52. 混合性結合組織病 Mixed connective tissue disease Clinical trials / Disease details


臨床試験数 : 8 薬物数 : 7 - (DrugBank : 3) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 1

  
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PhaseCountries
1NCT04988087
(ClinicalTrials.gov)
November 30, 202126/7/2021A Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)A Multi-center, Randomized, Participant- and Investigator- Blinded, Placebo-controlled, Parallel Group Basket Study to Evaluate the Safety, Tolerability and Efficacy of MHV370 in Participants With Sjögren's Syndrome or Mixed Connective Tissue DiseaseSjogren Syndrome;Mixed Connective Tissue DiseaseDrug: MHV370;Drug: PlaceboNovartis PharmaceuticalsNULLRecruiting18 Years75 YearsAll60Phase 2China;Germany;Hungary;Spain;United Kingdom
2EUCTR2020-004937-19-ES
(EUCTR)
11/10/202105/08/2021A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)A multi-center, randomized, participant- and investigator- blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease Sjögren’s syndrome Mixed connective tissue disease
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MHV370
Product Code: MHV370
INN or Proposed INN: Not yet established
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Hungary;Taiwan;Poland;Spain;Israel;Germany;United Kingdom;Switzerland;China
3EUCTR2020-004937-19-HU
(EUCTR)
21/09/202106/08/2021A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)A multi-center, randomized, participant- and investigator- blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease Sjögren’s syndrome Mixed connective tissue disease
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MHV370
Product Code: MHV370
INN or Proposed INN: Not yet established
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Taiwan;Hungary;Spain;Poland;Israel;Germany;United Kingdom;Switzerland;China
4EUCTR2020-004937-19-DE
(EUCTR)
08/09/202129/07/2021A study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjogren's Syndrome (SjS) or Mixed Connective Tissue Disease (MCTD)A multi-center, randomized, participant- and investigator- blinded, placebo-controlled, parallel group basket study to evaluate the safety, tolerability and efficacy of MHV370 in participants with Sjögren’s Syndrome or Mixed Connective Tissue Disease Sjögren’s syndrome Mixed connective tissue disease
MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: MHV370
Product Code: MHV370
INN or Proposed INN: Not yet established
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Hungary;Taiwan;Spain;Poland;Israel;Germany;United Kingdom;Switzerland;China
5NCT03430388
(ClinicalTrials.gov)
January 31, 201830/1/2018Yellow Fever Vaccine in Patients With Rheumatic DiseasesEvaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk AreaSystemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile DermatomyositisBiological: Yellow Fever vaccine (17D)University of Sao Paulo General HospitalNULLCompleted2 Years60 YearsAll600N/ABrazil
6JPRN-UMIN000018376
2015/07/2222/07/2015Efficacy and safety of rituximab for patients with severe rheumatic diseaseEfficacy and safety of rituximab for patients with severe rheumatic disease - Efficacy and safety of rituximab for patients with severe rheumatic disease Childhood-onset severe rheumatic disease(systemic lupus erhythematosus, dermatomyositis, poly myositis, systemic sclerosis , mixed connective tissue disease, Sjogren's syndrome, anti-phospholipid syndrome)1) Induction Therapy
rituximab 375mg/m2 (max500mg)
1-4 times/1-2 weeks

2) Maintenance Therapy
rituximab 375mg/m2 (max500mg)
1 times/6-12 months
Yokohama City University Hospital Department of PediatricsNULLComplete: follow-up complete2years-oldNot applicableMale and Female20Not selectedJapan
7NCT01862926
(ClinicalTrials.gov)
November 201422/5/2013Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILDA Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung DiseaseInterstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue DiseaseDrug: Rituximab;Drug: CyclophosphamideRoyal Brompton & Harefield NHS Foundation TrustImperial College London;University of East Anglia;University College London HospitalsCompleted18 Years80 YearsAll104Phase 2/Phase 3United Kingdom
8EUCTR2012-003633-42-GB
(EUCTR)
18/10/201322/08/2013A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseasesA randomized, double blind controlled trial comparing rituximab against intravenous cyclophosphamide in connective tissue disease associated interstitial lung disease - Rituximab versus cyclophosphamide in connective tissue disease-ILD 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 interstitial myopathy (including polymyositis/dermatomyositis) o Mixed connective tissue disease
MedDRA version: 14.1;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 14.1;Classification code 10022611;Term: Interstitial lung disease;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 14.1;Classification code 10027754;Term: Mixed connective tissue disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Classification code 10039710;Term: Scleroderma;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: MabThera
Product Name: Rituximab
INN or Proposed INN: Rituximab
Trade Name: Cyclophosphamide Injection 1g
Product Name: Cyclophosphamide Injection 1g
INN or Proposed INN: Cyclophosphamide
Royal Brompton and Harefield NHS Foundation TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
United Kingdom