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Clinical trials for Ocrelizumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    42 result(s) found for: Ocrelizumab. Displaying page 1 of 3.
    1  2  3  Next»
    EudraCT Number: 2017-004886-29 Sponsor Protocol Number: MN39158 Start Date*: 2018-05-22
    Sponsor Name:Roche Farma SA (Soc unipersonal) que realiza el ensayo en España y que actúa como representante F.Hoffmann-La Roche Ltd
    Full Title: 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 SPONSO...
    Medical condition: Multiple sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    20.0 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    20.1 10029205 - Nervous system disorders 10039720 Sclerosis multiple LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) EE (Completed) IE (Completed) CZ (Completed) FR (Trial now transitioned) DK (Trial now transitioned) SE (Trial now transitioned) FI (Completed) NL (Trial now transitioned) GB (GB - no longer in EU/EEA) BE (Trial now transitioned) SI (Trial now transitioned) PL (Trial now transitioned) PT (Trial now transitioned) SK (Trial now transitioned) BG (Trial now transitioned) HU (Trial now transitioned) IT (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-004128-41 Sponsor Protocol Number: WN42086 Start Date*: 2021-08-24
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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-REMITTI...
    Medical condition: Relapsing-Remitting Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Trial now transitioned) FR (Trial now transitioned) ES (Ongoing) DK (Trial now transitioned) PL (Trial now transitioned) NL (Trial now transitioned) PT (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned) DE (Trial now transitioned) BG (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) LV (Trial now transitioned) HR (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-005448-48 Sponsor Protocol Number: CN42097 Start Date*: 2022-03-15
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, NON-INFERIORITY, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, SAFETY AND RADIOLOGICAL AND CLINICAL EFFECTS OF SUBCUT...
    Medical condition: Multiple Sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063401 Primary progressive multiple sclerosis PT
    21.0 10029205 - Nervous system disorders 10080700 Relapsing multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) IT (Trial now transitioned) FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-000893-69 Sponsor Protocol Number: BN42082 Start Date*: 2020-10-28
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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
    Medical condition: Relapsing Multiple Sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    20.1 10029205 - Nervous system disorders 10039720 Sclerosis multiple LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PL (Trial now transitioned) PT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) NL (Ongoing) DE (Trial now transitioned) FR (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2020-000894-26 Sponsor Protocol Number: BN42083 Start Date*: 2020-10-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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 MULTIPL...
    Medical condition: Primary Progressive Multiple Sclerosis (MS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063401 Primary progressive multiple sclerosis PT
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    20.1 10029205 - Nervous system disorders 10039720 Sclerosis multiple LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: PT (Trial now transitioned) GB (GB - no longer in EU/EEA) HU (Trial now transitioned) FR (Trial now transitioned) DE (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) GR (Trial now transitioned) IT (Trial now transitioned) BG (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-001511-73 Sponsor Protocol Number: WA40404 Start Date*: 2019-12-23
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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
    Medical condition:
    Disease:
    Population Age: Gender:
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Trial now transitioned) PT (Trial now transitioned) IE (Completed) DE (Completed) BG (Trial now transitioned) ES (Ongoing) PL (Trial now transitioned) BE (Trial now transitioned) HU (Completed) HR (Trial now transitioned) IT (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-020338-25 Sponsor Protocol Number: WA25046 Start Date*: 2010-11-02
    Sponsor Name:F.Hoffmann-La Roche
    Full Title: 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
    Medical condition: Primary Progressive Multiple Sclerosis (PPMS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063401 Primary progressive multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: LT (Completed) ES (Ongoing) BE (Completed) FR (Completed) HU (Completed) NL (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) DE (Completed) PT (Completed) AT (Completed) FI (Completed) IT (Completed) GR (Completed) BG (Completed) DK (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2021-000063-79 Sponsor Protocol Number: MN42989 Start Date*: 2021-10-22
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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
    Medical condition: Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10071068 Clinically isolated syndrome PT
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Infants and toddlers, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002937-31 Sponsor Protocol Number: MA30143 Start Date*: 2017-09-12
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: An Open-Label, single-arm study to evaluate the effectiveness and safety of Ocrelizumab in patients with early stage relapsing remitting multiple sclerosis
    Medical condition: Relapsing remitting multiple sclerosis (RRMS)
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    20.1 10029205 - Nervous system disorders 10039720 Sclerosis multiple LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NO (Completed) SE (Completed) AT (Completed) DK (Completed) DE (Completed) PT (Completed) BE (Completed) HU (Completed) PL (Completed) SK (Completed) ES (Ongoing) BG (Completed) SI (Completed) NL (Completed) GB (GB - no longer in EU/EEA) FR (Ongoing) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-005746-15 Sponsor Protocol Number: MN43964 Start Date*: 2022-08-05
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A Multicenter, Single-arm, Open-label, Extension, Rollover Study To Evaluate The Long-term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis
    Medical condition: Primary Progressive Multiple Sclerosis (PPMS) Relapsing Multiple Sclerosis (RMS)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    21.1 10029205 - Nervous system disorders 10063401 Primary progressive multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: EE (Trial now transitioned) SE (Trial now transitioned) IT (Trial now transitioned) CZ (Trial now transitioned) LT (Trial now transitioned) NO (Completed) SK (Trial now transitioned) AT (Trial now transitioned) BE (Trial now transitioned) FI (Trial now transitioned) LV (Trial now transitioned) DE (Trial now transitioned) HU (Trial now transitioned) PT (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) HR (Trial now transitioned) FR (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-005355-16 Sponsor Protocol Number: WA20499 Start Date*: 2008-05-07
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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
    Medical condition: Systemic Lupus Erythematosus (SLE)
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) FR (Completed) DE (Completed) ES (Completed) HU (Prematurely Ended) NL (Prematurely Ended) PT (Prematurely Ended) SE (Prematurely Ended) PL (Completed)
    Trial results: View results
    EudraCT Number: 2006-005147-28 Sponsor Protocol Number: WA20494 Start Date*: 2007-07-25
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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 methot...
