DDrare: Database of Drug Development for Rare Diseases

53. シェーグレン症候群
［臨床試験数：234，薬物数：270（DrugBank：85），標的遺伝子数：49，標的パスウェイ数：174］

Searched query = "Sjogren syndrome", "Sjögren syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.005% Lacripep; 0.01% Lacripep; 0.02% Fm, SH; 0.02% Fm, SH, 0.05% CsA; 0.02% Fm, SH, AS; 0.9% sodium chloride; 13-valent pneumococcal conjugate vaccine; 1643368-58-4; 18F-FDG; 23-valent pneumococcal polysaccharide vaccine; 552-02; ABATACEPT; ABBV-323; ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED; AMG 557/MEDI5872; AS; ASCs; Abatacept; Abatacept Placebo; Abatacept SC; Acycloguanosine; Alginate; Allogeneic Mesenchymal Stem Cells (AlloMSC); Allogeneic Stem Cell Transplant; Allogeneic adipose tissue-derived stromal/stem cells; Aloe vera; Anti-CD28dAb; Anti-CD28dab; Anti-pandemic H1N1 influenza vaccine; Artificial Saliva; Autologous Serum 20%; Autologous Serum 50%; Autologous Stem Cell Transplant; Autologous serum; Aún no establecido; B / Phuket / 3073/2013-like virus); BELIMUMAB; BENLYSTA; BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO; BMS-188667; BMS-931699; BMS-986142; BMS-986195; BMS986142; BMS986195; BTK Inhibitor; BUPI5; BUPIVACAINE HYDROCHLORIDE; Baminercept; Belimumab; Benlysta; Benlysta (Belimumab); Biopsy of the labial salivary gland; Blood sample; Branebrutinib; Bupivacaine; Bupizenge; CDZ173; CFZ533; CFZ533 (iscalimab); CFZ533 active - Cohort 1; CFZ533 active - Cohort 2; CFZ533 active - Cohort 3; CFZ533 active -Cohort 3; CICLOSPORIN; CO; CSCC_ASC(22); Calcium; Calcium carbonate; Calcium carbonate D; Carbomer; Carbomer 974P; Carbonate; Cathepsin S; Cathepsin S Inhibitor; Cathepsin S inhibitor; Cellulose; Cevimeline; Chloride; Ciclosporin; Citric Acid based Mouthwash; Citric acid; Coconut; Cryostor CS10; CsA; Cyclosporin; Cyclosporin A; Cyclosporine; Cyclosporine A; Cyclosporins; Dehydroepiandrosterone; Dexamethasone; Dexamethasone Parotid Irrigation; Diquafosol; Dornase alfa; E4; EFALIZUMAB; Efalizumab; Endura; Estetrol; Etanercept; FILGOTINIB; FMP-30; Filgotinib; GS-4059; GS-6034; GS-9876; GSK2618960; GSK2618960 2 mg/kg; Gadoterate; Ginseng; Glycyrrhiza; Gold; HGS1006, LymphoStat-B; HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA; HYDROCORTISONE SODIUM PHOSPHATE; HYDROXYCHLOROQUINE; HrIL-2 active; Hyaluronate; Hyaluronic acid; Hydrocortisone; Hydroxychloroquine; IL-2; ISCALIMAB; Ianalumab; Iguratimod; Ikervis; Impact; Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; Iscalimab; KCT-0809 ophthalmic solution; Korean Red Ginseng; LEFLUNOMIDE; LO2A eye drops; LOU064; LY3090106; Lacryvisc; Lanraplenib; Leflunomide; Leflunomide Mylan; Leflunomide mylan; Leniolisib; Levocarnitine; Levofloxacin; Licorice; LimphoStat-B; Lipitor®; Liposic; MABTHERA; MABTHERA - 1 FIALA 500 MG 50 ML; MEDI4920; METILPREDNISOLONE; MabThera; MabThera (Rituximab); MabThera (rituximab); Maxidex; Meglumine; Methotrexate; Methyl cellulose; MighTeaFlow; Mizoribine; Mucosta; Mycophenolate; Mycophenolate mofetil; Mycophenolate sodium; NGX267; NaCl 0,9%; Nivolumab; ORENCIA; ORENCIA 125 mg solution for injection in pre-filled syringe; OSE-127; Olive; Olive Oil; Olive oil; Omalizumab; Ophthalmic Emulsion; Orencia; Other: 0.02% Fm, SH, tBCL; Other: No treatment; Other: autologous serum and rebamipide 2%; Other: carboxy methyl cellulose; Other: natural herbs of coconut, aloe vera, and pepperint; P-552; PAH; PARACETAMOLO; PRP injection; Parsaclisib; Phosphate; Pilocarpine; Pilocarpine Hydrochloride; Plaquenil; Prednisone; Privigen 100 mg/ml, solution pour perfusion; Privigen® 100mg/ml at the dose of 2g/kg of body weight; Probiotic Product - Cap; Procedure: MRI Imaging with intravenous contrast with gadoterate