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"
191 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR20000370572021-01-012020-08-26A 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
2EUCTR2019-002713-19-HU30/12/202002/11/2020A 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: 21.1Level: LLTClassification code 10059142Term: Sjoegren's syndromeSystem 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
3NCT04605978December 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
4EUCTR2020-001942-20-GR04/12/202012/10/2020Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
5EUCTR2020-001526-59-DE19/11/202003/08/2020Efficacy 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2020-001942-20-HU16/11/202017/09/2020Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
7EUCTR2020-000511-77-HU13/11/202022/10/2020Safety, 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
8EUCTR2020-000511-77-DE12/11/202024/09/2020Safety, 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
9EUCTR2020-001526-59-GB20/10/202014/07/2020Efficacy 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
10EUCTR2020-001526-59-HU06/10/202028/07/2020Efficacy 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11ChiCTR20000351942020-10-012020-08-02The 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
12EUCTR2019-002205-22-FR01/10/202013/01/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
13ChiCTR20000379892020-09-082020-09-08Bushen 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
14EUCTR2019-002205-22-DE12/08/202007/07/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 23.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
15EUCTR2020-002804-38-DK12/08/202016/06/2020A 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: 20.0Level: LLTClassification code 10023350Term: Keratoconjunctivitis siccaSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16ChiCTR20000334202020-06-012020-05-31Investigating 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
17EUCTR2019-002205-22-GB01/05/202007/01/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
18EUCTR2019-002205-22-ES06/04/202023/01/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
19ChiCTR20000303422020-04-012020-02-29Treatment 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
20EUCTR2019-002205-22-PL29/03/202007/02/2020Clinical 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: 21.1Level: PTClassification code 10042945Term: Systemic lupus erythematosusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 21.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem 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
21EUCTR2018-004476-35-NL26/03/202013/06/2019Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
22NCT04252209March 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
23EUCTR2019-002713-19-PL26/02/202022/11/2019A 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
174 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Greece;Spain;Turkey;United Kingdom;Italy;India;France;Mexico;Argentina;Poland;Peru;China;Korea, Republic of
24EUCTR2019-003131-31-NL05/02/202012/12/2019Ravagalimab 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
25EUCTR2018-004476-35-SE22/01/202002/07/2019Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
26EUCTR2019-002713-19-GB15/01/202021/11/2019A 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: 21.1Level: LLTClassification code 10059142Term: Sjoegren's syndromeSystem 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
27EUCTR2018-004476-35-GB07/01/202006/06/2019Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
28EUCTR2018-004387-54-GB02/12/201930/04/2019A 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
29EUCTR2018-004476-35-DE22/10/201924/06/2019Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
30EUCTR2018-004387-54-DK21/10/201916/07/2019A 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04129164October 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
32EUCTR2018-004476-35-AT26/09/201910/07/2019Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
33EUCTR2018-004476-35-IT10/09/201928/04/2020Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
34EUCTR2018-004476-35-SI06/09/201917/09/2019Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
35EUCTR2018-004387-54-BE26/08/201901/07/2019A 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2018-004387-54-ES21/08/201908/05/2019A 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
252 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China
37EUCTR2018-004476-35-PT19/08/201923/05/2019Study 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
260 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;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
38EUCTR2018-004476-35-GR07/08/201919/06/2019Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
39EUCTR2018-004476-35-HU07/08/201904/06/2019Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
40EUCTR2018-004387-54-HU24/06/201929/04/2019A 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41ChiCTR19000226962019-06-012019-04-22A 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;China
42EUCTR2018-004387-54-DE20/05/201903/04/2019A 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
43NCT03926286April 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
44NCT03816345April 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
45ChiCTR19000213452019-02-122019-02-16Effect 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2017-001371-24-FR08/01/201915/10/2018Intravenous 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
24 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance
47NCT03817424December 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
48NCT03865888October 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
49NCT03627065September 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
50NCT03436576September 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
51EUCTR2016-003558-34-PL19/06/201814/05/2018A 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
52NCT03540823April 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
