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 53. シェーグレン症候群 [臨床試験数:130,薬物数:158(DrugBank:64),標的遺伝子数:45,標的パスウェイ数:170] 

Searched query = "Sjogren syndrome", "Sjögren syndrome"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.

Search in Page    e.g. "Phase 3", "Not recruiting", "Japan"    Synonyms (DrugBank) were also searched for.
No.TrialIDDate_
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1NCT03953703December 1, 20199 September 2019Levocarnitine for Dry Eye in Sjogren's SyndromeA Randomized Placebo-controlled, Double Blind Phase 2 Clinical Trial of Levocarnitine for the Treatment of Keratoconjunctivitis Sicca in Sjogren's SyndromeSjogren's Syndrome;Keratoconjunctivitis SiccaDrug: Levocarnitine;Drug: PlaceboVanderbilt University Medical CenterNot recruiting18 Years75 YearsAll60Phase 2
2NCT04093531November 20194 November 2019Pilot Trial of Ustekinumab for Primary Sjögren's SyndromePilot Trial of Ustekinumab for Primary Sjögren's SyndromePrimary Sjögren SyndromeDrug: UstekinumabUniversity of RochesterNot recruiting18 Years75 YearsAll15Phase 1
3NCT04129164October 23, 20194 November 2019A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's SyndromeA Phase 2 Randomized, Double-blind, Placebo-controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects With Sjögren's Syndrome (SS)Sjögren's SyndromeDrug: VIB4920;Drug: PlaceboViela BioNot recruiting18 Years75 YearsAll174Phase 2
4NCT03905525October 1, 20194 November 2019Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjögren's SyndromeA 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjögren's Syndrome (TWINSS)Sjögren SyndromeDrug: CFZ533;Other: PlaceboNovartis PharmaceuticalsRecruiting18 YearsN/AAll260Phase 2Australia;Hungary;Japan;Turkey
5NCT03841318September 201926 August 2019Involvement of Immune Cells Derived From the Intestine in Sjogren's SyndromeInvolvement of Immune Cells Derived From the Intestine in Sjogren's SyndromeSjogren's SyndromeBiological: blood sample;Biological: biopsy of the labial salivary glandUniversity Hospital, BordeauxNot recruiting18 YearsN/AAll200N/AFrance
No.TrialIDDate_
enrollement
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
6ChiCTR19000246422019-08-0122 July 2019Clinical Study of Iguratimod in the Treatment of Primary Sjogren's SyndromeClinical Study of Iguratimod in the Treatment of Primary Sjogren's SyndromePrimary Sjogren's SyndromeExperimental group:Iguratimod+Prednisone;control group:HCQ+Prednisone;Chongqing Hospital of Traditional Chinese MedcineRecruiting1865BothExperimental group:30;control group:30;N/AChina
7NCT04035668July 12, 201911 November 2019A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's SyndromeAn Adaptive Phase 2 Randomized Double-blind, Placebo-controlled Multi-center Study to Evaluate the Safety and Efficacy of Multiple LOU064 Doses in Patients With Moderate to Severe Sjögren's Syndrome (LOUiSSe)Sjögren SyndromeDrug: LOU064;Drug: PlaceboNovartis PharmaceuticalsRecruiting18 Years75 YearsAll252Phase 2Australia;Germany;Hungary;Spain;Switzerland
8NCT04078386June 28, 201916 September 2019A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's SyndromeA Phase II Study of RC18, a Recombinant Human B Lymphocyte Stimulator Receptor:Immunoglobulin G( IgG ) Fc Fusion Protein for Injection for the Treatment of Subjects With Primary Sjögren's SyndromePrimary Sjögren's SyndromeBiological: Placebo;Biological: RC18 240 mg;Biological: RC18 160 mgRemeGenRecruiting18 Years65 YearsAll30Phase 2China
9NCT03700138June 24, 20192 September 2019Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory NeuropathiesProspective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory NeuropathiesPrimary Sjögren's Syndrome Painful Sensory NeuropathiesDrug: Privigen® 100mg/ml at the dose of 2g/kg of body weight;Drug: NaCl 0,9%University Hospital, Strasbourg, FranceRecruiting18 Years80 YearsAll24Phase 3France
10NCT03983408June 17, 201924 June 2019Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic DiseaseImpact of Korean Red Ginseng on Fatigue in Patients With Rheumatic DiseaseSjögren's Syndrome;Rheumatic Diseases;Korean Red GinsengDietary Supplement: Korean Red ginseng;Dietary Supplement: PlaceboHanyang UniversityThe Korean Society of GinsengNot recruiting19 Years75 YearsAll120N/AKorea, Republic of
No.TrialIDDate_
enrollement
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agemin
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PhaseCountries
11ChiCTR19000226962019-06-0130 April 2019A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndromeA prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndromeSjogren syndromeexperimental group :Iguratimod 25mg bid po;control group:hydroxychloroquine 0.2-0.4g/d+prednison0.2-0.5mg/kg.d;Shanghai Tongji HospitalNot Recruiting1870Bothexperimental group :60;control group:60;Phase 4China
12NCT03926286April 15, 201914 October 2019Fecal Microbial Transplant (FMT) for Sjogrens SyndromeFecal Microbial Transplant for Sjogrens SyndromeSjogren's SyndromeDrug: FMP-30University of MiamiSjogrens Syndrome Foundation;Microbiome Health Research InstituteNot recruiting18 YearsN/AAll10Phase 1United States
13NCT03816345April 4, 201911 November 2019Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable CancerA Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)Advanced Malignant Neoplasm;Autoimmune Disease;Crohn Disease;Dermatomyositis;Inflammatory Bowel Disease;Metastatic Malignant Neoplasm;Multiple Sclerosis;Rheumatoid Arthritis;Sjogren Syndrome;Systemic Lupus Erythematosus;Systemic Scleroderma;Ulcerative Colitis;Unresectable Malignant NeoplasmBiological: NivolumabNational Cancer Institute (NCI)Recruiting18 YearsN/AAll264Phase 1United States
14ChiCTR19000213452019-02-1218 February 2019Effect of Iguratimod on Primary Sjogren's SyndromeObservation of Iguratimod's Effect on Primary Sjogren's Syndrome, A randomized, double-blind, placebo-controlled trialPrimary Sjogren's SyndromeControl group :Hydrochloroquine;Treatment group:Iguratimod;Tianjin Medical University General HospitalRecruiting1875BothControl group :30;Treatment group:30;New Treatment Measure Clinical StudyChina
15EUCTR2017-001371-24-FR08/01/201928 February 2019Intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathiesProspective, randomised, placebo-controlled study of polyvalent intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies - TINISSPrimary Sjögren's syndrome associated painful sensory neuropathies;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Privigen 100 mg/ml, solution pour perfusion
Pharmaceutical Form: Solution for infusion
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Intravenous drip use (Noncurrent)
Hôpitaux Universitaires de StrasbourgAuthorised Female: yes
Male: yes
24Phase 3France
No.TrialIDDate_
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16NCT03817424December 13, 201830 September 2019A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisA Phase 1 Randomized, Placebo-Controlled, Blinded, Multiple Ascending Dose Study to Evaluate VIB7734 in Systemic Lupus Erythematosus, Cutaneous Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and DermatomyositisSystemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;DermatomyositisDrug: VIB7734;Drug: PlaceboViela BioRecruiting18 Years75 YearsAll32Phase 1United States;Poland;Spain
