OCRELIZUMAB ( DrugBank: Ocrelizumab )
3 diseases
| ID | Disease name (Link within this page) | Number of trials |
|---|---|---|
| 13 | Multiple sclerosis/Neuromyelitis optica | 245 |
| 46 | Malignant rheumatoid arthritis | 37 |
| 49 | Systemic lupus erythematosus | 19 |
13. Multiple sclerosis/Neuromyelitis optica
Clinical trials : 3,342 / Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05266469 (ClinicalTrials.gov) | May 1, 2022 | 23/2/2022 | Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf | Exploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf Region | Relapsing Multiple Sclerosis | Other: Ofatumumab;Other: Ocrelizumab | Novartis Pharmaceuticals | NULL | Not yet recruiting | 18 Years | 100 Years | All | 240 | NULL | |
| 2 | NCT05285891 (ClinicalTrials.gov) | April 30, 2022 | 8/3/2022 | Ocrelizumab Discontinuation in Relapsing Multiple Sclerosis | Randomized, Blinded Discontinuation Trial of Ocrelizumab in Early Relapsing Multiple Sclerosis (AMS05) | Multiple Sclerosis | Biological: Ocrelizumab;Drug: Placebo for Ocrelizumab | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence (ACE) | Not yet recruiting | 18 Years | 55 Years | All | 175 | Phase 4 | NULL |
| 3 | NCT04998812 (ClinicalTrials.gov) | March 31, 2022 | 6/8/2021 | A Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy | A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Potentially Exposed To Ocrelizumab During Pregnancy | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Ocrelizumab | Hoffmann-La Roche | PPD;LabCorp;Illingworth | Recruiting | 18 Years | 40 Years | Female | 44 | Phase 4 | United States;France;Spain;United Kingdom;Canada;Germany;Italy;Switzerland |
| 4 | NCT05232825 (ClinicalTrials.gov) | March 31, 2022 | 27/1/2022 | A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis | A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis | Relapsing Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Ocrelizumab IV;Drug: Ocrelizumab SC;Drug: Methylprednisolone IV;Drug: Diphenhydramine IV;Drug: Dexamethasone given orally;Drug: Desloratadine given orally | Hoffmann-La Roche | NULL | Not yet recruiting | 18 Years | 65 Years | All | 232 | Phase 3 | United States;Brazil;Canada;Czechia;Italy;Poland;Russian Federation;Spain;Turkey;Ukraine |
| 5 | EUCTR2021-004791-34-NL (EUCTR) | 16/03/2022 | 15/03/2022 | Personalized dosing of ocrelizumab in MS | Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis: a randomized controlled trial | Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: ocrelizumab | VU medical center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 296 | Phase 4 | Netherlands | ||
| 6 | NCT05269004 (ClinicalTrials.gov) | March 15, 2022 | 11/2/2022 | A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis | A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Not yet recruiting | 18 Years | N/A | All | 1300 | Phase 3 | NULL |
| 7 | EUCTR2020-005448-48-CZ (EUCTR) | 15/03/2022 | 05/05/2021 | A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS | 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: 21.0;Classification code 10080700;Term: Relapsing 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Russian Federation;Italy;France;Czech Republic;Canada;Poland;Brazil;Australia;New Zealand | ||
| 8 | NCT05208840 (ClinicalTrials.gov) | February 28, 2022 | 12/1/2022 | A Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis | Open-Label Multicenter Study To Determine The Effect Of Ocrelizumab On Leptomeningeal Inflammation In Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 50 | Phase 4 | Russian Federation |
| 9 | EUCTR2020-004128-41-BG (EUCTR) | 15/02/2022 | 15/10/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 10 | NCT04877457 (ClinicalTrials.gov) | February 15, 2022 | 30/4/2021 | Ocrelizuamb for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease. | A Phase 4, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy of Ocrelizumab in Patients With Radiologically Isolated Syndrome | Radiologically Isolated Syndrome;Multiple Sclerosis | Drug: Ocrelizumab;Other: Placebo | Yale University | Genentech, Inc. | Recruiting | 18 Years | 40 Years | All | 100 | Phase 4 | United States |
| 11 | EUCTR2020-001205-23-SE (EUCTR) | 08/02/2022 | 06/12/2021 | Ocrelizumab VErsus Rituximab off-Label at the Onset of Relapsing MS Disease | Ocrelizumab VErsus Rituximab off-Label at the Onset of RelapsingMS Disease (OVERLORD-MS) - OVERLORD-MS | Remitting Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus Product Name: Ocrelizumab Trade Name: Rituximab Product Name: Rituximab | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 211 | Phase 3 | Sweden | ||
| 12 | NCT05123703 (ClinicalTrials.gov) | February 4, 2022 | 16/11/2021 | A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis | A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Drug: Ocrelizumab;Other: Ocrelizumab Placebo;Drug: Fingolimod;Other: Fingolimod Placebo | Hoffmann-La Roche | PPD | Recruiting | 10 Years | 17 Years | All | 233 | Phase 3 | United States;Argentina;Spain;Ukraine;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Denmark;Germany;Greece;Hungary;Italy;Mexico;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Switzerland;Turkey;United Kingdom |
| 13 | EUCTR2020-004128-41-NL (EUCTR) | 22/12/2021 | 14/09/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 14 | EUCTR2019-003919-53-DE (EUCTR) | 13/12/2021 | 11/02/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Peru;Australia;Denmark;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 15 | EUCTR2020-004128-41-BE (EUCTR) | 10/12/2021 | 10/12/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | ||
| 16 | EUCTR2020-004128-41-GR (EUCTR) | 23/11/2021 | 06/10/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 17 | EUCTR2019-003919-53-BG (EUCTR) | 16/11/2021 | 16/07/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | United 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 | ||
| 18 | NCT05131984 (ClinicalTrials.gov) | November 15, 2021 | 10/11/2021 | Ocrelizumab Access by Socio-Economic Status | Ocrelizumab Treatment Access and Outcomes by Gender, Race, and Socio-economic Status in Multiple Sclerosis Patients: Real World Investigation | Multiple Sclerosis | Drug: Ocrelizumab | Brigham and Women's Hospital | Genentech, Inc.;Boston Medical Center | Not yet recruiting | 18 Years | N/A | All | 600 | United States | |
| 19 | EUCTR2021-000063-79-ES (EUCTR) | 22/10/2021 | 23/07/2021 | A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving Ocrelizumab | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] MedDRA version: 20.0;Level: PT;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | France;United States;Canada;Spain;Australia;Germany;United Kingdom;Switzerland;Italy | ||
| 20 | EUCTR2020-004128-41-IT (EUCTR) | 11/10/2021 | 07/10/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS - Operetta 2 | 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: GILENYA - 0.5 MG - CAPSULE RIGIDE - USO ORALE Product Name: N/A Product Code: [N/A] INN or Proposed INN: FINGOLIMOD Trade Name: GILENYA - 0.25 MG - CAPSULE RIGIDE - USO ORALE Product Name: N/A Product Code: [N/A] INN or Proposed INN: FINGOLIMOD Trade Name: Ocrevus Product Name: N/A Product Code: [N/A] INN or Proposed INN: Ocrelizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 21 | EUCTR2021-000062-14-ES (EUCTR) | 08/10/2021 | 23/07/2021 | A Study to Evaluate B Cell Levels in Infants Potentially Exposed to Ocrelizumab During Pregnancy | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] 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 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 44 | Phase 4 | France;United States;Canada;Spain;Australia;Germany;United Kingdom;Switzerland;Italy | ||
| 22 | EUCTR2020-004128-41-PL (EUCTR) | 04/10/2021 | 13/09/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 23 | NCT04767698 (ClinicalTrials.gov) | October 1, 2021 | 18/2/2021 | Addition of Belimumab to B-cell Depletion in Relapsing-remitting Multiple Sclerosis | Addition of Belimumab to B-cell Depletion to Produce Prolonged Remission of Relapsing-remitting Multiple Sclerosis Disease Activity | Multiple Sclerosis | Drug: Belimumab;Drug: Short-course Ocrelizumab;Drug: Continued Ocrelizumab | Johns Hopkins University | GlaxoSmithKline | Recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States |
| 24 | NCT04874597 (ClinicalTrials.gov) | October 2021 | 14/4/2021 | Investigation of the Effect of Ocrelizumab on Peripheral Lymphocyte Immunophenotypes With Suppressive Capacity in MS | The Effect of Ocrelizumab on the Peripheral Lymphocyte Immunophenotypes With Suppressive Capacity in Patients With Multiple Sclerosis Previously Treated With Disease Modifying Therapy - A Prospective Exploratory Observational Study | Multiple Sclerosis | Drug: Ocrelizumab | Dr Recai Turkoglu | Health Sciences University Istanbul Haydarpasa Numune Training and Research Hospital | Not yet recruiting | 18 Years | N/A | All | 20 | Turkey | |
| 25 | NCT04998851 (ClinicalTrials.gov) | September 16, 2021 | 6/8/2021 | A Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab | A Phase IV Multicenter, Open-Label Study Evaluating B Cell Levels In Infants Of Lactating Women With CIS Or MS Receiving Ocrelizumab | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Ocrelizumab | Hoffmann-La Roche | PPD;LabCorp;Illingworth | Recruiting | 18 Years | 40 Years | Female | 20 | Phase 4 | United States;United Kingdom;Australia;Canada;France;Germany;Italy;Spain;Switzerland |
| 26 | EUCTR2020-005448-48-PL (EUCTR) | 13/09/2021 | 09/07/2021 | A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS | 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: 21.0;Classification code 10080700;Term: Relapsing 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Russian Federation;Italy;France;Canada;Poland;Brazil;Australia;New Zealand | ||
| 27 | EUCTR2019-003919-53-DK (EUCTR) | 07/09/2021 | 01/03/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;France;Australia;Denmark;Peru;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 28 | NCT04971005 (ClinicalTrials.gov) | August 27, 2021 | 12/8/2020 | Ocrelizumab or Alemtuzumab Compared With Autologous Hematopoietic Stem Cell Transplantation in Multiple Sclerosis - a Phase-2 Randomised Controlled Trial | A Randomised Controlled Trial to Compare Ocrelizumab or Alemtuzumab With Autologous Hematopoietic Stem Cell Transplantation (aHSCT) in High Inflammatory Multiple Sclerosis (COAST) | Relapsing-Remitting Multiple Sclerosis | Drug: Autologous Hematopoietic Stem Cell Transplantation;Drug: Ocrelizumab;Drug: Alemtuzumab | Universitätsklinikum Hamburg-Eppendorf | Neovii Biotech;Clinical Trial Center North (CTC North GmbH & Co. KG) | Recruiting | 18 Years | 55 Years | All | 50 | Phase 2 | Germany |
| 29 | EUCTR2020-004128-41-HU (EUCTR) | 24/08/2021 | 15/07/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 30 | EUCTR2017-004886-29-HR (EUCTR) | 24/08/2021 | 03/12/2021 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 31 | EUCTR2020-005448-48-ES (EUCTR) | 11/08/2021 | 14/06/2021 | A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS | Multiple Sclerosis (MS) 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] | Trade Name: Ocrevus 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 | Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 3 | France;Czechia;Brazil;Spain;Italy | ||
| 32 | EUCTR2017-004886-29-HU (EUCTR) | 27/07/2021 | 01/06/2021 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1127 | Phase 3 | Sweden;Netherlands;Norway;Bulgaria;Denmark;Belgium;Brazil;Poland;Argentina;Mexico;Hungary;Czech Republic;France;Italy;United Kingdom;Turkey;Ireland;Spain;Finland;Slovenia;Slovakia;Estonia;Czechia;Portugal | ||
| 33 | EUCTR2020-005448-48-IT (EUCTR) | 05/07/2021 | 17/08/2021 | A Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Radiological and Clinical Effects of Subcutaneous (SC) Ocrelizumab versus Intravenous (IV) Ocrelizumab in Patients with Multiple Sclerosis | A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUTANEOUS OCRELIZUMAB VERSUS INTRAVENOUS OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS - - | Multiple Sclerosis (MS) 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] | Trade Name: Ocrevus Product Name: ocrelizumab Product Code: [RO4964913] INN or Proposed INN: Ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab Product Code: [RO4964913] INN or Proposed INN: Ocrelizumab | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 232 | Phase 3 | France;Czechia;Spain;Brazil;Italy | ||
