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Clinical trials for Inflammatory myopathy

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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    20 result(s) found for: Inflammatory myopathy. Displaying page 1 of 1.
    EudraCT Number: 2021-001277-23 Sponsor Protocol Number: ARGX-113-2007 Start Date*: 2022-10-26
    Sponsor Name:argenx BV
    Full Title: A Phase 2/3, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group, 2-Arm, Multicenter, Operationally Seamless Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Phar...
    Medical condition: Active Idiopathic Inflammatory Myopathy (IIM)
    Disease: Version SOC Term Classification Code Term Level
    24.1 10028395 - Musculoskeletal and connective tissue disorders 10085970 Idiopathic inflammatory myopathy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Trial now transitioned) BE (Trial now transitioned) LT (Trial now transitioned) SE (Trial now transitioned) DE (Trial now transitioned) HU (Trial now transitioned) IE (Trial now transitioned) AT (Trial now transitioned) ES (Trial now transitioned) PT (Trial now transitioned) IT (Trial now transitioned) SK (Trial now transitioned) PL (Trial now transitioned) BG (Trial now transitioned) GR (Trial now transitioned) CZ (Trial now transitioned) NL (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000391-15 Sponsor Protocol Number: AIFA-2016-02364869 Start Date*: 2018-06-05
    Sponsor Name:Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia
    Full Title: Multicentric, open-label, prospective study of subcutaneous tocilizumab in adult patients with refractory myositis
    Medical condition: Myositis (dermatomyositis [DM] or polymyositis [PM])
    Disease: Version SOC Term Classification Code Term Level
    20.0 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10028653 Myositis PT
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10036102 Polymyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-002269-77 Sponsor Protocol Number: IM101611 Start Date*: 2017-08-07
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Phase 3, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC with Standard Treatment Compared to Standard Treatment Alone in Improving Disease Activity in ...
    Medical condition: Idiopathic Inflammatory Myopathy (IIM; eg, Dermatomyositis [DM], Polymyositis [PM], autoimmune necrotizing myopathy)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10042753 Symptomatic inflammatory myopathy LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) CZ (Prematurely Ended) SE (Completed) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-020521-40 Sponsor Protocol Number: DG-EF 01/09 Start Date*: 2010-06-21
    Sponsor Name:EPIFARMA S.R.L.
    Full Title: Evaluation of therapeutic equivalence of diclofenac gel 1% formulation compared to Voltaren emulGel 1% gel in subjects with traumatic pathology: a double blind, randomized, phase III multicentre st...
    Medical condition: Painful and traumatic inflammation of the joints, muscles, tendons and ligaments.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10028393 HLGT
    9.1 10023213 HLGT
    9.1 10043237 HLGT
    9.1 10028302 HLGT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-005202-98 Sponsor Protocol Number: 80202135IIM2001 Start Date*: 2022-11-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Nipocalimab in Participants with Active Idiopathic Inflammatory Myo...
    Medical condition: Active Idiopathic Inflammatory Myopathies (IIM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10028640 Myopathies HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) HU (Trial now transitioned) CZ (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-001753-17 Sponsor Protocol Number: ATYR1940-C-002 Start Date*: 2014-09-19
    Sponsor Name:aTyr Pharma, Inc.
    Full Title: A Placebo-Controlled, Randomized, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biological Activity of ATYR1940 in Adult Patients with Molecularly Define...
    Medical condition: Facioscapulohumeral muscular dystrophy
    Disease: Version SOC Term Classification Code Term Level
    17.1 10010331 - Congenital, familial and genetic disorders 10064087 Facioscapulohumeral muscular dystrophy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003346-27 Sponsor Protocol Number: ATYR1940-C-003 Start Date*: Information not available in EudraCT
    Sponsor Name:ATYR PHARMA, INC.
    Full Title: An Open-Label, Intrapatient Dose-Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Biological Activity of ATYR1940 in Patients With Early Onset and Other Pediatric Onset Fa...
    Medical condition: Early Onset and Other Pediatric Onset Facioscapulohumeral Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10064087 Facioscapulohumeral muscular dystrophy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-001912-36 Sponsor Protocol Number: ATYR1940-C-005 Start Date*: 2015-08-04
    Sponsor Name:aTyr Pharma, Inc.
    Full Title: An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, Biological Activity, and Systemic Exposure of ATYR1940 in Adult Patients with Facioscapulohumeral Muscular Dystrophy (F...
    Medical condition: Facioscapulohumeral muscular dystrophy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10064087 Facioscapulohumeral muscular dystrophy PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-003670-40 Sponsor Protocol Number: PAN.1 Start Date*: 2018-04-05
    Sponsor Name:Beatrix Children's Hospital, University Medical Center Groningen
    Full Title: Pediatric Ards Neuromuscular blockade (PAN) study: Life-threatening acute respiratory failure in children: to breathe or not to breathe spontaneously, that's the question.
    Medical condition: Pediatric Acute Respiratory Distress Syndrome necessitating mechanical ventilation
    Disease:
    Population Age: Newborns, Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-001910-88 Sponsor Protocol Number: ATYR1940-C-004 Start Date*: 2015-12-17
    Sponsor Name:aTyr Pharma, Inc.
    Full Title: An Open-Label, Intrapatient Dose Escalation Study to Evaluate the Safety, Tolerability, Immunogenicity, and Biological Activity of ATYR1940 in Patients with Limb Girdle and Facioscapulohumeral Musc...
    Medical condition: Limb Girdle Muscular Dystrophy and Facioscapulohumeral Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10064087 Facioscapulohumeral muscular dystrophy PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2020-001710-37 Sponsor Protocol Number: NL73727 Start Date*: 2021-05-26
    Sponsor Name:Academisch Medisch Centrum
    Full Title: Intravenous immunoglobulin and prednisone vs. prednisone in newly diagnosed myositis: a double blind randomized clinical trial.