17EUCTR2017-004929-33-AT05/12/20187 January 2019Effect 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 syndromeprimary or secondary Sjögren Syndrome;Therapeutic area: Diseases [C] - Eye Diseases [C11]Trade Name: Ikervis
Product Name: Ikervis
Pharmaceutical Form: Eye drops, emulsion
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 1-
Trade Name: Softacort
Product Name: Softacort
Pharmaceutical Form: Eye drops, solution in single-dose container
INN or Proposed INN: HYDROCORTISONE SODIUM PHOSPHATE
CAS Number: 6000-74-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3.35-
KH Hietzing, Department of OphthalmologyAuthorisedFemale: yes
Male: yes
20Phase 4Austria
18NCT03865888October 30, 20183 June 2019Comparing 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: Tacrolimus;Drug: CyclosporinsPavly MoawdNot recruiting20 Years70 YearsAll60Phase 3Egypt
19NCT03627065September 24, 201830 September 2019A Study of INCB050465 in Primary Sjögren's SyndromeAn Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: ParsaclisibIncyte CorporationRecruiting18 YearsN/AAll12Phase 2United States
20NCT03436576September 12, 201810 September 2018Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry EyeComparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry EyeDry Eye;Keratoconjunctivitis Sicca;Sjogren's Syndrome;Corneal Diseases;Conjunctival Diseases;Keratitis;Lacrimal Apparatus DiseasesDrug: Autologous Serum 20%;Drug: Autologous Serum 50%Pontificia Universidad Catolica de ChileHospital Dr. Sótero del RíoRecruiting18 YearsN/AAll20Phase 3Chile
No.TrialIDDate_
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PhaseCountries
21NCT03540823April 23, 20186 May 2019Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic DiseasesImmunogenicity and Safety of Influenza A/H3N2 Vaccine in Patients With Rheumatologic DiseasesSystemic Lupus;Sjogren's SyndromeBiological: Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)University of Sao Paulo General HospitalNot recruiting9 YearsN/AAll300Phase 4Brazil
22NCT03319420March 29, 201822 July 2019Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's SyndromeA Randomized, Double-Masked, Comparative Study Versus Systane Ultra UD, to Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's SyndromeDry Eye Due to Sjögren's SyndromeDrug: LO2A eye drops;Drug: Systane Ultra UDOcuwize LTDRecruiting18 Years95 YearsAll60Phase 4Israel
23NCT03434106February 10, 201819 February 2018Sjögren's Syndrome Is Associated With Meibomian Gland DysfunctionSjögren's Syndrome Is Associated With Meibomian Gland DysfunctionMeibomian Gland Dysfunction;Sjögren's SyndromeDrug: liposic;Drug: Tears Naturale ForteLanZhou UniversityRecruiting45 Years60 YearsFemale60N/AChina
24ChiCTR18000146232018-02-0129 January 2018A prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren SyndromeA prospective study on therapeutic effect of Mesenchymal stem cell on patients with primary Sjogren SyndromeSjogren Syndromestem cell group: Intravenous use mesenchymal stem cell ;hydroxychloroquine group:oral use hydroxychloroquine ;Tongji Hospital of Tongji UniversityRecruitingBothstem cell group:20;hydroxychloroquine group:20;New Treatment Measure Clinical StudyChina
25NCT03430388January 31, 20186 May 2019Yellow 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 HospitalNot recruiting2 Years60 YearsAll600N/ABrazil
No.TrialIDDate_
enrollement
Last_Refreshed_
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Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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agemin
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PhaseCountries
26ChiCTR-IPR-170137722018-01-0111 December 2017A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry EyeA Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry EyeSjogren's Syndrome Dry Eyegroup of tacrolimus eye drops:tacrolimus eye drops;group of flurometholone eye drops:flurometholone eye drops;The Eye Hospital of Wenzhou Medical UniversityNot RecruitingBothgroup of tacrolimus eye drops:30;group of flurometholone eye drops:30;Post-marketChina
27NCT03840538January 1, 201825 February 2019Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's SyndromeProbiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's SyndromeSjogren's SyndromeDrug: Probiotic Product - CapCairo UniversityNot recruiting30 Years70 YearsAll32Phase 1/Phase 2Egypt
28NCT03239600September 19, 201711 June 2018A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Proof of Mechanism of GSK2618960 in Primary Sjögren's Syndrome (pSS)A Two Part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren's SyndromeAutoimmune DiseasesDrug: GSK2618960 2 mg/kg;Drug: Placebo;Drug: MethotrexateGlaxoSmithKlineNot recruiting18 Years70 YearsAll0Phase 2United Kingdom
29NCT03226444June 30, 201711 November 2019Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's SyndromeA Double-Masked, Randomized, Multi-Center Phase 2 Study to Evaluate the Efficacy and Safety of Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's SyndromePrimary Sjögren Syndrome;Dry EyeDrug: 0.005% Lacripep;Drug: 0.01% Lacripep;Drug: PlaceboTearSolutions, Inc.Not recruiting18 YearsN/AAll201Phase 1/Phase 2United States
30EUCTR2016-003292-22-FR09/06/201728 February 2019Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s SyndromePrimary Sjogren’s syndrome
MedDRA version: 19.1 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: VAY736
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Not established
CAS Number: Not establis
Current Sponsor code: VAY736
Other descriptive name: VAY736 antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Novartis Pharma AGAuthorised Female: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Japan;Germany;Netherlands;Romania;Belgium;Poland
No.TrialIDDate_
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31EUCTR2016-003292-22-DE06/06/201723 July 2018Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s SyndromePrimary Sjogren’s syndrome
MedDRA version: 20.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: ianalumab
CAS Number: Not establis
Current Sponsor code: VAY736
Other descriptive name: VAY736 antibody
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
Novartis Pharma AGAuthorisedFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
32NCT03060005May 1, 201716 December 2017Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ?Sjögren's Syndrome;Meibomian Gland DysfunctionDrug: Tears Naturale Forte;Drug: liposicTung Wah HospitalRecruiting50 Years60 YearsFemale80N/AChina
33NCT03100942May 1, 201722 October 2019Safety and Efficacy Study of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's SyndromeA Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects With Active Sjogren's SyndromeSjogren's SyndromeDrug: Tirabrutinib placebo;Drug: Lanraplenib placebo;Drug: Filgotinib placebo;Drug: Tirabrutinib;Drug: Lanraplenib;Drug: FilgotinibGilead SciencesGalapagos NVNot recruiting18 Years75 YearsAll152Phase 2United States;Poland;Spain;United Kingdom
