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
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04988087 (ClinicalTrials.gov) | November 30, 2021 | 26/7/2021 | A 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 | Sjogren Syndrome;Mixed Connective Tissue Disease | Drug: MHV370;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 60 | Phase 2 | China;Germany;Hungary;Spain;United Kingdom |
| 2 | EUCTR2020-004937-19-ES (EUCTR) | 11/10/2021 | 05/08/2021 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Hungary;Taiwan;Poland;Spain;Israel;Germany;United Kingdom;Switzerland;China | ||
| 3 | EUCTR2020-004937-19-HU (EUCTR) | 21/09/2021 | 06/08/2021 | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Taiwan;Hungary;Spain;Poland;Israel;Germany;United Kingdom;Switzerland;China | ||
| 4 | EUCTR2020-004937-19-DE (EUCTR) | 08/09/2021 | 29/07/2021 | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 2 | Hungary;Taiwan;Spain;Poland;Israel;Germany;United Kingdom;Switzerland;China | ||
| 5 | NCT03430388 (ClinicalTrials.gov) | January 31, 2018 | 30/1/2018 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | NULL | Completed | 2 Years | 60 Years | All | 600 | N/A | Brazil |
| 6 | JPRN-UMIN000018376 | 2015/07/22 | 22/07/2015 | Efficacy and safety of rituximab for patients with severe rheumatic disease | Efficacy 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 Pediatrics | NULL | Complete: follow-up complete | 2years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| 7 | NCT01862926 (ClinicalTrials.gov) | November 2014 | 22/5/2013 | Rituximab Versus Cyclophosphamide in Connective Tissue Disease-ILD | A Randomized, Double Blind Controlled Trial Comparing Rituximab Against Intravenous Cyclophosphamide in Connective Tissue Disease Associated Interstitial Lung Disease | Interstitial Lung Disease;Scleroderma;Idiopathic Inflammatory Myositis;Mixed Connective Tissue Disease | Drug: Rituximab;Drug: Cyclophosphamide | Royal Brompton & Harefield NHS Foundation Trust | Imperial College London;University of East Anglia;University College London Hospitals | Completed | 18 Years | 80 Years | All | 104 | Phase 2/Phase 3 | United Kingdom |
| 8 | EUCTR2012-003633-42-GB (EUCTR) | 18/10/2013 | 22/08/2013 | A trial of rituximab compared to usual best care in patients with interstitial (inflammatory or scarring conditions) lung disease due to systemic autoimmune (connective tissue) diseases | A 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 Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom |