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Clinical trials for Autoantibodies

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   44346   clinical trials with a EudraCT protocol, of which   7374   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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    164 result(s) found for: Autoantibodies. Displaying page 1 of 9.
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    EudraCT Number: 2017-000225-12 Sponsor Protocol Number: CNTO148DML1001 Start Date*: 2017-08-01
    Sponsor Name:Janssen Biologics BV
    Full Title: A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents and Young Adults with Pre-Symptomatic Type 1 Diabetes
    Medical condition: A Phase 1b Study to Evaluate SIMPONI® (golimumab) Therapy in Children, Adolescents and Young Adults with Pre-Symptomatic Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2015-003028-30 Sponsor Protocol Number: 808040019 Start Date*: 2015-11-02
    Sponsor Name:Technische Universität München, Fakultät für Medizin
    Full Title: Fr1da Insulin Intervention - Mechanistic study using oral insulin for immune and treatment efficacy in secondary prevention of type 1 diabetes
    Medical condition: Risk for type 1 diabetes
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-004926-26 Sponsor Protocol Number: PRV-031-001 Start Date*: 2019-11-21
    Sponsor Name:Provention Bio, Inc.
    Full Title: A Phase 3, Randomized, Double-Blind, Multinational, Placebo-Controlled Study to Evaluate Efficacy and Safety of Teplizumab (PRV-031), a Humanized, FcR Non-Binding, anti-CD3 Monoclonal Antibody, in ...
    Medical condition: Type 1 Diabetes (T1D)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10012594 Diabetes LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) PL (Completed) DE (Completed) FR (Completed) FI (Ongoing) BE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2014-000488-42 Sponsor Protocol Number: Teng-001 Start Date*: 2014-05-12
    Sponsor Name:Leiden University Medical Center
    Full Title: The SYNBioSe Study A proof-of-concept study involving synergetic B-cell imunnomodulation in patients with refractory systemic lupus erythematosus
    Medical condition: Systemic lupus erythematosus
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004859 10025139 Lupus erythematosus systemic LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2004-002620-18 Sponsor Protocol Number: IM101-046 Start Date*: 2005-05-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Multi-National Randomized, Double-Blind, Exploratory Study of Abatacept versus Placebo in Preventing the Development of Rheumatoid Arthritis in Adult Subjects with Undifferentiated Inflammatory A...
    Medical condition: Rheumatoid Arthritis, NOS
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) BE (Completed) IT (Completed) ES (Completed)
    Trial results: Removed from public view
    EudraCT Number: 2022-001781-35 Sponsor Protocol Number: UKER-BC007-01 Start Date*: 2023-05-16
    Sponsor Name:Universitätsklinikum Erlangen
    Full Title: Prospective, explorative, randomized, controlled, double-blind, cross-over phase IIa clinical trial to investigate safety and tolerability as well as potential clinical effects of BC007 in patients...
    Medical condition: Post-COVID syndrome
    Disease: Version SOC Term Classification Code Term Level
    24.0 100000004862 10085505 Post-COVID syndrome LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-003755-64 Sponsor Protocol Number: DiAPREV/2014 Start Date*: 2014-11-13
    Sponsor Name:Helena Elding Larsson
    Full Title: A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® in combination with Vitamin D on the progression to type 1 diabetes in children with multip...
    Medical condition: Children with HLA risk and persistent islet autoantibody positivity which is associated with a defined risk for type 1 diabetes
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2018-000686-37 Sponsor Protocol Number: 65114 Start Date*: 2019-08-16
    Sponsor Name:Leiden univerisity medical centre
    Full Title: (Methyl)prednisolone and diazoxide in type 1 diabetes at onset
    Medical condition: Type 1 diabetes
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-004532-10 Sponsor Protocol Number: POI-1 Start Date*: 2018-05-23
    Sponsor Name:Karolinska University Hospital
    Full Title: Effects of immunomodulatory therapy on gonadal function in women with autoimmune premature ovarian insufficiency
    Medical condition: Autoimmune premature ovarian insufficiency
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004860 10052660 Hypergonadotropic hypogonadism LLT
    Population Age: Adults Gender: Female
    Trial protocol: SE (Ongoing) NO (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001392-21 Sponsor Protocol Number: P018.087 Start Date*: 2018-09-25
    Sponsor Name:Leiden University Medical Center
    Full Title: A randomized trial to investigate the reset of humoral autoimmunity by combining belimumab with rituximab in severe systemic lupus erythematosus
    Medical condition: systemic lupus erythematosus
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004859 10042947 Systemic lupus erythematosus synd LLT
    20.0 100000004857 10029142 Nephritis systemic lupus erythematosus LLT
    21.1 100000004859 10042948 Systemic lupus erythematosus syndrome aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2013-002248-98 Sponsor Protocol Number: TN-10 Start Date*: 2016-01-15
    Sponsor Name:TrialNet Coordinating Center
    Full Title: Anti-CD3 mAb (teplizumab) for prevention of diabetes in relatives at-risk for Type 1 diabetes mellitus
    Medical condition: Anti-CD3 monoclonal antibody is to be used for the prevention of type 1 diabetes mellitus in relatives at risk for developing the disease.