meglumine; Procedure: Minor Salivary gland (labial) biopsy; Procedure: Sialoendoscopy; Procedure: pilocarpine; RC18 160 mg; RC18 240 mg; RITUXIMAB; RO545-9072/F03; RO5459072; RSLV-132; Radiation: 11C-MET PET/CT Imaging; Radiation: 18F-FDG PET/CT Imaging; Raptiva; Raptiva 100 mg/ml powder and solvent for solution for injection; Ravagalimab; Rebamipide; Refresh Endura; Remibrutinib; Restasis; Rituxan (US, Canada, Japan), MabThera (rest of world); Rituximab; Rituximab (anti-CD20); Rituximab, Mabthera; S95011; S95011 concentrate for solution for infusion; SALINE; SAR441344; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; SOLU-MEDROL; SS-1; SVS20; Saline; Sandimmun Optoral; Sodium chloride; Sodium hyaluronate; Softacort; Solu-Medrol; Solu-medrol; Standard care Hyaluronic acid eye drops; Sulfate; Systane Ultra UD; TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE; TCM (Gan-Lu-Yin)GLY; Tachipirina; Tacrolimus; Tears Naturale Forte; Tetracycline; Thalidomide; Thymosin Beta 4 eye drops; Thymosin beta 4; Tibulizumab; Tibulizumab (LY3090106); Tirabrutinib; Tocilizumab; Tofacitinib; UCB5857; Ustekinumab; VAY736; VAY736 antibody; VAY736 higher dose; VAY736 lower dose; VIB4920; VIB7734; Vehicle Control; Vitamin A; Vitamin D3; Water; XYZAL - 20 COMPRESSE RI; Xeros; Xylitol; Xyzal; Yellow Fever Vaccine; Yellow Fever vaccine (17D); [NA]; [na]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	ChiCTR2000034924	2020-10-30	2020-07-24	Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese	Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese	Rheumatoid arthritis, Sjogren's syndrome	Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets;	The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	NULL	Pending			Both	Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler	Phase 1	China
2	NCT03983408 (ClinicalTrials.gov)	June 17, 2019	10/6/2019	Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease	Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease	Sjögren's Syndrome;Rheumatic Diseases;Korean Red Ginseng	Dietary Supplement: Korean Red Ginseng;Dietary Supplement: Placebo	Hanyang University	The Korean Society of Ginseng	Recruiting	19 Years	75 Years	All	120	N/A	Korea, Republic of
3	NCT03762824 (ClinicalTrials.gov)	June 14, 2016	3/12/2018	Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease	Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.	Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;Spondyloarthritis	Biological: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine	Region Skane	NULL	Active, not recruiting	18 Years	N/A	All	300	Phase 4	NULL
4	JPRN-UMIN000019009	2015/08/19	14/09/2015	The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome		The dry eye patients complicated with Sjogren's syndrome	Mucosta ophthalmic suspensionUD2%, q.i.d. and Soft Santear, t.d. for 4weeks in both eyes Soft Santear, q.i.d. for 4weeks	Kyoto Prefectural University of Medicine	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	60	Not selected	Japan
5	JPRN-UMIN000010796	2013/06/01	24/05/2013	Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers		Sjogren's syndrome	single oral administration of pilocarpine. salagen (KISSEI PHARMACEUTICAL CO.,LTD.) 5mg 1Tablet.	Oita University Faculty of Medicine	NULL	Pending	20years-old	Not applicable	Male and Female	30	Not applicable	Japan
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	NCT01369589 (ClinicalTrials.gov)	November 2010	6/6/2011	An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness	An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's Syndrome	Xerostomia;Sjogren's Syndrome	Drug: P-552;Drug: Placebo	Parion Sciences	NULL	Completed	18 Years	N/A	All	24	Phase 1;Phase 2	United States