| 34 | EUCTR2017-004886-29-SK (EUCTR) | 02/07/2021 | 15/03/2021 | A 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 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] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 659 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 35 | EUCTR2017-004886-29-BG (EUCTR) | 29/06/2021 | 15/04/2021 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Czechia;Estonia;Slovakia;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Norway;Sweden | ||
| 36 | EUCTR2019-003919-53-HU (EUCTR) | 17/06/2021 | 23/04/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Peru;Australia;Denmark;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 37 | EUCTR2017-004886-29-PT (EUCTR) | 25/05/2021 | 12/03/2021 | A 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 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] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 38 | NCT04676555 (ClinicalTrials.gov) | May 11, 2021 | 16/12/2020 | Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis | Time and Motion Study for Ocrelizumab and Ofatumumab Administration in Relapsing Multiple Sclerosis | Relapsing Forms of Multiple Sclerosis | Drug: Ocrelizumab;Drug: Ofatumumab | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 100 Years | All | 2 | United States;Australia;United Kingdom | |
| 39 | NCT04688788 (ClinicalTrials.gov) | April 28, 2021 | 22/12/2020 | Non-inferiority Study of Ocrelizumab and Rituximab in Active Multiple Sclerosis | Danish Non-inferiority Study of Ocrelizumab and Rituximab in MS (DanNORMS): A Randomized Study Comparing the Efficacy of Ocrelizumab and Rituximab in Active Multiple Sclerosis | Relapsing Remitting Multiple Sclerosis;Secondary Progressive Multiple Sclerosis;Primary Progressive Multiple Sclerosis | Drug: Rituximab;Drug: Ocrelizumab;Drug: Fexofenadine;Drug: Paracetamol;Drug: Methylprednisolone | Rigshospitalet, Denmark | Odense University Hospital;Aarhus University Hospital;Aalborg University Hospital;Herlev Hospital;Hillerod Hospital, Denmark;Zealand University Hospital;Kolding Sygehus;Regional Hospital Holstebro;Hvidovre University Hospital;Hospital of South West Jutland, Esbjerg, Denmark;GCP unit, Copenhagen University Hospital;GCP-unit at Aarhus University Hospital, Aarhus, Denmark;Hospital of Southern Jutland, Sønderborg, Denmark;Hospital of Central Denmark Region, Viborg, Denmark;Danske Regioner | Recruiting | 18 Years | 65 Years | All | 594 | Phase 3 | Denmark |
| 40 | NCT04843774 (ClinicalTrials.gov) | April 20, 2021 | 9/4/2021 | Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA) | Vaccine-generated Immunity in Ocrelizumab-treated Patients: Longitudinal Assessments (VIOLA) | Multiple Sclerosis | Drug: SARS-COV-2 mRNA Vaccine | NYU Langone Health | NULL | Recruiting | 18 Years | 65 Years | All | 60 | United States | |
| 41 | EUCTR2019-003919-53-PT (EUCTR) | 09/04/2021 | 11/02/2021 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | Portugal;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Peru;Australia;Denmark;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 42 | EUCTR2019-003919-53-AT (EUCTR) | 19/03/2021 | 29/12/2020 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | Switzerland;France;Denmark;Peru;Australia;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand;United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation | ||
| 43 | EUCTR2019-003919-53-GR (EUCTR) | 18/03/2021 | 24/12/2020 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;France;Peru;Australia;Denmark;South Africa;Latvia;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 44 | EUCTR2017-004886-29-PL (EUCTR) | 09/03/2021 | 15/01/2021 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Czechia;Estonia;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Bulgaria;Norway;Netherlands;Sweden | ||
| 45 | EUCTR2017-004886-29-SI (EUCTR) | 04/03/2021 | 23/12/2020 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Estonia;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Netherlands;Sweden | ||
| 46 | NCT04650321 (ClinicalTrials.gov) | March 1, 2021 | 16/11/2020 | Home Based Infusions for Ocrelizumab | Evaluating the Feasibility of Pandemic Forward, Telehealth Based Home Based Infusions | Multiple Sclerosis | Drug: Ocrelizumab at home | University of Colorado, Denver | Genentech, Inc. | Recruiting | 18 Years | 55 Years | All | 110 | Phase 4 | United States |
| 47 | EUCTR2020-000894-26-GR (EUCTR) | 26/02/2021 | 06/11/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 699 | Phase 3 | United States;Portugal;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 48 | EUCTR2020-000893-69-DK (EUCTR) | 24/02/2021 | 16/09/2020 | A 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 | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | Germany;New Zealand;Poland;Belgium;Brazil;Argentina;Canada;Mexico;Hungary;United Kingdom;Turkey;Czechia;Netherlands;Peru;Denmark;Australia;France;Switzerland;Italy;Russian Federation;Israel;Ukraine;Spain;Greece;Portugal;United States | ||
| 49 | EUCTR2017-004886-29-BE (EUCTR) | 24/02/2021 | 14/12/2020 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 50 | EUCTR2020-000894-26-BG (EUCTR) | 15/02/2021 | 29/01/2021 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive 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 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;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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 699 | Phase 3 | United States;Portugal;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 51 | NCT04387734 (ClinicalTrials.gov) | February 5, 2021 | 11/5/2020 | Effects of Ocrevus in Relapsing Multiple Sclerosis | Effects and Mechanisms of Ocrevus on Ambulatory Functions in People With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ocrelizumab;Drug: Platform | Georgia State University | Multiple Sclerosis Center of Atlanta | Recruiting | 18 Years | 65 Years | All | 60 | Phase 4 | United States |
| 52 | EUCTR2020-000894-26-DK (EUCTR) | 02/02/2021 | 02/09/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 699 | Phase 3 | United States;Portugal;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 53 | EUCTR2020-000893-69-GR (EUCTR) | 26/01/2021 | 06/11/2020 | A 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 | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand | ||
| 54 | EUCTR2019-003919-53-GB (EUCTR) | 17/12/2020 | 26/11/2020 | FENtrepid: A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 946 | Phase 3 | United 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 | ||
| 55 | NCT04640818 (ClinicalTrials.gov) | December 17, 2020 | 18/11/2020 | Safety and Efficacy of Cladribine Therapy After Anti CD20 Therapy | Safety and Efficacy of a Therapy With Cladribine Following a Treatment With Anti CD20 Compounds in Relapsing Multiple Sclerosis Patients: a Pilot Study | Multiple Sclerosis | Drug: Cladribine Oral Tablet;Drug: Rituximab;Drug: Ocrelizumab | Claudio Gobbi | Merck AG Switzerland | Recruiting | 18 Years | 80 Years | All | 45 | Switzerland | |
| 56 | EUCTR2020-002981-15-DK (EUCTR) | 15/12/2020 | 13/07/2020 | Non-inferiority study of ocrelizumab and rituximab in active multiple sclerosis. | Danish non-inferiority study of ocrelizumab and rituximab in MS (DanNORMS): A randomized study comparing the efficacy of ocrelizumab and rituximab in active multiple sclerosis. - DanNORMS | Multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;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 INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Ruxience INN or Proposed INN: RITUXIMAB | Danish Multiple Sclerosis Center, Rigshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 594 | Phase 3 | Denmark | ||
| 57 | NCT04548999 (ClinicalTrials.gov) | December 3, 2020 | 9/9/2020 | A 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 Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab;Drug: Antihistamine;Drug: Methylprednisolone | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 699 | Phase 3 | United States;Argentina;Belgium;Brazil;Bulgaria;Canada;Czechia;Denmark;France;Germany;Greece;Hungary;Italy;Mexico;Peru;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom |
| 58 | NCT04544436 (ClinicalTrials.gov) | November 26, 2020 | 4/9/2020 | A 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 Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab;Drug: Antihistamine;Drug: Methylprednisolone | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 786 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Peru;Poland;Portugal;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Czechia;Israel;Mexico;Netherlands |
| 59 | EUCTR2020-000894-26-IT (EUCTR) | 24/11/2020 | 25/01/2021 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive 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 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 LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 699 | Phase 3 | Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Denmark;Peru;Bulgaria;Germany;New Zealand | ||
| 60 | EUCTR2019-001967-58-FR (EUCTR) | 20/11/2020 | 27/05/2020 | Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dapirolizumab Pegol Product Code: BIIB133 INN or Proposed INN: DAPIROLIZUMAB PEGOL Trade Name: Ocrevus Product Name: OCREVUS INN or Proposed INN: OCRELIZUMAB Other descriptive name: OCRELIZUMAB | Biogen Idec Research Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 220 | Phase 2 | United States;Serbia;France;Spain;Poland;Belgium;Germany;Switzerland;Italy | ||
| 61 | EUCTR2020-000893-69-DE (EUCTR) | 19/11/2020 | 11/08/2020 | A 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 | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 62 | EUCTR2020-000893-69-NL (EUCTR) | 11/11/2020 | 10/08/2020 | A 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 | Relapsing Multiple Sclerosis (MS) 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] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 63 | EUCTR2020-000894-26-DE (EUCTR) | 03/11/2020 | 26/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 699 | Phase 3 | Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 64 | NCT04578639 (ClinicalTrials.gov) | November 2, 2020 | 22/9/2020 | Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing MS Disease | Ocrelizumab VErsus Rituximab Off-Label at the Onset of Relapsing | Relapsing Remitting Multiple Sclerosis | Drug: Rituximab;Drug: Ocrelizumab | Haukeland University Hospital | University Hospital, Akershus;Oslo University Hospital;Helse Stavanger HF;St. Olavs Hospital;University Hospital of North Norway | Recruiting | 18 Years | 60 Years | All | 211 | Phase 3 | Norway |
| 65 | EUCTR2020-000893-69-IT (EUCTR) | 29/10/2020 | 24/05/2021 | A 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 - NA | 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: 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;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: NA | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 66 | EUCTR2020-000893-69-PL (EUCTR) | 28/10/2020 | 09/07/2020 | A 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 | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 67 | NCT04544449 (ClinicalTrials.gov) | October 26, 2020 | 4/9/2020 | A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Ocrelizumab In Adult Participants With Primary Progressive Multiple Sclerosis | A 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 Progressive | Drug: fenebrutinib;Drug: ocrelizumab;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 946 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Canada;Colombia;Denmark;France;Greece;Hungary;Israel;Mexico;Peru;Poland;Portugal;Puerto Rico;Russian Federation;Spain;Switzerland;Turkey;Ukraine;United Kingdom;Belgium;Czechia;Germany;Italy;New Zealand |
| 68 | NCT04855617 (ClinicalTrials.gov) | October 26, 2020 | 19/4/2021 | Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis | Symptom Burden in Patients Treated With Ocrelizumab for Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | NYU Langone Health | Genentech, Inc. | Active, not recruiting | 18 Years | 80 Years | All | 122 | United States | |
