancing RMS Patients.Exploring the Safety and Tolerability of Conversion From Oral, Injectable, or Infusion Disease Modifying Therapies to Dose-titrated Oral Siponimod (Mayzent) in Patients With Advancing Forms of Relapsing Multiple Sclerosis: A 6-month Open Label, Multi- Center Phase IIIb StudyMultiple Sclerosis, Relapsing MS, Advancing Multiple SclerosisDrug: SiponimodNovartis PharmaceuticalsNULLRecruiting18 Years65 YearsAll400Phase 3United States;Puerto Rico
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT03825601
(ClinicalTrials.gov)
February 1, 201921/1/2019PET With [18F]Flumazenil as an Index of Neurodegeneration in MSPET With [18F]Flumazenil as an Index of Neurodegeneration in MS: Sensitivity at an Early Disease Stage and Pathophysiological MeaningMultiple Sclerosis;Relapsing-Remitting Multiple SclerosisDiagnostic Test: PET with [11C]FlumazenilInstitut National de la Santé Et de la Recherche Médicale, FranceNULLNot yet recruiting18 Years55 YearsAll45N/ANULL
92NCT03696485
(ClinicalTrials.gov)
February 1, 201930/9/2018Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMSA Prospective, Single Center, Open Label, Dose Escalation Phase I/IIa Study to Assess the Safety and Efficacy of an Intrathecal Administration of SCM-010 in Subjects With Secondary Progressive Multiple Sclerosis (SPMS)Secondary Progressive Multiple Sclerosis (SPMS)Biological: SCM-010Stem Cell Medicine Ltd.NULLNot yet recruiting18 Years60 YearsAll12Phase 1/Phase 2Israel
93NCT03784547
(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
94EUCTR2017-004703-51-ES
(EUCTR)
31/01/201925/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Farmacéutica, S.ANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
95EUCTR2017-004702-17-PL
(EUCTR)
25/01/201917/10/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2017-004703-51-FR
(EUCTR)
18/01/201922/10/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
97EUCTR2017-004703-51-DK
(EUCTR)
18/01/201911/12/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
98EUCTR2017-004886-29-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
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
99EUCTR2017-004703-51-DE
(EUCTR)
10/01/201927/09/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
100EUCTR2017-004703-51-FI
(EUCTR)
02/01/201911/12/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2018-002145-11-ES
(EUCTR)
02/01/201905/11/2018A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID TreatmentA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom
102NCT03650114
(ClinicalTrials.gov)
December 28, 201817/8/2018Long-term Safety, Tolerability and Effectiveness Study of Ofatumumab in Patients With Relapsing MSAn Open-label, Single Arm, Multi-center Extension Study Evaluating Long-term Safety, Tolerability and Effectiveness of Ofatumumab in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisBiological: Ofatumumab;Biological: Tetanus toxoid (TT) containing vaccine (Td, Tdap);Biological: 13-valent pneumococcal conjugate vaccine (13-PCV);Biological: 23-valent pneumococcal polysaccharide vaccine (23-PPV);Biological: Seasonal Quadrivalent influenza vaccine;Biological: Keyhole limpet hemocyanin (KLH) neo-antigenNovartis PharmaceuticalsNULLRecruiting18 YearsN/AAll2010Phase 3United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;India;Israel;Japan;Latvia;Lithuania;Mexico;Netherlands;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Sweden;Switzerland;Taiwan;Thailand;Turkey;United Kingdom
103NCT03689972
(ClinicalTrials.gov)
December 26, 201827/9/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment- Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab AdministrationMultiple Sclerosis, Relapsing-RemittingDrug: NatalizumabBiogenNULLActive, not recruiting18 Years60 YearsAll500Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom
104EUCTR2017-004703-51-SE
(EUCTR)
17/12/201815/11/2018 Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosis An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2233 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
105EUCTR2017-004702-17-ES
(EUCTR)
12/12/201817/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Novartis Farmacéutica, S.A.NULLNot Recruiting Female: yes
Male: yes
284 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Estonia;Czech Republic;Poland;Spain;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2017-004702-17-BG
(EUCTR)
03/12/201823/10/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
107NCT03944447
(ClinicalTrials.gov)
December 1, 20183/5/2019Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19Chronic Pain;Chronic Pain Syndrome;Chronic Pain Due to Injury;Chronic Pain Due to Trauma;Fibromyalgia;Seizures;Hepatitis C;Cancer;Crohn Disease;HIV/AIDS;Multiple Sclerosis;Traumatic Brain Injury;Sickle Cell Disease;Post Traumatic Stress Disorder;Tourette Syndrome;Ulcerative Colitis;Glaucoma;Epilepsy;Inflammatory Bowel Diseases;Parkinson Disease;Amyotrophic Lateral Sclerosis;Chronic Traumatic Encephalopathy;Anxiety;Depression;Insomnia;Autism;Opioid-use Disorder;Bipolar Disorder;Covid19;SARS-CoV Infection;COVID-19;Corona Virus Infection;CoronavirusDrug: Cannabis, MedicalOMNI Medical Services, LLCOMNI Medical Services IncRecruiting7 YearsN/AAll200000Phase 2United States
108EUCTR2017-004703-51-HU
(EUCTR)
29/11/201811/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
109EUCTR2017-004703-51-AT
(EUCTR)
28/11/201817/10/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3United States;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;Peru;South Africa;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Norway;Japan;Sweden
110EUCTR2017-004703-51-SK
(EUCTR)
21/11/201828/09/2018Long-term safety, tolerability and effectiveness study of ofatumumab in subjects with relapsing multiple sclerosisAn open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2233Phase 3Portugal;United States;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Italy;Switzerland;India;France;Peru;Australia;Denmark;South Africa;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Norway;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT03691077
(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
112EUCTR2017-004702-17-IT
(EUCTR)
07/11/201804/11/2020A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients - ND Multiple sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10028053;Term: MS;System Organ Class: 10029205 - Nervous system disorders
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]
Trade Name: FORMISTIN - 10 MG COMPRESSE RIVESTITE CON FILM 20 COMPRESSE
Product Name: Formistin 10 mg
Product Code: [Formistin 10 mg]
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [Tachipirina CPR 500mg]
Other descriptive name: paracetamolo 500 mg
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: Solumedrol IM 125mg/2ml
Product Code: [Metilprednisolone]
Other descriptive name: Metilprednisolone sodio succinato
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: Ofatumumab
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: [OMB157]
INN or Proposed INN: Ofatumumab
Other descriptive name: OFATUMUMAB
NOVARTIS PHARMA AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Czechia;Estonia;Spain;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Poland;Bulgaria;Germany;Latvia
113NCT03593590
(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
114EUCTR2017-004702-17-LV
(EUCTR)
02/11/201803/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Germany;Latvia;Italy
115EUCTR2017-004702-17-LT
(EUCTR)
31/10/201817/09/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2017-004702-17-CZ
(EUCTR)
23/10/201816/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