    Medical condition: idiopathic inflammatory myopathies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003868-42 Sponsor Protocol Number: R123899 Start Date*: 2020-05-19
    Sponsor Name:University of Manchester
    Full Title: A randomised, phase IIa treatment delayed-start trial of the oral JAK 1/2 inhibitor, baricitinib, in the treatment of adult idiopathic inflammatory myopathy
    Medical condition: Idiopathic Inflammatory Myopathy (IIM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10028395 - Musculoskeletal and connective tissue disorders 10028653 Myositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2016-004499-23 Sponsor Protocol Number: LIVERHOPE_SAFETY Start Date*: 2017-03-10
    Sponsor Name:IDIBAPS
    Full Title: Safety and tolerability of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis: a multicenter, double-blind, placebo controlled randomized clinical trial.
    Medical condition: Patients with decompensated cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    19.1 10019805 - Hepatobiliary disorders 10019641 Hepatic cirrhosis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) GB (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2016-000624-25 Sponsor Protocol Number: ATYR1940-C-006 Start Date*: 2016-06-22
    Sponsor Name:aTyr Pharma, Inc.
    Full Title: An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Biological Activity of ATYR1940 in Patients with Limb Girdle and Fascioscapulohumeral Muscular Dystrophy
    Medical condition: Limb Girdle Muscular Dystrophy and Facioscapulohumeral Muscular Dystrophy
    Disease: Version SOC Term Classification Code Term Level
    19.0 10010331 - Congenital, familial and genetic disorders 10064087 Facioscapulohumeral muscular dystrophy PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DK (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004766-26 Sponsor Protocol Number: NL58747 Start Date*: 2017-03-08
    Sponsor Name:Academic Medical Center
    Full Title: Intravenous immunoglobulins as early treatment in newly diagnosed idiopathic inflammatory myopathies (IMMEDIATE): a pilot study.
    Medical condition: idiopathic inflammatory myopathies
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-001698-25 Sponsor Protocol Number: LIVERHOPE_EFFICACY Start Date*: 2018-07-24
    Sponsor Name:IDIBAPS
    Full Title: Efficacy of the combination of simvastatin plus rifaximin in patients with decompensated cirrhosis to prevent ACLF development: a multicenter, double-blind, placebo controlled randomized clinical t...
    Medical condition: Patients with decompensated cirrhosis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004871 10009209 Cirrhosis bilary LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) NL (Completed) FR (Completed) GB (GB - no longer in EU/EEA) DE (Completed) BE (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000014-42 Sponsor Protocol Number: AQ-PRO-013 Start Date*: 2021-04-24
    Sponsor Name:Aquilon Pharmaceuticals
    Full Title: A randomized, double-blind, placebo-controlled, parallel, trial to determine the safety and efficacy of inhaled AQ001S in the management of acute COVID-19 symptoms
    Medical condition: COVID-19 related respiratory disease
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004862 10084270 SARS-CoV-2 acute respiratory disease LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed)
    Trial results: View results
    EudraCT Number: 2012-003633-42 Sponsor Protocol Number: RBHIPF004 Start Date*: 2013-10-18
    Sponsor Name:Royal Brompton and Harefield NHS Foundation Trust
    Full Title: A randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease
    Medical condition: A diagnosis of connective tissue disease associated interstitial lung disease, based on internationally accepted criteria, in one of the following categories: o Systemic sclerosis o Idiopathic inte...
    Disease: Version SOC Term Classification Code Term Level
    14.1 10040785 - Skin and subcutaneous tissue disorders 10012503 Dermatomyositis PT
    14.1 10038738 - Respiratory, thoracic and mediastinal disorders 10022611 Interstitial lung disease PT
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10027754 Mixed connective tissue disease PT
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10039710 Scleroderma PT
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10036102 Polymyositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2021-000938-34 Sponsor Protocol Number: MYTHS Start Date*: 2021-07-01
    Sponsor Name:AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA
    Full Title: Single blind randomized controlled trial to assess the safety and efficacy of high dose pulse intravenous corticosteroid therapy to treat patients with complicated/fulminant acute myocarditis
    Medical condition: Complicated/fulminant acute myocarditis
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10000932 Acute myocarditis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-004505-16 Sponsor Protocol Number: CONVINCE Start Date*: 2016-08-08
    Sponsor Name:University College Dublin
    Full Title: CONVINCE - (COlchicine for preventioN of Vascular Inflammation in Non- CardioEmbolic stroke) – a randomised clinical trial of low-dose colchicine for secondary prevention after stroke
    Medical condition: The prevention of recurrent stroke and coronary events (fatal and non- fatal) after ischaemic stroke and transient ischaemic attack (TIA) not caused by cardiac embolism or other causes unrelated to...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10044376 Transient cerebrovascular events HLT
    20.0 100000004866 10008205 Cerebrovascular embolism and thrombosis HLT
    22.1 10029205 - Nervous system disorders 10023027 Ischaemic stroke NOS LLT
    21.1 100000004866 10051615 Atherosclerotic cardiovascular disease LLT
    20.0 10029205 - Nervous system disorders 10007962 Central nervous system vascular disorders NEC HLT
    20.0 10029205 - Nervous system disorders 10007963 Central nervous system vascular disorders HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed) ES (Completed) GB (GB - no longer in EU/EEA) DE (Completed) CZ (Completed) DK (Completed) PT (Completed) BE (Completed) LT (Completed) NL (Completed)
    Trial results: (No results available)
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