| 69 | EUCTR2019-001967-58-PL (EUCTR) | 26/10/2020 | 25/06/2020 | Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with Relapsing Multiple Sclerosis (RMS) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Active-Reference (Ocrelizumab), Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Intravenous Dapirolizumab Pegol (BIIB133) in Relapsing Multiple Sclerosis - Efficacy and Safety Study of Dapirolizumab pegol (BIIB133) in Participants with RMS | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Dapirolizumab Pegol Product Code: BIIB133 INN or Proposed INN: DAPIROLIZUMAB PEGOL Trade Name: Ocrevus Product Name: OCREVUS INN or Proposed INN: OCRELIZUMAB Other descriptive name: OCRELIZUMAB | Biogen Idec Research Limited | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Serbia;France;Spain;Belgium;Poland;Germany;Switzerland;Italy | ||
| 70 | EUCTR2020-000893-69-BE (EUCTR) | 23/10/2020 | 23/10/2020 | A 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 | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Switzerland;France;Denmark;Peru;Australia;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Germany;New Zealand | ||
| 71 | EUCTR2020-000893-69-PT (EUCTR) | 12/10/2020 | 09/07/2020 | A 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 | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United States;Portugal;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Switzerland;France;Peru;Australia;Denmark;Netherlands;Czechia;Turkey;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Germany;New Zealand | ||
| 72 | EUCTR2020-000894-26-PT (EUCTR) | 12/10/2020 | 13/07/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 699 | Phase 3 | Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 73 | EUCTR2020-000893-69-HU (EUCTR) | 09/10/2020 | 06/08/2020 | A 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 | 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United 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 | ||
| 74 | EUCTR2020-000894-26-FR (EUCTR) | 08/10/2020 | 11/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 699 | Phase 3 | United 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 | ||
| 75 | EUCTR2020-000893-69-GB (EUCTR) | 25/09/2020 | 29/07/2020 | A 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United 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 | ||
| 76 | EUCTR2020-000894-26-GB (EUCTR) | 25/09/2020 | 30/07/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a HigherDose of Ocrelizumab in Adults with Primary Progressive 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 786 | Phase 3 | United 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 | ||
| 77 | EUCTR2020-000894-26-HU (EUCTR) | 22/09/2020 | 06/08/2020 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Primary Progressive 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 699 | Phase 3 | Portugal;United States;Czechia;Greece;Spain;Ukraine;Turkey;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Peru;Denmark;Bulgaria;Germany;New Zealand | ||
| 78 | NCT04466150 (ClinicalTrials.gov) | August 30, 2020 | 7/7/2020 | Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset | Impact of Ocrelizumab on Cerebrospinal Fluid Biomarkers at Multiple Sclerosis Onset | Relapsing Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Ocrelizumab | University of California, San Francisco | Genentech, Inc.;Valhalla Charitable Foundation | Recruiting | 18 Years | 50 Years | All | 30 | Phase 4 | United States |
| 79 | NCT04387110 (ClinicalTrials.gov) | August 7, 2020 | 4/5/2020 | Ocrelizumab in Breastmilk | Monoclonal Antibodies in Mothers' Milk and Infants: Ocrelizumab in Breastmilk | Multiple Sclerosis;Clinically Isolated Syndrome | Drug: Ocrelizumab | University of California, San Francisco | Genentech, Inc. | Active, not recruiting | 18 Years | 64 Years | Female | 20 | United States | |
| 80 | NCT04261790 (ClinicalTrials.gov) | August 1, 2020 | 6/2/2020 | Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis | Evaluating the Effects of Ocrelizumab on B-cell Tolerance Defect in Relapsing Multiple Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Johns Hopkins University | Genentech, Inc. | Active, not recruiting | 18 Years | 99 Years | All | 10 | Phase 4 | United States |
| 81 | NCT04377555 (ClinicalTrials.gov) | July 30, 2020 | 1/5/2020 | Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab. | An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab | Multiple Sclerosis, Relapsing | Drug: Ocrelizumab | Genentech, Inc. | NULL | Recruiting | 18 Years | 65 Years | All | 150 | Phase 4 | United States;Kenya;Puerto Rico |
| 82 | NCT04459988 (ClinicalTrials.gov) | July 1, 2020 | 30/6/2020 | Mechanistic Study of Ocrevus | Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | University of Michigan | NULL | Recruiting | 18 Years | 65 Years | All | 35 | United States | |
| 83 | NCT04458688 (ClinicalTrials.gov) | July 2020 | 30/6/2020 | Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis | Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study | Multiple Sclerosis, Relapsing-Remitting | Other: Observation of Ocrelizumab as Treatment in RRMS Patients | Wayne State University | NULL | Not yet recruiting | 18 Years | 60 Years | All | 80 | NULL | |
| 84 | NCT05081700 (ClinicalTrials.gov) | May 11, 2020 | 13/11/2020 | A Systems Approach to Understanding Disease Processes in Multiple Sclerosis | A Systems Approach to Understanding Disease Processes in Multiple Sclerosis | Multiple Sclerosis | Drug: All patients in the study will be treated with ocrelizumab | Providence Health & Services | Institute for Systems Biology;Genentech, Inc. | Active, not recruiting | 18 Years | 60 Years | All | 50 | United States | |
| 85 | EUCTR2019-003127-38-NL (EUCTR) | 09/04/2020 | 09/04/2020 | Research on the effect of add-on high dosage simvastatin treatment on progression in MS patients treated with ocrelizumab and natalizumab. | Efficacy of add-on high dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial. - SIMSON trial | Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Simvastatin INN or Proposed INN: SIMVASTATIN Other descriptive name: Simvastatine | VUmc Neurology Department | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | Netherlands | ||
| 86 | EUCTR2017-001313-93-DE (EUCTR) | 27/03/2020 | 12/02/2020 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United 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 | ||
| 87 | EUCTR2019-001549-42-GB (EUCTR) | 27/03/2020 | 03/02/2020 | Stem cell transplantation versus disease modifying therapy (alemtuzumab or ocrelizumab) for patients with highly active relapsing remitting MS | A multicentre, randomised controlled trial to evaluate the efficacy of autologous haematopoietic stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis. - StarMS | Highly active relapsing remitting multiple sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Cyclophosphamide INN or Proposed INN: Cyclophosphamide monohydrate INN or Proposed INN: Cyclophosphamide monohydrate Product Name: Filgrastim INN or Proposed INN: Filgrastim Trade Name: Thymoglobuline Product Name: Thymoglobuline INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin INN or Proposed INN: Rabbit anti-human thymocyte immunoglobulin Trade Name: Alemtuzumab Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Product Name: Lenograstim INN or Proposed INN: Lenograstim Trade Name: Ocrelizumab Product Name: Ocrelizumab | Sheffield Teaching Hospitals | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 198 | Phase 3 | United Kingdom | ||
| 88 | EUCTR2016-001166-29-DE (EUCTR) | 18/03/2020 | 12/08/2019 | A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) | A randomised controlled trial to compare ocrelizumab or alemtuzumab with autologous hematopoietic stem cell transplantation (aHSCT) in high inflammatory multiple sclerosis (COAST) - COAST | relapsing-remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Lemtrada Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: ALEMTUZUMAB Trade Name: Ocrevus Product Name: ocrelizumab INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB Product Name: autologous hematopoietic stem cells Product Code: aHSC | University Medical Centre Hamburg-Eppendorf | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 89 | EUCTR2018-001511-73-DE (EUCTR) | 17/03/2020 | 17/06/2019 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United 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 | ||
| 90 | EUCTR2018-001511-73-IE (EUCTR) | 16/03/2020 | 08/05/2019 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Bulgaria;Germany;New Zealand;Georgia;Romania;Croatia;Poland;Belgium;Brazil;Canada;Mexico;Hungary;Egypt;United Kingdom;Austria;Netherlands;Australia;France;Italy;Colombia;Russian Federation;Ireland;Ukraine;Spain;Portugal;Serbia;United States | ||
| 91 | EUCTR2016-002667-34-PL (EUCTR) | 06/03/2020 | 14/11/2019 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | AN 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | United States;Poland;Italy | ||
| 92 | EUCTR2018-001511-73-RO (EUCTR) | 06/03/2020 | 17/03/2022 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;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 | ||
| 93 | EUCTR2018-001511-73-PT (EUCTR) | 02/03/2020 | 30/04/2019 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United 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 | ||
| 94 | NCT04175834 (ClinicalTrials.gov) | February 5, 2020 | 22/11/2019 | Comparing Risk and Severity of IRRs in Patients Premedicated With Cetirizine vs. Diphenhydramine Prior to Ocrelizumab | Comparing the Risk and Severity of Infusion-Related Reactions in Patients Premedicated With Cetirizine Versus Diphenhydramine Prior to Ocrelizumab Infusions | Multiple Sclerosis;Infusion Reaction | Drug: antihistamine | Providence Health & Services | Genentech, Inc. | Active, not recruiting | 18 Years | 70 Years | All | 52 | Phase 3 | United States |
| 95 | NCT04230174 (ClinicalTrials.gov) | February 2020 | 13/1/2020 | Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia Activation | Effect of Ocrelizumab on Neuroinflammation in Multiple Sclerosis as Measured by 11C-PBR28 MR-PET Imaging of Microglia Activation | Multiple Sclerosis | Drug: 11C-PBR28 | Massachusetts General Hospital | Genentech, Inc. | Not yet recruiting | 18 Years | 65 Years | All | 24 | Phase 4 | NULL |
| 96 | NCT04075266 (ClinicalTrials.gov) | January 9, 2020 | 14/8/2019 | A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis | An Open-Label, Parallel-Group Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 10 Years | 18 Years | All | 36 | Phase 2 | United States;Italy;Poland |
| 97 | EUCTR2018-001511-73-GB (EUCTR) | 23/12/2019 | 09/04/2019 | 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 - ORATORIO HAND | 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 - 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: no | 1000 | Phase 3 | Portugal;Hungary;Poland;Spain;Ireland;Croatia;Bulgaria;Germany;United Kingdom | |||
| 98 | EUCTR2018-001511-73-HU (EUCTR) | 18/12/2019 | 08/11/2019 | A 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] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-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): no | Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;United Kingdom;Austria;Netherlands;Australia;France;Italy;Colombia;Russian Federation;Ireland;Ukraine;Spain;Portugal;United States;Belarus;Serbia | ||
| 99 | EUCTR2018-001511-73-HR (EUCTR) | 16/12/2019 | 17/01/2020 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United 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 | ||
| 100 | EUCTR2018-001511-73-BG (EUCTR) | 02/10/2019 | 19/06/2019 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | United States;Serbia;Portugal;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 | ||
| 101 | EUCTR2018-001511-73-PL (EUCTR) | 30/09/2019 | 06/08/2019 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Serbia;Belarus;United States;Portugal;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand | ||
