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 | EUCTR2021-003749-39-IT (EUCTR) | 15/12/2021 | 15/10/2021 | A 4 week, Phase III, multicenter, double-masked, study to evaluate safety and efficacy of Oxervate® (cenegermin) 20 mcg/mL ophthalmic solution in patients with severe Sjogren’s dry eye disease under treatment with Cyclosporine A. | A 4 week, Phase III, multicenter, double-masked, vehicle-controlled study to evaluate safety and efficacy of Cenegermin (Oxervate®) 20 mcg/mL ophthalmic solution versus vehicle, in patients with severe Sjogren’s dry eye disease under treatment with Cyclosporine A. - NGF0221 | Severe Sjogren’s dry eye disease MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Oxervate Product Name: OXERVATE Product Code: [Recombinant Human Nerve Growth Factor (rhNGF)] INN or Proposed INN: Cenegermin Other descriptive name: Recombinant form of human nerve growth factor produced in Escherichia Coli. | DOMPé FARMACEUTICI S.P.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 48 | Phase 3 | United States;Italy | ||
| 2 | NCT04835623 (ClinicalTrials.gov) | June 21, 2021 | 5/4/2021 | CEQUA for Sjogren's Syndrome Dry Eye | Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome | Dry Eye;Dry Eye Syndromes;Sjogren's Syndrome | Drug: Cyclosporine 0.09% Ophthalmic Solution | Center for Ophthalmic and Vision Research, LLC | Sun Pharmaceutical Industries Limited | Recruiting | 18 Years | 70 Years | All | 50 | Phase 4 | United States |
| 3 | NCT04597762 (ClinicalTrials.gov) | August 31, 2020 | 16/10/2020 | Effect of Ciclosporin Eyedrops on Sjögren Syndrome | Effect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren Syndrome | Dry Eye Syndromes | Drug: Cyclosporin;Drug: Hydrocortisone | Hospital Hietzing | NULL | Completed | 18 Years | 90 Years | All | 12 | N/A | Austria |
| 4 | NCT03865888 (ClinicalTrials.gov) | October 30, 2018 | 16/12/2018 | Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome | Evaluation of the Effect of Topical Application of Tacrolimus 0.03% (FK506) Eye Drops Versus Cyclosporine 0.05% Eye Drops in Treatment of Dry Eye in Secondary Sjogren Syndrome | Dry Eye;Sjogren Syndrome | Drug: Cyclosporins;Drug: Tacrolimus | Pavly Moawd | NULL | Completed | 20 Years | 70 Years | All | 60 | Phase 3 | Egypt |
| 5 | ChiCTR-IPR-15005990 | 2015-03-23 | 2015-02-10 | Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Sjogren's syndrome | Treatment group:glucocorticoid+CsA;Control group:glucocorticoid+placebo; | Peking University People's Hospital | NULL | Pending | 18 | 75 | Both | Treatment group:120;Control group:120; | China | |
| 6 | NCT02370550 (ClinicalTrials.gov) | March 2015 | 18/2/2015 | Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome | Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Sjogren's Syndrome | Drug: Cyclosporin A;Drug: Prednisone;Drug: Placebo;Drug: Calcium carbonate D | Peking University People's Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 4 | China |
| 7 | NCT02004067 (ClinicalTrials.gov) | January 2013 | 3/12/2013 | Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease | Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease | Primary Sjogren Syndrome;Secondary Sjogren Syndrome;Aqueous Deficient Dry Eye Disease;Evaporative Dry Eye Disease | Drug: Restasis;Drug: Refresh Endura | Federal University of São Paulo | Allergan | Completed | 18 Years | 65 Years | All | 100 | Phase 4 | Brazil |
| 8 | NCT01693393 (ClinicalTrials.gov) | March 2010 | 14/9/2012 | Low Dose Cyclosporin A in Primary Sjögren Syndrome | A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome | Sjögren´s Syndrome | Drug: Cyclosporine A | Charite University, Berlin, Germany | NULL | Completed | 18 Years | 75 Years | Both | 30 | Phase 2 | Germany |
| 9 | NCT00001731 (ClinicalTrials.gov) | November 1997 | 3/11/1999 | Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops | A Double-Masked, Randomized, Vehicle-Controlled Pilot Study of the Treatment of Keratoconjunctivitis Sicca With Topical Cyclosporin A 0.1% Emulsion | Keratoconjunctivitis Sicca;Sjogren's Syndrome | Drug: Cyclosporin A | National Eye Institute (NEI) | NULL | Completed | N/A | N/A | Both | 30 | Phase 2 | United States |
| 10 | EUCTR2009-013976-38-DE (EUCTR) | 07/12/2009 | Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - Cypress | Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - Cypress | Primary Sjögren's Syndrome MedDRA version: 12.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome | Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN | Charité Berlin, Department of rheumatology | Charité Berlin, department of rheumatology;Charité Berlin, department of rheumatology | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany |