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Clinical trials for Ofatumumab

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
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    • 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   44339   clinical trials with a EudraCT protocol, of which   7369   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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    82 result(s) found for: Ofatumumab. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2017-004703-51 Sponsor Protocol Number: COMB157G2399 Start Date*: 2019-01-10
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis
    Medical condition: Multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) SK (Trial now transitioned) HU (Trial now transitioned) GB (GB - no longer in EU/EEA) NL (Trial now transitioned) AT (Trial now transitioned) FR (Trial now transitioned) PT (Trial now transitioned) ES (Ongoing) CZ (Trial now transitioned) SE (Trial now transitioned) LT (Trial now transitioned) DK (Trial now transitioned) FI (Trial now transitioned) NO (Trial now transitioned) BE (Trial now transitioned) LV (Trial now transitioned) GR (Trial now transitioned) HR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-000307-20 Sponsor Protocol Number: COMB157GDE01 Start Date*: 2021-04-28
    Sponsor Name:Novartis Pharma Vertriebs GmbH
    Full Title: Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS)
    Medical condition: relapsing multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-016459-23 Sponsor Protocol Number: OCTO_018 Start Date*: 2011-01-13
    Sponsor Name:University of Oxford
    Full Title: Single arm NCRI feasibility study of CHOP in combination with Ofatumumab in induction and maintenance for patients with newly diagnosed Richter’s Syndrome
    Medical condition: Richter’s Syndrome; a high-grade transformation that occurs in 5-15% of patients with B cell chronic lymphocytic leukaemia (B-CLL).
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-000624-28 Sponsor Protocol Number: OFA2 Start Date*: Information not available in EudraCT
    Sponsor Name:IRCCS ISTITUTO GIANNINA GASLINI
    Full Title: Ofatumumab versus Rituximab in children with steroid and calcineurin inhibitor-dependent idiopatic nephrotic syndrome: an open-label, randomized, controlled, superiority trial.
    Medical condition: steroid and calcineurin inhibitor-dependent idiopatic nephrotic syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.1 10038359 - Renal and urinary disorders 10029164 Nephrotic syndrome PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-002700-39 Sponsor Protocol Number: CBAF312D2301 Start Date*: 2021-09-10
    Sponsor Name:Novartis Pharma AG
    Full Title: A 2-year randomized, 3-arm, double-blind, non-inferiority study comparing the efficacy and safety of ofatumumab and siponimod versus fingolimod in pediatric patients with multiple sclerosis followe...
    Medical condition: Multiple Sclerosis in pediatric patients
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029205 - Nervous system disorders 10028245 Multiple sclerosis PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Trial now transitioned) PT (Trial now transitioned) EE (Ongoing) FR (Trial now transitioned) BE (Trial now transitioned) LT (Prematurely Ended) AT (Trial now transitioned) SK (Trial now transitioned) ES (Ongoing) LV (Trial now transitioned) PL (Trial now transitioned) IT (Trial now transitioned) HR (Trial now transitioned) RO (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2007-002951-18 Sponsor Protocol Number: GEN411/OFA110634 Start Date*: 2007-12-10
    Sponsor Name:Genmab A/S
    Full Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who ha...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Prematurely Ended) IT (Completed) ES (Completed) GB (Completed) FR (Completed) SE (Completed) DK (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-022180-35 Sponsor Protocol Number: Uni-Koeln-1432 Start Date*: 2011-03-29
    Sponsor Name:University of Cologne
    Full Title: Ofatumumab in relapsed nodular lymphocyte predominant Hodgkin Lymphoma
    Medical condition: relapsed nodular lymphocyte predominat Hodgkin Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    12.1 10020227 Hodgkin's disease lymphocyte predominance type recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-000569-30 Sponsor Protocol Number: OFA1 Start Date*: 2015-06-16
    Sponsor Name:IRCCS ISTITUTO GIANNINA GASLINI
    Full Title: Ofatumumab in children with steroid- and calcineurin-inhibitor-resistant nephrotic syndrome: a double-blind randomized, controlled, superiority trial
    Medical condition: Steroid- and calcineurin-inhibitor-resistant nephrotic syndrome
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004857 10072914 Steroid-resistant nephrotic syndrome LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-002950-42 Sponsor Protocol Number: GEN410/OFA110635 Start Date*: 2007-10-18
    Sponsor Name:Genmab A/S
    Full Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy in adult patients with active rheumatoid arthritis who ha...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) LT (Prematurely Ended) CZ (Completed) PL (Completed) ES (Completed) GB (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2010-018780-42 Sponsor Protocol Number: OMB113676 Start Date*: 2010-10-28
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Phase III Randomized, Open Label Study of Single Agent Ofatumumab Vs. Single Agent Rituximab in Indolent B-Cell Non Hodgkin Lymphoma Relapsed After Rituximab-Containing Therapy
    Medical condition: Indolent B-Cell Non-Hodgkin's Lymphoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) CZ (Prematurely Ended) BG (Prematurely Ended) BE (Completed) FR (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2017-004702-17 Sponsor Protocol Number: COMB157G2102 Start Date*: 2018-09-01
    Sponsor Name:Novartis Pharma AG
    Full Title: A 12 week randomized open label parallel group multicenter study to evaluate bioequivalence of 20 mg subcutaneous ofatumumab injected by pre-filled syringe or autoinjector in adult RMS patients
    Medical condition: Multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Completed) CZ (Completed) EE (Completed) LV (Completed) LT (Completed) ES (Completed) PL (Completed) BG (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005178-43 Sponsor Protocol Number: OMB115991 Start Date*: 2012-02-08
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: A Phase II, Multi-centre Study Investigating the Safety and Efficacy of Ofatumumab and Bendamustine Combination in Patients with Untreated or Relapsed Chronic Lymphocytic Leukaemia (CLL)
    Medical condition: Untreated or Relapsed Chronic Lymphocytic Leukaemia
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10008968 Chronic lymphocytic leukaemia stage A(0) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Prematurely Ended) BE (Completed) ES (Completed) PL (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2012-001676-11 Sponsor Protocol Number: FIL_MIRO Start Date*: 2014-10-28
    Sponsor Name:FONDAZIONE ITALIANA LINFOMI ONLUS
    Full Title: "MIRO" study (Molecularly Oriented Immuno-radio-therapy): a multicenter phase II trail for the treatment on molecular basis of stage I / II Follicular Lymphoma with local radiotherapy with / witho...