| 102 | EUCTR2017-001362-25-NL (EUCTR) | 30/09/2019 | 10/09/2019 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Cyclophosphamide Product Name: Cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE Trade Name: Thymoglobuline® Product Name: Thymoglobuline® INN or Proposed INN: ANTITHYMOCYTE IMMUNOGLOBULIN Other descriptive name: ANTITHYMOCYTE IMMUNOGLOBULIN Trade Name: Lemtrada INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB Trade Name: Mavenclad Product Name: Cladribine INN or Proposed INN: CLADRIBINE Trade Name: Ocrevus Product Name: Ocrelizumab INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Denmark;Netherlands | ||
| 103 | EUCTR2018-001511-73-IT (EUCTR) | 03/09/2019 | 17/06/2021 | Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis | A PHASE IIIb MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN ADULTS WITH PRIMARY PROGRESSIVE MULTIPLE SCLEROSIS - N/A | 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 | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1000 | Phase 3 | Portugal;Serbia;Belarus;United States;Spain;Ukraine;Ireland;Russian Federation;Colombia;Italy;France;Peru;Australia;Netherlands;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;New Zealand | ||
| 104 | EUCTR2016-002667-34-IT (EUCTR) | 03/09/2019 | 20/01/2022 | A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizumab in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | AN OPEN-LABEL, PARALLEL-GROUP STUDY TO EVALUATE SAFETY,TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMIC EFFECTS OF OCRELIZUMAB IN CHILDREN AND ADOLESCENTS WITH RELAPSINGREMITTINGMULTIPLE SCLEROSIS - A Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Ocrelizum | 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: na | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 36 | Phase 2 | United States;Poland;Italy | ||
| 105 | EUCTR2018-001511-73-ES (EUCTR) | 21/08/2019 | 04/07/2019 | A 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] | Trade Name: Ocrevus Product Name: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-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): no | Serbia;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 | ||
| 106 | NCT04966338 (ClinicalTrials.gov) | August 19, 2019 | 27/6/2021 | Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis | A Phase III, Randomized, Two-armed, Double-blind, Parallel, Active-controlled Clinical Trial to Evaluate Equivalency of the Efficacy and Safety of Ocrelizumab (CinnaGen, Iran) in Comparison to Reference Product, Ocrevus® (Roche, Switzerland) in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis;Relapsing-Remitting | Biological: Ocrelizumab (CinnaGen, Iran);Biological: Ocrelizumab (Roche, Switzerland) | Cinnagen | NULL | Active, not recruiting | 18 Years | 55 Years | All | 170 | Phase 3 | Iran, Islamic Republic of |
| 107 | NCT04035005 (ClinicalTrials.gov) | August 12, 2019 | 17/7/2019 | A 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 | Multiple Sclerosis, Primary Progressive | Drug: Ocrelizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 1000 | Phase 3 | United States;Australia;Austria;Belgium;Bulgaria;Canada;Colombia;Croatia;Egypt;France;Georgia;Germany;Hungary;Ireland;Italy;Mexico;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom;Brazil;Netherlands |
| 108 | NCT03972306 (ClinicalTrials.gov) | August 12, 2019 | 29/5/2019 | A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis | A Phase Ib, Open-Label, Multicenter Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Patients With Multiple Sclerosis | Multiple Sclerosis (MS) | Drug: Ocrelizumab;Drug: rHuPH20 | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 65 Years | All | 135 | Phase 1 | United States;Canada |
| 109 | NCT03873389 (ClinicalTrials.gov) | June 12, 2019 | 12/3/2019 | Ocrelizumab Effects on the Metabolome in MS | Evaluating the Effects of Ocrelizumab on the Circulating Metabolome in Multiple Sclerosis (MS) | Multiple Sclerosis | Drug: Ocrelizumab | Johns Hopkins University | Genentech, Inc. | Active, not recruiting | 18 Years | 75 Years | All | 25 | United States | |
| 110 | NCT03853746 (ClinicalTrials.gov) | April 1, 2019 | 22/2/2019 | Short-term B-cell Depletion in Relapsing Multiple Sclerosis | Evaluating the Effects of Short-term B-cell Depletion on Long-term Disease Activity and Immune Tolerance in Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Johns Hopkins University | National Multiple Sclerosis Society | Active, not recruiting | 18 Years | 99 Years | All | 10 | Phase 4 | United States |
| 111 | NCT03784547 (ClinicalTrials.gov) | February 1, 2019 | 13/12/2018 | Real-world Data of Ocrelizumab in Multiple Sclerosis in LATAM | Real-world Patient Profile and Treatment Persistence of Ocrelizumab in Multiple Sclerosis: A Retrospective Analysis in Latin America | Multiple Sclerosis | Drug: Ocrelizumab | Hospital Italiano de Buenos Aires | NULL | Recruiting | N/A | N/A | All | 100 | Argentina | |
| 112 | EUCTR2017-004886-29-IE (EUCTR) | 11/01/2019 | 09/05/2018 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Czechia;Estonia;Slovenia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Bulgaria;Netherlands;Norway;Sweden | ||
| 113 | NCT03593590 (ClinicalTrials.gov) | November 12, 2018 | 11/7/2018 | Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis | A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | N/A | All | 1700 | Austria;Belgium;Brazil;Bulgaria;Chile;Colombia;Dominican Republic;Egypt;Italy;Kuwait;Montenegro;Netherlands;Panama;Paraguay;Poland;Portugal;Qatar;Romania;Russian Federation;Saudi Arabia;Serbia;Slovakia;Spain;Turkey;United Arab Emirates;United Kingdom;Israel | |
| 114 | NCT03691077 (ClinicalTrials.gov) | November 11, 2018 | 28/9/2018 | Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in MS Using PET-MRI With 18F-DPA714 | A Prospective Study Evaluating the Effect of Ocrelizumab on Brain Innate Immune Microglial Cells Activation in Multiple Sclerosis Using PET-MRI With 18F-DPA714 | Multiple Sclerosis;Relapse;Primary Progressive Multiple Sclerosis | Drug: Ocrelizumab | Assistance Publique - Hôpitaux de Paris | Roche Pharma AG;Institut du Cerveau et de la Moelle épinière | Recruiting | 18 Years | 60 Years | All | 51 | Phase 3 | France |
| 115 | NCT03396822 (ClinicalTrials.gov) | September 24, 2018 | 4/1/2018 | Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis | Meningeal Inflammation on 7T MRI as a Tool for Measuring and Predicting Ocrelizumab Response in Multiple Sclerosis | Multiple Sclerosis | Drug: Gadoteridol | University of Maryland, Baltimore | Genentech, Inc. | Active, not recruiting | 18 Years | 65 Years | All | 24 | United States | |
| 116 | NCT03606460 (ClinicalTrials.gov) | September 14, 2018 | 23/7/2018 | A 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 Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab Dose 1;Drug: Ocrelizumab Dose 2 and Dose 3 | Genentech, Inc. | NULL | Completed | 18 Years | 55 Years | All | 141 | Phase 3 | United States |
| 117 | EUCTR2017-004158-40-FR (EUCTR) | 11/09/2018 | 04/07/2018 | NA | A Prospective study evaluating the effect of ocrelizumab on brain innate immune Microglial cells Activation in Multiple Sclerosis using PET-MRI with 18F-DPA714 - INN-MS | Patients with Relapsing MS or primary progressive MS MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrevus INN or Proposed INN: ocrelizumab Other descriptive name: ocrelizumab | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 71 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 118 | EUCTR2017-004886-29-NL (EUCTR) | 05/09/2018 | 27/06/2018 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 659 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 119 | EUCTR2017-004886-29-CZ (EUCTR) | 08/08/2018 | 10/05/2018 | A 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1127 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 120 | NCT03589105 (ClinicalTrials.gov) | August 6, 2018 | 5/7/2018 | A Study to Provide Complementary Efficacy, Safety and Patient Reported Outcomes Data in Participants With Active Relapsing Forms of Multiple Sclerosis (MS) in a Pragmatic Setting | An 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 Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab 300 mg;Drug: Ocrelizumab 600 mg | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 423 | Phase 4 | France |
| 121 | NCT03562975 (ClinicalTrials.gov) | July 23, 2018 | 23/5/2018 | Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus | A Single-center Prospective Measurement of Upper Extremity Function in Multiple Sclerosis Patients With Advanced Disability Treated With Ocrevus™ | Multiple Sclerosis;Pathologic Processes;Demyelinating Diseases;Nervous System Diseases;Autoimmune Diseases;Immune System Diseases;Primary Progressive Multiple Sclerosis;Relapsing Remitting Multiple Sclerosis | Drug: Ocrelizumab | University of South Florida | Genentech, Inc. | Active, not recruiting | 18 Years | 70 Years | All | 18 | United States | |
| 122 | EUCTR2017-004886-29-SE (EUCTR) | 23/07/2018 | 05/06/2018 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 659 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 123 | NCT03599245 (ClinicalTrials.gov) | July 12, 2018 | 25/6/2018 | This 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 Trials | Multiple Sclerosis | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 1500 | Phase 3 | Argentina;Belgium;Brazil;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;Finland;France;Hungary;Ireland;Italy;Kuwait;Mexico;Netherlands;Norway;Poland;Portugal;Slovakia;Slovenia;Spain;Sweden;Turkey;United Kingdom |
| 124 | EUCTR2017-001313-93-CZ (EUCTR) | 09/07/2018 | 26/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United Arab Emirates;Morocco;Costa Rica;Spain;Lebanon;Ireland;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Czech Republic;Hungary;Mexico;Canada;Brazil;Poland;Germany;Algeria | ||
| 125 | EUCTR2017-004886-29-FR (EUCTR) | 05/07/2018 | 17/05/2018 | A 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] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | Authorised-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): no | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 126 | EUCTR2017-004886-29-GB (EUCTR) | 03/07/2018 | 02/07/2018 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1224 | Phase 3 | France;Czech Republic;Estonia;Finland;Spain;Ireland;Denmark;Netherlands;United Kingdom;Sweden | ||
| 127 | EUCTR2017-001362-25-DK (EUCTR) | 27/06/2018 | 21/03/2018 | Randomized study with stem cell transplantation versus standard treatment with alemtuzumab, cladribine or ocrelizumab in patients with relapsing remitting multiple sclerosis. | Randomized autologous hematopoietic stem cell transplantation versus alemtuzumab, cladribine or ocrelizumab for patients with relapsing remitting Multiple Sclerosis - RAM-MS | Relapsing remitting multiple sclerosis. MedDRA version: 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: Sendoxane Product Name: Cyclophosphamide Trade Name: Thymoglobuline® Product Name: Thymoglobuline® Trade Name: Lemtrada Product Name: alemtuzumab Trade Name: Sendoxane Product Name: Cyclophosphamide Trade Name: Mavenclad Product Name: Cladribine Trade Name: Ocrevus Product Name: Ocrelizumab | Helse Bergen HF, Haukeland University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Denmark;Netherlands | ||
| 128 | EUCTR2017-004886-29-IT (EUCTR) | 25/06/2018 | 17/06/2021 | A 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 INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIAL - A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis | Multiple sclerosis (MS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;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 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: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1224 | Phase 3;Phase 4 | Portugal;Czechia;Estonia;Slovakia;Slovenia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Denmark;Bulgaria;Netherlands;Norway;Sweden | ||
| 129 | EUCTR2017-001313-93-HU (EUCTR) | 21/06/2018 | 25/04/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 130 | EUCTR2017-004886-29-DK (EUCTR) | 21/06/2018 | 18/05/2018 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 659 | Phase 3 | Portugal;Estonia;Slovakia;Spain;Ireland;Italy;France;Denmark;Netherlands;Czechia;Slovenia;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Bulgaria;Norway;Sweden | ||
| 131 | EUCTR2017-004886-29-FI (EUCTR) | 19/06/2018 | 15/06/2018 | A 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 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 132 | EUCTR2017-001313-93-PL (EUCTR) | 08/06/2018 | 15/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United 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 | ||
| 133 | EUCTR2017-004886-29-EE (EUCTR) | 31/05/2018 | 18/04/2018 | A 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 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 134 | NCT03523858 (ClinicalTrials.gov) | May 28, 2018 | 16/4/2018 | A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis | An 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) | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 65 Years | All | 900 | Phase 3 | United 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 |
| 135 | EUCTR2017-004886-29-ES (EUCTR) | 22/05/2018 | 09/04/2018 | A 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] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd | NULL | Not 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): no | Estonia;Finland;Spain;Ireland;Turkey;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Norway;Sweden | ||
| 136 | EUCTR2017-001313-93-ES (EUCTR) | 11/05/2018 | 02/03/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN 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 LTD | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 137 | EUCTR2017-001313-93-IE (EUCTR) | 03/05/2018 | 06/02/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United 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 | ||
| 138 | EUCTR2018-000780-91-FR (EUCTR) | 26/04/2018 | 30/03/2018 | STUDY TO ASSESS OCRELIZUMAB EFFICACY, SAFETY AND IMPACT ON PATIENT REPORTED OUTCOMES (PROS) IN PATIENTS WITH ACTIVE RELAPSING MULTIPLE SCLEROSIS(PRO-MSACTIVE) | AN 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 SCLEROSIS(PRO-MSACTIVE) - PRO-MSActive | ACTIVE RELAPSING MULTIPLE SCLEROSIS (Active RMS) 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 10063400;Term: Secondary progressive multiple sclerosis;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: Ocrevus 300 mg, solution à diluer pour perfusion Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 570 | Phase 4 | France | ||
| 139 | EUCTR2017-001313-93-DK (EUCTR) | 04/04/2018 | 23/02/2018 | A Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients with Progressive Multiple Sclerosis | AN 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 900 | Phase 3 | United Arab Emirates;Morocco;Costa Rica;Spain;Ireland;Lebanon;Russian Federation;Colombia;Italy;France;Denmark;Netherlands;Bosnia and Herzegovina;Panama;Czechia;Guatemala;Egypt;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Germany;Algeria | ||
| 140 | EUCTR2016-002937-31-HR (EUCTR) | 29/11/2017 | 13/04/2018 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United 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 | ||
| 141 | NCT03025269 (ClinicalTrials.gov) | November 15, 2017 | 16/1/2017 | Ocrelizumab Effects on Physiological and Cognitive Changes in Multiple Sclerosis | Effect of Ocrelizumab on Gray Matter Pathology, Leptomeningeal Inflammation and Cognitive Dysfunction in Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | University at Buffalo | NULL | Completed | 18 Years | 60 Years | All | 30 | United States | |
| 142 | NCT03344094 (ClinicalTrials.gov) | October 12, 2017 | 13/10/2017 | Mechanism of Action of Ocrelizumab in Multiple Sclerosis | Mechanism of Action of Ocrelizumab in Multiple Sclerosis | Multiple Sclerosis;Immune System Diseases | Drug: ocrelizumab | University of Chicago | NULL | Recruiting | 18 Years | 65 Years | All | 30 | N/A | United States |
| 143 | EUCTR2016-002937-31-NO (EUCTR) | 12/09/2017 | 18/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Norway;Germany;Sweden;Slovakia;Portugal;United States | ||
| 144 | EUCTR2016-002937-31-DE (EUCTR) | 11/09/2017 | 02/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 145 | EUCTR2016-002937-31-GB (EUCTR) | 06/09/2017 | 05/09/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United 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 | ||
| 146 | EUCTR2016-002937-31-NL (EUCTR) | 21/08/2017 | 15/06/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1228 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 147 | EUCTR2016-002937-31-BG (EUCTR) | 02/08/2017 | 30/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Denmark;Australia;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 148 | EUCTR2016-002937-31-ES (EUCTR) | 31/07/2017 | 29/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 149 | EUCTR2016-002937-31-FR (EUCTR) | 26/07/2017 | 30/10/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United 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 | ||
| 150 | EUCTR2016-002937-31-PT (EUCTR) | 24/07/2017 | 04/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United 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 | ||
| 151 | EUCTR2016-002937-31-IT (EUCTR) | 24/07/2017 | 17/06/2021 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An Open-Label, single-arm study to Evaluate the Effectiveness and Safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis - ENSEMBLE | Relapsing remitting multiple sclerosis (RRMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;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 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: Ocrelizumab Product Code: RO4964913/F07-01 INN or Proposed INN: OCRELIZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | United States;Portugal;Slovakia;Spain;Italy;Switzerland;France;Denmark;Netherlands;Slovenia;Finland;Turkey;Austria;United Kingdom;Hungary;Mexico;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 152 | EUCTR2016-002937-31-BE (EUCTR) | 10/07/2017 | 05/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United 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 | ||
| 153 | EUCTR2016-002937-31-HU (EUCTR) | 29/06/2017 | 08/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 154 | EUCTR2016-002937-31-PL (EUCTR) | 26/06/2017 | 10/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden;Mexico;Hungary;United Kingdom;Austria;Turkey;Slovenia;Netherlands;Kuwait;Australia;Denmark;France;Italy;Switzerland;Lebanon;Spain;Slovakia;Portugal;United States | ||
| 155 | EUCTR2016-002937-31-AT (EUCTR) | 19/06/2017 | 20/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United 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 | ||
| 156 | EUCTR2016-002937-31-SE (EUCTR) | 19/06/2017 | 20/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Netherlands;Kuwait;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Croatia;Bulgaria;Germany;Norway;Sweden | ||
| 157 | EUCTR2016-002937-31-SK (EUCTR) | 16/06/2017 | 11/05/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 158 | EUCTR2016-002937-31-SI (EUCTR) | 16/06/2017 | 13/06/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden;United States;Portugal;Slovakia | ||
| 159 | EUCTR2016-002937-31-DK (EUCTR) | 08/06/2017 | 28/04/2017 | A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Early Stage Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1225 | Phase 3 | United States;Portugal;Slovakia;Spain;Lebanon;Switzerland;Italy;France;Australia;Denmark;Kuwait;Netherlands;Slovenia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 160 | NCT03085810 (ClinicalTrials.gov) | March 24, 2017 | 16/3/2017 | Study 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 Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 1225 | Phase 3 | United 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 |
| 161 | NCT02980042 (ClinicalTrials.gov) | January 1, 2017 | 9/11/2016 | Tolerability and Safety of Switching From Rituximab to Ocrelizumab in Patients With Relapsing Forms of Multiple Sclerosis | Evaluating the Tolerability and Safety Profile of Switching From Rituximab to Ocrelizumab: A Real World Evaluation of Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab;Drug: Rituximab | University of Colorado, Denver | NULL | Completed | 18 Years | 65 Years | All | 200 | Phase 3 | United States |
| 162 | EUCTR2015-004616-37-DE (EUCTR) | 24/11/2016 | 05/08/2016 | A 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: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 3 | United States;Germany;Switzerland;Sweden | ||
| 163 | EUCTR2015-005597-38-CZ (EUCTR) | 07/10/2016 | 17/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 164 | NCT02807285 (ClinicalTrials.gov) | October 2016 | 16/6/2016 | Expanded Access Program for Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis | An Open Label, MultiCenter, Expanded-Access Program for Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | Multiple Sclerosis | Drug: Ocrelizumab | Genentech, Inc. | NULL | No longer available | 18 Years | 55 Years | All | N/A | United States | |
| 165 | EUCTR2015-005597-38-FI (EUCTR) | 12/09/2016 | 21/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 166 | NCT02861014 (ClinicalTrials.gov) | September 9, 2016 | 5/8/2016 | A 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 Treatment | Multiple Sclerosis, Relapsing-Remitting | Biological: Ocrelizumab | Hoffmann-La Roche | NULL | Completed | 18 Years | 55 Years | All | 681 | Phase 3 | Australia;Belgium;Czechia;Denmark;Estonia;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;Turkey;United Kingdom;Czech Republic;Hong Kong |
| 167 | EUCTR2015-005597-38-IT (EUCTR) | 08/09/2016 | 04/11/2020 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;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 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: Ocrelizumab Product Code: [RO4964913/F07] INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. HOFFMANN - LA ROCHE LTD. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Czechia;Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 168 | EUCTR2015-004616-37-SE (EUCTR) | 03/08/2016 | 19/04/2016 | A 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: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;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. | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 3 | United States;Germany;Switzerland;Sweden | ||
| 169 | EUCTR2015-005597-38-BE (EUCTR) | 14/07/2016 | 16/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 170 | EUCTR2015-005597-38-NL (EUCTR) | 11/07/2016 | 01/06/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;Estonia;France;Czech Republic;Belgium;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 171 | EUCTR2015-005597-38-DE (EUCTR) | 29/06/2016 | 07/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 172 | EUCTR2015-005597-38-DK (EUCTR) | 02/06/2016 | 06/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 173 | EUCTR2015-005597-38-EE (EUCTR) | 25/05/2016 | 06/04/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 174 | EUCTR2015-005597-38-SE (EUCTR) | 25/05/2016 | 15/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 175 | EUCTR2015-005597-38-FR (EUCTR) | 23/05/2016 | 15/02/2018 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 176 | EUCTR2015-005597-38-GB (EUCTR) | 19/05/2016 | 09/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;United Kingdom;Switzerland;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 177 | EUCTR2015-005597-38-IE (EUCTR) | 13/05/2016 | 10/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 750 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;United Kingdom;Switzerland;Italy;France;Czech Republic;Belgium;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 178 | NCT02688985 (ClinicalTrials.gov) | April 29, 2016 | 18/2/2016 | Study 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 Sclerosis | Relapsing Multiple Sclerorsis;Multiple Sclerosis, Primary Progressive | Drug: Ocrelizumab;Procedure: Lumbar Puncture;Drug: Methyloprednisolone;Drug: Antihistamine | Genentech, Inc. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 127 | Phase 3 | United States;Canada;Germany;Sweden |
| 179 | EUCTR2015-005597-38-ES (EUCTR) | 26/04/2016 | 18/03/2016 | A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis | An 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 Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 600 | Phase 3 | Estonia;Greece;Finland;Spain;Ireland;Turkey;Italy;Switzerland;United Kingdom;France;Czech Republic;Belgium;Denmark;Norway;Netherlands;Germany;Sweden | ||
