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.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03953703
(ClinicalTrials.gov)
April 1, 202130/4/2019Levocarnitine for Dry Eye in Sjogren's SyndromeA Randomized Placebo-controlled, Double Blind Pilot Crossover Trial of Levocarnitine for the Treatment of Keratoconjunctivitis Sicca in Sjogren's SyndromeSjogren's Syndrome;Keratoconjunctivitis SiccaDrug: Levocarnitine;Drug: PlaceboVanderbilt University Medical CenterNULLNot yet recruiting18 Years75 YearsAll15Phase 2NULL
2ChiCTR2000037057
2021-01-012020-08-26A Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin GranulesA Randomized Double-blind Controlled Study on the Effect of Different Compatibility Ratios of Peony and Glycyrrhizae Herbs on the Clinical Efficacy of Jiedu Tongluo Shengjin Granules Sjogren syndromeThe first group : The dosage of peony and licorice in Jiedu Tongluo Shengjin Granules is: 12g of Radix Paeoniae Alba and 6g of raw licorice (2:1) ; The second group:The dosage of Peony and Glycyrrhiza in Jiedu Tongluo Shengjin Granules is: 18g of Radix Paeoniae and 6g of licorice (3 :1); The third group:The dosage of peony and licorice in Jiedu Tongluo Shengjin Granules is: Radix Paeoniae Alba 30g and raw licorice 6g (5:1);The fourth group:One-tenth of placebo detoxification Tongluo Shengjin granules (white peony 12g licorice 6g);Yueyang Integrated Traditional Chinese and Western Medicine Hospital affiliated to Shanghai University of Traditional Chinese MedicineNULLPending1865BothThe first group :30; The second group:30; The third group:30;The fourth group:30;China
3EUCTR2019-002713-19-HU
(EUCTR)
30/12/202002/11/2020A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS)A 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 syndrome
MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: VIB4920
INN or Proposed INN: Not applicable
Other descriptive name: MEDI4920
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
174Phase 2United States;Taiwan;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Peru;China;Korea, Republic of
4NCT04541589
(ClinicalTrials.gov)
December 18, 202014/8/2020Study of Safety and Tolerability of CFZ533 in Patients With Sjögren's SyndromeA TWINSS Extension Trial to Evaluate the Safety and Tolerability of CFZ533 (Iscalimab) at Two Dose Levels Administered Subcutaneously in Patients With Sjögren's SyndromeSjögren's SyndromeDrug: CFZ533 (iscalimab);Other: CFZ533 PlaceboNovartis PharmaceuticalsNULLNot yet recruiting18 Years90 YearsAll160Phase 2NULL
5NCT04496960
(ClinicalTrials.gov)
December 17, 20202/8/2020Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's SyndromeSafety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome Phase Ib-IIa Placebo-Controlled Clinical Trial and Associated Mechanistic StudiesSjogren's SyndromeDrug: tofacitinib;Other: PlaceboNational Institute of Dental and Craniofacial Research (NIDCR)NULLNot yet recruiting18 Years75 YearsAll30Phase 1;Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04605978
(ClinicalTrials.gov)
December 7, 202019/10/2020Efficacy and Safety of S95011 in Primary Sjögren's Syndrome PatientsA Phase IIa Efficacy and Safety Trial With Intravenous S95011 in Primary Sjögren's Syndrome Patients: An International, Multicentre, Randomised, Double-blind, Placebo-controlled StudyPrimary Sjögren's SyndromeDrug: S95011 concentrate for solution for infusion;Drug: Placebo concentrate for solution for infusionInstitut de Recherches Internationales ServierADIR, a Servier Group companyNot yet recruiting18 Years75 YearsAll45Phase 2United States;Australia;Canada;France;Germany;Hungary;Spain;United Kingdom
7EUCTR2020-001942-20-GR
(EUCTR)
04/12/202012/10/2020Study of safety and tolerability of CFZ533 in patients with Sjögren’s SyndromeA TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: ISCALIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
8EUCTR2020-001526-59-DE
(EUCTR)
19/11/202003/08/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary Sjögren’s Syndrome
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] - Immune System Diseases [C20]
Product Name: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom
9EUCTR2020-001942-20-HU
(EUCTR)
16/11/202017/09/2020Study of safety and tolerability of CFZ533 in patients with Sjögren’s SyndromeA TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: ISCALIMAB
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
10EUCTR2020-000511-77-HU
(EUCTR)
13/11/202022/10/2020Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA Sjögren’s syndrome
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] - Immune System Diseases [C20]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: SAR441344
Other descriptive name: SAR441344
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11NCT04572841
(ClinicalTrials.gov)
November 12, 202028/9/2020Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS)A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS)Sjögren's SyndromeDrug: SAR441344;Drug: PlaceboSanofiNULLRecruiting18 Years80 YearsAll88Phase 2United States;Canada
12EUCTR2020-000511-77-DE
(EUCTR)
12/11/202024/09/2020Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS)A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA Sjögren’s syndrome
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] - Immune System Diseases [C20]
Product Name: SAR441344
Product Code: SAR441344
INN or Proposed INN: SAR441344
Other descriptive name: SAR441344
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 2United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of
13NCT04615455
(ClinicalTrials.gov)
November 3, 20203/11/2020Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's SyndromeA Randomized Clinical Trial Evaluating Allogeneic Adipose-derived MesenchymAl Stem Cells as a Treatment of Dry Eye Disease in Patients With Sjögren's SyndromeKeratoconjunctivitis Sicca, in Sjogren's SyndromeDrug: ASCs;Drug: Cryostor CS10Rigshospitalet, DenmarkNULLRecruiting18 YearsN/AAll40Phase 2Denmark
14NCT04563195
(ClinicalTrials.gov)
November 202012/9/2020BAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's SyndromeBAFF/IL-17 Bispecific Antibody Treatment in Subjects With Primary Sjogren's SyndromePrimary Sjogren's SyndromeDrug: tibulizumab (LY3090106)Matthew C. BakerNULLNot yet recruiting18 Years85 YearsAll12Phase 2;Phase 3United States
15NCT04597762
(ClinicalTrials.gov)
October 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 HietzingNULLRecruiting18 Years90 YearsAll12N/AAustria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16ChiCTR2000034924
2020-10-302020-07-24Phase I clinical tolerance and pharmacokinetics of TGP capsule in ChinesePhase I clinical tolerance and pharmacokinetics of TGP capsule in Chinese Rheumatoid arthritis, Sjogren's syndromeGroup 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 MedicineNULLPendingBothGroup 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 tolerPhase 1China
17EUCTR2020-001526-59-GB
(EUCTR)
20/10/202014/07/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary Sjögren’s Syndrome
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] - Immune System Diseases [C20]
Product Name: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom
18EUCTR2020-001526-59-HU
(EUCTR)
06/10/202028/07/2020Efficacy and safety of S95011 in primary Sjögren’s Syndrome patientsA phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study Primary Sjögren’s Syndrome
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] - Immune System Diseases [C20]
Product Name: S95011
Product Code: S95011
INN or Proposed INN: S95011
Other descriptive name: OSE-127
Institut de Recherches Internationales ServierNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom
19ChiCTR2000035194
2020-10-012020-08-02The value of exosome miR29 for biomarker of primary Sjogren's syndrome with interstitial lung diseaseThe value of exosome miR29 for biomarker of primary Sjogren's syndrome with interstitial lung disease Sjogren's syndrome; Interstitial lung diseaseGold Standard:According to the clinical manifestations, chest imaging (cell-like change, ground glass change, solid shadow, mesh shadow), lung ventilation and diffusion function (FVC, DLCO), pathological biopsy and the elimination of ILD caused by other known reasons. If necessary, a surgical lung biopsy is feasible.;Index test:miRNA-29;Tongji Hosipital, Tongji University School of MedicineNULLRecruiting18BothTarget condition:60;Difficult condition:60China
20EUCTR2019-002205-22-FR
(EUCTR)
01/10/202013/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21ChiCTR2000037989
2020-09-082020-09-08Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trialBushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial primary Sjogren's syndromeexperimental group:Bushen Qingre Runzao Decoction 200ml bid po;control group:Hydroxychloroquine sulfate tablets 200ml bid po;China-Japan Friendship HospitalNULLRecruiting1875Bothexperimental group:48;control group:48;N/AChina
22NCT04397107
(ClinicalTrials.gov)
August 15, 20206/5/2020The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic DiseasesThe Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthritis)Systemic Lupus ErythematosusDrug: IL-2First Hospital of Jilin UniversityNULLRecruitingN/A17 YearsAll46N/AChina
