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.
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03953703 (ClinicalTrials.gov) | April 1, 2021 | 30/4/2019 | Levocarnitine for Dry Eye in Sjogren's Syndrome | A Randomized Placebo-controlled, Double Blind Pilot Crossover Trial of Levocarnitine for the Treatment of Keratoconjunctivitis Sicca in Sjogren's Syndrome | Sjogren's Syndrome;Keratoconjunctivitis Sicca | Drug: Levocarnitine;Drug: Placebo | Vanderbilt University Medical Center | NULL | Not yet recruiting | 18 Years | 75 Years | All | 15 | Phase 2 | NULL |
| 2 | ChiCTR2000037057 | 2021-01-01 | 2020-08-26 | A 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 | A 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 syndrome | The 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 Medicine | NULL | Pending | 18 | 65 | Both | The first group :30; The second group:30; The third group:30;The fourth group:30; | China | |
| 3 | EUCTR2019-002713-19-HU (EUCTR) | 30/12/2020 | 02/11/2020 | A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS) | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in Subjects with Sjögren’s Syndrome (SS) | Sjögren's syndrome MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: VIB4920 INN or Proposed INN: Not applicable Other descriptive name: MEDI4920 | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 174 | Phase 2 | United States;Taiwan;Italy;United Kingdom;India;France;Hungary;Mexico;Argentina;Poland;Peru;China;Korea, Republic of | ||
| 4 | NCT04496960 (ClinicalTrials.gov) | December 17, 2020 | 2/8/2020 | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome | Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome Phase Ib-IIa Placebo-Controlled Clinical Trial and Associated Mechanistic Studies | Sjogren's Syndrome | Drug: tofacitinib;Other: Placebo | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Not yet recruiting | 18 Years | 75 Years | All | 30 | Phase 1;Phase 2 | United States |
| 5 | NCT04605978 (ClinicalTrials.gov) | December 7, 2020 | 19/10/2020 | Efficacy and Safety of S95011 in Primary Sjögren's Syndrome Patients | A 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 | Drug: S95011 concentrate for solution for infusion;Drug: Placebo concentrate for solution for infusion | Institut de Recherches Internationales Servier | ADIR, a Servier Group company | Not yet recruiting | 18 Years | 75 Years | All | 45 | Phase 2 | United States;Australia;Canada;France;Germany;Hungary;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | EUCTR2020-001942-20-GR (EUCTR) | 04/12/2020 | 12/10/2020 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United 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 | ||
| 7 | EUCTR2020-001526-59-DE (EUCTR) | 19/11/2020 | 03/08/2020 | Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients | A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study | Primary Sjögren’s Syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: S95011 Product Code: S95011 INN or Proposed INN: S95011 Other descriptive name: OSE-127 | Institut de Recherches Internationales Servier | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom | ||
| 8 | EUCTR2020-001942-20-HU (EUCTR) | 16/11/2020 | 17/09/2020 | Study of safety and tolerability of CFZ533 in patients with Sjögren’s Syndrome | A TWINSS extension trial to evaluate the safety and tolerability of CFZ533 (iscalimab) at two dose levels administered subcutaneously in patients with Sjögren’s Syndrome | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: ISCALIMAB | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 160 | Phase 2 | United 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 | ||
| 9 | EUCTR2020-000511-77-HU (EUCTR) | 13/11/2020 | 22/10/2020 | Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS) | A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA | Sjögren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: SAR441344 Other descriptive name: SAR441344 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of | ||
| 10 | NCT04572841 (ClinicalTrials.gov) | November 12, 2020 | 28/9/2020 | Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Primary Sjögren's Syndrome (pSjS) | A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety, Tolerability, Pharmacokinetics, and Therapeutic Efficacy of SAR441344 in Adult Patients With Primary Sjögren's Syndrome (pSjS) | Sjögren's Syndrome | Drug: SAR441344;Drug: Placebo | Sanofi | NULL | Recruiting | 18 Years | 80 Years | All | 88 | Phase 2 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | EUCTR2020-000511-77-DE (EUCTR) | 12/11/2020 | 24/09/2020 | Safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in primary Sjögren’s syndrome (pSjS) | A randomized, double-blind, placebo-controlled, parallel-group study of the safety, tolerability, pharmacokinetics, and therapeutic efficacy of SAR441344 in adult patients with primary Sjögren’s syndrome (pSjS) - phaethuSA | Sjögren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SAR441344 Product Code: SAR441344 INN or Proposed INN: SAR441344 Other descriptive name: SAR441344 | Sanofi-Aventis Recherche & Développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 2 | United States;France;Taiwan;Hungary;Mexico;Canada;Argentina;Spain;Belgium;Netherlands;Germany;Korea, Republic of | ||