53NCT03319420March 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
54NCT03430388January 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
55NCT03840538January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2016-003292-22-PL28/09/201723/08/2017 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
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
57EUCTR2016-003292-22-NL25/07/201719/04/2017Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
58EUCTR2016-003292-22-BE17/07/201726/04/2017Study 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
59EUCTR2016-003558-34-GB03/07/201702/05/2017A 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
60NCT03226444June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2016-003292-22-HU29/06/201720/04/2017Study 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
62EUCTR2016-003292-22-AT19/06/201717/05/2017Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
63EUCTR2016-003292-22-FR09/06/201711/04/2017Study 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
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
64EUCTR2016-003292-22-DE06/06/201706/03/2017Study 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
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan
65EUCTR2016-003292-22-PT05/06/201720/03/2017Study 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
180 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;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
66EUCTR2016-003292-22-GB26/05/201720/03/2017Study 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: 21.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
67EUCTR2016-003558-34-ES25/05/201708/05/2017A 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
140 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;Poland;Spain;Italy;United Kingdom
68NCT03100942May 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
69EUCTR2016-000101-37-GR07/04/201715/03/2017Proof 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: 19.1Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.1Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.1Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.1Level: LLTClassification code 10040765Term: Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.1Level: PTClassification code 10048676Term: Sjogren-Larsson syndromeSystem 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
70EUCTR2016-003292-22-ES06/04/201710/03/2017Study 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: 19.1Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2016-000101-37-IT29/03/201727/02/2018Proof 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: 20.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1Level: PTClassification code 10048676Term: Sjogren-Larsson syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10040765Term: Sjogren'sSystem 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
72EUCTR2015-000400-26-GB17/03/201714/12/2016A 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: 19.0Level: PTClassification code 10061664Term: Autoimmune disorderSystem 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
73EUCTR2016-004258-14-GB21/02/201721/12/2016A 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
22 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited Kingdom
74EUCTR2014-004523-51-GR14/02/201703/01/2017UCB 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: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
75NCT03608761February 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2016-001948-19-SE02/02/201719/10/2016A 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: 20.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0Level: LLTClassification code 10040765Term: Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1Level: PTClassification code 10048676Term: Sjogren-Larsson syndromeSystem 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
77NCT03247686February 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
78JPRN-JapicCTI-17352101/2/201724/02/2017A 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
79NCT03023592February 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
80EUCTR2016-001948-19-CZ28/12/201627/10/2016A 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 System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10042846 Term: Syndrome Sjogren's System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0 Level: LLT Classification code 10040765 Term: Sjogren's 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 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Bristol-Myers Squibb International CorporationNULLNot Recruiting Female: yes
Male: yes
288 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noItaly;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;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
81NCT02915159December 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
82EUCTR2016-001948-19-FR02/12/201607/11/2016A 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: 19.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0Level: LLTClassification code 10040765Term: Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0Level: PTClassification code 10048676Term: Sjogren-Larsson syndromeSystem 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
83NCT02503189November 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
84NCT02503163November 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
85EUCTR2014-004616-12-PL21/11/201612/10/2016Study 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: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT02899377November 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
87NCT02843659October 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
88EUCTR2016-001586-87-GB29/09/201606/07/2016A 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
28 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited Kingdom
89EUCTR2014-004616-12-HU28/09/201617/08/2016Study 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: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
90EUCTR2015-004476-30-PL26/08/201620/07/2016A 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2014-004523-51-SE24/08/201605/07/2016UCB 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: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
92EUCTR2015-004476-30-DE18/07/201618/05/2016A 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: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
93NCT02701985July 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
94EUCTR2015-004476-30-FR27/06/201604/09/2017A 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
95EUCTR2015-004476-30-GB22/06/201616/03/2016A 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
70 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noPortugal;France;United States;Poland;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
96EUCTR2015-004476-30-PT15/06/201618/04/2016A 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
97NCT03762824June 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
98NCT02775916June 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
99EUCTR2014-004616-12-DE20/05/201617/03/2016Study 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: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
100NCT04111341May 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101NCT02631538February 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
102EUCTR2013-004808-19-DE05/02/201607/12/2015Study 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
103EUCTR2015-000400-26-IT18/01/201610/11/2020A 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: 20.0Level: PTClassification code 10061664Term: Autoimmune disorderSystem 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
104EUCTR2015-000400-26-NO08/01/201623/09/2015A 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: 18.0Level: PTClassification code 10061664Term: Autoimmune disorderSystem 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
105EUCTR2015-000400-26-NL28/12/201508/12/2015A 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: 18.1Level: PTClassification code 10061664Term: Autoimmune disorderSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2015-000400-26-SE15/12/201508/09/2015A 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: 20.0Level: PTClassification code 10061664Term: Autoimmune disorderSystem 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
107NCT02614716December 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
108EUCTR2015-000400-26-DE03/12/201501/10/2015A 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: 20.0Level: PTClassification code 10061664Term: Autoimmune disorderSystem 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
109EUCTR2015-000400-26-FR01/12/201524/02/2017A 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: 20.0Level: PTClassification code 10061664Term: Autoimmune disorderSystem 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
110EUCTR2015-000400-26-ES19/11/201505/10/2015A 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: 18.0Level: PTClassification code 10061664Term: Autoimmune disorderSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111NCT02610543October 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
112EUCTR2014-003140-12-NL21/09/201526/08/2015Leflunomide 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: 18.0Level: LLTClassification code 10040766Term: Sjogren's diseaseSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 18.0Level: LLTClassification code 10040765Term: Sjogren'sSystem 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
113EUCTR2014-004523-51-ES14/09/201501/06/2015UCB 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: 18.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
114EUCTR2014-004523-51-IT25/08/201515/12/2017UCB 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: 20.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
115JPRN-UMIN0000190092015/08/1914/09/2015The 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
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agemin
Inclusion_
agemax
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PhaseCountries
116NCT02503176August 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
117JPRN-UMIN0000183762015/07/2222/07/2015Efficacy 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
118NCT02334306June 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
119NCT02464319June 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
120EUCTR2014-004523-51-FR28/05/201520/07/2015UCB 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: 18.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
121EUCTR2014-004523-51-GB18/05/201501/04/2015UCB 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: 19.1Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
122EUCTR2014-003896-41-GB27/03/201505/02/2015MedImmune 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
42 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noFrance;United States;United Kingdom;Sweden
123NCT02633332February 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
124NCT02257957November 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
125NCT02291029October 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT02067910August 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
127EUCTR2013-004808-19-GB23/07/201407/03/2014Study 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
66 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): yes Therapeut1c conf1rmatory - (Phase 3): no Therapeut1c use (Phase 4): noUnited States;Hungary;Germany;Switzerland;United Kingdom
128EUCTR2013-004808-19-HU02/07/201406/05/2014Study 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: 18.1Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
129EUCTR2014-000417-31-NL01/07/201420/03/2014Abatacept 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: 16.1Level: LLTClassification code 10042846Term: Syndrome Sjogren'sSystem 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
130NCT02112019June 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131NCT02149420May 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