23EUCTR2019-002205-22-DE
(EUCTR)
12/08/202007/07/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
24EUCTR2020-002804-38-DK
(EUCTR)
12/08/202016/06/2020A clinical trial in which treatment with stem cells derived from adipose-tissue of healthy donors is tested in patients with reduced tear production due to Sjögren's SyndromeA randomized clinical trial evaluating allogeneic adipose-derived mesenchymal stem cells as a treatment of dry eye disease in Sjögren's Syndrome - AMASS The trial will include participants with Aqueous Deficient Dry Eye Disease due to Sjögrens syndrom (International Classification of Diseases-10: DM 350A)
MedDRA version: 20.0;Level: LLT;Classification code 10023350;Term: Keratoconjunctivitis sicca;System Organ Class: 100000004853;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Product Name: Allogeneic adipose tissue-derived stromal/stem cells
Product Code: CSCC_ASC(22)
INN or Proposed INN: CSCC_ASC(22)
Other descriptive name: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED
Rigshospitalet-GlostrupNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 2Denmark
25NCT03841318
(ClinicalTrials.gov)
August 3, 202013/2/2019Involvement 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, BordeauxNULLRecruiting18 YearsN/AAll200N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26ChiCTR2000033420
2020-06-012020-05-31Investigating the clinical efficacy of cevimeline in improving the symptoms of primary sjogren syndrome: a randomized controlled trial.Investigating the clinical efficacy of cevimeline in improving the symptoms of primary sjogren syndrome Sj?gren Syndromeexperimental group:Cevimeline;Control Group:placebo;The Affiliated Huai'an Hospital of Xuzhou Medical UniversityNULLRecruiting1855Bothexperimental group:33;Control Group:33;China
27EUCTR2019-002205-22-GB
(EUCTR)
01/05/202007/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom
28EUCTR2019-002205-22-ES
(EUCTR)
06/04/202023/01/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom
29ChiCTR2000030342
2020-04-012020-02-29Treatment of connective tissue diseases (including systemic lupus erythematosus, primary Sjogren's syndrome, etc.) by intensive immunosuppressive therapy combined with targeted drugs(PAH targeted therapy)——A double center clinical observation study of pulmonary hypertensionTreatment of connective tissue diseases (including systemic lupus erythematosus, primary Sjogren's syndrome, etc.) by intensive immunosuppressive therapy combined with targeted drugs(PAH targeted therapy)——A double center clinical observation study of pulmonary hypertension Connective tissue diseaseCase series:immunosuppressive and PAH target therapy;Guangdong Provincial People's HospitalNULLPending1875BothCase series:20;N/AChina
30EUCTR2019-002205-22-PL
(EUCTR)
29/03/202007/02/2020Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment.A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Branebrutinib
Product Code: BMS-986195
INN or Proposed INN: Branebrutinib
Other descriptive name: BMS986195
Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
INN or Proposed INN: ABATACEPT
Other descriptive name: ORENCIA
Bristol-Myers Squibb International CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
185Phase 2United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2018-004476-35-NL
(EUCTR)
26/03/202013/06/2019Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
32NCT01759108
(ClinicalTrials.gov)
March 13, 202023/12/2012Rebamipide AND Sjögren SyndromeRebamipide for the Treatment of Xerostomia in Sjögren SyndromeImproving Symptoms of Dry Mouth in Sjogren's SyndromeDrug: RebamipideUniversity of AlexandriaNULLRecruitingN/AN/AAll55N/AEgypt
33NCT04252209
(ClinicalTrials.gov)
March 202026/1/2020the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomiathe Effect of Mixture of Natural Products As Salivary Substitute In Comparison To Carboxy Methyl Cellulose In Treatment Of Xerostomia In Patients With Sjogren's Syndrome: Cross Over Randomized Clinical TrialSjogren's Syndrome;XerostomiaOther: natural herbs of coconut, aloe vera, and pepperint;Other: carboxy methyl celluloseCairo UniversityNULLNot yet recruiting18 Years80 YearsAll44Phase 3NULL
34EUCTR2019-002713-19-PL
(EUCTR)
26/02/202022/11/2019A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS)A 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 syndrome
MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859 ;Therapeutic area: Body processes [G] - Immune system processes [G12]
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
174Phase 2United States;Greece;Spain;Turkey;United Kingdom;Italy;India;France;Mexico;Argentina;Poland;Peru;China;Korea, Republic of
35EUCTR2019-003131-31-NL
(EUCTR)
05/02/202012/12/2019Ravagalimab Vs Placebo in Subjects with Moderately to Severely Active Primary Sjogren's SyndromeA Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects with Moderately to Severely Active Primary Sjogren’s Syndrome. Moderately to Severely Active Primary Sjogren's Syndrome
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] - Immune System Diseases [C20]
Product Name: Ravagalimab
Product Code: ABBV-323
INN or Proposed INN: Ravagalimab
Other descriptive name: ABBV-323
AbbVie Deutschland GmbH & Co. KGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45Phase 2Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2018-004476-35-SE
(EUCTR)
22/01/202002/07/2019Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
37NCT04093531
(ClinicalTrials.gov)
January 15, 20205/8/2019Pilot Trial of Ustekinumab for Primary Sjögren's SyndromePilot Trial of Ustekinumab for Primary Sjögren's SyndromePrimary Sjögren SyndromeDrug: UstekinumabUniversity of RochesterNULLRecruiting18 Years75 YearsAll15Phase 1United States
38EUCTR2019-002713-19-GB
(EUCTR)
15/01/202021/11/2019A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS)A 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 syndrome
MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: VIB4920
INN or Proposed INN: Not applicable
Other descriptive name: MEDI4920
Viela Bio, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
174Phase 2China;Korea, Republic of;United States;Greece;Turkey;United Kingdom;Italy;India;France;Mexico;Argentina;Poland;Peru
39NCT04186871
(ClinicalTrials.gov)
January 7, 202028/11/2019Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid ArthritisA Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects With Active Rheumatoid ArthritisAutoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's SyndromeDrug: branebrutinib;Drug: abatacept;Drug: branebrutinib placeboBristol-Myers SquibbNULLRecruiting18 Years65 YearsAll185Phase 2United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom
40EUCTR2018-004476-35-GB
(EUCTR)
07/01/202006/06/2019Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2018-004387-54-GB
(EUCTR)
02/12/201930/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with 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’s Syndrome (SjS)
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] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;United Kingdom;Switzerland;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
42EUCTR2018-004476-35-DE
(EUCTR)
22/10/201924/06/2019Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
43EUCTR2018-004387-54-DK
(EUCTR)
21/10/201916/07/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with 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’s Syndrome (SjS)
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] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Denmark;Australia;Bulgaria;Germany;China
44NCT04129164
(ClinicalTrials.gov)
October 16, 20192/10/2019A 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 BioNULLRecruiting18 Years75 YearsAll174Phase 2United States;Korea, Republic of;Poland;United Kingdom
45NCT03905525
(ClinicalTrials.gov)
October 1, 201925/3/2019Study 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 PharmaceuticalsNULLRecruiting18 YearsN/AAll260Phase 2United States;Australia;Austria;Brazil;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Russian Federation;Slovenia;Turkey;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2018-004476-35-AT
(EUCTR)
26/09/201910/07/2019Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
47EUCTR2018-004476-35-IT
(EUCTR)
10/09/201928/04/2020Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
48EUCTR2018-004476-35-SI
(EUCTR)
06/09/201917/09/2019Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
49EUCTR2018-004387-54-BE
(EUCTR)
26/08/201901/07/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with 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’s Syndrome (SjS)
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: LOU064
INN or Proposed INN: Not yet established
Product Code: LOU064
INN or Proposed INN: Not yet established
Product Code: LOU064
INN or Proposed INN: Not yet established
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
50EUCTR2018-004387-54-ES
(EUCTR)
21/08/201908/05/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with 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’s Syndrome (SjS)