| 180 | NCT02637856 (ClinicalTrials.gov) | February 11, 2016 | 18/12/2015 | A 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 Treatment | Multiple Sclerosis, Relapsing-Remitting | Drug: Ocrelizumab | Genentech, Inc. | NULL | Completed | 18 Years | 55 Years | All | 608 | Phase 3 | United States;Canada |
| 181 | NCT02545868 (ClinicalTrials.gov) | October 27, 2015 | 8/9/2015 | A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis | A 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 Sclerosis | Multiple Sclerosis, Relapsing-Remitting | Biological: 23-PPV;Biological: 13-PCV Booster;Biological: Influenza Vaccine;Biological: KLH;Drug: OCR;Biological: TT Vaccine | Hoffmann-La Roche | NULL | Completed | 18 Years | 55 Years | All | 102 | Phase 3 | United States;Canada |
| 182 | EUCTR2010-020338-25-NL (EUCTR) | 02/03/2013 | 30/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 183 | EUCTR2010-020315-36-CZ (EUCTR) | 18/10/2012 | 22/08/2012 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 184 | EUCTR2010-020337-99-NL (EUCTR) | 13/04/2012 | 19/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg /10ml Product Code: RO4964913 F07 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-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): no | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Netherlands;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 185 | EUCTR2010-020315-36-BG (EUCTR) | 28/11/2011 | 19/08/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 186 | EUCTR2010-020315-36-BE (EUCTR) | 14/11/2011 | 30/06/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-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): no | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 187 | EUCTR2010-020315-36-IE (EUCTR) | 04/11/2011 | 08/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 188 | EUCTR2010-020337-99-PL (EUCTR) | 25/10/2011 | 13/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Bulgaria;Germany;New Zealand | ||
| 189 | EUCTR2010-020337-99-GB (EUCTR) | 20/10/2011 | 05/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 190 | EUCTR2010-020315-36-GB (EUCTR) | 20/10/2011 | 16/08/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 191 | EUCTR2010-020315-36-ES (EUCTR) | 18/10/2011 | 21/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Croatia;United States;Bosnia and Herzegovina;Spain;Argentina;Mexico;Belgium;Belarus;Peru;Canada;Ukraine;Russian Federation;United Kingdom;Brazil;Sweden;Italy;Ireland;Turkey;Colombia | |||
| 192 | EUCTR2010-020315-36-SK (EUCTR) | 18/10/2011 | 28/06/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Belarus;United States;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 193 | EUCTR2010-020315-36-FR (EUCTR) | 07/10/2011 | 02/09/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 194 | EUCTR2010-020315-36-IT (EUCTR) | 05/10/2011 | 27/12/2011 | A study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-Blind, Double Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: OCRELIZUMAB Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | ROCHE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 469 | Colombia;Turkey;Ireland;Italy;Sweden;Brazil;United Kingdom;Russian Federation;Canada;Ukraine;Belarus;Peru;Belgium;Argentina;Mexico;Spain;Bosnia and Herzegovina;United States;Croatia | |||
| 195 | EUCTR2010-020315-36-DE (EUCTR) | 22/09/2011 | 08/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 196 | EUCTR2010-020337-99-ES (EUCTR) | 21/09/2011 | 20/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;Serbia;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain | |||
| 197 | NCT01412333 (ClinicalTrials.gov) | September 20, 2011 | 8/8/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 835 | Phase 3 | United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic;Morocco |
| 198 | EUCTR2010-020337-99-IT (EUCTR) | 19/09/2011 | 29/03/2012 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a inPatients With Relapsing Multiple Sclerosis. | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study ToEvaluate The Efficacy And Safety Of Ocrelizumab In Comparison ToInterferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: OCRELIZUMAB Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: NA | ROCHE | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain | |||
| 199 | EUCTR2010-020337-99-DE (EUCTR) | 05/09/2011 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 200 | NCT01247324 (ClinicalTrials.gov) | August 31, 2011 | 23/11/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 821 | Phase 3 | Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;United States;Czech Republic;Morocco;New Zealand;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France |
| 201 | EUCTR2010-020315-36-SE (EUCTR) | 31/08/2011 | 05/07/2011 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina | ||
| 202 | EUCTR2010-020337-99-SK (EUCTR) | 23/06/2011 | 14/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 203 | EUCTR2010-020338-25-DE (EUCTR) | 08/06/2011 | 06/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10 ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10 ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 204 | EUCTR2010-020338-25-PL (EUCTR) | 04/06/2011 | 14/05/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Peru;Australia;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 205 | EUCTR2010-020338-25-BE (EUCTR) | 26/05/2011 | 22/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 206 | EUCTR2010-020338-25-BG (EUCTR) | 11/05/2011 | 19/01/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: Ro 496-4913/F03 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 207 | EUCTR2010-020337-99-BG (EUCTR) | 07/03/2011 | 17/12/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 208 | NCT01194570 (ClinicalTrials.gov) | March 2, 2011 | 28/8/2010 | A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis | A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Drug: Ocrelizumab;Other: Placebo | Hoffmann-La Roche | NULL | Active, not recruiting | 18 Years | 55 Years | All | 732 | Phase 3 | United States;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Czechia;Finland;France;Germany;Greece;Hungary;Israel;Italy;Lithuania;Mexico;Netherlands;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Spain;Switzerland;Ukraine;United Kingdom;Uruguay;Czech Republic;Denmark;Turkey |
| 209 | EUCTR2010-020338-25-DK (EUCTR) | 02/03/2011 | 07/02/2011 | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 15.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 650 | Phase 3 | Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria;Netherlands;Germany | ||
| 210 | EUCTR2010-020337-99-BE (EUCTR) | 23/02/2011 | 12/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 211 | EUCTR2010-020337-99-CZ (EUCTR) | 21/02/2011 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 212 | EUCTR2010-020337-99-PT (EUCTR) | 04/02/2011 | 29/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Serbia;Portugal;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 213 | EUCTR2010-020338-25-AT (EUCTR) | 26/01/2011 | 18/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 214 | EUCTR2010-020338-25-GR (EUCTR) | 21/01/2011 | 17/01/2011 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 215 | EUCTR2010-020337-99-AT (EUCTR) | 20/01/2011 | 18/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 216 | EUCTR2010-020338-25-CZ (EUCTR) | 20/01/2011 | 05/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 217 | EUCTR2010-020337-99-LT (EUCTR) | 17/01/2011 | 27/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 218 | EUCTR2010-020338-25-PT (EUCTR) | 12/01/2011 | 14/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: OCREVUS Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Poland;Belgium;Brazil;Bulgaria;Germany;Norway;New Zealand;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Lithuania;Finland;Czechia;Netherlands;Denmark;Australia;Peru;France;Italy;Switzerland;Israel;Russian Federation;Ukraine;Spain;Greece;Slovakia;Portugal;United States | ||
| 219 | EUCTR2010-020338-25-GB (EUCTR) | 29/12/2010 | 05/10/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 220 | EUCTR2010-020337-99-LV (EUCTR) | 29/12/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 221 | EUCTR2010-020338-25-ES (EUCTR) | 20/12/2010 | 17/09/2010 | Estudio de fase III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ocrelizumab en adultos con esclerosis múltiple progresiva primaria A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Estudio de fase III, multicéntrico, aleatorizado, de grupos paralelos, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de ocrelizumab en adultos con esclerosis múltiple progresiva primaria A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Esclerosis múltiple progresiva primaria (EMPP) MedDRA version: 12.1;Level: LLT;Classification code 10063401;Term: Primary progressive multiple sclerosis | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: - | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Bulgaria | ||
| 222 | EUCTR2010-020338-25-FI (EUCTR) | 15/12/2010 | 15/12/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Belgium;Brazil;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 223 | EUCTR2010-020337-99-FI (EUCTR) | 15/12/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 224 | EUCTR2010-020338-25-IT (EUCTR) | 07/12/2010 | 24/12/2010 | A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adultswith Primary Progressive Multiple Sclerosis. - ORATORIO | A Phase III, multicentre, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adultswith Primary Progressive Multiple Sclerosis. - ORATORIO | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 9.1;Level: LLT;Classification code 10063401 | Product Name: ocrelizumab | F. Hoffmann - La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 650 | Phase 3 | Portugal;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Czech Republic;Belgium;Denmark;Bulgaria | ||
| 225 | EUCTR2010-020337-99-EE (EUCTR) | 26/11/2010 | 27/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | ||
| 226 | EUCTR2010-020338-25-HU (EUCTR) | 17/11/2010 | 29/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 18.0;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: Ro 496-4913/F03 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | Portugal;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Switzerland;Italy;France;Peru;Australia;Denmark;Netherlands;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Poland;Brazil;Belgium;Bulgaria;Norway;Germany;New Zealand | ||
| 227 | EUCTR2010-020337-99-HU (EUCTR) | 17/11/2010 | 11/10/2010 | A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I | Relapsing Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 800 | Portugal;United States;Serbia;Estonia;Morocco;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand | |||
| 228 | EUCTR2010-020338-25-LT (EUCTR) | 02/11/2010 | 02/09/2010 | A Study of Ocrelizumab in Patients With Primary Progressive Multiple Sclerosis | A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis - Oratorio | Primary Progressive Multiple Sclerosis (PPMS) MedDRA version: 21.1;Level: PT;Classification code 10063401;Term: Primary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: ocrelizumab 300mg/10ml Product Code: Ro 496-4913/F07 INN or Proposed INN: ocrelizumab | F.Hoffmann-La Roche | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 630 | Phase 3 | United States;Portugal;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Peru;Netherlands;Czechia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Brazil;Belgium;Poland;Bulgaria;Germany;Norway;New Zealand | ||
| 229 | EUCTR2007-006338-32-FI (EUCTR) | 08/10/2008 | 30/06/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 230 | EUCTR2007-006338-32-BG (EUCTR) | 07/10/2008 | 31/07/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Multiple sclerosis is a disabling disease of brain and spinal cord thatdisrupts flow of information within brain, characterized by flare-ups withperiods of remission in between (relapsing remitting) MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: oclelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 231 | EUCTR2007-006338-32-BE (EUCTR) | 15/09/2008 | 17/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 232 | EUCTR2007-006338-32-IT (EUCTR) | 11/09/2008 | 02/10/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI. | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with RRMS. | Relapsing-Remitting Multiple Sclerosis (RRMS). MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: Ocrelizumab Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | F.Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Denmark;Bulgaria;Netherlands;Germany | ||