117EUCTR2017-004702-17-EE
(EUCTR)
17/09/201828/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Czech Republic;Estonia;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
118NCT03606460
(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
119NCT03560739
(ClinicalTrials.gov)
September 11, 201815/5/2018A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS PatientsA 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS PatientsMultiple SclerosisCombination Product: ofatumumab with PRF;Combination Product: ofatumumab with AINovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll284Phase 2United States;Austria;Bulgaria;Czechia;Estonia;Latvia;Lithuania;Russian Federation;Spain
120EUCTR2017-004886-29-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121EUCTR2017-004702-17-AT
(EUCTR)
01/09/201810/08/2018A 12 week study to evaluate bioequivalence of ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients.A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients Multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Trade Name: Arzerra
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
284Phase 2United States;Estonia;Czech Republic;Spain;Poland;Lithuania;Austria;Russian Federation;Bulgaria;Latvia;Germany;Italy
122EUCTR2014-000253-36-NL
(EUCTR)
30/08/201816/04/2018A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersA Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: Inebilizumab
MedImmune LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2;Phase 3Serbia;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;India;Peru;Australia;South Africa;Netherlands;China;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;New Zealand;Japan
123EUCTR2017-004886-29-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
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
124NCT03589105
(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
125EUCTR2017-004886-29-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
126NCT03567057
(ClinicalTrials.gov)
July 18, 201822/5/2018A Safety and Efficacy Study of ADS-5102 in Patients With Multiple Sclerosis and Walking ImpairmentA Multicenter, Open-Label Safety and Efficacy Study of ADS-5102 Amantadine Extended Release Capsules in Patients With Multiple Sclerosis and Walking ImpairmentMultiple Sclerosis;Walking ImpairmentDrug: ADS-5102Adamas Pharmaceuticals, Inc.NULLActive, not recruiting18 Years70 YearsAll540Phase 3United States;Canada
127NCT03599245
(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
128EUCTR2017-001313-93-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
900 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPanama;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
129EUCTR2017-004886-29-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
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
130EUCTR2017-004886-29-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2017-001313-93-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
132EUCTR2017-004886-29-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
133EUCTR2017-004886-29-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
134EUCTR2017-001313-93-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
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited 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
135EUCTR2017-004886-29-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
136NCT03552211
(ClinicalTrials.gov)
May 30, 201825/4/2018Evaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple SclerosisEvaluation of the Incidence of Relapses in Patients With Biotin-treated Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: biotin;Other: propensity scoreUniversity Hospital, Clermont-FerrandOFSEP (Observatoire Français de la Sclérose en Plaques);SFSEP (Société Francophone de la Sclérose en Plaques);MedDay Pharmaceuticals SAUnknown status18 Years80 YearsAll3000France
137NCT03523858
(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
138EUCTR2017-004886-29-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
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden
139EUCTR2017-001313-93-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
140EUCTR2017-001313-93-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03585569
(ClinicalTrials.gov)
May 1, 201816/3/2018 Treating MS Patients With Lower Extremity Spasticity Using DysportA Prospective, Open Label, Single Center Study of Patients With Multiple Sclerosis With Lower Extremity Spasticity Who Are Treated With DysportMultiple Sclerosis;Spasticity, MuscleBiological: Abobotulinumtoxin ANeurology Center of New England P.C.IpsenUnknown statusN/AN/AAll30Phase 3United States
142EUCTR2017-004101-40-HR
(EUCTR)
27/04/201816/05/2019Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Serbia;Belarus;United States;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
143EUCTR2017-001313-93-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
144NCT03319732
(ClinicalTrials.gov)
April 3, 201813/10/2017A Study to Evaluate the Long-term Safety of Arbaclofen Extended-Release Tablets for Patients With Spasticity Due to MSAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients With Spasticity (Study OS440-3005)Multiple Sclerosis;Spasticity, MuscleDrug: ArbaclofenOsmotica Pharmaceutical US LLCNULLActive, not recruiting18 Years65 YearsAll323Phase 3United States
145EUCTR2017-004101-40-BG
(EUCTR)
23/03/201809/01/2018Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;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
146EUCTR2017-004101-40-PL
(EUCTR)
21/03/201812/02/2018Long-Term Study of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with SpasticityAn Open-Label Study to Evaluate the Long-Term Safety of Arbaclofen Extended-Release Tablets in Multiple Sclerosis Patients with Spasticity (Study OS440-3005). Spasticity in patients with multiple sclerosis
MedDRA version: 20.0;Level: LLT;Classification code 10041416;Term: Spasticity;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Arbaclofen Extended Release Tablets
Product Code: OS440
INN or Proposed INN: Arbaclofen
Other descriptive name: AERT, (R)-Baclofen
Osmotica Pharmaceutical US LLCNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Serbia;Belarus;Poland;Ukraine;Croatia;Russian Federation;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
147JPRN-JapicCTI-173711
15/3/201814/09/2017Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label OfatumumabA 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label Ofatumumab Relapsing Multiple SclerosisIntervention name : Ofatumumab
INN of the intervention : -
Dosage And administration of the intervention : Ofatumumab 20 mg subcutaneous injections every 4 weeks
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : Placebo subcutaneous injection matching to ofatumumab every 4 weeks
Novartis Pharma K.K.NULLcomplete1855BOTH30Phase 2Japan, Russia
148NCT03249714
(ClinicalTrials.gov)
March 15, 201811/8/2017Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label OfatumumabA 24-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Ofatumumab in Patients With Relapsing Multiple Sclerosis Followed by an Extended Treatment of at Least 24 Weeks With Open-label OfatumumabRelapsing Multiple SclerosisDrug: Ofatumumab subcutaneous injection;Drug: Placebo subcutaneous injection matching ofatumumabNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll64Phase 2Japan;Russian Federation
149NCT03551275
(ClinicalTrials.gov)