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]
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
252Phase 2United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2018-004476-35-PT
(EUCTR)
19/08/201923/05/2019Study 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) - TWINSS Sjögren 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Russian Federation;Israel;Chile;Colombia;Italy;United Kingdom;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Korea, Republic of;Sweden
52EUCTR2018-004476-35-GR
(EUCTR)
07/08/201919/06/2019Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
53EUCTR2018-004476-35-HU
(EUCTR)
07/08/201904/06/2019Study 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) - TWINSS Sjögren syndrome
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] - Immune System Diseases [C20]
Product Name: iscalimab
Product Code: CFZ533
INN or Proposed INN: iscalimab
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 2United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of
54ChiCTR1900024642
2019-08-012019-07-19Clinical Study of Iguratimod in the Treatment of Primary Sjogren's SyndromeClinical Study of Iguratimod in the Treatment of Primary Sjogren's Syndrome Primary Sjogren's SyndromeExperimental group:Iguratimod+Prednisone;control group:HCQ+Prednisone;Chongqing Hospital of Traditional Chinese MedcineNULLRecruiting1865BothExperimental group:30;control group:30;N/AChina
55NCT04035668
(ClinicalTrials.gov)
July 12, 20198/7/2019A 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 PharmaceuticalsNULLRecruiting18 Years75 YearsAll252Phase 2United States;Australia;Belgium;Bulgaria;China;Denmark;Germany;Hungary;Spain;Switzerland;Taiwan;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT04078386
(ClinicalTrials.gov)
June 28, 201918/7/2019A 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 mgRemeGenNULLRecruiting18 Years65 YearsAll30Phase 2China
57NCT03700138
(ClinicalTrials.gov)
June 24, 201924/8/2018Intravenous 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, FranceNULLRecruiting18 Years80 YearsAll24Phase 3France
58EUCTR2018-004387-54-HU
(EUCTR)
24/06/201929/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with 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’s Syndrome (SjS)
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: LOU064
INN or Proposed INN: Not yet established
Product Code: LOU064
INN or Proposed INN: Not yet established
Product Code: LOU064
INN or Proposed INN: Not yet established
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China
59NCT03983408
(ClinicalTrials.gov)
June 17, 201910/6/2019Impact 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 GinsengRecruiting19 Years75 YearsAll120N/AKorea, Republic of
60ChiCTR1900022696
2019-06-012019-04-22A 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 syndrome Sjogren syndromeexperimental group :Iguratimod 25mg bid po;control group:hydroxychloroquine 0.2-0.4g/d+prednison0.2-0.5mg/kg.d;Shanghai Tongji HospitalNULLPending1870Bothexperimental group :60;control group:60;Phase 4China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2018-004387-54-DE
(EUCTR)
20/05/201903/04/2019A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with 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’s Syndrome (SjS)
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] - Immune System Diseases [C20]
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Product Code: LOU064
INN or Proposed INN: remibrutinib
Other descriptive name: LOU064
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
252Phase 2United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China
62NCT03926286
(ClinicalTrials.gov)
April 15, 201916/4/2019Fecal Microbial Transplant (FMT) for Sjogrens SyndromeFecal Microbial Transplant for Sjogrens SyndromeSjogren's SyndromeDrug: FMP-30University of MiamiSjogrens Syndrome Foundation;Microbiome Health Research InstituteCompleted18 YearsN/AAll10Phase 1United States
63NCT03816345
(ClinicalTrials.gov)
April 4, 201924/1/2019Nivolumab 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)NULLRecruiting18 YearsN/AAll264Phase 1United States
64ChiCTR1900021345
2019-02-122019-02-16Effect of Iguratimod on Primary Sjogren's SyndromeObservation of Iguratimod's Effect on Primary Sjogren's Syndrome, A randomized, double-blind, placebo-controlled trial Primary Sjogren's SyndromeControl group :Hydrochloroquine;Treatment group:Iguratimod;Tianjin Medical University General HospitalNULLRecruiting1875BothControl group :30;Treatment group:30;China
65EUCTR2017-001371-24-FR
(EUCTR)
08/01/201915/10/2018Intravenous 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 - TINISS Primary Sjögren's syndrome associated painful sensory neuropathies;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Hôpitaux Universitaires de StrasbourgNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
24Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66NCT03817424
(ClinicalTrials.gov)
December 13, 201822/1/2019A 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 BioNULLCompleted18 Years75 YearsAll31Phase 1United States;Poland;Spain
67EUCTR2017-004929-33-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
68NCT03865888
(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
69NCT03627065
(ClinicalTrials.gov)
September 24, 20188/8/2018A 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 CorporationNULLCompleted18 YearsN/AAll10Phase 2United States
70NCT03436576
(ClinicalTrials.gov)
September 12, 201812/2/2018Efficacy 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 Sotero del RioUnknown status18 YearsN/AAll20Phase 3Chile
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2016-003558-34-PL
(EUCTR)
19/06/201814/05/2018A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with 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 Syndrome Active 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] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
Other descriptive name: GS-9876
Product Name: tirabrutinib
Product Code: GS-4059
INN or Proposed INN: GS-4059
Other descriptive name: GS-4059
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;Spain;Poland;United Kingdom
72NCT03540823
(ClinicalTrials.gov)
April 23, 201814/5/2018Evaluation 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 HospitalNULLCompleted9 YearsN/AAll300Phase 4Brazil
73NCT03319420
(ClinicalTrials.gov)
March 29, 201819/10/2017Evaluate 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 LTDNULLRecruiting18 Years95 YearsAll60Phase 4Israel
74NCT03434106
(ClinicalTrials.gov)
February 10, 20189/2/2018Sjögren'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 UniversityNULLUnknown status45 Years60 YearsFemale60N/AChina
75ChiCTR1800014623
2018-02-012018-01-24A 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 Syndrome Sjogren Syndromestem cell group: Intravenous use mesenchymal stem cell ;hydroxychloroquine group:oral use hydroxychloroquine ;Tongji Hospital of Tongji UniversityNULLRecruitingBothstem cell group:20;hydroxychloroquine group:20;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT03430388
(ClinicalTrials.gov)
January 31, 201830/1/2018Yellow 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 HospitalNULLCompleted2 Years60 YearsAll600N/ABrazil
77NCT03840538
(ClinicalTrials.gov)
January 1, 201812/2/2019Probiotics 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 UniversityNULLCompleted30 Years70 YearsAll32Phase 1;Phase 2Egypt
78ChiCTR-IPR-17013772
2018-01-012017-12-08A 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 Eye Sjogren'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 UniversityNULLPendingBothgroup of tacrolimus eye drops:30;group of flurometholone eye drops:30;China
79EUCTR2016-003292-22-PL
(EUCTR)
28/09/201723/08/2017 Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome Primary Sjogren’s syndrome
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] - Immune System Diseases [C20]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
80NCT03239600
(ClinicalTrials.gov)
September 19, 201719/6/2017A 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: MethotrexateGlaxoSmithKlineNULLWithdrawn18 Years70 YearsAll0Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2016-003292-22-NL
(EUCTR)
25/07/201719/04/2017Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doserangingstudy to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primarySjogren's Syndrome Primary Sjogren’s syndrome
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] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
82EUCTR2016-003292-22-BE
(EUCTR)
17/07/201726/04/2017Study of safety and efficacy of ianalumab in patients with primary Sjogren's Syndrome (pSS)A randomized, double-blind, placebo-controlled multicenter phase 2 doseranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren's Syndrome. Primary 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
INN or Proposed INN: Ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
83EUCTR2016-003558-34-GB
(EUCTR)
03/07/201702/05/2017A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with 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 Syndrome Active 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] - Musculoskeletal Diseases [C05]
