53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details
臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188
| 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 | EUCTR2019-002470-32-NL (EUCTR) | 12/12/2022 | 23/07/2021 | NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients | NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY | Primary Sjögren’s syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PLAQUENIL Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil INN or Proposed INN: Mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Arava Product Name: Leflunomide INN or Proposed INN: LEFLUNOMIDE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Netherlands;Italy | ||
| 2 | NCT05016297 (ClinicalTrials.gov) | July 14, 2022 | 26/6/2021 | Efficacy and Safety of Baricitinib in Sjogren's Syndrome | A Multi-center, Prospective, Open-label, Randomized Study to Explore Efficacy and Safety of Baricitinib in Active Primary Sjogren's Syndrome Patients | Sjogren's Syndrome | Drug: Baricitinib;Drug: Hydroxychloroquine | Peking Union Medical College Hospital | Eli Lilly and Company | Recruiting | 18 Years | 75 Years | All | 87 | Phase 2 | China |
| 3 | ChiCTR2200057578 | 2022-03-01 | 2022-03-15 | Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial | Tofacitinib treatment in patients with primary Sjogren syndrome: a prospective pilot trial | Sjogren Syndrome | Control group:Same dose of hydroxychloroquine sulfate as before;Intervention group:Tofacitinib 5mg bid po+the same dose of hydroxychloroquine sulfate as before; | Ningbo Medical Center Lihuili Hospital | NULL | Pending | 15 | 70 | Both | Control group:60;Intervention group:60; | Phase 4 | China |
| 4 | NCT05113004 (ClinicalTrials.gov) | January 20, 2022 | 2/11/2021 | New Clinical End-points in Patients With Primary Sjögren's Syndrome | NEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients | Primary Sjögren's Syndrome (pSS) | Drug: Hydroxychloroquine 400mg/d;Drug: Leflunomide 20mg/d;Drug: Mycophenolate mofetil 2000mg/d;Drug: Placebo of Hydroxychloroquine 400mg/d;Drug: Placebo of Leflunomide 20mg/d;Drug: Placebo of Mycophenolate mofetil 2000mg/d | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 18 Years | N/A | All | 300 | Phase 2 | France |
| 5 | EUCTR2019-002470-32-NO (EUCTR) | 14/12/2021 | 26/08/2021 | NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients | NEw Clinical End-points in patients with primary Sjögren’s Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY | Primary Sjögren’s syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: PLAQUENIL Product Name: Hydroxychloroquine INN or Proposed INN: Hydroxychloroquine Other descriptive name: HYDROXYCHLOROQUINE SULFATE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil INN or Proposed INN: Mycophenolate mofetil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Arava Product Name: Leflunomide INN or Proposed INN: LEFLUNOMIDE | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS ( AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | Netherlands;Norway;Italy | ||
| 6 | EUCTR2019-002470-32-IT (EUCTR) | 05/10/2021 | 27/01/2022 | Nuovi end-points clinici in pazienti con sindrome di Sjögren primaria (pSS): uno studio interventistico basato sulla stratificazione dei pazienti. | NEw Clinical End-points in patients with primary Sjögren's Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY | Primary Sjögren's syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Arava Product Name: Leflunomide Product Code: [Leflunomide] INN or Proposed INN: LEFLUNOMIDE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil Product Code: [mycophenolate mofetil] INN or Proposed INN: MICOFENOLATO MOFETILE Trade Name: PLAQUENIL Product Name: Hydroxychloroquine Product Code: [Hydroxychloroquine] INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE | ASSITANCE PUBLIQUE DES HOPITAUX DE PARIS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;Greece;Spain;Norway;Netherlands;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2020-001933-11-NL (EUCTR) | 10/06/2021 | 04/06/2021 | Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome | Leflunomide and Hydroxychloroquine combination therapy for primary Sjögren’s Syndrome - RepurpSS-II study | Primary Sjogren Syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Leflunomide Product Name: Leflunomide Trade Name: Plaquenil Product Name: Hydroxychloroquine | University Medical Center Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | Netherlands | ||
| 8 | ChiCTR1800014623 | 2018-02-01 | 2018-01-24 | A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren Syndrome | A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren Syndrome | Sjogren Syndrome | stem cell group: Intravenous use mesenchymal stem cell ;hydroxychloroquine group:oral use hydroxychloroquine ; | Tongji Hospital of Tongji University | NULL | Recruiting | Both | stem cell group:20;hydroxychloroquine group:20; | China | |||
| 9 | EUCTR2014-003140-12-NL (EUCTR) | 21/09/2015 | 26/08/2015 | Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's Syndrome | Optimizing DMARD-therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome - LEF-HCQ combination therapy in pSS | Sjogren's Syndrome MedDRA version: 18.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Leflunomide Mylan Product Name: Leflunomide mylan INN or Proposed INN: LEFLUNOMIDE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: HYDROXYCHLOROQUINE | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | Netherlands | ||||
| 10 | NCT01601028 (ClinicalTrials.gov) | July 2011 | 29/4/2012 | Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome | Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome | Autoimmune Diseases;Sjogren's Syndrome;Dry Eye | Drug: Hydroxychloroquine;Drug: Placebo | Seoul National University Hospital | NULL | Completed | 19 Years | N/A | Both | 39 | Phase 3 | Korea, Republic of |
| 11 | JPRN-UMIN000004477 | 2010/11/01 | 01/11/2010 | Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk | Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk - Hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome with annular erythema | Systemic/cutaneous lupus erythematosusSjogren's syndrome | Hydroxychloroquine 200 mg will be administrated once daily. If insufficient, dosage can be escalated to 400 mg twice daily, but not exceed 6.5 mg/kg/day. | Kanazawa University Graduate School of Medical Science | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 10 | Not applicable | Japan |
| 12 | NCT00632866 (ClinicalTrials.gov) | March 2008 | 29/2/2008 | Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome | Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: Hydroxychloroquine;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Sanofi | Completed | 18 Years | N/A | Both | 120 | Phase 3 | France |
| 13 | NCT00873496 (ClinicalTrials.gov) | January 2005 | 31/3/2009 | Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients | Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study. | Sjögren's Syndrome;Xerostomia | Drug: Hydroxychloroquine | Ege University | NULL | Completed | N/A | N/A | Female | 30 | N/A | Turkey |