February 22, 201813/2/2018Dose Escalation Study of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 in Patients With Relapsing-Remitting Multiple SclerosisA Multicenter Open-Label Non-Comparative Dose Escalation Study (Phase 1) of the Pharmacodynamics, Pharmacokinetics, Safety, and Immunogenicity of BCD-132 (JSC BIOCAD, Russia) in Patients With Relapsing-Remitting Multiple SclerosisMultiple SclerosisBiological: BCD-132BiocadNULLUnknown status18 Years60 YearsAll48Phase 1Russian Federation
150EUCTR2017-001224-22-DE
(EUCTR)
23/01/201828/07/2017Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing 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 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;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
151EUCTR2017-001224-22-NL
(EUCTR)
11/01/201812/09/2017Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS Multiple Sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10067063;Term: Progressive relapsing 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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Opicinumab
Product Code: BIIB033
INN or Proposed INN: Opicinumab
Other descriptive name: BIIB033 (ANTI-LINGO)
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Spain;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Australia;Netherlands;Germany;Sweden
152EUCTR2017-001224-22-GB
(EUCTR)
28/12/201712/07/2017Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing 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 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden
153EUCTR2017-001224-22-CZ
(EUCTR)
19/12/201714/08/2017Efficacy and Safety of BIIB033 as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying Therapies - Efficacy and Safety of BIIB033 as an Add-on Therapy to DMTs in RMS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10067063;Term: Progressive relapsing 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 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Netherlands;Germany;Sweden
154NCT03362294
(ClinicalTrials.gov)
December 11, 201715/11/2017Safety and Efficacy of Monthly Long-acting IM Injection of 40 mg GA Depot in Subjects With PPMSA Prospective, Multicenter, Single Arm, Open Label, Phase IIa Study to Assess the Safety and Efficacy of Once-a-month Long-acting Intramuscular Injection of 40mg Glatiramer Acetate (GA Depot) in Subjects With Primary Progressive Multiple Sclerosis (PPMS)Primary Progressive Multiple SclerosisDrug: GA Depot 40mg once monthlyMapi Pharma Ltd.NULLRecruiting18 Years65 YearsAll24Phase 2Israel
155EUCTR2016-003100-30-DE
(EUCTR)
29/11/201707/03/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;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
156EUCTR2016-002937-31-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
157NCT03222973
(ClinicalTrials.gov)
November 14, 201717/7/2017Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With Optional Open-Label Extension in Subjects With Relapsing Multiple Sclerosis to Evaluate the Efficacy and Safety of BIIB033 as an Add-On Therapy to Anti-Inflammatory Disease-Modifying TherapiesMultiple SclerosisDrug: BIIB033 (opicinumab);Drug: PlaceboBiogenNULLActive, not recruiting18 Years58 YearsAll263Phase 2United States;Australia;Belgium;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom
158NCT03350633
(ClinicalTrials.gov)
November 1, 201710/11/2017Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum DisordersSafety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 TrialNeuromyelitis Optica Spectrum Disorders;Neuromyelitis OpticaDrug: Tocilizumab Injection;Drug: AzathioprineTianjin Medical University General HospitalNULLCompleted18 YearsN/AAll118Phase 2/Phase 3China
159EUCTR2016-003100-30-GR
(EUCTR)
27/10/201721/04/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) 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]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway;Sweden
160NCT03368664
(ClinicalTrials.gov)
October 24, 20172/11/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients With RRMS With Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Paediatric Patients With Relapsing Remitting Multiple Sclerosis (RRMS) With Disease Activity on Prior Disease Modifying Therapy (DMT)Multiple SclerosisDrug: Alemtuzumab GZ402673;Drug: Glatiramer acetate;Drug: Beta-Interferon;Drug: Methylprednisolone;Drug: Ranitidine;Drug: Ceterizine;Drug: Dexchlorpheniramine;Drug: Paracetamol;Drug: Acyclovir;Drug: Prednisolone;Drug: Diphenydramine;Drug: Other H1 antagonistGenzyme, a Sanofi CompanyNULLActive, not recruiting10 Years17 YearsAll50Phase 3Austria;Belgium;Bulgaria;Czechia;France;Germany;Greece;Italy;Netherlands;Poland;Portugal;Russian Federation;Spain;Turkey;United Kingdom;Norway;Switzerland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT03283826
(ClinicalTrials.gov)
October 19, 201713/9/2017Phase 1 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple SclerosisA Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisBiological: ATA188;Drug: PlaceboAtara BiotherapeuticsNULLRecruiting18 Years55 YearsAll97Phase 1United States;Australia
162EUCTR2015-005431-41-PL
(EUCTR)
16/10/201707/04/2016A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Ukraine;Turkey;Russian Federation;Italy;Canada;Poland;Malaysia;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
163EUCTR2016-003100-30-NO
(EUCTR)
12/10/201712/04/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Netherlands;Norway;Germany;Sweden
164EUCTR2016-003100-30-NL
(EUCTR)
28/09/201711/05/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Poland;Bulgaria;Netherlands;Germany;Norway;Sweden
165NCT03257358
(ClinicalTrials.gov)
September 19, 201718/8/2017A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg FingolimodA 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]Relapsing Multiple SclerosisDrug: FingolimodNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll382Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2016-002937-31-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
167EUCTR2016-002937-31-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
168EUCTR2016-002937-31-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
169EUCTR2016-003100-30-PT
(EUCTR)
28/08/201704/05/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) 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]
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
170NCT03183869
(ClinicalTrials.gov)
August 24, 20179/5/2017Fecal Microbial Transplantation in Relapsing Multiple Sclerosis PatientsFecal Microbial Transplantation in Relapsing Multiple Sclerosis PatientsAutoimmune Diseases;Relapsing Multiple SclerosisDrug: Fecal microbiotaLawson Health Research InstituteNULLTerminated18 YearsN/AAll14Phase 2Canada
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2016-002937-31-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
1228 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
172EUCTR2016-003100-30-AT
(EUCTR)
03/08/201710/08/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) 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]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
173EUCTR2016-002937-31-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
174EUCTR2016-002937-31-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
175EUCTR2016-002937-31-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2016-002937-31-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
177EUCTR2016-003100-30-BE
(EUCTR)
14/07/201722/05/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) 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]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;Switzerland;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
178EUCTR2016-002937-31-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
179EUCTR2016-002937-31-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