Product Name: Filgotinib
Product Code: GS-6034
INN or Proposed INN: FILGOTINIB
Product Name: GS-9876
Product Code: GS-9876
INN or Proposed INN: GS-9876
Other descriptive name: GS-9876
Product Name: tirabrutinib
Product Code: GS-4059
INN or Proposed INN: GS-4059
Other descriptive name: GS-4059
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 2United States;Spain;Poland;United Kingdom
84NCT03226444
(ClinicalTrials.gov)
June 30, 201719/7/2017Lacripep™ 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.NULLCompleted18 YearsN/AAll204Phase 1;Phase 2United States
85EUCTR2016-003292-22-HU
(EUCTR)
29/06/201720/04/2017Study 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 Syndrome Primary 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 Code: VAY736
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT02962895
(ClinicalTrials.gov)
June 27, 20173/11/2016Safety and Efficacy of VAY736 in Patients With Primary Sjogren's Syndrome (pSS)Study of Safety and Efficacy of Multiple VAY736 Doses in Patients With Moderate to Severe Primary Sjogren's Syndrome (pSS)Primary Sjogren SyndromeBiological: VAY736;Other: PlaceboNovartis PharmaceuticalsNULLActive, not recruiting18 Years75 YearsAll195Phase 2United States;Argentina;Austria;Belgium;Chile;France;Germany;Hungary;Israel;Italy;Japan;Netherlands;Poland;Portugal;Romania;Russian Federation;Spain;Taiwan;United Kingdom
87EUCTR2016-003292-22-AT
(EUCTR)
19/06/201717/05/2017Study 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 multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome Primary Sjogren’s syndrome
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] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
88EUCTR2016-003292-22-FR
(EUCTR)
09/06/201711/04/2017Study 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 Syndrome Primary 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]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: 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
89EUCTR2016-003292-22-DE
(EUCTR)
06/06/201706/03/2017Study 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 Syndrome Primary Sjogren’s syndrome
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] - Immune System Diseases [C20]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: 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
90EUCTR2016-003292-22-PT
(EUCTR)
05/06/201720/03/2017Study 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 multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome Primary Sjogren’s syndrome
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] - Immune System Diseases [C20]
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
180Phase 2Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2016-003292-22-GB
(EUCTR)
26/05/201720/03/2017Study 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 multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome Primary Sjogren’s syndrome
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] - Immune System Diseases [C20]
Product Name: ianalumab
Product Code: VAY736
INN or Proposed INN: ianalumab
Other descriptive name: VAY736 antibody
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan
92EUCTR2016-003558-34-ES
(EUCTR)
25/05/201708/05/2017A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with 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 Syndrome Active 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] - Musculoskeletal Diseases [C05]
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
140Phase 2France;United States;Poland;Spain;Italy;United Kingdom
93NCT03100942
(ClinicalTrials.gov)
May 1, 201731/3/2017Study to Assess Safety and Efficacy 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: Lanraplenib;Drug: Filgotinib;Drug: Tirabrutinib;Drug: Lanraplenib placebo;Drug: Filgotinib placebo;Drug: Tirabrutinib placeboGilead SciencesGalapagos NV;Ono Pharmaceutical Co. LtdCompleted18 Years75 YearsAll152Phase 2United States;Poland;Spain;United Kingdom
94NCT03060005
(ClinicalTrials.gov)
May 1, 201723/1/2017Is 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 HospitalNULLRecruiting50 Years60 YearsFemale80N/AChina
95ChiCTR-INR-17011220
2017-04-242017-04-23The Efficacy and Safety of Low Dose IL-2Therapy in Chinese patients with primary Sjogren's syndromeThe Efficacy and Safety of Low Dose IL-2Therapy in Chinese patients with primary Sjogren's syndrome primary Sj?gren’s syndromeLl-2 group:IL-2 treatment; non IL-2 group:conventional treatment;the Second Hospital of Shanxi Medical UniversityNULLRecruitingBothLl-2 group:90; non IL-2 group:90;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2016-000101-37-GR
(EUCTR)
07/04/201715/03/2017Proof 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 Syndrome - POC H2H study subjects with moderate to severe Sjögren's syndrome
MedDRA version: 19.1;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Other descriptive name: BMS986142
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Other descriptive name: BMS986142
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
160Phase 2Poland;Belgium;Romania;Peru;Denmark;South Africa;Norway;Netherlands;United States;Greece;Russian Federation;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico
97EUCTR2016-003292-22-ES
(EUCTR)
06/04/201710/03/2017Study 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 Syndrome Primary 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
INN or Proposed INN: Not established
Other descriptive name: VAY736 antibody
Novartis Farmacéutica, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 2Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Chile;Portugal;United States;Taiwan;Spain;Austria;Russian Federation
98ChiCTR-INR-16009629
2017-04-012016-10-26A 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 syndrome primary 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 MedicineNULLPending1870Bothlow 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-conChina
99EUCTR2016-000101-37-IT
(EUCTR)
29/03/201727/02/2018Proof 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 Syndrome - POC H2H study subjects with moderate to severe Sjögren's syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1;Level: PT;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BTK Inhibitor
Product Code: BMS-986142
INN or Proposed INN: BTK Inhibitor
Other descriptive name: BMS986142
Product Name: BTK Inhibitor
Product Code: 1643368-58-4
INN or Proposed INN: BTK Inhibitor
Other descriptive name: BMS986142
Product Name: Anti-CD28dab
Product Code: BMS-931699
INN or Proposed INN: Anti-CD28dAb
Other descriptive name: Anti-CD28dAb
BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Greece;Russian Federation;Chile;Colombia;Italy;United Kingdom;France;Mexico;Poland;Belgium;Romania;Peru;Denmark;South Africa;Netherlands;Norway
100EUCTR2015-000400-26-GB
(EUCTR)
17/03/201714/12/2016A 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: 19.0;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)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2016-004258-14-GB
(EUCTR)
21/02/201721/12/2016A 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 pts Primary 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]
GlaxoSmithKline Research & Development LimitedNULLNot Recruiting Female: yes
Male: yes
22Phase 2United Kingdom
102EUCTR2014-004523-51-GR
(EUCTR)
14/02/201703/01/2017UCB 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 SYNDROME Primary Sjogren’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 Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Italy;United Kingdom;Sweden
103NCT03608761
(ClinicalTrials.gov)
February 6, 20179/7/2018Comparison 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 PosadasNULLCompleted18 YearsN/AFemale21Phase 4Argentina
104EUCTR2016-001948-19-SE
(EUCTR)
02/02/201719/10/2016A 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 Syndrome Adults with moderately to severely Active Primary Sjögrens Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
288Phase 3Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of
105NCT03247686
(ClinicalTrials.gov)
February 1, 20173/8/2017A 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 TrustCompleted18 Years70 YearsAll28Phase 2United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106JPRN-JapicCTI-173521
01/2/201724/02/2017A 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 Syndrome Primary 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.NULLcomplete18BOTH172Phase 3NULL
107NCT03023592
(ClinicalTrials.gov)
February 201715/1/2017Study of Iguratimod in Sjögren's SyndromeA Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's SyndromeSjogren's SyndromeDrug: IguratimodPeking Union Medical College HospitalNULLRecruiting18 Years75 YearsAll30Phase 1;Phase 2China
108EUCTR2016-001948-19-CZ
(EUCTR)
28/12/201627/10/2016A 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 Syndrome Adults with moderately to severely Active Primary Sjögrens Syndrome
MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
288Phase 3Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of
109NCT02915159
(ClinicalTrials.gov)
December 6, 201623/9/2016A 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 DiseaseBiological: Abatacept;Other: PlaceboBristol-Myers SquibbNULLCompleted18 YearsN/AAll250Phase 3United States;Argentina;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Puerto Rico;Sweden;Canada;Czech Republic
110EUCTR2016-001948-19-FR
(EUCTR)
02/12/201607/11/2016A 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 Syndrome Adults with moderately to severely Active Primary Sjögrens Syndrome
MedDRA version: 19.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Orencia
INN or Proposed INN: ABATACEPT
Bristol-Myers Squibb International CorporationNULLNot RecruitingFemale: yes
Male: yes
288Phase 3Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT02503189
(ClinicalTrials.gov)
November 23, 201617/7/2015A 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.NULLCompleted20 YearsN/AAllPhase 3Japan
112NCT02503163
(ClinicalTrials.gov)
November 23, 201617/7/2015A 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.NULLCompleted20 YearsN/AAllPhase 3Japan
113EUCTR2014-004616-12-PL
(EUCTR)
21/11/201612/10/2016Study 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 syndrome Primary 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
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Hungary;Poland;Germany
114NCT02899377
(ClinicalTrials.gov)
November 18, 201623/8/2016A 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.Completed30 YearsN/AAll25N/AUnited Kingdom
115NCT02843659
(ClinicalTrials.gov)
October 18, 20168/7/2016Proof 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 SquibbNULLTerminated18 Years70 YearsAll45Phase 2United States;Australia;Chile;Colombia;Italy;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;France;Hungary
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2016-001586-87-GB
(EUCTR)
29/09/201606/07/2016A 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 Syndrome Primary Sjogrens Syndrome;Therapeutic area: Body processes [G] - Immune system processes [G12]Resolve Therapeutics, LLCNULLNot Recruiting Female: yes
Male: yes
28Phase 2United Kingdom
117EUCTR2014-004616-12-HU
(EUCTR)
28/09/201617/08/2016Study 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 syndrome Primary 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
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Hungary;Poland;Germany
118EUCTR2015-004476-30-PL
(EUCTR)
26/08/201620/07/2016A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary 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 Name: Cathepsin S inhibitor
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Portugal;France;United States;Poland;Germany;United Kingdom
119EUCTR2014-004523-51-SE
(EUCTR)
24/08/201605/07/2016UCB 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 SYNDROME Primary Sjogren’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 Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden
120EUCTR2015-004476-30-DE
(EUCTR)
18/07/201618/05/2016A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary 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 Name: Cathepsin S Inhibitor
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Portugal;France;United States;Poland;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT02701985
(ClinicalTrials.gov)
July 5, 20163/3/2016A 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: Placebo;Drug: RO5459072Hoffmann-La RocheNULLCompleted18 Years75 YearsAll75Phase 2United States;France;Germany;Poland;Portugal;United Kingdom
122EUCTR2015-004476-30-FR
(EUCTR)
27/06/201604/09/2017A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary 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 Name: Cathepsin S
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Portugal;United States;France;Poland;Germany;Italy;United Kingdom
123EUCTR2015-004476-30-GB
(EUCTR)
22/06/201616/03/2016A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary 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]
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
70Phase 2Portugal;France;United States;Poland;Germany;United Kingdom
124EUCTR2015-004476-30-PT
(EUCTR)
15/06/201618/04/2016A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s SyndromeA MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME Primary 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 Name: Cathepsin S inhibitor
Product Code: RO545-9072/F03
INN or Proposed INN: Not applicable
Other descriptive name: RO5459072
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;United States;Portugal;Poland;Germany;United Kingdom
125NCT03762824
(ClinicalTrials.gov)
June 14, 20163/12/2018Combined 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: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccineRegion SkaneNULLActive, not recruiting18 YearsN/AAll300Phase 4NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT02775916
(ClinicalTrials.gov)
June 1, 201616/5/2016Safety, 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 PharmaceuticalsNULLCompleted18 Years75 YearsAll30Phase 2Germany;Hungary
127EUCTR2014-004616-12-DE
(EUCTR)
20/05/201617/03/2016Study 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 syndrome Primary 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
INN or Proposed INN: leniolisib
Other descriptive name: CDZ173
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
30Phase 2Hungary;Poland;Germany
128NCT04111341
(ClinicalTrials.gov)
May 6, 201626/9/2019A 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 UniversityNULLCompleted20 Years80 YearsAll30Phase 2Taiwan
129NCT03411850
(ClinicalTrials.gov)
May 201630/6/2016Sjogrens 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
130NCT02631538
(ClinicalTrials.gov)
February 17, 201614/12/2015Safety 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 rituximabGlaxoSmithKlineNULLCompleted18 YearsN/AAll86Phase 2Argentina;Canada;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2013-004808-19-DE
(EUCTR)
05/02/201607/12/2015Study 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's primary 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
INN or Proposed INN: Not yet established
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
66Phase 2United States;Hungary;Germany;United Kingdom;Switzerland
132NCT02691949
(ClinicalTrials.gov)
February 201616/2/2016Efficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's SyndromeEfficacy and Safety of Mycophenolate Mofetil in subjectswithSjogren's SyndromeSjogren's SyndromeDrug: Mycophenolate mofetilKaohsiung Medical UniversityNULLEnrolling by invitation20 Years75 YearsBoth54Phase 2NULL
133EUCTR2015-000400-26-IT
(EUCTR)
18/01/201610/11/2020A 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. - NA 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 - 1 FIALA 500 MG 50 ML
Product Name: MABTHERA
Product Code: [NA]
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO
Product Name: BENLYSTA
Product Code: [na]
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: SOLU-MEDROL
Product Code: [na]
INN or Proposed INN: METILPREDNISOLONE
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [na]
INN or Proposed INN: PARACETAMOLO
Trade Name: XYZAL - 20 COMPRESSE RI
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
134ChiCTR-OIB-16007789
2016-01-182015-12-300.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation Sjogren's syndromeTacrolimus therapy group:0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days;Eye Institute of Xiamen UniversityNULLRecruiting1870BothTacrolimus therapy group:30;4 (Phase 4 study)China
135EUCTR2015-000400-26-NO
(EUCTR)
08/01/201623/09/2015A 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: 18.0;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)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2015-000400-26-NL
(EUCTR)
28/12/201508/12/2015A 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: 18.1;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)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Germany;Netherlands;United Kingdom;Italy;Sweden
137EUCTR2015-000400-26-SE
(EUCTR)
15/12/201508/09/2015A 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)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
138NCT02614716
(ClinicalTrials.gov)
December 10, 201524/11/2015A 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 CompanyNULLCompleted18 Years65 YearsAll32Phase 1United States;Bulgaria;Georgia;Romania
139EUCTR2015-000400-26-DE
(EUCTR)
03/12/201501/10/2015A 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)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
140EUCTR2015-000400-26-FR
(EUCTR)
01/12/201524/02/2017A 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)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;Norway
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT02495129
(ClinicalTrials.gov)
December 20158/7/2015Study 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 PharmaceuticalsNULLWithdrawnN/AN/AAll0Phase 1;Phase 2Netherlands
142EUCTR2015-000400-26-ES
(EUCTR)
19/11/201505/10/2015A 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: 18.0;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)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline, S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;Sweden
143NCT02610543
(ClinicalTrials.gov)
October 201518/11/2015UCB 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 SciencesTerminated18 Years75 YearsAll27Phase 2France;Italy;Spain;Sweden;United Kingdom;Greece
144EUCTR2014-003140-12-NL
(EUCTR)
21/09/201526/08/2015Leflunomide 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 pSS Sjogren's Syndrome
MedDRA version: 18.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Leflunomide Mylan
Product Name: Leflunomide mylan
INN or Proposed INN: LEFLUNOMIDE
Trade Name: Plaquenil
Product Name: Plaquenil
INN or Proposed INN: HYDROXYCHLOROQUINE
UMC UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
Netherlands
145EUCTR2014-004523-51-ES
(EUCTR)
14/09/201501/06/2015UCB 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 SYNDROME Primary Sjogren?s Syndrome
MedDRA version: 18.0;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: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2014-004523-51-IT
(EUCTR)
25/08/201515/12/2017UCB PROOF OF CONCEPT STUDY IN PATIENTS WITH PRIMARY SJ?GREN'S SYNDROMEA RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OFCONCEPTSTUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJ?GREN'S SYNDROME - NA Primary Sj?gren'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: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB CELLTECH (UK BRANCH OF UCB PHARMA SA)NULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Netherlands;United Kingdom;Italy;Sweden
147JPRN-UMIN000019009
2015/08/1914/09/2015The 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 syndromeMucosta 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 MedicineNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Not selectedJapan
148NCT02503176
(ClinicalTrials.gov)
August 201517/7/2015An 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.NULLTerminated20 YearsN/AAllPhase 3Japan
149JPRN-UMIN000018376
2015/07/2222/07/2015Efficacy 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 disease Childhood-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 PediatricsNULLComplete: follow-up complete2years-oldNot applicableMale and Female20Not selectedJapan
150NCT02334306
(ClinicalTrials.gov)
June 8, 201512/12/2014A 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 Subjects With Primary Sjögren's SyndromePrimary Sjögren's SyndromeBiological: AMG 557/MEDI5872;Other: PlaceboMedImmune LLCAmgenCompleted18 Years75 YearsAll32Phase 2United States;France;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
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agemin
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agemax
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size
PhaseCountries
151NCT02464319
(ClinicalTrials.gov)
June 1, 201530/5/2015A 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.Completed18 Years65 YearsAll60Phase 2China
152EUCTR2014-004523-51-FR
(EUCTR)
28/05/201520/07/2015UCB 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 SYNDROME Primary Sjogren’s Syndrome
MedDRA version: 18.0;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: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden
153EUCTR2014-004523-51-GB
(EUCTR)
18/05/201501/04/2015UCB 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 SYNDROME Primary 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
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
Product Name: UCB5857
Product Code: UCB5857
INN or Proposed INN: UCB5857
Other descriptive name: UCB5857
UCB Celltech, UKNULLNot RecruitingFemale: yes
Male: yes
58Phase 2France;Greece;Spain;Italy;United Kingdom;Sweden
154EUCTR2014-003896-41-GB
(EUCTR)
27/03/201505/02/2015MedImmune 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 Syndrome Primary 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]
MedImmune, LLCNULLNot Recruiting Female: yes
Male: yes
42Phase 2France;United States;United Kingdom;Sweden
155ChiCTR-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
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agemin
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agemax
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gender
Target_
size
PhaseCountries
156NCT02370550
(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
157NCT02633332
(ClinicalTrials.gov)
February 201530/11/2015Use 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 & NaturaNULLCompleted18 Years75 YearsBoth15Phase 1Italy
158NCT02257957
(ClinicalTrials.gov)
November 201424/9/2014Platelet -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 ColombiaNULLNot yet recruiting18 YearsN/ABoth30Phase 3NULL
159NCT02291029
(ClinicalTrials.gov)
October 22, 20144/11/2014Safety, 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 PharmaceuticalsNULLCompleted18 Years75 YearsAll69Phase 2United States;Germany;Hungary;Switzerland;United Kingdom
160NCT02067910
(ClinicalTrials.gov)
August 201414/2/2014Efficacy 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 SquibbCompleted18 YearsN/AAll80Phase 3Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
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gender
Target_
size
PhaseCountries
161EUCTR2013-004808-19-GB
(EUCTR)
23/07/201407/03/2014Study 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's primary 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]
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
66Phase 2United States;Hungary;Germany;Switzerland;United Kingdom
162EUCTR2013-004808-19-HU
(EUCTR)
02/07/201406/05/2014Study 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's primary Sjögren’s syndrome
MedDRA version: 18.1;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: CFZ533
INN or Proposed INN: Not yet established
Product Code: CFZ533
INN or Proposed INN: Not yet established
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
42Phase 2Hungary;Germany;United Kingdom;Switzerland
163EUCTR2014-000417-31-NL
(EUCTR)
01/07/201420/03/2014Abatacept treatment in primary Sjögrens SyndromeRandomized, double-blind, placebo-controlled phase III study (ASAP III study) to assess the efficacy and safety of Abatacept treatment in patients with primary Sjögren’s syndrome(ASAP III study = Abatacept Sjögren Active Patients phase III study) - ASAPIII Primary Sjögren's syndrome (pSS)
MedDRA version: 16.1;Level: LLT;Classification code 10042846;Term: Syndrome Sjogren's;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Orencia
Product Name: Abatacept
Product Code: BMS-188667
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Netherlands
164NCT02112019
(ClinicalTrials.gov)
June 20148/4/2014Endoscopic 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 JagerNULLActive, not recruiting18 Years70 YearsAll50N/ANetherlands
165NCT02149420
(ClinicalTrials.gov)
May 23, 20149/9/2013PD 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 PharmaceuticalsNULLCompleted18 Years75 YearsAll27Phase 2Germany;France;Netherlands;United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2013-000250-22-DE
(EUCTR)
11/04/201416/10/2013A single dose study to assess the effect 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 syndrome - CVAY736X2201 Seropositive primary 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: VAY736
INN or Proposed INN: VAY736
Other descriptive name: VAY736
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
28Phase 2Germany
167JPRN-UMIN000013234
2014/04/0101/04/2014Effect of the dual treatment of diquafosol sodium and rebamipide on dry eye syndrome related to chronic graft versus host disease and Sjogrens syndrome Dry 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 MedicineNULLComplete: follow-up complete20years-old75years-oldMale and Female20Not applicableJapan
168NCT02110446
(ClinicalTrials.gov)
February 20141/4/2014Evaluation 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
169NCT02855658
(ClinicalTrials.gov)
February 201413/7/2016Modulation 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
170NCT01716312
(ClinicalTrials.gov)
January 8, 201423/10/2012Omalizumab 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)National Institute of Arthritis and Musculasketal and Skin DiseasesCompleted18 Years100 YearsAll17Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171ChiCTR-IPR-14005441
2014-01-012014-08-10A 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 syndrome primary Sjogren syndrometreatment group:hydroxychloroquine+Jiedu Tongluo Shengjin Decoction;Yueyang Hospital of Integrative Traditional Chinese and Western Medicine Affiliated to Shanghai University of Traditional Chinese MedicineNULLRecruiting1865Bothtreatment group:30;I (Phase 1 study)NULL
172NCT02027298
(ClinicalTrials.gov)
November 201318/11/2013Abatacept 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 SquibbWithdrawn18 YearsN/AAll0Phase 2United States
173NCT01782235
(ClinicalTrials.gov)
July 24, 201330/1/2013Efficacy 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, FranceNULLCompleted18 Years80 YearsAll110Phase 2;Phase 3France
174JPRN-UMIN000010796
2013/06/0124/05/2013Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers Sjogren's syndromesingle oral administration of pilocarpine.
