53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details


臨床試験数 : 283 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181

  
16 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-003749-39-IT
(EUCTR)
15/12/202115/10/2021A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 3United States;Italy
2NCT04835623
(ClinicalTrials.gov)
June 21, 20215/4/2021CEQUA for Sjogren's Syndrome Dry EyeEffects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's SyndromeDry Eye;Dry Eye Syndromes;Sjogren's SyndromeDrug: Cyclosporine 0.09% Ophthalmic SolutionCenter for Ophthalmic and Vision Research, LLCSun Pharma Global FZERecruiting18 Years70 YearsAll50Phase 4United States
3NCT04597762
(ClinicalTrials.gov)
August 31, 202016/10/2020Effect of Ciclosporin Eyedrops on Sjögren SyndromeEffect of Ciclosporin Eyedrops on Ocular Symptoms and Optical Quality in Patients With Sjögren SyndromeDry Eye SyndromesDrug: Cyclosporin;Drug: HydrocortisoneHospital HietzingNULLCompleted18 Years90 YearsAll12N/AAustria
4EUCTR2017-004929-33-AT
(EUCTR)
05/12/201827/11/2018Effect of Ciclosporin eyedrops on symptoms of the eye and visual quality in patients with dry eye syndrome and primary or secondary Sjögren syndromeEffect of Ciclosporin eyedrops on ocular symptoms and optical image quality in patients with primary or secondary Sjögren syndrome primary or secondary Sjögren Syndrome;Therapeutic area: Diseases [C] - Eye Diseases [C11]Trade Name: Ikervis
Product Name: Ikervis
INN or Proposed INN: CICLOSPORIN
Trade Name: Softacort
Product Name: Softacort
INN or Proposed INN: HYDROCORTISONE SODIUM PHOSPHATE
KH Hietzing, Department of OphthalmologyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Austria
5NCT03865888
(ClinicalTrials.gov)
October 30, 201816/12/2018Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren SyndromeEvaluation 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 SyndromeDry Eye;Sjogren SyndromeDrug: Cyclosporins;Drug: TacrolimusPavly MoawdNULLCompleted20 Years70 YearsAll60Phase 3Egypt
6ChiCTR-IPR-15005990
2015-03-232015-02-10Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled TrialCyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial Sjogren's syndromeTreatment group:glucocorticoid+CsA;Control group:glucocorticoid+placebo;Peking University People's HospitalNULLPending1875BothTreatment group:120;Control group:120;China
7NCT02370550
(ClinicalTrials.gov)
March 201518/2/2015Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's SyndromeCyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled TrialSjogren's SyndromeDrug: Cyclosporin A;Drug: Prednisone;Drug: Placebo;Drug: Calcium carbonate DPeking University People's HospitalNULLRecruiting18 Years75 YearsAll240Phase 4China
8NCT02004067
(ClinicalTrials.gov)
January 20133/12/2013Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye DiseaseSafety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye DiseasePrimary Sjogren Syndrome;Secondary Sjogren Syndrome;Aqueous Deficient Dry Eye Disease;Evaporative Dry Eye DiseaseDrug: Restasis;Drug: Refresh EnduraFederal University of São PauloAllerganCompleted18 Years65 YearsAll100Phase 4Brazil
9NCT01693393
(ClinicalTrials.gov)
March 201014/9/2012Low Dose Cyclosporin A in Primary Sjögren SyndromeA Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren SyndromeSjögren´s SyndromeDrug: Cyclosporine ACharite University, Berlin, GermanyNULLCompleted18 Years75 YearsBoth30Phase 2Germany
10EUCTR2007-001377-28-PT
(EUCTR)
09/01/200925/08/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
11EUCTR2007-001377-28-DE
(EUCTR)
01/09/200815/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
12EUCTR2007-001377-28-NL
(EUCTR)
15/07/200829/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
13EUCTR2007-001377-28-AT
(EUCTR)
26/06/200827/05/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
14EUCTR2007-001377-28-FR
(EUCTR)
11/06/200829/02/2008Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAILPhase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder
MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic
MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis
MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome
MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome
MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis
MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis
MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus
MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease
MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative
MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis
MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis
MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia
MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis
MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome
MedDRA version: 9.1;Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Merck Serono International S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
15NCT00001731
(ClinicalTrials.gov)
November 19973/11/1999Treatment of Dry Eye Syndrome With Cyclosporin A Eye DropsA Double-Masked, Randomized, Vehicle-Controlled Pilot Study of the Treatment of Keratoconjunctivitis Sicca With Topical Cyclosporin A 0.1% EmulsionKeratoconjunctivitis Sicca;Sjogren's SyndromeDrug: Cyclosporin ANational Eye Institute (NEI)NULLCompletedN/AN/ABoth30Phase 2United States
16EUCTR2009-013976-38-DE
(EUCTR)
07/12/2009Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - CypressPhase 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 rheumatologyCharité Berlin, department of rheumatology;Charité Berlin, department of rheumatologyAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Germany