180EUCTR2016-002937-31-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2016-002820-10-DE
(EUCTR)
26/06/201708/11/2016Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) Remitting-Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Zinbryta
Product Name: Daclizumab
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: DAC HYP
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Canada;Germany;Italy;United Kingdom
182EUCTR2016-002937-31-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
183EUCTR2016-002937-31-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
184EUCTR2016-002937-31-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
185EUCTR2016-002937-31-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
1228 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2016-002937-31-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
187NCT03239860
(ClinicalTrials.gov)
June 6, 201712/7/2017Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple SclerosisA Long-Term International, Extension of Study GNC-003 With GNbAC1 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GNbAC1 Monoclonal AntibodyGeNeuro SALes Laboratoires Servier;Worldwide Clinical Trials;Institut de Recherches Internationales ServierTerminated18 Years55 YearsAll220Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
188EUCTR2016-003100-30-GB
(EUCTR)
05/06/201727/03/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) 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]
Trade Name: Lemtrada
Product Name: Lemtrada
Product Code: GZ402673
INN or Proposed INN: alemtuzumab
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
65Phase 3Portugal;Greece;Spain;Turkey;Austria;Russian Federation;United Kingdom;Switzerland;Italy;France;Belgium;Poland;Bulgaria;Germany;Netherlands;Norway
189EUCTR2015-002500-91-SE
(EUCTR)
01/06/201727/06/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2495Phase 3Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia
190NCT03381170
(ClinicalTrials.gov)
June 1, 201718/12/2017An Extension of the TG1101-RMS201 TrialAn Open Label Extension of the TG1101-RMS201 Trial, for Subjects Currently Enrolled in TG1101-RMS201Treated With Ublituximab for Relapsing Forms of Multiple SclerosisRelapsing Remitting Multiple SclerosisBiological: UblituximabTG Therapeutics, Inc.NULLActive, not recruiting18 Years55 YearsAll48Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2016-003587-39-SE
(EUCTR)
22/05/201723/03/2017This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3700Phase 4Sweden
192EUCTR2011-005249-12-SI
(EUCTR)
15/05/201713/03/2017Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
165 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;France;Macedonia, the former Yugoslav Republic of;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland;Bulgaria
193EUCTR2016-001448-21-PL
(EUCTR)
09/05/201713/01/2017A Study of Efficacy and Safety of M2951 in Relapsing Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. Relapsing Multiple Sclerosis
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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: M2951
Product Code: M2951
INN or Proposed INN: M2951
Other descriptive name: M2951
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 2United States;Serbia;Czech Republic;Slovakia;Spain;Poland;Ukraine;Turkey;Croatia;Russian Federation;Bulgaria;United Kingdom
194EUCTR2011-005249-12-PT
(EUCTR)
24/04/201701/02/2017Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS Multiple Sclerosis
MedDRA version: 19.1;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: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Israel;Russian Federation;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland
195NCT02881567
(ClinicalTrials.gov)
April 18, 201724/8/2016Efficacy and Safety of Daclizumab in Participants With RRMS Switching From NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)Relapsing-Remitting Multiple Sclerosis (RRMS)Drug: DaclizumabBiogenAbbVieTerminated18 Years55 YearsAll41Phase 3United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2016-001448-21-BG
(EUCTR)
11/04/201714/02/2017A Study of Efficacy and Safety of M2951 in Relapsing Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. Relapsing Multiple Sclerosis
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 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria
197EUCTR2016-003100-30-IT
(EUCTR)
11/04/201714/05/2019A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) - na 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]
GENZYME CORPORATIONNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
198NCT03085810
(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
199EUCTR2016-003100-30-ES
(EUCTR)
04/04/201722/02/2017A Study to Evaluate Efficacy, Safety, and Tolerability of Alemtuzumab in Pediatric Patients with RRMS with Disease Activity on Prior DMTA Multi-center, Open-label, Single-arm, Before and After Switch Study to Evaluate the Efficacy, Safety and Tolerability of Alemtuzumab in Pediatric Patients with Relapsing Remitting Multiple Sclerosis (RRMS) with Disease Activity on Prior Disease Modifying Therapy (DMT) Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Greece;Spain;Turkey;Austria;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Norway;Netherlands;Germany;Sweden
200EUCTR2014-000253-36-GR
(EUCTR)
31/03/201730/01/2017A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersA Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 19.1;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
MedImmune LLCNULLNot Recruiting Female: yes
Male: yes
212 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Taiwan;Estonia;Hong Kong;Greece;Thailand;Spain;Ukraine;Russian Federation;Israel;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2013-002318-11-FR
(EUCTR)
21/03/201717/06/2015A study on the safety and effectiveness of BG00012 in children from 10 to less than 18 years old with a type of Multiple Sclerosis that is called Relapsing-Remitting Multiple Sclerosis.Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;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: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Serbia;Spain;Ukraine;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Sweden
202EUCTR2011-005249-12-NL
(EUCTR)
15/03/201708/11/2016Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS Multiple Sclerosis
MedDRA version: 19.0;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: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;Serbia;United States;Estonia;Morocco;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina
203EUCTR2016-002820-10-GB
(EUCTR)
13/03/201708/11/2016Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - 205MS305_Biogen Remitting-Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Zinbryta
Product Name: Zinbryta
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: DAC HYP
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Canada;Denmark;Germany;Italy;United Kingdom
204NCT02975349
(ClinicalTrials.gov)
March 7, 201723/11/2016A Study of Efficacy and Safety of M2951 in Subjects With Relapsing Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 With a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients With Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity.Relapsing-remitting Multiple SclerosisDrug: M2951;Drug: Placebo;Drug: TecfideraEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyActive, not recruiting18 Years65 YearsAll267Phase 2Bulgaria;Czechia;Poland;Russian Federation;Serbia;Slovakia;Spain;Ukraine;Germany;United States
205EUCTR2016-001448-21-SK
(EUCTR)
16/02/201725/10/2016A Study of Efficacy and Safety of M2951 in Relapsing Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. Relapsing Multiple Sclerosis