salagen (KISSEI PHARMACEUTICAL CO.,LTD.)
5mg 1Tablet.
Oita University Faculty of MedicineNULLPending20years-oldNot applicableMale and Female30Not applicableJapan
175JPRN-UMIN000010710
2013/05/1515/05/2013Effective 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 centerNULLComplete: follow-up complete20years-old80years-oldMale and Female60Phase 2Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176JPRN-UMIN000004237
2013/03/3119/09/2010Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age Sjogren'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 UniversityNULLComplete: follow-up complete10years-old20years-oldMale and Female5Phase 2Japan
177NCT02147509
(ClinicalTrials.gov)
March 201313/5/2014Evaluation 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 LiNULLCompleted18 Years70 YearsBoth64N/AChina
178NCT03578900
(ClinicalTrials.gov)
January 1, 201318/5/2018Quality 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;Dentaid SLCompleted18 YearsN/AAll289Phase 4NULL
179NCT02004067
(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
180JPRN-UMIN000008427
2012/07/1313/07/2012Evaluation of efficacy of rebamipide ophthalmic suspension in patients with dry eye associated with Sjogren's syndrome. Patients with dry eye associated with Sjogren's syndrome.Mucosta ophthalmic suspension UD2%Kanazawa Medical UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female30Not selectedJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT01552681
(ClinicalTrials.gov)
July 20129/3/2012Baminercept, 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;BiogenTerminated18 Years75 YearsAll52Phase 2United States
182NCT01584947
(ClinicalTrials.gov)
April 201223/4/2012Clinical Trials With a Local Anesthetic Lozenge for the Treatment of Chronic Oral PainClinical Trials With a Local Anesthetic Lozenge for the Treatment of Oral Mucosal Pain in Burning Mouth Syndrome, Sjögrens Syndrome and Lichen Planus.Chronic PainDrug: Bupivacaine;Drug: PlaceboHvidovre University HospitalOracain II ApsTerminated18 Years75 YearsBoth31Phase 2Denmark
183EUCTR2011-006196-19-DK
(EUCTR)
28/02/201230/01/2012Clinical 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 Lozenge Oral 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
INN or Proposed INN: BUPIVACAINE HYDROCHLORIDE
Clinical Research Centre, Hvidovre University HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 2Denmark
184NCT01601028
(ClinicalTrials.gov)
July 201129/4/2012Hydroxychloroquine 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 HospitalNULLCompleted19 YearsN/ABoth39Phase 3Korea, Republic of
185NCT01316770
(ClinicalTrials.gov)
May 1, 201115/3/2011Dexamethasone 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: Dexamethasone Parotid Irrigation;Drug: Placebo Parotid IrrigationNational Institute of Dental and Craniofacial Research (NIDCR)NULLTerminated18 YearsN/AFemale14Phase 2United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT01357447
(ClinicalTrials.gov)
May 201118/5/2011Pulmozyme 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: SalineUConn HealthNULLWithdrawn18 YearsN/AAll0Phase 1United States
187NCT01647737
(ClinicalTrials.gov)
March 201114/5/2012Green Tea Lozenges for the Management of Dry MouthA Natural Formulation for Patients Diagnosed With XerostomiaXerostomia;Sjogren Syndrome;Dry MouthDietary Supplement: MighTeaFlow;Dietary Supplement: XylitolAugusta UniversityGlaxoSmithKlineCompleted18 Years75 YearsAll60Phase 1;Phase 2United States
188NCT01393132
(ClinicalTrials.gov)
March 20117/7/2011Comparative 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 InstituteCompleted18 Years90 YearsAll9Phase 2United States
189EUCTR2010-021430-64-GB
(EUCTR)
03/12/201004/11/2010A clinical trial to show whether there is an improvment in symptoms after the administration of rituximab in patients with primary Sjögren’s syndrome.A randomised double blind placebo controlled clinical trial of anti B-cell therapy in patients with primary Sjögren’s syndrome. - TRACTISS (Rituximab / Placebo in Sjogren's Syndrome) Version 1.0 Primary Sjögren’s syndrome (PSS).