| 233 | NCT00676715 (ClinicalTrials.gov) | July 31, 2008 | 9/5/2008 | A Study of the Efficacy and Safety of Ocrelizumab in Patients With Relapsing-Remitting Multiple Sclerosis | Phase II, Multicenter, Randomized, Parallel-Group, Partially Blinded, Placebo and Avonex Controlled Dose Finding Study to Evaluate the Efficacy As Measured by Brain MRI Lesions, and Safety of 2 Dose Regimens of Ocrelizumab in Patients With RRMS | Multiple Sclerosis, Relapsing-Remitting | Drug: Placebo;Drug: Ocrelizumab;Drug: Avonex | Genentech, Inc. | Roche Pharma AG | Active, not recruiting | 18 Years | 55 Years | All | 220 | Phase 2 | United States;Belgium;Bulgaria;Canada;Czechia;Denmark;France;Germany;Italy;Mexico;Romania;Russian Federation;Serbia;Slovakia;Spain;Switzerland;Ukraine;United Kingdom;Czech Republic;Finland;Netherlands |
| 234 | EUCTR2007-006338-32-GB (EUCTR) | 28/07/2008 | 07/03/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 235 | EUCTR2007-006338-32-ES (EUCTR) | 16/07/2008 | 28/03/2008 | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom | ||
| 236 | EUCTR2007-006338-32-DE (EUCTR) | 09/07/2008 | 17/03/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrrelizumab 300 mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrrelizumab 300 mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | F. Hoffman-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 237 | EUCTR2007-006338-32-NL (EUCTR) | 09/07/2008 | 29/05/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy | ||
| 238 | EUCTR2007-006338-32-DK (EUCTR) | 09/07/2008 | 09/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 239 | EUCTR2007-006338-32-SK (EUCTR) | 16/06/2008 | 09/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Other descriptive name: OCRELIZUMAB | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 240 | EUCTR2007-006338-32-CZ (EUCTR) | 28/05/2008 | 01/04/2008 | A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab Trade Name: Ocrevus Product Name: Ocrelizumab 300mg Product Code: RO4964913/F07 INN or Proposed INN: ocrelizumab | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany | ||
| 241 | EUCTR2007-006338-32-FR (EUCTR) | 06/05/2008 | 26/02/2008 | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis | Relapsing remitting multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Product Name: Ocrelizumab Product Code: RO4964913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMab 2H7 Trade Name: Avonex INN or Proposed INN: INTERFERON BETA-1A | Hoffman La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 2 | France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom | ||
| 242 | EUCTR2021-000063-79-DE (EUCTR) | 25/08/2021 | A Study to Evaluate B Cell Levels in Infants of Lactating Women with Clinically Isolated Syndrome or Multiple sclerosis Receiving Ocrelizumab | A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY | Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications] MedDRA version: 20.0;Level: PT;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.1;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 20 | Phase 4 | France;United States;Canada;Spain;Germany;United Kingdom;Switzerland;Italy | |||
| 243 | EUCTR2020-004128-41-FR (EUCTR) | 23/07/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany | |||
| 244 | EUCTR2020-004128-41-AT (EUCTR) | 01/12/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Denmark;Australia;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Bulgaria;Germany | |||
| 245 | EUCTR2020-004128-41-DK (EUCTR) | 02/09/2021 | A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison with Fingolimod in Children and Adolescents with Relapsing-Remitting Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS | Relapsing-Remitting Multiple Sclerosis MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Ocrevus INN or Proposed INN: Ocrelizumab Other descriptive name: OCRELIZUMAB Trade Name: Gilenya INN or Proposed INN: Fingolimod Other descriptive name: FINGOLIMOD | F. Hoffmann-La Roche Ltd | NULL | NA | Female: yes Male: yes | 233 | Phase 3 | United States;Serbia;Portugal;Greece;Spain;Ukraine;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Netherlands;Czechia;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Romania;Bulgaria;Germany |
46. Malignant rheumatoid arthritis
Clinical trials : 4,325 / Drugs : 2,671 - (DrugBank : 417) / Drug target genes : 187 - Drug target pathways : 224
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2006-005330-20-CZ (EUCTR) | 19/02/2010 | 19/04/2007 | anti TNF-IR phase III | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Hungary;Czech Republic;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 2 | JPRN-JapicCTI-090764 | 01/6/2009 | 26/05/2009 | Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis | Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis | Rheumatoid Arthritis | Intervention name : Ocrelizumab Dosage And administration of the intervention : 500 mg will be administered by intravenous infusion on Day 1 and Day 15. Repeat courses of therapy with ocrelizumab may be administered basically every 24 weeks, a minimum interval of 12 weeks, between courses. | Chugai Pharmaceutical Co., Ltd. | NULL | 20 | BOTH | 200 | Phase 3 | NULL | ||
| 3 | NCT00808210 (ClinicalTrials.gov) | March 5, 2009 | 11/12/2008 | A Study to Evaluate Ocrelizumab in Combination With Methotrexate Compared With Infliximab Plus Methotrexate in Patients With Active Rheumatoid Arthritis Currently Responding Inadequately to Etanercept or Adalimumab | A PHASE II RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRELIZUMAB IN COMBINATION WITH METHOTREXATE, COMPARED TO INFLIXIMAB PLUS METHOTREXATE IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS CURRENTLY RESPONDING INADEQUATELY TO ETANERCEPT OR ADALIMUMAB | Rheumatoid Arthritis | Drug: Infliximab;Drug: Methotrexate;Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | NULL | Terminated | 18 Years | N/A | All | 28 | Phase 2 | United States |
| 4 | EUCTR2006-005353-30-GB (EUCTR) | 04/11/2008 | 01/04/2008 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. | Rheumatoid arthritis MedDRA version: 15.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not 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): no | Spain;Lithuania;Austria;Italy;United Kingdom | ||
| 5 | NCT00779220 (ClinicalTrials.gov) | October 2008 | 23/10/2008 | A Study to Evaluate the Efficacy, Safety and Pharmacokinetics/Pharmacodynamics (PK/PD) of Ocrelizumab in Patients With Rheumatoid Arthritis | A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis | Drug: placebo;Drug: methotrexate;Drug: ocrelizumabu 50mg;Drug: ocrelizumabu 200mg;Drug: ocrelizumab 500mg | Chugai Pharmaceutical | NULL | Terminated | 20 Years | N/A | Both | 152 | Phase 2 | Japan |
| 6 | EUCTR2007-005759-41-DE (EUCTR) | 21/05/2008 | 21/02/2008 | A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusion | A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy - FEATURE: Ocrelizumab in MTX-IR RA-patients; mono- vs. dual infusion | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | United Kingdom;Germany;France;Spain;Italy | |||
| 7 | EUCTR2007-005759-41-IT (EUCTR) | 06/05/2008 | 10/10/2008 | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy. - ND | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy. - ND | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: Ocrelizumab Product Code: RO-496-4913 | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Spain;Germany;United Kingdom;Italy | |||
| 8 | EUCTR2007-005759-41-GB (EUCTR) | 29/04/2008 | 29/02/2008 | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy - FEATURE | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Germany;Italy;United Kingdom | ||
| 9 | NCT00673920 (ClinicalTrials.gov) | April 24, 2008 | 5/5/2008 | A Study to Evaluate Ocrelizumab Compared With Placebo in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Given As a Single Infusion or Dual Infusion Compared With Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 18 Years | N/A | All | 314 | Phase 3 | United States |
| 10 | EUCTR2007-005759-41-ES (EUCTR) | 23/04/2008 | 19/02/2008 | Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy | Estudio internacional randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab administrado en un régimen de una o dos infusiones, comparado con placebo, en pacientes con artritis reumatoide activa que manifiestan una respuesta inadecuada a tratamiento con metotrexato.A Randomized, Double-Blind, Parallel-Group, InternationalStudy to Evaluate the Safety and Efficacy of Ocrelizumab Givenas a Single Infusion or Dual Infusion Compared with Placebo inPatients with Active Rheumatoid Arthritis Who Have anInadequate Response to Methotrexate Therapy | Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Germany;Italy;United Kingdom | ||
| 11 | EUCTR2007-005759-41-FR (EUCTR) | 19/03/2008 | 12/02/2008 | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy | A Randomized, Double-Blind, Parallel-Group, International Study to Evaluate the safety and Efficacy of Ocrelizumab Given as a Single Infusion or Dual Infusion Compared with Placebo in Patients with Active Rheumatoid Arthritis Who Have an inadequate Response to Methotrexate Therapy | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Spain;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2004-002132-26-GB (EUCTR) | 19/02/2008 | 11/03/2005 | A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A | A randomized placebo-controlled, multicenter, blinded Phase I/II study of the safety of escalating single intravenous doses of ocrelizumab (Ro 496-4913, PRO70769, rhuMAb 2H7) in patients with moderate to severe rheumatoid arthritis receiving stable doses of concomitant methotrexate but with unsatisfactory clinical response. - N/A | Rheumatoid Arthritis | Product Name: Ocrelizumab / rhuMAb 2H7 Product Code: Ro 496-4913 INN or Proposed INN: Ocrelizumab Other descriptive name: rhuMAb 2H7 | F. Hoffmann-La Roche Limited | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;United Kingdom | ||
| 13 | EUCTR2006-005353-30-AT (EUCTR) | 19/12/2007 | 23/05/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. | Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | Spain;Lithuania;Austria;United Kingdom;Italy | |||
| 14 | EUCTR2006-005330-20-SE (EUCTR) | 22/10/2007 | 27/08/2007 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | |||
| 15 | EUCTR2006-005353-30-LT (EUCTR) | 10/10/2007 | 28/06/2007 | A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) FILM. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab in combination with methotrexate (MTX) compared to MTX alone in methotrexate- naïve patients with active rheumatoid arthritis. - FILM | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Panama;Philippines;Taiwan;Thailand;Spain;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;Mexico;Argentina;Brazil;Poland;Australia;Peru;South Africa;New Zealand;Korea, Republic of | |||
| 16 | EUCTR2006-005330-20-IT (EUCTR) | 10/10/2007 | 15/10/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-α therapy. - ND | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-α therapy. - ND | Rheumatoid Arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073 | Product Name: Ocrelizumab Product Code: RO 496-4913 | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | |||
| 17 | EUCTR2006-005353-30-IT (EUCTR) | 01/10/2007 | 19/07/2007 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - ND | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab in combinationwith methotrexate (MTX) compared to MTX alone inmethotrexate- naïve patients with active rheumatoid arthritis. - ND | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO496-4913 | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | 600 | Spain;Lithuania;Austria;United Kingdom;Italy | |||