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 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Merck KGaANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206NCT02949908
(ClinicalTrials.gov)
February 9, 201717/10/2016MEasuring Satisfaction of Treatment With REbif After Initial Treatment of Multiple Sclerosis (MS)A Phase IV, Prospective, Multicenter, Open Label, Uncontrolled, Non-interventional, Single Arm Study to Measure Treatment Satisfaction of Multiple Sclerosis (MS) Patients on Rebif® After Discontinuing Initial First-line TreatmentMultiple SclerosisDrug: RebifMerck KGaA, Darmstadt, GermanyMerck B.V., NetherlandsTerminated18 Years65 YearsAll2Phase 4Germany
207EUCTR2016-001448-21-CZ
(EUCTR)
06/02/201701/11/2016A Study of Efficacy and Safety of M2951 in Relapsing Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. Relapsing Multiple Sclerosis
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;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: M2951
Product Code: M2951
Other descriptive name: M2951
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 2Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom
208NCT03062579
(ClinicalTrials.gov)
February 1, 201713/2/2017A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSDSingle-center, Open Label Trial of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active Neuromyelitis Optica Spectrum Disorders (NMOSD)Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica;Devic's DiseaseDrug: TocilizumabFu-Dong ShiNULLCompleted18 YearsN/AAll10Phase 1/Phase 2China
209NCT03177083
(ClinicalTrials.gov)
January 30, 201726/1/2017Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current TherapyOpen-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients With Relapsing Remitting Multiple Sclerosis (MS) Transitioning From Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)Relapsing Remitting Multiple SclerosisDrug: peginterferon beta-1a;Drug: interferon beta-1a;Drug: interferon beta-1bBiogenNULLCompleted18 Years65 YearsAll80Phase 4Portugal
210EUCTR2014-000253-36-HU
(EUCTR)
24/01/201723/11/2016A Clinical Study to test the effect of the drug MEDI-551 in Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisordersA Double-masked, Placebo-controlled Study with Open-label Period to Evaluate the Efficacy and Safety of MEDI-551 in Adult Subjects with Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders. - A Double-masked, Placebo-controlled Study with Open label Period to Evaluate MEDI-551 in NMO/NMOSD Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders (NMO/NMOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: MEDI-551
Product Code: MEDI-551
INN or Proposed INN: Inebilizumab
MedImmune LLCNULLNot RecruitingFemale: yes
Male: yes
252Phase 2;Phase 3United States;Portugal;Serbia;Hong Kong;Estonia;Taiwan;Greece;Spain;Thailand;Ukraine;Israel;Russian Federation;Colombia;Australia;Peru;South Africa;Netherlands;Moldova, Republic of;Korea, Republic of;Turkey;Czech Republic;Hungary;Mexico;Canada;Poland;Bulgaria;Germany;Japan;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211NCT04570670
(ClinicalTrials.gov)
January 6, 201722/9/2020Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy SubjectsA Single-Dose, Randomized, Open-Label, 2-Way Crossover, Comparative Bioavailability Study of BLS-11 (Monomethyl Fumarate) 190 mg and Tecfidera (Dimethyl Fumarate) 240 mg in Healthy Male and Female Subjects Under Fasting ConditionsRelapsing Remitting Multiple SclerosisDrug: monomethyl fumarate 190 mg;Drug: dimethyl fumarate 240 mgBanner Life Sciences LLCNULLCompleted18 Years55 YearsAll50Phase 1NULL
212EUCTR2016-001448-21-ES
(EUCTR)
05/01/201726/10/2016A Study of Efficacy and Safety of M2951 in Relapsing Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled Phase II Study of M2951 with a Parallel, Open-Label, Active Control Group (Tecfidera), in Patients with Relapsing Multiple Sclerosis to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Biological Activity. Relapsing Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: M2951
Product Code: M2951
INN or Proposed INN: M2951
Other descriptive name: M2951
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Tecfidera
Product Name: Tecfidera
INN or Proposed INN: Tecfidera
Other descriptive name: DIMETHYL FUMARATE
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 2Serbia;United States;Czech Republic;Slovakia;Poland;Spain;Ukraine;Croatia;Turkey;Russian Federation;Bulgaria;United Kingdom
213EUCTR2015-005431-41-HR
(EUCTR)
30/11/201615/12/2016A late stage clinical trial to investigate the efficacy and safety of Satralizumab (SA237) monotherapy in patients with Neuromyelitis Optica and Neuromyelitis Optica Spectrum DisorderA Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Satralizumab (SA237) as Monotherapy in Patients With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD) Neuromyelitis optica (NMO) and NMO spectrum disorder (MNOSD)
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab (120 mg/vial)
Product Code: Satralizumab (RO5333787/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
Product Name: Satralizumab (120 mg/PFS with NSD)
Product Code: Satralizumab (RO5333787/SA237)
INN or Proposed INN: Satralizumab (r-INN)
Other descriptive name: RO5333787
F. Hoffmann-La Roche Ltd.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 3United States;Taiwan;Ukraine;Turkey;Italy;Canada;Malaysia;Poland;Croatia;Romania;Bulgaria;Georgia;Korea, Republic of
214EUCTR2015-004616-37-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
215EUCTR2016-000434-21-PT
(EUCTR)
14/11/201614/09/2016PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) 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: Plegridy 125 micrograms
INN or Proposed INN: Peginterferon beta-1a
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Rebif 22 micrograms
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 44 micrograms
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Betaferon 250 microgram/ml
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Trade Name: Extavia 250 micrograms/ml
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Trade Name: Plegridy 63 micrograms
INN or Proposed INN: Peginterferon beta-1a
Other descriptive name: PEGINTERFERON BETA-1A
Biogen PortugalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 4Portugal
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT02913157
(ClinicalTrials.gov)
November 201620/9/2016Hydroxychloroquine in Primary Progressive Multiple SclerosisOpen-label, Single-center, Single-arm Futility Trial Evaluating Oral Hydroxychloroquine 200mg BID for Reducing Progression of Disability in Patients With Primary Progressive Multiple Sclerosis (PPMS)Multiple Sclerosis, Primary ProgressiveDrug: HydroxychloroquineUniversity of CalgaryNULLActive, not recruiting18 Years65 YearsAll35Phase 2Canada
217EUCTR2015-005597-38-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
218NCT02807285
(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
219JPRN-UMIN000024312
2016/09/2025/05/2017Studies of efficacy and safety of the combined use of febuxostat and inosine for patients with Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosis, and changes of blood and urine purine compounds. Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis or multiple sclerosisTreatment with febuxostat 20 mg and inosine 0.5 g, twice a day for 2 weeksTsukuba International Clinical Pharmacology ClinicNULLComplete: follow-up complete20years-old80years-oldMale and Female12Not selectedJapan
220EUCTR2015-005597-38-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