MedDRA version: 14.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: MabThera (rituximab)
Product Name: MabThera (Rituximab)
Product Code: N/A
INN or Proposed INN: Rituximab
Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of world)
University of LeedsNULLNot RecruitingFemale: yes
Male: yes
110United Kingdom
190JPRN-UMIN000004477
2010/11/0101/11/2010Efficacy and safety of hydroxychloroquine for systemic/cutaneous lupus erythematosus or Sjogren's syndrome patients with annular erythema on the face and/or trunk Systemic/cutaneous lupus erythematosusSjogren'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 ScienceNULLComplete: follow-up complete20years-old75years-oldMale and Female10Not applicableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191NCT01369589
(ClinicalTrials.gov)
November 20106/6/2011An 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 SciencesNULLCompleted18 YearsN/AAll24Phase 1;Phase 2United States
192EUCTR2009-015558-40-NL
(EUCTR)
28/07/201023/12/2009Abatacept treatment in patients with primary Sjögren’s syndromeAbatacept treatment in patients with primary Sjögren’s syndrome Sjögren’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: OrenciaUniversity Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Netherlands
193NCT01151644
(ClinicalTrials.gov)
April 201025/6/2010Safety 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 PauloActive, not recruitingN/AN/ABoth5000Phase 4Brazil
194NCT01693393
(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
195NCT01081184
(ClinicalTrials.gov)
March 20103/3/2010Neurotrophins Implications in Primary Sjögren SyndromeNeurotrophins Implications in Primary Sjögren SyndromePrimary Sjögren SyndromeBiological: blood sampleUniversity Hospital, LimogesNULLCompleted18 YearsN/ABoth40N/AFrance
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196NCT01160666
(ClinicalTrials.gov)
March 20109/7/2010Efficacy 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.Completed18 YearsN/ABoth20Phase 2France
197NCT01850979
(ClinicalTrials.gov)
February 20101/5/2013Treatment 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 HospitalNULLCompleted40 Years60 YearsBoth24Phase 4Brazil
198EUCTR2009-015978-35-FR
(EUCTR)
30/11/200901/10/2009Etude 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 - BELISS Syndrome Sjogren's
MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's
Product Name: HGS1006, LymphoStat-B
INN or Proposed INN: belimumab
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2France
199NCT01008982
(ClinicalTrials.gov)
August 20095/11/2009Efficacy 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 MisericordiaCompleted18 Years90 YearsBoth15Phase 2Italy
200NCT00953485
(ClinicalTrials.gov)
June 20094/8/2009Allogeneic 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 SchoolNULLRecruiting15 Years70 YearsBoth20Phase 1;Phase 2China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201JPRN-UMIN000029307
2009/02/0127/09/2017Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients Sjogren's syndromePilocarpine / sodium alginate solution (0.32 mL, pilocarpine 0.96 mg) is administered intra-orally 3 times a day for 7 days.Teikyo UniversityNULLComplete: follow-up complete16years-oldNot applicableMale and Female50Not selectedJapan
202NCT00852839
(ClinicalTrials.gov)
February 200926/2/2009A 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 SciencesNULLCompleted18 Years80 YearsAll140Phase 2United States
203EUCTR2007-001377-28-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
204JPRN-UMIN000001460
2008/10/0129/10/2008The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndrome Sjogren's syndromeOral pilocarpine hydrochloride for 4 weeks.Department of Pediatrics, Graduate School of Medicine, Chiba UniverityNULLComplete: follow-up complete6years-old16years-oldMale and Female10Not selectedJapan
205EUCTR2007-003537-16-NL
(EUCTR)
04/09/200809/08/2007Estetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept StudyEstetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept Study Primary Sjogren's Syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10040767;Term: Sjogren's syndrome
Product Name: estetrol
Product Code: E4
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2007-001377-28-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
207EUCTR2007-001377-28-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
208EUCTR2007-001377-28-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
209EUCTR2007-001377-28-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
210NCT00632866
(ClinicalTrials.gov)
March 200829/2/2008Hydroxychloroquine 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 ParisSanofiCompleted18 YearsN/ABoth120Phase 3France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2007-001708-19-GB
(EUCTR)
21/02/200801/08/2007A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial.A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial. treatment on bilateral moderate dry eye syndrome due to Sjögren's syndrome or diagnosed as a primary syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10013774;Term: Dry eye
TRB CHEMEDICA INTERNATIONAL SANULLNot Recruiting Female: yes
Male: yes
300Phase 3France;United Kingdom
212NCT00631358
(ClinicalTrials.gov)
February 200829/2/2008Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid InterventionSjogren's SyndromeDrug: Maxidex;Other: No treatmentAlcon ResearchNULLCompleted17 YearsN/AAll97Phase 4Canada
213NCT00637793
(ClinicalTrials.gov)
February 200811/3/2008Study 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 TherapeuticsNULLCompleted21 Years55 YearsBoth24Phase 2United States
214JPRN-UMIN000000997
2008/01/0128/01/2008The 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 hydrate Xerostomia 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 HealthComplete: follow-up complete20years-old90years-oldMale and Female12Phase 1Japan
215EUCTR2007-001708-19-FR
(EUCTR)
23/08/200706/08/2007A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial.A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial. treatment on bilateral moderate dry eye syndrome due to Sjögren's syndrome or diagnosed as a primary syndrome
MedDRA version: 9.1;Level: LLT;Classification code 10013774;Term: Dry eye
Product Name: SVS20
Product Code: SVS20
INN or Proposed INN: sodium hyaluronate
Trade Name: Lacryvisc
INN or Proposed INN: carbomer 974P
Product Name: SALINE
INN or Proposed INN: sodium chloride
TRB CHEMEDICA INTERNATIONAL SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 3United Kingdom;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216NCT00426543
(ClinicalTrials.gov)
January 200723/1/2007Effect of B-cell Depletion in Patients With Primary Sjögren's SyndromePhase 1 Study of B-cell Depletion With Rituximab on Oral, Ocular and General Disease Manifestations in Patients With Primary Sjögren's SyndromePrimary Sjögren's Syndrome;Xerostomia;Hyposalivation;Keratoconjunctivitis Sicca;FatigueDrug: MabThera (rituximab);Drug: Rituximab, MabtheraUniversity of CopenhagenRigshospitalet, DenmarkCompleted18 Years70 YearsFemale21Phase 2Denmark
217NCT00438048
(ClinicalTrials.gov)
November 200620/2/2007A 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 AhumadaCompleted18 YearsN/ABoth76Phase 4Chile
218NCT00363350
(ClinicalTrials.gov)
August 200610/8/2006Rituximab 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 RocheCompleted18 Years85 YearsBoth30Phase 1;Phase 2Netherlands
219NCT00344448
(ClinicalTrials.gov)
June 200623/6/2006Pilot 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)NULLTerminated18 YearsN/AAll10Phase 2United States
220NCT00542763
(ClinicalTrials.gov)
April 200510/10/2007Mycophenolate 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 MuensterNovartisCompleted18 Years75 YearsBoth12Phase 1Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT04470479
(ClinicalTrials.gov)
March 1, 20057/7/2020Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens SyndromeOral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens SyndromeDry EyeDrug: Pilocarpine Hydrochloride;Drug: PlaceboFederal University of São PauloNULLCompleted18 Years65 YearsAll32Phase 3Brazil
222NCT00233363
(ClinicalTrials.gov)
March 20054/10/2005Exploratory 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.NULLCompleted20 YearsN/ABoth100Phase 2Japan
223NCT00873496
(ClinicalTrials.gov)
January 200531/3/2009Effects 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 UniversityNULLCompletedN/AN/AFemale30N/ATurkey
224NCT00101829
(ClinicalTrials.gov)
April 200413/1/2005Anti-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 ExcellenceCompleted18 Years75 YearsAll12Phase 1United States
225NCT00278512
(ClinicalTrials.gov)
August 200315/1/2006Hematopoietic 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 UniversityNULLTerminated16 Years60 YearsBoth7Phase 1United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226NCT00543166
(ClinicalTrials.gov)
February 20039/10/2007Sex 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 UniversityActive, not recruiting18 Years80 YearsBoth107Phase 4Finland
227NCT00025818
(ClinicalTrials.gov)
May 200126/10/2001Six 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 EmulsionAllerganNULLCompleted18 YearsN/ABoth290Phase 3United States
228NCT00391924
(ClinicalTrials.gov)
May 200024/10/2006Dehydroepiandrosterone 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 AssociationCompleted18 YearsN/AFemale120Phase 2Netherlands
229NCT00001954
(ClinicalTrials.gov)
December 199918/1/2000Etanercept Therapy for Sjogren's SyndromeEtanercept Therapy for Sjogren's SyndromeSjogren's SyndromeDrug: EtanerceptNational Institute of Dental and Craniofacial Research (NIDCR)NULLCompletedN/AN/ABoth28Phase 2United States
230NCT00001731
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
231NCT00001598
(ClinicalTrials.gov)
May 19973/11/1999DHEA 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)NULLCompletedN/AN/AFemale28Phase 2United States
232NCT00001599
(ClinicalTrials.gov)
May 19973/11/1999Pilot 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)NULLCompletedN/AN/AFemale28Phase 2United States
233EUCTR2009-013976-38-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
234JPRN-JapicCTI-050036
06/09/2005Exploratory 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 syndrome Dry mouth in patients with Sjogren's syndromeIntervention name : Rebamipide
Dosage And administration of the intervention : Oral
Otsuka Pharmaceutical Co., Ltd.NULL20BOTHPhase 2NULL