| 18 | EUCTR2006-005147-28-GB (EUCTR) | 25/09/2007 | 18/12/2008 | MTX-IR Phase III | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | Rheumatoid Arthritis (RA) MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 19 | EUCTR2006-005147-28-GR (EUCTR) | 11/09/2007 | 04/05/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | Rheumatoid Arthritis (RA) Lower Lever Term (LLT) code number 10039073 | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | United Kingdom;Germany;France;Spain;Greece;Austria | |||
| 20 | EUCTR2006-005330-20-SK (EUCTR) | 07/09/2007 | 10/04/2008 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Czech Republic;Hungary;Slovenia;Slovakia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 21 | EUCTR2006-005330-20-SI (EUCTR) | 30/08/2007 | 22/06/2007 | anti-TNF-IR phase III | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 22 | EUCTR2006-005330-20-NL (EUCTR) | 15/08/2007 | 13/06/2007 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. - SCRIPT | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. - SCRIPT | Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Slovenia;Spain;Belgium;Germany;Netherlands;Italy;Sweden | |||
| 23 | EUCTR2006-005147-28-DE (EUCTR) | 25/07/2007 | 05/02/2007 | MTX-IR Phase III | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | Rheumatoid Arthritis (RA) MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 24 | EUCTR2006-005330-20-DE (EUCTR) | 18/07/2007 | 09/03/2007 | anti TNF-IR phase III | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis MedDRA version: 15.0;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 25 | EUCTR2006-005330-20-FR (EUCTR) | 16/07/2007 | 26/03/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 26 | NCT00485589 (ClinicalTrials.gov) | June 11, 2007 | 11/6/2007 | A Study of Ocrelizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis Who Are Naive to Methotrexate (FILM) | A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab in Combination With Methotrexate (MTX) Compared to MTX Alone in Methotrexate- Naive Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Methotrexate;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 18 Years | N/A | All | 613 | Phase 3 | United States |
| 27 | EUCTR2006-005330-20-BE (EUCTR) | 07/06/2007 | 28/02/2007 | anti TNF-IR phase III | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 800 | Phase 3 | France;Czech Republic;Hungary;Slovakia;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | ||
| 28 | EUCTR2006-005330-20-HU (EUCTR) | 01/06/2007 | 10/04/2007 | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | A randomized, double-blind, parallel group, international study toevaluate the safety and efficacy of ocrelizumab compared toplacebo in patients with active rheumatoid arthritis who have aninadequate response to at least one anti-TNF-a therapy. | Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | France;Hungary;Slovenia;Spain;Belgium;Netherlands;Germany;Italy;Sweden | |||
| 29 | EUCTR2006-005147-28-BE (EUCTR) | 24/05/2007 | 21/02/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | Rheumatoid Arthritis (RA) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 30 | NCT00476996 (ClinicalTrials.gov) | May 15, 2007 | 18/5/2007 | A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-a Therapy (SCRIPT) | A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-a Therapy | Rheumatoid Arthritis | Drug: Leflunomide;Drug: Methotrexate;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 18 Years | N/A | All | 836 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;France;Germany;Hungary;Israel;Italy;Japan;Mexico;Netherlands;New Zealand;Panama;Peru;Poland;Slovakia;Slovenia;Spain;Sweden;Switzerland;Taiwan |
| 31 | EUCTR2006-005147-28-FR (EUCTR) | 07/05/2007 | 06/03/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. | Rheumatoid Arthritis (RA) MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ocrelizumab Product Code: RO 496-4913/F03 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 32 | EUCTR2006-005147-28-AT (EUCTR) | 16/04/2007 | 23/03/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. - STAGE | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis continuing methotrexate treatment. - STAGE | Rheumatoid Arthritis (RA) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | France;Greece;Spain;Belgium;Austria;Germany;United Kingdom | ||
| 33 | NCT00406419 (ClinicalTrials.gov) | December 27, 2006 | 30/11/2006 | A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE) | A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment | Rheumatoid Arthritis | Drug: Methotrexate;Drug: ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 18 Years | N/A | All | 1015 | Phase 3 | United States |
| 34 | NCT02720120 (ClinicalTrials.gov) | October 2005 | 22/3/2016 | A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA) | A Randomized Placebo-Controlled, Multi-Center, Phase I/II Study of the Safety of Escalating Single Intravenous Doses of Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769) in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate But With Unsatisfactory Clinical Response | Rheumatoid Arthritis | Drug: Ocrelizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 18 Years | 80 Years | Both | 175 | Phase 1/Phase 2 | Australia;Belgium;Canada;Netherlands;New Zealand;Russian Federation;Spain;United Kingdom |
| 35 | NCT00077870 (ClinicalTrials.gov) | February 2004 | 12/2/2004 | A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis | A Randomized, Placebo-Controlled, Multicenter, Blinded Phase I/II Study of the Safety of Escalating Doses of Ocrelizumab (PRO70769) in Subjects With Moderate to Severe Rheumatoid Arthritis Receiving Stable Doses of Concomitant Methotrexate | Rheumatoid Arthritis | Drug: ocrelizumab | Genentech, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 237 | Phase 1/Phase 2 | United States |
| 36 | JPRN-JapicCTI-070479 | 26/11/2007 | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. | A randomized, double-blind, parallel group, international study to evaluate the safety and efficacy of ocrelizumab compared to placebo in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. | Rheumatoid arthritis | Intervention name : Ocrelizumab Dosage And administration of the intervention : Patients will be randomized to receive placebo, ocrelizumab 200mg i.v. or ocrelizumab 500mg i.v. on days 1 and 15. A repeat course of i.v. treatment will be administered at weeks 24 and 26. | Chugai Pharmaceutical Co., Ltd. | NULL | 20 | BOTH | Phase 3 | NULL | ||||
| 37 | JPRN-JapicCTI-080650 | 23/10/2008 | Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis. | Dose-Response Study of Ocrelizumab for Rheumatoid Arthritis. | Rheumatoid Arthritis | Intervention name : Ocrelizumab Dosage And administration of the intervention : 50mg,200mg,500mg twice as an IV infusion on Days1 and 15 Control intervention name : Placebo Dosage And administration of the control intervention : administered twice as an IV infusion on Days1 and 15 | Chugai Pharmaceutical Co., Ltd. | NULL | 20 | BOTH | Phase 2 | NULL |
49. Systemic lupus erythematosus
Clinical trials : 946 / Drugs : 722 - (DrugBank : 186) / Drug target genes : 117 - Drug target pathways : 199
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2006-005357-29-BG (EUCTR) | 18/06/2008 | 17/04/2008 | Clinical trial to study a drug in people with kidney disease related to lupus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG | Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis MedDRA version: 15.1;Level: PT;Classification code 10025140;Term: Lupus nephritis;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Sweden;United Kingdom;Germany;Netherlands;Bulgaria;Spain;Hungary;France;Portugal | |||
| 2 | EUCTR2006-005357-29-GB (EUCTR) | 07/05/2008 | 16/08/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | ||
| 3 | EUCTR2006-005355-16-GB (EUCTR) | 07/05/2008 | 16/08/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 4 | EUCTR2006-005355-16-SE (EUCTR) | 10/04/2008 | 21/12/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 5 | EUCTR2006-005355-16-PL (EUCTR) | 04/04/2008 | 03/01/2008 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | United Kingdom;Sweden;Portugal;France;Hungary;Spain;Poland;Netherlands;Germany | ||
| 6 | EUCTR2006-005355-16-DE (EUCTR) | 25/03/2008 | 01/10/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;United Kingdom;Germany;Netherlands;France;Spain;Poland;Sweden | |||
| 7 | EUCTR2006-005357-29-PT (EUCTR) | 07/03/2008 | 23/11/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Hungary;Portugal;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden | |||
| 8 | EUCTR2006-005355-16-PT (EUCTR) | 07/03/2008 | 23/11/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Hungary;Portugal;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 9 | EUCTR2006-005357-29-NL (EUCTR) | 22/02/2008 | 22/11/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 369 | Portugal;Hungary;Germany;United Kingdom;Netherlands;Bulgaria;France;Spain;Sweden | |||
| 10 | EUCTR2006-005355-16-NL (EUCTR) | 22/02/2008 | 22/11/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 11 | NCT00626197 (ClinicalTrials.gov) | February 2008 | 20/2/2008 | A Study to Evaluate Ocrelizumab in Patients With Nephritis Due to Systemic Lupus Erythematosus (BELONG) | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With WHO or ISN Class III or IV Nephritis Due to Systemic Lupus Erythematosus | Lupus Nephritis;Systemic Lupus Erythematosus | Drug: corticosteroids;Drug: cyclophosphamide;Drug: mycophenolate mofetil;Drug: ocrelizumab;Drug: placebo | Genentech, Inc. | Roche Pharma AG | Completed | 16 Years | N/A | All | 381 | Phase 3 | United States |
| 12 | EUCTR2006-005357-29-DE (EUCTR) | 31/01/2008 | 01/10/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus - BELONG | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Portugal;Hungary;United Kingdom;Germany;Netherlands;Bulgaria;France;Spain;Sweden | |||
| 13 | EUCTR2006-005357-29-SE (EUCTR) | 30/01/2008 | 21/12/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Portugal;France;Hungary;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | |||
| 14 | NCT00539838 (ClinicalTrials.gov) | December 19, 2007 | 3/10/2007 | A Study to Evaluate Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus (BEGIN) | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus | Drug: Prednisone;Drug: Immunosuppressive regime (azathioprine, mycophenolate mofetil or methotrexate);Drug: Methylprednisolone;Drug: Ocrelizumab;Drug: Placebo | Genentech, Inc. | Roche Pharma AG | Terminated | 16 Years | N/A | All | 33 | Phase 3 | United States |
| 15 | EUCTR2006-005355-16-HU (EUCTR) | 21/11/2007 | 18/10/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Portugal;Hungary;Germany;United Kingdom;Netherlands;France;Spain;Poland;Sweden | |||
| 16 | EUCTR2006-005357-29-HU (EUCTR) | 21/11/2007 | 18/10/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Phase 3 | Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | ||
| 17 | EUCTR2006-005355-16-FR (EUCTR) | 15/11/2007 | 28/08/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Patients With Active Systemic Lupus Erythematosus | Systemic Lupus Erythematosus (SLE) MedDRA version: 9.1;Level: LLT;Classification code 10042945;Term: Systemic lupus erythematosus | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 423 | Phase 3 | Portugal;France;Hungary;Poland;Spain;Netherlands;Germany;United Kingdom;Sweden | ||
| 18 | EUCTR2006-005357-29-FR (EUCTR) | 09/11/2007 | 24/08/2007 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Patients with ISN/RPS or WHO class III or IV Active Lupus Nephritis MedDRA version: 9.1;Level: LLT;Classification code 10025140;Term: Lupus nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Phase 3 | Portugal;France;Hungary;Poland;Spain;Bulgaria;Netherlands;Germany;United Kingdom;Sweden | ||
| 19 | EUCTR2006-005357-29-PL (EUCTR) | 10/01/2008 | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | A Randomised, Double-Blind, Placebo Controlled, Parallel-Group, Multicenter Study To Evaluate The Efficacy and Safety of Two Doses of Ocrelizumab in Subjects With WHO or ISN Class III or IV Nephritis Due To Systemic Lupus Erythematosus | Lupus Nephritis | Product Name: ocrelizumab Product Code: RO 496-4913 INN or Proposed INN: ocrelizumab Other descriptive name: RhuMAb 2H7 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 369 | Phase 3 | Portugal;France;Hungary;Spain;Poland;Bulgaria;Netherlands;Germany;United Kingdom;Sweden |