    Disease: Version SOC Term Classification Code Term Level
    20.1 10042613 - Surgical and medical procedures 10066284 Diabetes prophylaxis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000659-42 Sponsor Protocol Number: TN-22 Start Date*: 2019-03-12
    Sponsor Name:TrialNet Coordinating Center
    Full Title: HYDROXYCHLOROQUINE FOR PREVENTION OF ABNORMAL GLUCOSE TOLERANCE AND DIABETES IN INDIVIDUALS AT-RISK FOR TYPE 1 DIABETES MELLITUS
    Medical condition: individuals at-risk for type 1 diabetes mellitus (T1D)
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Prematurely Ended) GB (GB - no longer in EU/EEA) IT (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2014-005287-15 Sponsor Protocol Number: 808040017 Start Date*: 2015-07-15
    Sponsor Name:Technische Universität München, Fakultät für Medizin
    Full Title: - PRE-POINT-EARLY STUDY - Pilot study using oral insulin at early age for immune efficacy in primary prevention of type 1 diabetes
    Medical condition: Risk for type 1 diabetes
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-007180-16 Sponsor Protocol Number: RITIS Start Date*: 2009-05-13
    Sponsor Name:LUMC
    Full Title: INFLUENCE OF B CELL DEPLETION BY MONOCLONAL ANTI-CD20 ANTIBODIES IN SYSTEMIC SCLERODERMA
    Medical condition: systemic sclerosis
    Disease: Version SOC Term Classification Code Term Level
    9.1 10039710 Scleroderma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2018-002632-24 Sponsor Protocol Number: P160915 Start Date*: 2018-11-13
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Therapeutic plasma exchange, rituximab and intravenous immunoglobulins (IVIg) for severe acute exacerbation of idiopathic pulmonary fibrosis admitted in ICU: an open, randomized, controlled trial
    Medical condition: severe acute exacerbation of idiopathic pulmonary fibrosis
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2011-006329-42 Sponsor Protocol Number: CAD0111 Start Date*: 2012-10-11
    Sponsor Name:G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
    Full Title: Short course of Bortezomib in anemic patients with refractory cold agglutinin disease
    Medical condition: Anaemia with refractory cold agglutinin disease
    Disease: Version SOC Term Classification Code Term Level
    14.1 10005329 - Blood and lymphatic system disorders 10009868 Cold type haemolytic anaemia PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-007484-16 Sponsor Protocol Number: DIAPREV/2008 Start Date*: 2009-02-27
    Sponsor Name:Helena Elding Larsson
    Full Title: DIAPREV-IT Diabetes Prevention Immune Tolerance. A double-blind, randomized investigator-initiated study to determine the safety and the effect of Diamyd® on the progression to type 1 diabetes in ...
    Medical condition: Children with HLA risk and persistent islet autoantibody positivity which is associated with a defined risk for type 1 diabetes
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2015-003379-31 Sponsor Protocol Number: 808040015 Start Date*: 2017-01-31
    Sponsor Name:Technische Universität München, Fakultät für Medizin
    Full Title: An immune efficacy study for primary prevention using intranasal insulin therapy in islet autoantibody negative children at high genetic risk for type 1 diabetes
    Medical condition: Risk for type 1 diabetes
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-018775-17 Sponsor Protocol Number: TRX4_DM_019_EU_10 Start Date*: 2010-07-02
    Sponsor Name:GlaxoSmithKline
    Full Title: DEFEND 2: Durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10012608 Diabetes mellitus insulin-dependent LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) DE (Prematurely Ended) FI (Completed) GB (Completed) ES (Completed) IT (Completed) DK (Completed) BE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2021-002245-15 Sponsor Protocol Number: CCM-RNT-202102 Start Date*: 2021-05-25
    Sponsor Name:Charité - Universitätsmedizin Berlin
    Full Title: A low-interventional study to investigate the efficacy and safety of SARS-CoV-2 vaccines in patients with rheumatic diseases.
    Medical condition: Auto Immune Rheumatic Diseases (AIRD) and patients without rheumatic autoimmune diseases (control group).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10072736 Rheumatic disorder PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    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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