34ChiCTR-INR-160096292017-04-0122 May 2017A double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndromeA double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndromeprimary Sjogren's Syndromelow disease activity-experimental group:Jiedu Tongluo Shengjin prescription;low disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-experimental group:Jiedu Tongluo Shengjin prescription;moderate disease activity-experimental group:prednisone 10mg/d;moderate disease activity-experimental group:Hydorxychloroquine 0.2g/d;moderate disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-control group:prednisone 10mg/d;moderate disease activity-control group:Hydorxychloroquine 0.2g/d;Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese MedicineNot Recruiting1870Bothlow disease activity-experimental group:27;low disease activity-control group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-conNew Treatment Measure Clinical StudyChina
35EUCTR2016-004258-14-GB21/02/20178 May 2017A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren’s Syndrome.A two part Phase IIa Study, to Evaluate the Safety and Tolerability, Pharmacokinetics, Proof of Mechanism and Potential for Efficacy of an Anti-IL-7 Receptor-a Monoclonal Antibody (GSK2618960) in the Treatment of Primary Sjögren’s Syndrome. - GSK2618960, PH2a, 2-part, repeat IV dose, Immunogenecity, Safety and PK/PD Study in pSS ptsPrimary Sjögren’s Syndrome
MedDRA version: 19.0 Level: LLT Classification code 10021295 Term: IL-7 therapy System Organ Class: 100000004865 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: GSK2618960
Product Code: GSK2618960
Pharmaceutical Form: Solution for injection
INN or Proposed INN: GSK2618960
CAS Number: N/A
Current Sponsor code: GSK2618960
Other descriptive name: GSK2618960
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
GlaxoSmithKline Research & Development LimitedAuthorisedFemale: yes
Male: yes
22Phase 2United Kingdom
No.TrialIDDate_
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36NCT03608761February 6, 201718 December 2018Comparison Between Rebamipide 2% Versus Autologous SerumComparison Between Rebamipide 2% Versus Autologous Serum in the Treatement of the Moderate to Severe Dry Eye Associate With Sjögren Syndrome. Pilot, Crossed, Controled, Randomized And Open StudyDry Eye Syndromes;Sjögren SyndromeDrug: Rebamipide;Biological: autologous serum;Other: autologous serum and rebamipide 2%Hospital Nacional Profesor Alejandro PosadasNot recruiting18 YearsN/AFemale21Phase 4Argentina
37JPRN-JapicCTI-17352101/2/201716 July 2019A Phase 3 study of Abatacept in Patients with Primary Sjogrens SyndromeA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjogrens SyndromePrimary Sjogrens SyndromeIntervention name : Abatacept
INN of the intervention : Abatacept
Dosage And administration of the intervention : Abatacept 125 mg subcutaneous injection once per week
Control intervention name : Abatacept Placebo
Dosage And administration of the control intervention : Placebo for Abatacept subcutaneous injection once per week
Bristol-Myers Squibb K.K.Not Recruiting18BOTH172Phase 3
38NCT03247686February 1, 201730 September 2019A Study of RSLV-132 in Subjects With Primary Sjogren's SyndromeA Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's SyndromeSjogren's SyndromeDrug: RSLV-132;Drug: PlaceboResolve TherapeuticsUniversity Hospital Birmingham;Newcastle-upon-Tyne Hospitals NHS TrustNot recruiting18 Years70 YearsAll28Phase 2United Kingdom
39NCT03023592February 201716 December 2017Study of Iguratimod in Sjögren's SyndromeA Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's SyndromeSjogren's SyndromeDrug: IguratimodPeking Union Medical College HospitalRecruiting18 Years75 YearsAll30Phase 1/Phase 2China
40NCT02915159December 6, 201610 December 2018A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens SyndromeA Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens SyndromeSjogrens DiseaseOther: Placebo;Biological: AbataceptBristol-Myers SquibbNot recruiting18 YearsN/AAll253Phase 3United States;Argentina;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Puerto Rico;Sweden;Canada;Czech Republic
No.TrialIDDate_
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41NCT02503163November 23, 201616 December 2017A Long-term Study of KCT-0809 in Dry Eye Patients With Sjögren's SyndromeDry Eye With Sjögren's SyndromeDrug: KCT-0809 ophthalmic solutionKissei Pharmaceutical Co., Ltd.Not recruiting20 YearsN/AAllPhase 3Japan
42NCT02503189November 23, 201616 December 2017A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's SyndromeDry Eye With Sjögren's SyndromeDrug: KCT-0809 ophthalmic solution;Drug: PlaceboKissei Pharmaceutical Co., Ltd.Not recruiting20 YearsN/AAllPhase 3Japan
43NCT02899377November 18, 20164 November 2019A PH I Pilot Imaging Study to Evaluate Molecular Imaging Methods in HVs and pSS PtsA Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren's SyndromeAutoimmune DiseasesRadiation: 18F-FDG PET/CT Imaging;Radiation: 11C-MET PET/CT Imaging;Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine;Procedure: Minor Salivary gland (labial) biopsyGlaxoSmithKlineQuintiles, Inc.Not recruiting30 YearsN/AAll25N/AUnited Kingdom
44NCT02843659October 18, 20169 October 2018Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's SyndromeA Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Subjects With Moderate to Severe Primary Sjögren's SyndromeSjögren's SyndromeDrug: BMS-931699;Drug: BMS-986142;Drug: PlaceboBristol-Myers SquibbNot recruiting18 Years70 YearsAll45Phase 2United States;Australia;Chile;Colombia;Italy;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;France;Hungary
45EUCTR2016-001586-87-GB29/09/201628 February 2019A Phase 2 Study of RSLV-132 in Subjects with Sjogren’s SyndromeA Phase 2, Double Blind, Placebo Controlled Study of RSLV-132 in Subjects with Primary Sjogren’s Syndrome - RSLV-132 in Primary Sjogren’s SyndromePrimary Sjogrens Syndrome;Therapeutic area: Body processes [G] - Immune system processes [G12]Product Name: RSLV-132
Pharmaceutical Form: Concentrate for solution for infusion
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intravenous use
Resolve Therapeutics, LLCNot Recruiting Female: yes
Male: yes
28Phase 2United Kingdom
No.TrialIDDate_
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Last_Refreshed_
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46NCT02701985July 5, 201616 December 2017A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's SyndromeA Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's SyndromeSjogren's SyndromeDrug: RO5459072;Drug: PlaceboHoffmann-La RocheNot recruiting18 Years75 YearsAll75Phase 2United States;France;Germany;Poland;Portugal;United Kingdom
47NCT03762824June 14, 201618 December 2018Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic DiseaseCombined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;SpondyloarthritisBiological: 23-valent pneumococcal polysaccharide vaccine;Biological: 13-valent pneumococcal conjugate vaccineRegion SkaneNot recruiting18 YearsN/AAll300Phase 4
48NCT02775916June 1, 201611 June 2018Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's SyndromeA Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CDZ173 in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: CDZ173;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 Years75 YearsAll30Phase 2Germany;Hungary
49EUCTR2014-004616-12-DE20/05/201619 March 2018Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CDZ173A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndromePrimary Sjögren's syndrome
MedDRA version: 19.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CDZ173
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Novartis Pharma Services AGNot RecruitingFemale: yes
Male: yes
30Phase 2Hungary;Poland;Germany