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;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
221NCT02861014
(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
222EUCTR2015-005160-41-DE
(EUCTR)
27/07/201604/03/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults 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]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 3United States;Serbia;Canada;Spain;Poland;Belgium;Ukraine;Bulgaria;Russian Federation;Germany
223EUCTR2015-005597-38-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
224EUCTR2015-005597-38-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
225EUCTR2015-005597-38-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
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;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
226EUCTR2015-005160-41-BG
(EUCTR)
27/06/201604/05/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1 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]
Alkermes, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany
227NCT02797015
(ClinicalTrials.gov)
June 23, 201626/5/2016Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMSA Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: RPC1063CelgeneNULLCompleted18 Years55 YearsAll22Phase 1United States
228EUCTR2015-002500-91-HR
(EUCTR)
13/06/201606/07/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
229EUCTR2016-000464-42-DE
(EUCTR)
13/06/201611/04/2016The Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of AlemtuzumabA Prospective, Open-label, Interventional Phase IIIb Clinical Trial to Investigate the Effectiveness of an Additional Course of Alemtuzumab in Relapsing Remitting Multiple Sclerosis Patients After 2 Courses of Alemtuzumab - LemCourse 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]
Genzyme GmbHNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noGermany
230EUCTR2015-005160-41-PL
(EUCTR)
07/06/201613/04/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis - EVOLVE-MS-1 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]
Alkermes, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Canada;Belgium;Spain;Poland;Ukraine;Russian Federation;Bulgaria;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231EUCTR2015-002500-91-PT
(EUCTR)
06/06/201613/04/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
232EUCTR2015-005160-41-ES
(EUCTR)
06/06/201620/04/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults with Relapsing Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Alkermes, Inc.NULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Canada;Poland;Belgium;Spain;Ukraine;Russian Federation;Bulgaria;Germany
233EUCTR2015-005597-38-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
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
234EUCTR2015-002500-91-LT
(EUCTR)
31/05/201617/03/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2495Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
235EUCTR2015-005597-38-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
236EUCTR2015-005597-38-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
237EUCTR2015-005597-38-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
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noEstonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
238EUCTR2015-005597-38-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
239EUCTR2015-005597-38-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
240NCT02720107
(ClinicalTrials.gov)
May 12, 201621/3/2016Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)Long-term Follow up of Patients With Relapsing-remitting Multiple Sclerosis Enrolled in the Multicenter, Single-arm, Open-label Biobank Study (CFTY720DDE01), to Investigate Changes in Biomarkers After 48 Months of Treatment With 0.5 mg Fingolimod (FTY720)Relapsing-remitting Multiple SclerosisDrug: fingolimodNovartis PharmaceuticalsNULLCompleted18 YearsN/AAll133Phase 4Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
241NCT02688985
(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
242EUCTR2015-005160-41-BE
(EUCTR)
27/04/201607/03/2016an Open Label Study of ALKS 8700 in Adults with Multiple SclerosisA Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults 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]
Product Name: N/A
Product Code: ALKS 8700 Delayed Release (DR) Capsule
INN or Proposed INN: Not available
Other descriptive name: ALKS 8700
Alkermes, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Serbia;United States;Canada;Poland;Spain;Belgium;Ukraine;Russian Federation;Bulgaria;Germany
243EUCTR2015-005597-38-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
244EUCTR2015-002500-91-LV
(EUCTR)
20/04/201619/02/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2496 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
245EUCTR2013-002318-11-DE
(EUCTR)
15/04/201603/09/2015Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Kuwait;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
246EUCTR2015-002500-91-EE
(EUCTR)
04/04/201607/03/2016A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2495 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
247NCT02782858
(ClinicalTrials.gov)
April 201623/5/2016Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MSAn International, Double-blind, Randomised, Placebo-controlled Phase IIb Trial to Assess the Efficacy, Safety, and Pharmacokinetics of GNbAC1 in Patients With Relapsing Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: GNbAC1;Drug: PlaceboGeNeuro SALes Laboratoires Servier (LLS);Institut de Recherches Internationales Servier;Worldwide Clinical TrialsCompleted18 Years55 YearsAll270Phase 2Bulgaria;Croatia;Czechia;Estonia;Germany;Hungary;Italy;Poland;Russian Federation;Serbia;Spain;Ukraine
248EUCTR2013-002318-11-ES
(EUCTR)
02/03/201608/05/2015Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With relapsing-remitting multiple sclerosis (RRMS).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis - CONNECT Relapsing-Remitting Multiple Sclerosis
MedDRA version: 18.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;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: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Serbia;Portugal;Spain;Turkey;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Croatia;Denmark;Sweden
249EUCTR2015-001973-42-PL
(EUCTR)
22/02/201619/01/2016Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis 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: BG00012
Product Code: BG00012
INN or Proposed INN: Dimethyl Fumarate
Other descriptive name: Dimethyl Fumarate
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Belgium;Poland;Croatia;Lithuania;Bulgaria;Kuwait
250EUCTR2015-000922-12-DE
(EUCTR)
12/02/201602/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
251NCT02637856
(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
252EUCTR2015-001973-42-BG
(EUCTR)
11/02/201602/02/2016Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait
253EUCTR2015-001973-42-LT
(EUCTR)
11/02/201627/11/2015Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis 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: BG00012
Product Code: BG00012
INN or Proposed INN: Dimethyl Fumarate
Other descriptive name: Dimethyl Fumarate
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Poland;Belgium;Croatia;Lithuania;Bulgaria;Kuwait
254EUCTR2015-000922-12-FR
(EUCTR)
28/01/201626/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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]
Teva Pharmaceutical Industries, LtdNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
255EUCTR2015-001973-42-HR
(EUCTR)
26/01/201628/04/2016Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis
MedDRA version: 19.0;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: BG00012
Product Code: BG00012
INN or Proposed INN: Dimethyl Fumarate
Other descriptive name: Dimethyl Fumarate
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Slovakia;Canada;Poland;Belgium;Lithuania;Turkey;Croatia;Austria;Bulgaria;Kuwait;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
256EUCTR2015-002500-91-SK
(EUCTR)
22/01/201628/10/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain
257EUCTR2015-002500-91-PL
(EUCTR)
20/01/201601/12/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
258EUCTR2015-002500-91-BG
(EUCTR)
13/01/201620/10/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCl
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru
259EUCTR2015-000922-12-ES
(EUCTR)
12/01/201613/01/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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: Copaxone 20 mg/ml
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
820Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
260EUCTR2015-000922-12-PL
(EUCTR)
05/01/201603/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
261EUCTR2015-000922-12-BE
(EUCTR)
04/01/201601/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
262NCT02276963
(ClinicalTrials.gov)
January 201621/10/2014Ublituximab for Acute Neuromyelitis Optica (NMO) RelapsesPhase I, Single-Center, Open Label Trial of Ublituximab + Glucocorticoids for the Treatment of Acute Optic Neuritis and/or Transverse Myelitis in Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)Neuromyelitis Optica;Neuromyelitis Optica Spectrum DisorderDrug: UblituximabJohns Hopkins UniversityNULLCompleted18 Years100 YearsAll6Phase 1United States
263NCT02644044
(ClinicalTrials.gov)
January 201623/3/2015Intrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm StudyIntrathecal Methotrexate for Progressive Multiple Sclerosis: An Open Label Single Arm StudyTo Evaluate the Effect of Therapy With IT MTX on the Disease Course of Patients With Progressive MSDrug: Intrathecal methotrexateTel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 Years75 YearsBoth30Phase 0NULL
264EUCTR2015-000922-12-IE
(EUCTR)
22/12/201509/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
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]
Teva Pharmaceutical Industries, LtdNULLNot Recruiting Female: yes
Male: yes
840 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
265EUCTR2015-001973-42-BE
(EUCTR)
17/12/201523/11/2015Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis
MedDRA version: 19.0;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: BG00012
Product Code: BG00012
INN or Proposed INN: Dimethyl Fumarate
Other descriptive name: Dimethyl Fumarate
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Czech Republic;Canada;Poland;Belgium;Lithuania;Croatia;Turkey;Austria;Bulgaria;Kuwait
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
266EUCTR2015-000922-12-FI
(EUCTR)
15/12/201507/12/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Poland;Belgium;Croatia;Germany
267EUCTR2015-000922-12-HR
(EUCTR)
11/12/201504/02/2016A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.1;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: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
268NCT02634307
(ClinicalTrials.gov)
December 10, 201516/12/2015A Study of ALKS 8700 in Adults With Relapsing Remitting Multiple Sclerosis (MS) EVOLVE-MS-1A Phase 3 Open Label Study to Evaluate the Long-term Safety and Tolerability of ALKS 8700 in Adults With Relapsing Remitting Multiple SclerosisMultiple SclerosisDrug: ALKS 8700BiogenAlkermes, Inc.Active, not recruiting18 Years65 YearsAll1057Phase 3United States;Belgium;Bulgaria;Canada;Germany;Poland;Russian Federation;Serbia;Spain;Ukraine
269EUCTR2013-001151-12-HR
(EUCTR)
08/12/201501/02/2016EXTENSION STUDY OF ECULIZUMAB IN RELAPSING NEUROMYELITIS OPTICA SUBJECTSA PHASE III, OPEN-LABEL, EXTENSION TRIAL OF ECU-NMO-301 TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN PATIENTS WITH RELAPSING NEUROMYELITIS OPTICA (NMO) Relapsing Neuromyelitis Optica
MedDRA version: 20.0;Level: LLT;Classification code 10029322;Term: Neuromyelitis optica;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
132Phase 3United States;Saudi Arabia;Taiwan;Hong Kong;Martinique;Spain;Russian Federation;Colombia;Italy;France;Malaysia;Australia;Denmark;Peru;Korea, Republic of;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Singapore;Romania;Croatia;Germany;Japan;Sweden
270NCT02583594
(ClinicalTrials.gov)
December 6, 201516/10/2015A Study to Characterize Subcutaneous or Intravenous Alemtuzumab in Patients With Progressive Multiple SclerosisA Phase 1, Exploratory, Randomized, Open-label, 2-Arm Study to Characterize the Pharmacodynamics, Pharmacokinetics, Safety, and Tolerability of Alemtuzumab 12mg Administered Subcutaneously or Intravenously in Patients With Progressive Multiple SclerosisProgressive Multiple SclerosisDrug: Acyclovir;Drug: Methylprednisolone;Drug: alemtuzumab GZ402673;Drug: Paracetamol;Drug: Loratadine;Drug: Ceterizine;Drug: DexchlorpheniramineGenzyme, a Sanofi CompanyNULLActive, not recruiting18 YearsN/AAll24Phase 1Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
271NCT02893111
(ClinicalTrials.gov)
December 201527/8/2016Efficacy and Safety of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum DisorderSingle-center, Open Label Trial of Bortezomib as add-on Treatment in Relapsing Neuromyelitis Optica Spectrum DisorderNeuromyelitis Optica Spectrum DisorderDrug: BortezomibTianjin Medical University General HospitalNULLCompleted18 YearsN/AFemale5Phase 2China
272EUCTR2015-002500-91-ES
(EUCTR)
24/11/201505/10/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Receptos, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2350Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden
273EUCTR2012-003735-32-GR
(EUCTR)
19/11/201506/08/2015Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment Relapsing-remitting multiple sclerosis (RR MS)
MedDRA version: 18.0;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: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: masitinib mesylate
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinb mesylate
Other descriptive name: masitinib mesylate
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany
274EUCTR2015-000922-12-AT
(EUCTR)
19/11/201501/10/2015A clinical study to assess medication satisfaction in patients with Relapsing Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml Three Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients with Relapsing Remitting Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
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]
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Copaxone 40 mg/ml
INN or Proposed INN: Not applicable
Other descriptive name: GLATIRAMER ACETATE
Teva Pharmaceutical Industries, LtdNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
275EUCTR2015-002500-91-GR
(EUCTR)
18/11/201504/11/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod HCI
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2496Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
276EUCTR2015-002500-91-GB
(EUCTR)
10/11/201518/09/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
2496Phase 3United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
277EUCTR2015-002500-91-BE
(EUCTR)
10/11/201502/09/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2496 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
278EUCTR2011-005249-12-LT
(EUCTR)
06/11/201502/10/2015Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS 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: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: TERIFLUNOMIDE