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

ChiCTR2000034924

2020-10-30

2020-07-24

Phase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese

Rheumatoid arthritis, Sjogren's syndrome

Group 1 (single dose tolerance test):test drug or placebo;Group2(single dose tolerance test):test drug or placebo;Group3(single dose tolerance test):test drug or placebo;Group4(single dose tolerance test):test drug or placebo;Group 5(single dose tolerance test):test drug or placebo;Group 6(single dose tolerance test):test drug or placebo;Group 7 (multiple dose tolerance test) :test drug or placebo;Group 8 (multiple dose tolerance test):test drug or placebo;Group 9 (single dose pharmacokinetic test):test drug;Group 10 (single dose pharmacokinetic test):test drug;Group 11 (single dose pharmacokinetic test):test drug;Group 12 (single dose pharmacokinetic test):test drug;Group 13 (multiple dose pharmacokinetic test):test drug;Group 14 (food impact test):test drug;Group 15 (antibiotic effect test):test drug and levofloxacin tablets;

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

NULL

Pending

Both

Group 1 (single dose tolerance test):4;Group2(single dose tolerance test):6;Group3(single dose tolerance test):8;Group4(single dose tolerance test):8;Group 5(single dose tolerance test):8;Group 6(single dose tolerance test):8;Group 7 (multiple dose toler

Phase 1

China

NCT03983408
(ClinicalTrials.gov)

June 17, 2019

10/6/2019

Impact of Korean Red Ginseng on Fatigue in Patients With Rheumatic Disease

Sjögren's Syndrome;Rheumatic Diseases;Korean Red Ginseng

Dietary Supplement: Korean Red Ginseng;Dietary Supplement: Placebo

Hanyang University

The Korean Society of Ginseng

Recruiting

19 Years

75 Years

All

120

N/A

Korea, Republic of

NCT03762824
(ClinicalTrials.gov)

June 14, 2016

3/12/2018

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease

Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response.

Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;Spondyloarthritis

Biological: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine

Region Skane

NULL

Active, not recruiting

18 Years

N/A

All

300

Phase 4

NULL

JPRN-UMIN000019009

2015/08/19

14/09/2015

The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome

The dry eye patients complicated with Sjogren's syndrome

Mucosta ophthalmic suspensionUD2%, q.i.d. and Soft Santear, t.d. for 4weeks in both eyes
Soft Santear, q.i.d. for 4weeks

Kyoto Prefectural University of Medicine

NULL

Complete: follow-up complete

20years-old

Not applicable

Male and Female

Not selected

Japan

JPRN-UMIN000010796

2013/06/01

24/05/2013

Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers

Sjogren's syndrome

single oral administration of pilocarpine.
salagen (KISSEI PHARMACEUTICAL CO.,LTD.)
5mg 1Tablet.

Oita University Faculty of Medicine

NULL

Pending

20years-old

Not applicable

Male and Female

Not applicable

Japan

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT01369589
(ClinicalTrials.gov)

November 2010

6/6/2011

An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness

An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's Syndrome

Xerostomia;Sjogren's Syndrome

Drug: P-552;Drug: Placebo

Parion Sciences

NULL

Completed

18 Years

N/A

All

Phase 1;Phase 2

United States