50NCT04111341May 6, 201614 October 2019A Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.A Double Blind, Randomized, Placebo Controlled Clinical Trial to Evaluate the Safety and Efficacy of Traditional Chinese Medicine in Sjögren's Syndrome.Sjögren's SyndromeDrug: TCM (Gan-Lu-Yin)GLY;Drug: PLACEBOChung Shan Medical UniversityNot recruiting20 Years80 YearsAll30Phase 2Taiwan
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
51NCT03411850May 201629 January 2018Sjogrens Syndrome Measured by UltrasoundDisease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot StudySjogren's SyndromeBiological: Orencia;Other: PlaceboArthritis & Rheumatism Associates, P.C.Bristol-Myers SquibbRecruiting18 Years65 YearsAll20Phase 2United States
52NCT02631538February 17, 20167 October 2019Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's SyndromeA Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's SyndromeSjogren's SyndromeDrug: Belimumab;Drug: Rituximab;Drug: Placebo belimumab;Drug: Placebo rituximabGlaxoSmithKlineNot recruiting18 YearsN/AAll79Phase 2Argentina;Canada;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom
53NCT02691949February 20163 October 2016Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's SyndromeEfficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's SyndromeSjogren's SyndromeDrug: Mycophenolate mofetilKaohsiung Medical UniversityRecruiting20 Years75 YearsBoth54Phase 2
54ChiCTR-OIB-160077892016-01-1818 April 20170.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluationSjogren's syndromeTacrolimus therapy group:0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days;Eye Institute of Xiamen UniversityRecruiting1870BothTacrolimus therapy group:30;Phase 4 studyChina
55EUCTR2015-000400-26-SE15/12/201528 February 2019A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome.Primary Sjogrens disease
MedDRA version: 20.0 Level: PT Classification code 10061664 Term: Autoimmune disorder System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Other descriptive name: MABTHERA
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Concentrate for solution for injection
Route of administration of the placebo: Intravenous use
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
CAS Number: 356547-88-1
Current Sponsor code: GSK1550188
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe
Route of administration of the placebo: Subcutaneous use
GlaxoSmithKline R&D LtdAuthorised Female: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
56NCT02614716December 10, 201518 December 2018A Study of LY3090106 in Participants With Sjögren's Syndrome (SS)A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3090106 in Subjects With Sjögren's SyndromeSjögren's SyndromeDrug: LY3090106;Drug: PlaceboEli Lilly and CompanyNot recruiting18 Years65 YearsAll32Phase 1United States;Bulgaria;Georgia;Romania
57NCT02495129December 201516 December 2017Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's SyndromeA Three-part, Partially Open Label and Double-blind, Randomized Study to Assess the Pharmacodynamic Effects, Safety, Tolerability and Preliminary Efficacy of VAY736 in Patients With Primary Sjögren's Syndrome Using [Zr-89]-Rituximab PET/CTPrimary Sjögren's SyndromeDrug: VAY736 lower dose;Drug: VAY736 higher doseNovartis PharmaceuticalsNot recruitingN/AN/AAll0Phase 1/Phase 2Netherlands
58NCT02610543October 201530 September 2019UCB Proof of Concept Study in Patients With Primary Sjögren's SyndromeA Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy of UCB5857 Over 12 Weeks in Subjects With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: UCB5857;Drug: PlaceboUCB CelltechPRA Health SciencesNot recruiting18 Years75 YearsAll27Phase 2France;Italy;Spain;Sweden;United Kingdom;Greece
59EUCTR2014-003140-12-NL21/09/20156 October 2015Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's SyndromeOptimizing DMARD-therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome - LEF-HCQ combination therapy in pSSSjogren'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 System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0 Level: LLT Classification code 10042846 Term: Syndrome Sjogren's System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0 Level: LLT 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
Pharmaceutical Form: Capsule
INN or Proposed INN: LEFLUNOMIDE
CAS Number: 75706-12-6
Concentration unit: Bq/mg becquerel(s)/milligram
Concentration type: equal
Concentration number: 20-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: Plaquenil
Product Name: Plaquenil
Pharmaceutical Form: Capsule
INN or Proposed INN: HYDROXYCHLOROQUINE
CAS Number: 118-42-3
Concentration unit: Bq/mg becquerel(s)/milligram
Concentration type: equal
Concentration number: 400-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
UMC UtrechtAuthorisedFemale: yes
Male: no
Netherlands
60JPRN-UMIN0000183762015/07/2223 April 2019Efficacy 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 diseaseChildhood-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 PediatricsNot Recruiting2years-oldNot applicableMale and Female20Not selectedJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
61NCT02334306June 8, 201517 September 2018A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's SyndromeA Phase 2a, Randomized, Placebo Controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's SyndromePrimary Sjögren's SyndromeBiological: AMG 557/MEDI5872;Other: PlaceboMedImmune LLCAmgenNot recruiting18 Years75 YearsAll32Phase 2United States;France;Sweden;United Kingdom
62NCT02503176June 2, 201511 June 2018An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's SyndromeDry Eye With Sjögren's SyndromeDrug: KCT-0809 ophthalmic solutionKissei Pharmaceutical Co., Ltd.Not recruiting20 YearsN/AAllPhase 3Japan
63NCT02464319June 1, 201511 June 2018A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's SyndromeSafety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: hrIL-2 active;Drug: hrIL-2 placeboPeking University People's HospitalMonash University;Beijing ShuangLu Pharmaceutical Co., Ltd.Not recruiting18 Years65 YearsAll60Phase 2China
64EUCTR2014-004523-51-GB18/05/201510 September 2018UCB Proof of Concept Study in patients with Primary Sjogren’s SyndromeA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROMEPrimary Sjogren’s Syndrome
MedDRA version: 19.1 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB5857
Product Code: UCB5857
Pharmaceutical Form: Capsule
INN or Proposed INN: UCB5857
CAS Number: 1362850-20-1
Current Sponsor code: UCB5857
Other descriptive name: UCB5857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: UCB5857
Product Code: UCB5857
Pharmaceutical Form: Capsule
INN or Proposed INN: UCB5857
CAS Number: 1362850-20-1
Current Sponsor code: UCB5857
Other descriptive name: UCB5857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Product Name: UCB5857
Product Code: UCB5857
Pharmaceutical Form: Capsule
INN or Proposed INN: UCB5857
CAS Number: 1362850-20-1
Current Sponsor code: UCB5857
Other descriptive name: UCB5857
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
UCB Celltech, UKNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Italy;United Kingdom;Sweden
65EUCTR2014-003896-41-GB27/03/201528 February 2019MedImmune Sjogren's Syndrome StudyA Phase 2a, Randomized, Placebo-controlled, Proof of Mechanism Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Subjects with Primary Sjogren’s SyndromePrimary Sjogren’s Syndrome
MedDRA version: 18.1 Level: LLT Classification code 10042846 Term: Syndrome Sjogren's System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: AMG 557/MEDI5872
Product Code: AMG 557/MEDI5872
Pharmaceutical Form: Solution for injection
INN or Proposed INN: AMG 557/MEDI5872
Current Sponsor code: AMG 557/MEDI5872
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 70-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
MedImmune, LLCNot Recruiting Female: yes
Male: yes
42Phase 2France;United States;United Kingdom;Sweden
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
66NCT02633332February 201528 December 2015Use of Well Known Drugs for New Destination - RA Improvement (RANT)Observational Retrospective Study About the Use of Well Known Drugs in Combination to Obtain a New Drug to Improve Quality of Life/Health in Patient With Diagnosed Rheumatoid Arthritis Not Responding to Commonly Used TreatmentsRheumatoid Arthritis;Autoimmune Diseases;Disorder of Synovium;Sjogren's Syndrome;Acute and Chronic Inflammation;Disorder of Pleura and Pleural Cavity;Felty's Syndrome;Rheumatoid NodulesDrug: Vitamin D3;Drug: Lipitor®;Drug: Acycloguanosine;Drug: Tetracycline;Drug: methotrexate;Drug: etanerceptUniversità Popolare Homo & NaturaNot recruiting18 Years75 YearsBoth15Phase 1Italy
67NCT02257957November 201419 February 2015Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry EyePlatelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry EyeDry Eye;Sjogren SyndromeDrug: PRP injection;Drug: Standard care Hyaluronic acid eye dropsUniversidad Nacional de ColombiaNot recruiting18 YearsN/ABoth30Phase 3
68NCT02291029October 22, 201426 August 2019Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's SyndromeA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of CFZ533 in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: CFZ533 active - Cohort 1;Drug: CFZ533 placebo- Cohort 1;Drug: CFZ533 active - Cohort 2;Drug: CFZ533 placebo - Cohort 2;Drug: CFZ533 active -Cohort 3;Drug: CFZ533 active - Cohort 3Novartis PharmaceuticalsNot recruiting18 Years75 YearsAll69Phase 2United States;Germany;Hungary;Switzerland;United Kingdom
69NCT02067910August 20149 September 2019Efficacy and Safety of Abatacept in Patients With Primary Sjögren's SyndromeRandomized, Double-blind, Placebo-controlled Phase III Study to Assess the Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome (ASAP III Study = Abatacept Sjögren Active Patients Phase III Study)Sjögren's SyndromeDrug: Abatacept SCUniversity Medical Center GroningenBristol-Myers SquibbNot recruiting18 YearsN/AAll80Phase 3Netherlands
70EUCTR2013-004808-19-GB23/07/201428 February 2019Study in patients with primary Sjögren’s syndrome with the aim to assess safety, tolerability, pharmacokinetics (way the body absorbs, distributes, and gets rid of the drug) and preliminary efficacy of CFZ533A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren'sprimary Sjögren’s syndrome
MedDRA version: 20.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not yet established
Current Sponsor code: CFZ533
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 150-
Novartis Pharma Services AGNot Recruiting Female: yes
Male: yes
66Phase 2United States;Hungary;Germany;Switzerland;United Kingdom
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
71NCT02112019June 201416 December 2017Endoscopic Treatment of Salivary Glands Affected by Sjögren's SyndromeEndoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot StudySjögren's SyndromeProcedure: Sialoendoscopy;Drug: saline;Drug: hydrocortisoneDerk Jan JagerNot recruiting18 Years70 YearsAll50N/ANetherlands
72NCT02149420May 23, 20149 October 2018PD of VAY736 in Patients With Primary Sjögren's SyndromeA Single Dose, Double-blind, Placebo-controlled, Parallel Study to Assess the Pharmacodynamics, Pharmacokinetics and Safety and Tolerability of VAY736 in Patients With Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: VAY736;Drug: PlaceboNovartis PharmaceuticalsNot recruiting18 Years75 YearsAll27Phase 2Germany;France;Netherlands;United States
73JPRN-UMIN0000132342014/04/012 April 2019Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndromeDry eye related to chronic GVHD and Sjogren s syndromeDiquafosol sodium and rebamipide ophthalmic solution
Artifical tears, vitamin A ophthalmic solution, or/and sodium hyaluronate ophthalmic solution
Keio University School of MedicineNot Recruiting20years-old75years-oldMale and Female20Not applicableJapan
74NCT02110446February 20148 February 2016Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's SyndromeEvaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome - A Randomized Control TrialSjögren's SyndromeDrug: SS-1;Drug: PlaceboChang Gung Memorial HospitalChang Gung University;National Science Council, Taiwan;China Medical University, China;China Medical University HospitalRecruiting20 Years75 YearsBoth60Phase 2Taiwan
75NCT02855658February 201415 August 2016Modulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's SyndromeModulation of Immunity-related Gene Expression Under the Chinese Herbal Formula SS-1 Treatment for Sjögren's SyndromeSjögren's SyndromeDrug: SS-1;Drug: PlaceboChina Medical University HospitalChang Gung Memorial Hospital;China Medical University, China;National Research Program for Biopharmaceuticals (NRPB)Recruiting20 Years75 YearsBoth90Phase 2Taiwan
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
76NCT01716312January 8, 201411 November 2019Omalizumab for LupusA Phase 1b, Randomized, Double-Blind, Placebo Controlled Study With an Open Label Extension to Evaluate the Safety and Tolerability of Omalizumab, A Humanized IgG1 Monoclonal Antibody in Patients With Lupus (STOP LUPUS)Systemic Lupus Erthematosus;Sjogren's SyndromeDrug: OmalizumabNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Not recruiting18 Years100 YearsAll17Phase 1United States
77ChiCTR-IPR-140054412014-01-0118 April 2017A double blind randomized study of Jiedu Tongluo Shengjin Decoction in treatment of primary Sjogren syndromeA double blind randomized study of Jiedu Tongluo Shengjin Decoction in treatment of primary Sjogren syndromeprimary Sjogren syndrometreatment group:hydroxychloroquine+Jiedu Tongluo Shengjin Decoction;Yueyang Hospital of Integrative Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese MedicineRecruiting1865Bothtreatment group:30;Phase 1 study
78NCT02027298November 201316 December 2017Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II StudyAbatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II StudyPrimary Sjogren's Syndrome;Secondary Sjogren's Syndrome;Inflammatory Arthritis;Rheumatoid ArthritisDrug: AbataceptThe Cleveland ClinicBristol-Myers SquibbNot recruiting18 YearsN/AAll0Phase 2United States
79NCT01782235July 24, 20132 September 2019Efficacy of Tocilizumab in Primary Sjögren's Syndrome.A Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy of Tocilizumab for the Treatment of Primary Sjögren's Syndrome.Primary Sjögren's Syndrome (pSS)Drug: Tocilizumab;Drug: PlaceboUniversity Hospital, Strasbourg, FranceNot recruiting18 Years80 YearsAll110Phase 2/Phase 3France
80JPRN-UMIN0000107962013/06/012 April 2019Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteersSjogren's syndromesingle oral administration of pilocarpine.
salagen (KISSEI PHARMACEUTICAL CO.,LTD.)
5mg 1Tablet.