| 12 | EUCTR2020-001526-59-GB (EUCTR) | 20/10/2020 | 14/07/2020 | Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients | A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study | Primary Sjögren’s Syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: S95011 Product Code: S95011 INN or Proposed INN: S95011 Other descriptive name: OSE-127 | Institut de Recherches Internationales Servier | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom | ||
| 13 | EUCTR2020-001526-59-HU (EUCTR) | 06/10/2020 | 28/07/2020 | Efficacy and safety of S95011 in primary Sjögren’s Syndrome patients | A phase IIa efficacy and safety trial with intravenous S95011 in primary Sjögren’s Syndrome patients. An international, multicentre, randomised, double-blind, placebo-controlled study | Primary Sjögren’s Syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: S95011 Product Code: S95011 INN or Proposed INN: S95011 Other descriptive name: OSE-127 | Institut de Recherches Internationales Servier | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | United States;France;Hungary;Canada;Spain;Australia;Germany;United Kingdom | ||
| 14 | EUCTR2019-002205-22-FR (EUCTR) | 01/10/2020 | 13/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 15 | ChiCTR2000035194 | 2020-10-01 | 2020-08-02 | The value of exosome miR29 for biomarker of primary Sjogren's syndrome with interstitial lung disease | The value of exosome miR29 for biomarker of primary Sjogren's syndrome with interstitial lung disease | Sjogren's syndrome; Interstitial lung disease | Gold 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 Medicine | NULL | Recruiting | 18 | Both | Target condition:60;Difficult condition:60 | China | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | ChiCTR2000037989 | 2020-09-08 | 2020-09-08 | Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial | Bushen Qingre Runzao decoction for primary Sjogren's syndrome: a randomized controlled trial | primary Sjogren's syndrome | experimental group:Bushen Qingre Runzao Decoction 200ml bid po;control group:Hydroxychloroquine sulfate tablets 200ml bid po; | China-Japan Friendship Hospital | NULL | Recruiting | 18 | 75 | Both | experimental group:48;control group:48; | N/A | China |
| 17 | EUCTR2019-002205-22-DE (EUCTR) | 12/08/2020 | 07/07/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| 18 | EUCTR2020-002804-38-DK (EUCTR) | 12/08/2020 | 16/06/2020 | A 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 Syndrome | A randomized clinical trial evaluating allogeneic adipose-derived mesenchymal stem cells as a treatment of dry eye disease in Sjögren's Syndrome - AMASS | The trial will include participants with Aqueous Deficient Dry Eye Disease due to Sjögrens syndrom (International Classification of Diseases-10: DM 350A) MedDRA version: 20.0;Level: LLT;Classification code 10023350;Term: Keratoconjunctivitis sicca;System Organ Class: 100000004853;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Product Name: Allogeneic adipose tissue-derived stromal/stem cells Product Code: CSCC_ASC(22) INN or Proposed INN: CSCC_ASC(22) Other descriptive name: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED | Rigshospitalet-Glostrup | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | Denmark | ||
| 19 | ChiCTR2000033420 | 2020-06-01 | 2020-05-31 | Investigating 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 Syndrome | experimental group:Cevimeline;Control Group:placebo; | The Affiliated Huai'an Hospital of Xuzhou Medical University | NULL | Recruiting | 18 | 55 | Both | experimental group:33;Control Group:33; | China | |
| 20 | EUCTR2019-002205-22-GB (EUCTR) | 01/05/2020 | 07/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | EUCTR2019-002205-22-ES (EUCTR) | 06/04/2020 | 23/01/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom | ||
| 22 | ChiCTR2000030342 | 2020-04-01 | 2020-02-29 | Treatment 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 | Treatment 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 disease | Case series:immunosuppressive and PAH target therapy; | Guangdong Provincial People's Hospital | NULL | Pending | 18 | 75 | Both | Case series:20; | N/A | China |