    Medical condition: Stage I/II Follicular Lymphoma
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001042-33 Sponsor Protocol Number: OFA3 Start Date*: Information not available in EudraCT
    Sponsor Name:IRCCS Istituto Giannina Gaslini
    Full Title: Efficacy of humanized anti-CD20 antibodies (Ofatumumab) in the treatment of childhood steroid-dependent nephrotic syndrome and development of cell biomarkers predicting outcome.
    Medical condition: steroid dependent nephrotic syndrome
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004857 10018365 Glomerulonephritis and nephrotic syndrome HLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2007-002945-18 Sponsor Protocol Number: GEN412/OFA110633 Start Date*: 2007-10-15
    Sponsor Name:Genmab A/S
    Full Title: A double-blind, randomized, placebo controlled, parallel group, multi-center, phase III trial of ofatumumab investigating clinical efficacy and safety in adult patients with active rheumatoid arthr...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005186-20 Sponsor Protocol Number: 7965-012 Start Date*: 2012-07-12
    Sponsor Name:Schering-Plough Research Institute, a Division of Schering Corporation.
    Full Title: A Phase 3 Study to Evaluate the Efficacy and Safety of Dinaciclib or Ofatumumab in Subjects with Refractory Chronic Lymphocytic Leukemia (CLL)
    Medical condition: chronic lymphocytic leukemia (CLL)
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004864 10008976 Chronic lymphocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NO (Completed) CZ (Completed) SE (Completed) FI (Completed) LT (Prematurely Ended) LV (Completed) ES (Completed) HU (Completed) IT (Completed) PL (Prematurely Ended) BE (Prematurely Ended) GR (Completed) EE (Prematurely Ended) SK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2007-004223-38 Sponsor Protocol Number: GEN414/OMS115102 Start Date*: 2009-01-05
    Sponsor Name:GlaxoSmithKline UK
    Full Title: A double-blind, randomized, placebo-controlled, multicenter, dose-finding trial of ofatumumab in RRMS patients
    Medical condition: Relapsing Remitting Multiple Sclerosis (RRMS)
    Disease: Version SOC Term Classification Code Term Level
    13.1 10029205 - Nervous system disorders 10063399 Relapsing-remitting multiple sclerosis PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) DK (Completed) DE (Completed) SE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2015-005418-31 Sponsor Protocol Number: COMB157G2301 Start Date*: 2016-10-17
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis
    Medical condition: multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    19.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: BE (Completed) DE (Completed) HU (Completed) GB (Completed) SE (Completed) DK (Completed) CZ (Completed) SK (Completed) ES (Completed) NL (Completed) EE (Completed) BG (Completed) GR (Completed) PL (Completed) HR (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-004878-31 Sponsor Protocol Number: GEN413 Start Date*: 2007-12-10
    Sponsor Name:GlaxoSmithKline Research & Development Ltd
    Full Title: An open-label, international, multi-center, phase II, extension trial investigating long-term efficacy and safety of repeated treatment courses of ofatumumab, a fully human monoclonal anti-CD20 ant...
    Medical condition: Rheumatoid Arthritis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039073 Rheumatoid arthritis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed) GB (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2015-005419-33 Sponsor Protocol Number: COMB157G2302 Start Date*: 2016-10-21
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis
    Medical condition: multiple sclerosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10048393 Multiple sclerosis relapse PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) BE (Completed) FI (Completed) GB (Completed) AT (Completed) CZ (Completed) PT (Completed) SK (Completed) ES (Completed) LV (Completed) LT (Completed) BG (Completed) FR (Completed) HR (Completed) IT (Completed)
    Trial results: View results
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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
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