Oita University Faculty of MedicineNot Recruiting20years-oldNot applicableMale and Female30Not applicableJapan
No.TrialIDDate_
enrollement
Last_Refreshed_
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PhaseCountries
81JPRN-UMIN0000107102013/05/152 April 2019Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial-Xerostomia in Sjogrens syndromeRebamipide was administered orally at 100 mg each time three times a day after meals for 8 weeks.
Placebo was administered orally three times a day after meals for 8 weeks.
Tochigi medical centerNot Recruiting20years-old80years-oldMale and Female60Phase 2Japan
82JPRN-UMIN0000042372013/03/312 April 2019Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric ageSjogren's syndrome in pediatric ageMizoribine 10 mg/kg (up to 500 mg) will be administered once daily twice a week.Graduate School of Medicine, Chiba UniversityNot Recruiting10years-old20years-oldMale and Female5Phase 2Japan
83NCT02147509March 201319 February 2015Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's SyndromeEvaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's SyndromeSjögren's Syndrome Patients With Severe Dry EyeDrug: 0.02% Fm, SH;Drug: 0.02% Fm, SH, 0.05% CsA;Other: 0.02% Fm, SH, tBCL;Drug: 0.02% Fm, SH, ASJinyang LiNot recruiting18 Years70 YearsBoth64N/AChina
84NCT03578900January 1, 201316 July 2018Quality of Life and Sjögren SyndromeQuality of Life in a Portuguese Population With Primary Sjögren SyndromeXerostomia;Hyposalivation;Quality of Life;Sjogren's SyndromeDrug: Xeros;Drug: Citric Acid based MouthwashGrupo de Investigação em Bioquímica e Biologia OralUniversity of Lisbon;Portuguese Institute of Rheumatology;DentaidNot recruiting18 YearsN/AAll289Phase 4
85NCT02004067January 201316 December 2017Safety 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 PauloAllerganNot recruiting18 Years65 YearsAll100Phase 4Brazil
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86NCT01759108December 201219 February 2015Rebamipide for the Treatment of Xerostomia in sjögren SyndromeImproving Symptoms of Dry Mouth in Sjogren's SyndromeDrug: RebamipideFaculty of Medicine, University of AlexandriaRecruitingN/AN/ABoth55N/AEgypt
87NCT01552681July 201219 October 2017Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's SyndromeA Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Baminercept, a Lymphotoxin-beta Receptor Fusion Protein, for the Treatment of Primary Sjögren's Syndrome (ASJ02)Primary Sjögren's SyndromeBiological: Baminercept;Other: PlaceboNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of Excellence;BiogenNot recruiting18 Years75 YearsAll52Phase 2United States
88EUCTR2011-006196-19-DK28/02/201219 December 2016Clinical Trials with lozenge as local anaesthesia as treatment for oral pain of patients with burning mouth syndrome and Sjögrens syndromClinical Trials with lozenge as local anaesthesia as treatment of oral pain in burning mouth syndrome and Sjögrens syndrome - SB LozengeOral pain caused by the illnesses burning mouth syndrome, Sjögren's syndrome and lichen planus;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]Product Name: Bupizenge
Product Code: BUPI5
Pharmaceutical Form: Lozenge
INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE
CAS Number: 18010-40-7
Concentration unit: IU/mg international unit(s)/milligram
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of the placebo: Lozenge
Route of administration of the placebo: Oropharyngeal use
Clinical Research Centre, Hvidovre University HospitalNot RecruitingFemale: yes
Male: yes
60Phase 2Denmark
89NCT01601028July 201119 February 2015Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's SyndromePhase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's SyndromeAutoimmune Diseases;Sjogren's Syndrome;Dry EyeDrug: Hydroxychloroquine;Drug: PlaceboSeoul National University HospitalNot recruiting19 YearsN/ABoth39Phase 3Korea, Republic of
90NCT01316770May 1, 201112 November 2018Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome SubjectsA Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome SubjectsSjögren's Syndrome;XerostomiaDrug: Placebo Parotid Irrigation;Drug: Dexamethasone Parotid IrrigationNational Institute of Dental and Craniofacial Research (NIDCR)Not recruiting18 YearsN/AFemale14Phase 2United States
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91NCT01357447May 201119 February 2015Pulmozyme for Sjogren's Associated CoughA Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated CoughSjogren's Syndrome;CoughDrug: Dornase alfa;Drug: SalineUniversity of Connecticut Health CenterNot recruiting18 YearsN/ABoth0Phase 1United States
92NCT01393132March 201119 October 2017Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry EyeComparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry EyeDry Eye;Sjogren's Syndrome;Graft vs. Host DiseaseDrug: Thymosin Beta 4 eye drops;Drug: Vehicle ControlMichigan Cornea Consultants, PCKresge Eye InstituteNot recruiting18 Years90 YearsAll9Phase 2United States
93NCT01647737March 201119 October 2017Green Tea Lozenges for the Management of Dry MouthA Natural Formulation for Patients Diagnosed With XerostomiaXerostomia;Sjogren Syndrome;Dry MouthDietary Supplement: MighTeaFlow;Dietary Supplement: XylitolAugusta UniversityGlaxoSmithKlineNot recruiting18 Years75 YearsAll60Phase 1/Phase 2United States
94JPRN-UMIN0000044772010/11/012 April 2019Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunkSystemic/cutaneous lupus erythematosus Sjogren's syndromeHydroxychloroquine 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 ScienceNot Recruiting20years-old75years-oldMale and Female10Not applicableJapan
95NCT01369589November 201029 April 2019An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal WetnessAn Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's SyndromeXerostomia;Sjogren's SyndromeDrug: P-552;Drug: PlaceboParion SciencesNot recruiting18 YearsN/AAll24Phase 1/Phase 2United States
No.TrialIDDate_
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96EUCTR2009-015558-40-NL28/07/201019 March 2012Abatacept treatment in patients with primary Sjögren’s syndromeAbatacept treatment in patients with primary Sjögren’s syndromeSjögren’s syndrome (SS) is a chronic, systemic, lymphoproliferative autoimmune disease affecting the exocrine glands. The salivary and lacrimal glands are most commonly affected, resulting in dry mouth and dry eyes. Extraglandular involvement can occur in SS, and includes, amongst others, pulmonary disease, renal disease and vasculitis. Moreover, almost all patients suffer from restricting fatigue.