| 23 | EUCTR2019-002205-22-PL (EUCTR) | 29/03/2020 | 07/02/2020 | Clinical research study to measure how good and how safe Branebrutinib compared to a placebo is in treating participants with Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or participants with Rheumatoid Arthritis when being treated with Branebrutinib and methotrexate followed with Abatacept treatment. | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy and Safety of Branebrutinib Treatment in Subjects with Active Systemic Lupus Erythematosus or Primary Sjögren’s Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Subjects with Active Rheumatoid Arthritis.- SLE Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib in Systemic Lupus Erythematosus.- pSS Sub-protocol: Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of Branebrutinib in Primary Sjögren’s Syndrome. - RA Sub-protocol: Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Branebrutinib Treatment Followed by Abatacept Treatment in Subjects with Rheumatoid Arthritis. | SLE Sub-protocol: Systemic Lupus ErythematosuspSS Sub-protocol: Primary Sjögren’s SyndromeRA Sub-protocol: Rheumatoid Arthritis MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Branebrutinib Product Code: BMS-986195 INN or Proposed INN: Branebrutinib Other descriptive name: BMS986195 Trade Name: ORENCIA 125 mg solution for injection in pre-filled syringe Product Name: Abatacept Product Code: BMS-188667 INN or Proposed INN: ABATACEPT Other descriptive name: ORENCIA | Bristol-Myers Squibb International Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 185 | Phase 2 | United States;France;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom | ||
| 24 | EUCTR2018-004476-35-NL (EUCTR) | 26/03/2020 | 13/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United 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 | ||
| 25 | NCT04252209 (ClinicalTrials.gov) | March 2020 | 26/1/2020 | the Effect of Mixture of Natural Products As Salivary Substitutes in Treatment Of Xerostomia | the 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 Trial | Sjogren's Syndrome;Xerostomia | Other: natural herbs of coconut, aloe vera, and pepperint;Other: carboxy methyl cellulose | Cairo University | NULL | Not yet recruiting | 18 Years | 80 Years | All | 44 | Phase 3 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2019-002713-19-PL (EUCTR) | 26/02/2020 | 22/11/2019 | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 174 | Phase 2 | United States;Greece;Spain;Turkey;United Kingdom;Italy;India;France;Mexico;Argentina;Poland;Peru;China;Korea, Republic of | |||
| 27 | EUCTR2019-003131-31-NL (EUCTR) | 05/02/2020 | 12/12/2019 | Ravagalimab Vs Placebo in Subjects with Moderately to Severely Active Primary Sjogren's Syndrome | A Phase 2a, Double-Blind, Randomized, Placebo-Controlled Study of Ravagalimab in Subjects with Moderately to Severely Active Primary Sjogren’s Syndrome. | Moderately to Severely Active Primary Sjogren's Syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ravagalimab Product Code: ABBV-323 INN or Proposed INN: Ravagalimab Other descriptive name: ABBV-323 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | Phase 2 | Netherlands | ||
| 28 | EUCTR2018-004476-35-SE (EUCTR) | 22/01/2020 | 02/07/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;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 | ||
| 29 | EUCTR2019-002713-19-GB (EUCTR) | 15/01/2020 | 21/11/2019 | A study to look at the effectiveness and safety of test product VIB4920 in subjects with Sjögren’s Syndrome (SS) | A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy and Safety of VIB4920 in subjects with Sjögren’s Syndrome (SS) | Sjögren's syndrome MedDRA version: 21.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: VIB4920 INN or Proposed INN: Not applicable Other descriptive name: MEDI4920 | Viela Bio, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 174 | Phase 2 | China;Korea, Republic of;United States;Greece;Turkey;United Kingdom;Italy;India;France;Mexico;Argentina;Poland;Peru | ||
| 30 | EUCTR2018-004476-35-GB (EUCTR) | 07/01/2020 | 06/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;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. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 31 | NCT04186871 (ClinicalTrials.gov) | January 7, 2020 | 28/11/2019 | Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis | 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 | Autoimmune Disorder;Rheumatoid Arthritis;Systemic Lupus Erythematosus;Primary Sjögren's Syndrome | Drug: branebrutinib;Drug: abatacept;Drug: branebrutinib placebo | Bristol-Myers Squibb | NULL | Recruiting | 18 Years | 65 Years | All | 185 | Phase 2 | United States;Argentina;Australia;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom |
| 32 | EUCTR2018-004387-54-GB (EUCTR) | 02/12/2019 | 30/04/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) | Sjögren’s Syndrome (SjS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;United Kingdom;Switzerland;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China | ||
| 33 | EUCTR2018-004476-35-DE (EUCTR) | 22/10/2019 | 24/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;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 | ||
| 34 | EUCTR2018-004387-54-DK (EUCTR) | 21/10/2019 | 16/07/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) | Sjögren’s Syndrome (SjS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Denmark;Australia;Bulgaria;Germany;China | ||
| 35 | NCT04129164 (ClinicalTrials.gov) | October 16, 2019 | 2/10/2019 | A Study to Evaluate the Efficacy and Safety of VIB4920 in Participants With Sjögren's Syndrome | 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 | Drug: VIB4920;Drug: Placebo | Viela Bio | NULL | Recruiting | 18 Years | 75 Years | All | 174 | Phase 2 | United States;Korea, Republic of;Poland;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 36 | NCT03905525 (ClinicalTrials.gov) | October 1, 2019 | 25/3/2019 | Study of Safety and Efficacy of Multiple Doses of CFZ533 in Two Distinct Populations of Patients With Sjögren's Syndrome | A 48-week, 6-arm, Randomized, Double-blind, Placebo-controlled Multicenter Trial to Assess the Safety and Efficacy of Multiple CFZ533 Doses Administered Subcutaneously in Two Distinct Populations of Patients With Sjögren's Syndrome (TWINSS) | Sjögren Syndrome | Drug: CFZ533;Other: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 260 | Phase 2 | United States;Australia;Austria;Brazil;Canada;Chile;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Russian Federation;Slovenia;Turkey;United Kingdom |
| 37 | EUCTR2018-004476-35-AT (EUCTR) | 26/09/2019 | 10/07/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United 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 | ||
| 38 | EUCTR2018-004476-35-IT (EUCTR) | 10/09/2019 | 28/04/2020 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United 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 | ||
| 39 | EUCTR2018-004476-35-SI (EUCTR) | 06/09/2019 | 17/09/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United 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 | ||
| 40 | EUCTR2018-004387-54-BE (EUCTR) | 26/08/2019 | 01/07/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) | Sjögren’s Syndrome (SjS) MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LOU064 INN or Proposed INN: Not yet established Product Code: LOU064 INN or Proposed INN: Not yet established Product Code: LOU064 INN or Proposed INN: Not yet established | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 41 | EUCTR2018-004387-54-ES (EUCTR) | 21/08/2019 | 08/05/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China | |||
| 42 | EUCTR2018-004476-35-PT (EUCTR) | 19/08/2019 | 23/05/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;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 | |||
| 43 | EUCTR2018-004476-35-GR (EUCTR) | 07/08/2019 | 19/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | Portugal;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 | ||
| 44 | EUCTR2018-004476-35-HU (EUCTR) | 07/08/2019 | 04/06/2019 | Study of safety and efficacy of multiple doses of CFZ533 in two distinct populations of patients with Sjögren’s Syndrome | A 48-week, 6-arm, randomized, double-blind, placebo-controlled multicenter trial to assess the safety and efficacy of multiple CFZ533 doses administered subcutaneously in two distinct populations of patients with Sjögren’s Syndrome (TWINSS) - TWINSS | Sjögren syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: iscalimab Product Code: CFZ533 INN or Proposed INN: iscalimab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 260 | Phase 2 | United 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 | ||
| 45 | NCT04035668 (ClinicalTrials.gov) | July 12, 2019 | 8/7/2019 | A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome | An 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 Syndrome | Drug: LOU064;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | 75 Years | All | 252 | Phase 2 | United States;Australia;Belgium;Bulgaria;China;Denmark;Germany;Hungary;Spain;Switzerland;Taiwan;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 46 | NCT03700138 (ClinicalTrials.gov) | June 24, 2019 | 24/8/2018 | Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies | Prospective, Randomised, Placebo-controlled Study of Polyvalent Intravenous Immunoglobulins for the Treatment of Primary Sjögren's Syndrome Associated Painful Sensory Neuropathies | Primary Sjögren's Syndrome Painful Sensory Neuropathies | Drug: Privigen® 100mg/ml at the dose of 2g/kg of body weight;Drug: NaCl 0,9% | University Hospital, Strasbourg, France | NULL | Recruiting | 18 Years | 80 Years | All | 24 | Phase 3 | France |