    Medical condition: Rheumatoid Arthritis (RA)
    Disease: Version SOC Term Classification Code Term Level
    15.0 10028395 - Musculoskeletal and connective tissue disorders 10028395 Musculoskeletal and connective tissue disorders SOC
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) ES (Completed) FR (Completed) AT (Completed) GR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2006-005357-29 Sponsor Protocol Number: WA20500 Start Date*: 2008-05-07
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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 Nephrit...
    Medical condition: Lupus Nephritis
    Disease:
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) FR (Completed) DE (Completed) HU (Completed) ES (Completed) NL (Completed) PT (Prematurely Ended) SE (Completed) PL (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2007-006338-32 Sponsor Protocol Number: WA21493 Start Date*: 2008-05-06
    Sponsor Name:Hoffman La Roche Ltd
    Full Title: 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 do...
    Medical condition: Relapsing remitting multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063399 Relapsing-remitting multiple sclerosis LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) GB (Completed) DE (Completed) ES (Completed) CZ (Completed) SK (Completed) DK (Completed) BE (Completed) NL (Completed) FI (Completed) BG (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2010-020337-99 Sponsor Protocol Number: WA21092 Start Date*: 2011-10-20
    Sponsor Name:F.Hoffmann-La Roche
    Full Title: 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 Sc...
    Medical condition: Relapsing Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) FR (Completed) CZ (Completed) LV (Completed) HU (Completed) FI (Completed) DE (Completed) BE (Completed) SK (Completed) AT (Completed) NL (Ongoing) LT (Completed) EE (Completed) PT (Completed) BG (Completed) ES (Ongoing) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005353-30 Sponsor Protocol Number: WA20497 Start Date*: 2007-11-14
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: Estudio internacional, randomizado, doble ciego, con grupos de tratamiento paralelos para evaluar la seguridad y eficacia de ocrelizumab en combinación con metotrexato (MTX) comparado con MTX como ...
    Medical condition: Artritis Reumatoide
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) AT (Completed) LT (Completed) IT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-000062-14 Sponsor Protocol Number: MN42988 Start Date*: 2021-10-08
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY
    Medical condition: Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) [in line with the locally approved indications]
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    20.0 10029205 - Nervous system disorders 10071068 Clinically isolated syndrome PT
    Population Age: In utero, Under 18, Adults Gender: Male, Female
    Trial protocol: ES (Ongoing) DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2010-020315-36 Sponsor Protocol Number: WA21093 Start Date*: 2011-10-18
    Sponsor Name:F.Hoffmann-La Roche
    Full Title: 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 Sc...
    Medical condition: Relapsing Multiple Sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SK (Completed) BE (Completed) SE (Completed) DE (Completed) ES (Ongoing) GB (GB - no longer in EU/EEA) BG (Completed) FR (Completed) IE (Completed) IT (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2021-006107-15 Sponsor Protocol Number: 21-PP-23 Start Date*: 2022-01-17
    Sponsor Name:University Nice Hospital
    Full Title: LONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB IN FRENCH PATIENTS WITH PROGRESSIVE MS: CONSONANCE EXTENSION STUDY
    Medical condition: progressive multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029205 - Nervous system disorders 10053395 Progressive multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004791-34 Sponsor Protocol Number: BLOOMS Start Date*: 2022-03-16
    Sponsor Name:VU medical center
    Full Title: Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis: a randomized controlled trial
    Medical condition: Multiple sclerosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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