MedDRA version: 12.0 Level: LLT Classification code 10040767 Term: Sjogren's syndrome
Trade Name: Orencia
Pharmaceutical Form: Powder for concentrate for solution for infusion
University Medical Center GroningenAuthorisedFemale: yes
Male: yes
15Netherlands
97NCT01151644April 201019 February 2015Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesSafety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic DiseasesRheumatoid Arthritis;Spondyloarthritis;Systemic Lupus Erythematosus (SLE);Dermatomyositis (DM);DMixed Connective Tissue Disease;Systemic Vasculitis;Systemic Sclerosis (SSc);Sjögren's Syndrome;Antiphospholipid Syndrome;Juvenile Idiopathic Arthritis;Juvenile SLE;Juvenile DMBiological: Anti-pandemic H1N1 influenza vaccineUniversity of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloNot recruitingN/AN/ABoth5000Phase 4Brazil
98NCT01081184March 201019 February 2015Neurotrophins Implications in Primary Sjögren SyndromeNeurotrophins Implications in Primary Sjögren SyndromePrimary Sjögren SyndromeBiological: blood sampleUniversity Hospital, LimogesNot recruiting18 YearsN/ABoth40N/AFrance
99NCT01160666March 201019 February 2015Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's SyndromeA Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS (BAFF) Antibody, in Subjects With Primary Sjögren's SyndromeSjögren's SyndromeDrug: BelimumabAssistance Publique - Hôpitaux de ParisHuman Genome Sciences Inc.Not recruiting18 YearsN/ABoth20Phase 2France
100NCT01693393March 201010 August 2015Low 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, GermanyNot recruiting18 Years75 YearsBoth30Phase 2Germany
No.TrialIDDate_
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101NCT01850979February 201019 February 2015Treatment of Dry Eye Using 0.03% Tacrolimus Eye DropsTreatment of Dry Eye Using 0.03% Tacrolimus Eye Drops: Prospective Double-Blind Randomized StudySjogren Syndrome;Dry Eye SyndromeDrug: Tacrolimus;Drug: Olive OilUniversity of Sao Paulo General HospitalNot recruiting40 Years60 YearsBoth24Phase 4Brazil
102EUCTR2009-015978-35-FR30/11/200919 March 2012Etude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISSEtude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISSSyndrome Sjogren's
MedDRA version: 8.1 Level: PT Classification code 10042846 Term: Syndrome Sjogren's
Product Name: HGS1006, LymphoStat-B
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: belimumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 400-
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)AuthorisedFemale: yes
Male: yes
30Phase 2France
103NCT01008982August 200919 February 2015Efficacy and Safety of Belimumab in Primary Sjögren's SyndromeA Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Primary Sjögren's Syndrome.Sjögren's SyndromeDrug: LimphoStat-BUniversity of UdineAzienda Ospedaliera S. Maria della MisericordiaNot recruiting18 Years90 YearsBoth15Phase 2Italy
104NCT00953485June 200919 February 2015Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome (pSS)Clinical Trial of Allogeneic Mesenchymal Stem Cells Transplantation for Primary Sjögren's Syndrome - Phase ?/?Sjogren's Syndrome;Mesenchymal Stem CellsBiological: Allogeneic Mesenchymal Stem Cells (AlloMSC)The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting15 Years70 YearsBoth20Phase 1/Phase 2China
105JPRN-UMIN0000293072009/02/012 April 2019Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patientsSjogren's syndromePilocarpine / sodium alginate solution (0.32 mL, pilocarpine 0.96 mg) is administered intra-orally 3 times a day for 7 days.Teikyo UniversityNot Recruiting16years-oldNot applicableMale and Female50Not selectedJapan
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106NCT00852839February 200924 September 2018A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's SyndromeA Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's SyndromeDry Mouth Associated With Sjogren's Syndrome;XerostomiaDrug: Placebo;Drug: 552-02Parion SciencesNot recruiting18 Years80 YearsAll140Phase 2United States
107EUCTR2009-013976-38-DE18 April 2012Phase 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) - CypressPrimary Sjögren's Syndrome
MedDRA version: 12.1 Level: LLT Classification code 10059142 Term: Sjoegren's syndrome
Trade Name: Sandimmun Optoral
Product Name: Sandimmun Optoral
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade Name: Sandimmun Optoral
Product Name: Sandimmun Optoral
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Trade Name: Sandimmun Optoral
Product Name: Sandimmun Optoral
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: CICLOSPORIN
CAS Number: 59865-13-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Charité Berlin, Department of rheumatologyCharité Berlin, department of rheumatology;Charité Berlin, department of rheumatologyAuthorisedFemale: yes
Male: yes
Phase 2Germany
108JPRN-UMIN0000014602008/10/012 April 2019The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndromeSjogren's syndromeOral pilocarpine hydrochloride for 4 weeks.Department of Pediatrics, Graduate School of Medicine, Chiba UniverityNot Recruiting6years-old16years-oldMale and Female10Not selectedJapan
109EUCTR2007-003537-16-NL04/09/200819 March 2012Estetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept StudyEstetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept StudyPrimary Sjogren's Syndrome
MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome
Product Name: estetrol
Product Code: E4
Pharmaceutical Form: Oral solution
Erasmus MCAuthorisedFemale: yes
Male: no
Netherlands
110EUCTR2007-001377-28-FR11/06/200819 March 2012Phase 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™-TRAILAdult 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 newly diagnosed autoimmune disorders OR who developed severe thrombocytopenia.
MedDRA version: 9.1 Level: LLT Classification code 10061664 Term: Autoimmune disorder
MedDRA version: 9.1 Level: LLT Classification code 10025139 Term: Lupus erythematosus systemic
MedDRA version: 9.1 Level: LLT Classification code 10047888 Term: Wegener's granulomatosis
MedDRA version: 9.1 Level: LLT Classification code 10002817 Term: Antiphospholipid syndrome
MedDRA version: 9.1 Level: LLT Classification code 10040767 Term: Sjogren's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
MedDRA version: 9.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis
MedDRA version: 9.1 Level: LLT Classification code 10045228 Term: Type I diabetes mellitus
MedDRA version: 9.1 Level: LLT Classification code 10011401 Term: Crohn's disease
MedDRA version: 9.1 Level: LLT Classification code 10009900 Term: Colitis ulcerative
MedDRA version: 9.1 Level: LLT Classification code 10003827 Term: Autoimmune hepatitis
MedDRA version: 9.1 Level: LLT Classification code 10049046 Term: Autoimmune thyroiditis
MedDRA version: 9.1 Level: LLT Classification code 10003822 Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1 Level: LLT Classification code 10034697 Term: Pernicious anemia
MedDRA version: 9.1 Level: LLT Classification code 10028417 Term: Myasthenia gravis
MedDRA version: 9.1 Level: LLT Classification code 10018620 Term: Goodpasture's syndrome
MedDRA version: 9.1 Level: LLT Classification code 10
Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Efalizumab
Other descriptive name: EFALIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 100-
Merck Serono International S.A.AuthorisedFemale: yes
Male: yes
92Phase 4Portugal;Germany;Netherlands;France;Austria
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111NCT00632866March 200819 February 2015Hydroxychloroquine Versus Placebo in Primary Sjögren's SyndromeRandomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's SyndromePrimary Sjögren's SyndromeDrug: Hydroxychloroquine;Drug: PlaceboAssistance Publique - Hôpitaux de ParisSanofiNot recruiting18 YearsN/ABoth120Phase 3France
112NCT00631358February 200819 October 2017Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid InterventionSjogren's SyndromeDrug: Maxidex;Other: No treatmentAlcon ResearchNot recruiting17 YearsN/AAll97Phase 4Canada
113NCT00637793February 200819 February 2015Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's SyndromeA Double-Blind, Placebo-Controlled, Cross Over Study Using a Latin Square Design to Evaluate the Safety, Tolerability, and Efficacy of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjogren's SyndromeXerostomia;Sjogren's SyndromeDrug: NGX267TorreyPines TherapeuticsNot recruiting21 Years55 YearsBoth24Phase 2United States
114JPRN-UMIN0000009972008/01/012 April 2019The non-blind test crossover controlled trial how we used a physically unimpaired person volunteer about quantity of salivary secretion increase action of gargle remedy of cevimeline hydrochloride hydrateXerostomia due to Sjogren`s syndromeIt is a gargle with a test drug(Cevimeline hydrochloride hydrate 30mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo1 (Cevimeline hydrochloride hydrate 9mg+Hachiazule(TM)gargle 2g+distilled water 50cc)for two minutes. wash out, It is a gargle with false placebo2 (Hachiazule(TM)gargle2g+distilled water 50cc)for two minutes.