132EUCTR2013-000250-22-DE11/04/201416/10/2013A 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: 19.0Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
133JPRN-UMIN0000132342014/04/0101/04/2014Effect 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 appl1cableJapan
134NCT02110446February 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
135NCT01716312January 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
136NCT01782235July 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
137JPRN-UMIN0000107962013/06/0124/05/2013Impact 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 appl1cableJapan
138JPRN-UMIN0000107102013/05/1515/05/2013Effective 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
139JPRN-UMIN0000042372013/03/3119/09/2010Efficacy 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
140NCT02147509March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141NCT03578900January 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
142NCT02004067January 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
143JPRN-UMIN0000084272012/07/1313/07/2012Evaluation 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
144EUCTR2011-006196-19-DK28/02/201230/01/2012Clinical 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
145NCT01601028July 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146NCT01357447May 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
147NCT01647737March 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
148NCT01393132March 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
149EUCTR2010-021430-64-GB03/12/201004/11/2010A 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: 14.1Level: PTClassification code 10040767Term: Sjogren's syndromeSystem 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
150JPRN-UMIN0000044772010/11/0101/11/2010Efficacy 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 appl1cableJapan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT01369589November 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
152EUCTR2009-015558-40-NL28/07/201023/12/2009Abatacept 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: 12.0Level: LLTClassification code 10040767Term: Sjogren's syndrome
Trade Name: OrenciaUniversity Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Netherlands
153NCT01151644April 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
154NCT01693393March 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
155NCT01081184March 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
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gender
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PhaseCountries
156NCT01160666March 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
157NCT01850979February 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
158EUCTR2009-015978-35-FR30/11/200901/10/2009Etude 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: 8.1Level: PTClassification code 10042846Term: 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
159NCT01008982August 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
160JPRN-UMIN0000293072009/02/0127/09/2017Efficacy 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161NCT00852839February 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
162EUCTR2007-001377-28-PT09/01/200925/08/2008Phase 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: 9.1Level: LLTClassification code 10061664Term: Autoimmune disorder
MedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemic
MedDRA version: 9.1Level: LLTClassification code 10047888Term: Wegener's granulomatosis
MedDRA version: 9.1Level: LLTClassification code 10002817Term: Antiphospholipid syndrome
MedDRA version: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndrome
MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
MedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative
MedDRA version: 9.1Level: LLTClassification code 10003827Term: Autoimmune hepatitis
MedDRA version: 9.1Level: LLTClassification code 10049046Term: Autoimmune thyroiditis
MedDRA version: 9.1Level: LLTClassification code 10003822Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1Level: LLTClassification code 10034697Term: Pernicious anemia
MedDRA version: 9.1Level: LLTClassification code 10028417Term: Myasthenia gravis
MedDRA version: 9.1Level: LLTClassification code 10018620Term: Goodpasture's syndrome
MedDRA version: 9.1Level: LLTClassification 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
163JPRN-UMIN0000014602008/10/0129/10/2008The 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
164EUCTR2007-003537-16-NL04/09/200809/08/2007Estetrol 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: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndrome
Product Name: estetrol
Product Code: E4
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: no
Netherlands
165EUCTR2007-001377-28-DE01/09/200815/05/2008Phase 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: 9.1Level: LLTClassification code 10061664Term: Autoimmune disorder
MedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemic
MedDRA version: 9.1Level: LLTClassification code 10047888Term: Wegener's granulomatosis
MedDRA version: 9.1Level: LLTClassification code 10002817Term: Antiphospholipid syndrome
MedDRA version: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndrome
MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
MedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative
MedDRA version: 9.1Level: LLTClassification code 10003827Term: Autoimmune hepatitis
MedDRA version: 9.1Level: LLTClassification code 10049046Term: Autoimmune thyroiditis
MedDRA version: 9.1Level: LLTClassification code 10003822Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1Level: LLTClassification code 10034697Term: Pernicious anemia
MedDRA version: 9.1Level: LLTClassification code 10028417Term: Myasthenia gravis
MedDRA version: 9.1Level: LLTClassification code 10018620Term: Goodpasture's syndrome
MedDRA version: 9.1Level: LLTClassification 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2007-001377-28-NL15/07/200829/05/2008Phase 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: 9.1Level: LLTClassification code 10061664Term: Autoimmune disorder
MedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemic
MedDRA version: 9.1Level: LLTClassification code 10047888Term: Wegener's granulomatosis
MedDRA version: 9.1Level: LLTClassification code 10002817Term: Antiphospholipid syndrome
MedDRA version: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndrome
MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
MedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative
MedDRA version: 9.1Level: LLTClassification code 10003827Term: Autoimmune hepatitis
MedDRA version: 9.1Level: LLTClassification code 10049046Term: Autoimmune thyroiditis
MedDRA version: 9.1Level: LLTClassification code 10003822Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1Level: LLTClassification code 10034697Term: Pernicious anemia
MedDRA version: 9.1Level: LLTClassification code 10028417Term: Myasthenia gravis
MedDRA version: 9.1Level: LLTClassification code 10018620Term: Goodpasture's syndrome
MedDRA version: 9.1Level: LLTClassification 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
167EUCTR2007-001377-28-AT26/06/200827/05/2008Phase 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: 9.1Level: LLTClassification code 10061664Term: Autoimmune disorder
MedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemic
MedDRA version: 9.1Level: LLTClassification code 10047888Term: Wegener's granulomatosis
MedDRA version: 9.1Level: LLTClassification code 10002817Term: Antiphospholipid syndrome
MedDRA version: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndrome
MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
MedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative
MedDRA version: 9.1Level: LLTClassification code 10003827Term: Autoimmune hepatitis
MedDRA version: 9.1Level: LLTClassification code 10049046Term: Autoimmune thyroiditis
MedDRA version: 9.1Level: LLTClassification code 10003822Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1Level: LLTClassification code 10034697Term: Pernicious anemia
MedDRA version: 9.1Level: LLTClassification code 10028417Term: Myasthenia gravis
MedDRA version: 9.1Level: LLTClassification code 10018620Term: Goodpasture's syndrome
MedDRA version: 9.1Level: LLTClassification 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
168EUCTR2007-001377-28-FR11/06/200829/02/2008Phase 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: 9.1Level: LLTClassification code 10061664Term: Autoimmune disorder
MedDRA version: 9.1Level: LLTClassification code 10025139Term: Lupus erythematosus systemic
MedDRA version: 9.1Level: LLTClassification code 10047888Term: Wegener's granulomatosis
MedDRA version: 9.1Level: LLTClassification code 10002817Term: Antiphospholipid syndrome
MedDRA version: 9.1Level: LLTClassification code 10040767Term: Sjogren's syndrome
MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis
MedDRA version: 9.1Level: LLTClassification code 10028245Term: Multiple sclerosis
MedDRA version: 9.1Level: LLTClassification code 10045228Term: Type I diabetes mellitus
MedDRA version: 9.1Level: LLTClassification code 10011401Term: Crohn's disease
MedDRA version: 9.1Level: LLTClassification code 10009900Term: Colitis ulcerative
MedDRA version: 9.1Level: LLTClassification code 10003827Term: Autoimmune hepatitis
MedDRA version: 9.1Level: LLTClassification code 10049046Term: Autoimmune thyroiditis
MedDRA version: 9.1Level: LLTClassification code 10003822Term: Autoimmune haemolytic anaemia NOS
MedDRA version: 9.1Level: LLTClassification code 10034697Term: Pernicious anemia
MedDRA version: 9.1Level: LLTClassification code 10028417Term: Myasthenia gravis
MedDRA version: 9.1Level: LLTClassification code 10018620Term: Goodpasture's syndrome
MedDRA version: 9.1Level: LLTClassification 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
169NCT00632866March 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
170EUCTR2007-001708-19-GB21/02/200801/08/2007A 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
300 Human pharmacology (Phase 1): no Therapeut1c exploratory (Phase 2): no Therapeut1c conf1rmatory - (Phase 3): yes Therapeut1c use (Phase 4): noFrance;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171NCT00631358February 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
172NCT00637793February 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
173JPRN-UMIN0000009972008/01/0128/01/2008The 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
174EUCTR2007-001708-19-FR23/08/200706/08/2007A 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: 9.1Level: LLTClassification code 10013774Term: 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
175NCT00426543January 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176NCT00438048November 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
177NCT00363350August 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
178NCT00344448June 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
179NCT00542763April 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
180NCT04470479March 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181NCT00233363March 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
182NCT00873496January 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
183NCT00101829April 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
184NCT00025818May 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
185NCT00391924May 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186NCT00001954December 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
187NCT00001731November 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
188NCT00001598May 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
189NCT00001599May 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
190EUCTR2009-013976-38-DE07/12/2009Phase 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: 12.1Level: LLTClassification code 10059142Term: 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191JPRN-JapicCTI-05003606/09/2005Exploratory 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.NULL20BOTHNULL