Genzyme CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria
279EUCTR2015-000922-12-IT
(EUCTR)
05/11/201528/02/2018A clinical study to assess medication satisfaction in patients with RelapsingRemitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/mlThree Times a Week compared to Copaxone 20 mg/ml dailyA Multinational, Multicenter, Randomized, Parallel Group, Open-Label Studyto Assess Medication Satisfaction in Patients with Relapsing RemittingMultiple Sclerosis (RRMS) Treated with Subcutaneous Injections ofCopaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Comparedto 20 mg/mL Daily (CONFIDENCE) - CONFIDENCE Relapsing-Remitting Multiple Sclerosis (RRMS)
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: COPAXONE - 20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE 30 SIRINGHE
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: GLATIRAMER ACETATO
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: GLATIRAMER ACETATO
TEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INCNULLNot RecruitingFemale: yes
Male: yes
840Phase 4United States;Finland;Spain;Ireland;Turkey;Austria;Israel;Russian Federation;Italy;France;Mexico;Argentina;Belgium;Poland;Croatia;Germany
280NCT02686684
(ClinicalTrials.gov)
November 201511/2/2016Tecfidera Diffusion Tensor ImagingAn Open-label, Observational, Single-blinded, Longitudinal Study to Evaluate the Effect of Dimethyl Fumarate on Gray and White Matter Pathology in Subjects With Relapsing Multiple SclerosisMultiple Sclerosis, Dimethyl Fumarate, Diffusion Tensor Imaging Magnetic Resonance ImagingDrug: Dimethyl fumarateUniversity at BuffaloNULLCompleted18 YearsN/ABoth115N/ANULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
281NCT02545868
(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
282NCT02576717
(ClinicalTrials.gov)
October 16, 201528/9/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis PatientsMultiple SclerosisDrug: RPC1063CelgeneNULLActive, not recruiting18 Years55 YearsAll2495Phase 3United States;Belarus;Belgium;Bosnia and Herzegovina;Bulgaria;Croatia;Estonia;Georgia;Germany;Greece;Hungary;Italy;Latvia;Lithuania;Moldova, Republic of;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Spain;Sweden;Ukraine;United Kingdom
283EUCTR2015-002500-91-HU
(EUCTR)
12/10/201526/08/2015A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple SclerosisA Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Celgene International II Sàrl (CIS II)NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2496 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium;Serbia;Belarus;United States;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
284EUCTR2014-005003-24-DE
(EUCTR)
12/10/201525/02/2015A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis'Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years Relapsing-Remitting Multiple Sclerosis
MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Finland;Lebanon;Lithuania;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia
285NCT02410200
(ClinicalTrials.gov)
September 30, 20152/4/2015Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With RRMSOpen-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 YearsMultiple Sclerosis, Relapsing-RemittingDrug: dimethyl fumarateBiogenNULLCompleted10 Years17 YearsAll22Phase 2United States;Belgium;Bulgaria;Czechia;Germany;Kuwait;Latvia;Lebanon;Poland;Turkey;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
286EUCTR2014-005003-24-PL
(EUCTR)
25/09/201512/06/2015A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis'Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years Relapsing-Remitting Multiple Sclerosis
MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia
287EUCTR2014-005003-24-CZ
(EUCTR)
21/09/201502/03/2015A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis'Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years Relapsing-Remitting Multiple Sclerosis
MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
18Phase 2United States;Lebanon;Turkey;Lithuania;Israel;Italy;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia
288EUCTR2014-005003-24-BG
(EUCTR)
21/08/201513/05/2015A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis'Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years Relapsing-Remitting Multiple Sclerosis
MedDRA version: 19.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
18Phase 2United States;Lebanon;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Australia;Bulgaria;Germany;Kuwait;Latvia
289NCT02525874
(ClinicalTrials.gov)
August 11, 201510/7/2015Effect of BG00012 on Lymphocyte Subsets and Immunoglobulins in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).An Open-Label Study to Assess the Effects of BG00012 on Lymphocyte Subsets in Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting;Multiple SclerosisDrug: dimethyl fumarateBiogenNULLCompleted18 Years65 YearsAll218Phase 3United States;Belgium;Bulgaria;Kuwait;Lithuania;Poland;Turkey;Croatia
290NCT02499900
(ClinicalTrials.gov)
August 10, 20151/7/2015Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis Treated With Copaxone®CONFIDENCE: A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study to Assess Medication Satisfaction in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Treated With Subcutaneous Injections of Copaxone(R) (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared to 20 mg/mL DailyMultiple SclerosisDrug: Copaxone®Teva Pharmaceutical Industries, Ltd.NULLCompleted18 YearsN/AAll861Phase 4United States;Argentina;Austria;Belgium;Croatia;Finland;France;Germany;Ireland;Italy;Mexico;Poland;Puerto Rico;Russian Federation;Spain;Turkey
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
291EUCTR2014-000395-26-DE
(EUCTR)
07/08/201509/04/2014Description ofchanges in that part of the nervous sstem that is processing visual information over an extended perion of time in patients with relapsing remitting multiple sclerosis who take TecfideraA 3-year open-label, exploratory, single arm study to describe long term changes in the visual system of patients with relapsing remitting multiple sclerosis (RRMS) on oral dimethyl fumarate - VISION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 18.0;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: Tecfidera
INN or Proposed INN: Dimethyl fumarate
Other descriptive name: DIMETHYL FUMARATE
Biogen GmbHNULLNot RecruitingFemale: yes
Male: yes
600Phase 4Germany
292NCT02683863
(ClinicalTrials.gov)
August 201514/1/2016Pharmacokinetics of DMF and the Effects of DMF on Exploratory BiomarkersAn Open Label Study of the Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers in Subjects With Secondary Progressive Multiple SclerosisMultiple SclerosisDrug: BG00012 (DMF) (Tecfidera®.)Multiple Sclerosis Center of Northeastern New YorkBiogenCompleted25 Years65 YearsAll20Phase 4United States
293EUCTR2014-005003-24-BE
(EUCTR)
29/07/201530/06/2015A study of BG00012 on MRI lesions and Pharmacokinetics in children from 10 to less than 18 years old with a type of Multiple Sclerosis called 'Relapsing, Remitting Multiple Sclerosis'Open-Label, Multicenter, Multiple-Dose Study of the Effect of BG00012 on MRI Lesions and Pharmacokinetics in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis Aged 10 to 17 Years Relapsing-Remitting Multiple Sclerosis
MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;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: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Finland;Lebanon;Turkey;Lithuania;Israel;United Kingdom;Italy;France;Czech Republic;Poland;Belgium;Australia;Bulgaria;Germany;Kuwait;Latvia
294EUCTR2013-002318-11-PL
(EUCTR)<