It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes.
It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
It is a gargle with a test drug for two minutes. wash out, It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes.
It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes. wash out,It is a gargle with false placebo2 for two minutes.
It is a gargle with false placebo2 for two minutes. wash out, It is a gargle with false placebo1 for two minutes. wash out, It is a gargle with a test drug for two minutes.
Department of Dentistry and Oral Surgery, Tochigi National HospitalNational Institute of Public HealthNot Recruiting20years-old90years-oldMale and Female12Phase 1Japan
115NCT00438048November 200619 February 2015A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy TreatmentXerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial SalivaPrimary Sjogren;Secondary Sjogren;XerostomiaProcedure: pilocarpine;Drug: Artificial SalivaPontificia Universidad Catolica de ChileFormulario MAgistral Farmacias AhumadaNot recruiting18 YearsN/ABoth76Phase 4Chile
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116NCT00363350August 200619 February 2015Rituximab Treatment in Sjogren's SyndromeRituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled TrialSjogren's SyndromeDrug: rituximab (anti-CD20)University Medical Centre GroningenHoffmann-La RocheNot recruiting18 Years85 YearsBoth30Phase 1/Phase 2Netherlands
117NCT00344448June 200619 October 2017Pilot Study of Raptiva to Treat Sjogren's SyndromeA Randomized, Placebo Controlled, Proof of Concept, Study of Raptiva, a Humanized Anti-CD-11a Monoclonal Antibody, in Patients With Sjogren's SyndromeSjogren's SyndromeDrug: RaptivaNational Institute of Dental and Craniofacial Research (NIDCR)Not recruiting18 YearsN/AAll10Phase 2United States
118NCT00542763April 200519 February 2015Mycophenolate Sodium Treatment in Patients With Primary Sjogren's SyndromeMycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome - An Open Label Pilot TrialPrimary Sjogren's SyndromeDrug: Mycophenolate sodiumUniversity Hospital MuensterNovartisNot recruiting18 Years75 YearsBoth12Phase 1Germany
119NCT00233363March 200519 February 2015Exploratory Study for Dry Mouth in Patients With Sjögren’s SyndromeAn Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren’s SyndromeXerostomia;Sjogren's SyndromeDrug: RebamipideOtsuka Pharmaceutical Co., Ltd.Not recruiting20 YearsN/ABoth100Phase 2Japan
120NCT00873496January 200519 February 2015Effects of Hydroxychloroquine on Oral Complaints of Sjögren PatientsEffects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study.Sjögren's Syndrome;XerostomiaDrug: HydroxychloroquineEge UniversityNot recruitingN/AN/AFemale30N/ATurkey
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121NCT00101829April 200416 December 2017Anti-CD20 Antibody Therapy for Sjogren's SyndromeAn Open-Label, One Arm, Phase I Safety Study of Anti-CD20 Antibody (Rituximab, Rituxan) Therapy in the Treatment of Primary Sjogren's SyndromeSjogren's SyndromeDrug: RituximabNational Institute of Allergy and Infectious Diseases (NIAID)Autoimmunity Centers of ExcellenceNot recruiting18 Years75 YearsAll12Phase 1United States
122NCT00278512August 20038 August 2016Hematopoietic Stem Cell Support in VasculitisHigh Dose Immune Suppression With Hematopoietic Stem Cell Support in Refractory Vasculitis, Necrotizing Vasculitis, Neurovascular Behcet's Disease, and Sjogren's SyndromeVasculitisBiological: Autologous Stem Cell Transplant;Biological: Allogeneic Stem Cell TransplantNorthwestern UniversityNot recruiting16 Years60 YearsBoth7Phase 1United States
123NCT00543166February 200319 February 2015Sex Steroids in Sjögren's Syndrome: Effect of Substitution Treatment on FatigueSex Steroids in Sjögren's Syndrome: Effect of Substitution Treatment on FatigueSjogren's SyndromeDrug: dehydroepiandrosteroneHelsinki UniversityGöteborg University;Uppsala UniversityNot recruiting18 Years80 YearsBoth107Phase 4Finland
124NCT00025818May 200119 February 2015Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye SyndromeKeratoconjunctivitis Sicca;Sjogren's Syndrome;Lupus Erythematosus, Systemic;Arthritis, Rheumatoid;Scleroderma, SystemicDrug: Ophthalmic EmulsionAllerganNot recruiting18 YearsN/ABoth290Phase 3United States
125NCT00391924May 200019 February 2015Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's SyndromeFatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone AdministrationLupus Erythematosus, Systemic;Sjogren's SyndromeDrug: DehydroepiandrosteroneUMC UtrechtUniversity Medical Centre Groningen;Dutch Arthritis AssociationNot recruiting18 YearsN/AFemale120Phase 2Netherlands
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126NCT00001954December 199919 February 2015Etanercept Therapy for Sjogren's SyndromeEtanercept Therapy for Sjogren's SyndromeSjogren's SyndromeDrug: EtanerceptNational Institute of Dental and Craniofacial Research (NIDCR)Not recruitingN/AN/ABoth28Phase 2United States
127NCT00001731November 199719 February 2015Treatment 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)Not recruitingN/AN/ABoth30Phase 2United States
128NCT00001598May 199719 February 2015DHEA Treatment for Sjogren's SyndromeDehydroepiandrosterone (DHEA) Treatment for Sjogren's SyndromeLacrimal Apparatus Disease;Salivary Gland Disease;Sjogren's Syndrome;XerostomiaDrug: DehydroepiandrosteroneNational Institute of Dental and Craniofacial Research (NIDCR)Not recruitingN/AN/AFemale28Phase 2United States
129NCT00001599May 199719 February 2015Pilot Study of Thalidomide to Treat Sjogren's SyndromePilot Study of Thalidomide for Sjogren's SyndromeSjogren's Syndrome;XerostomiaDrug: ThalidomideNational Institute of Dental and Craniofacial Research (NIDCR)Not recruitingN/AN/AFemale28Phase 2United States
130JPRN-JapicCTI-05003623 April 2019Exploratory study of rebamipide to evaluate the efficacy and safety in treatment of dry mouth in patients with Sjogren's syndromeExploratory study of rebamipide to evaluate the efficacy and safety in treatment of dry mouth in patients with Sjogren's syndromeDry mouth in patients with Sjogren's syndromeIntervention name : Rebamipide
Dosage And administration of the intervention : Oral
Otsuka Pharmaceutical Co., Ltd.20BOTHPhase 2

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