| 47 | EUCTR2018-004387-54-HU (EUCTR) | 24/06/2019 | 29/04/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) | Sjögren’s Syndrome (SjS) MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LOU064 INN or Proposed INN: Not yet established Product Code: LOU064 INN or Proposed INN: Not yet established Product Code: LOU064 INN or Proposed INN: Not yet established | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;China | ||
| 48 | ChiCTR1900022696 | 2019-06-01 | 2019-04-22 | A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndrome | A prospective, controlled, randomized, open-label, single-center study for eramyd in the treatment of active sjogren's syndrome | Sjogren syndrome | experimental group :Iguratimod 25mg bid po;control group:hydroxychloroquine 0.2-0.4g/d+prednison0.2-0.5mg/kg.d; | Shanghai Tongji Hospital | NULL | Pending | 18 | 70 | Both | experimental group :60;control group:60; | Phase 4 | China |
| 49 | EUCTR2018-004387-54-DE (EUCTR) | 20/05/2019 | 03/04/2019 | A Phase 2 study to evaluate the safety and efficacy of LOU064 in patients with Sjögren’s Syndrome | An adaptive Phase 2 randomized double-blind, placebo-controlled multi-center study to evaluate the safety and efficacy of multiple LOU064 doses in patients with moderate to severe Sjögren’s Syndrome (LOUiSSe) | Sjögren’s Syndrome (SjS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Product Code: LOU064 INN or Proposed INN: remibrutinib Other descriptive name: LOU064 | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 252 | Phase 2 | United States;Taiwan;Spain;Switzerland;United Kingdom;Hungary;Jordan;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;China | ||
| 50 | NCT03926286 (ClinicalTrials.gov) | April 15, 2019 | 16/4/2019 | Fecal Microbial Transplant (FMT) for Sjogrens Syndrome | Fecal Microbial Transplant for Sjogrens Syndrome | Sjogren's Syndrome | Drug: FMP-30 | University of Miami | Sjogrens Syndrome Foundation;Microbiome Health Research Institute | Completed | 18 Years | N/A | All | 10 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 51 | NCT03816345 (ClinicalTrials.gov) | April 4, 2019 | 24/1/2019 | Nivolumab in Treating Patients With Autoimmune Disorders or Advanced, Metastatic, or Unresectable Cancer | A 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 Neoplasm | Biological: Nivolumab | National Cancer Institute (NCI) | NULL | Recruiting | 18 Years | N/A | All | 264 | Phase 1 | United States |
| 52 | ChiCTR1900021345 | 2019-02-12 | 2019-02-16 | Effect of Iguratimod on Primary Sjogren's Syndrome | Observation of Iguratimod's Effect on Primary Sjogren's Syndrome, A randomized, double-blind, placebo-controlled trial | Primary Sjogren's Syndrome | Control group :Hydrochloroquine;Treatment group:Iguratimod; | Tianjin Medical University General Hospital | NULL | Recruiting | 18 | 75 | Both | Control group :30;Treatment group:30; | China | |
| 53 | EUCTR2017-001371-24-FR (EUCTR) | 08/01/2019 | 15/10/2018 | Intravenous immunoglobulins for the treatment of primary Sjögren's syndrome associated painful sensory neuropathies | Prospective, 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 Strasbourg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 3 | France | |||
| 54 | NCT03817424 (ClinicalTrials.gov) | December 13, 2018 | 22/1/2019 | A Study to Evaluate VIB7734 in Participants With Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE), Sjogren's Syndrome, Systemic Sclerosis, Polymyositis, and Dermatomyositis | A 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 Dermatomyositis | Systemic Lupus Erythematosus;Cutaneous Lupus Erythematosus;Sjogren's Syndrome;Systemic Sclerosis;Polymyositis;Dermatomyositis | Drug: VIB7734;Drug: Placebo | Viela Bio | NULL | Completed | 18 Years | 75 Years | All | 31 | Phase 1 | United States;Poland;Spain |
| 55 | NCT03865888 (ClinicalTrials.gov) | October 30, 2018 | 16/12/2018 | Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome | Evaluation 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 Syndrome | Dry Eye;Sjogren Syndrome | Drug: Cyclosporins;Drug: Tacrolimus | Pavly Moawd | NULL | Completed | 20 Years | 70 Years | All | 60 | Phase 3 | Egypt |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 56 | NCT03627065 (ClinicalTrials.gov) | September 24, 2018 | 8/8/2018 | A Study of INCB050465 in Primary Sjögren's Syndrome | An Open-Label Phase 2 Study of INCB050465 in Participants With Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: Parsaclisib | Incyte Corporation | NULL | Completed | 18 Years | N/A | All | 10 | Phase 2 | United States |
| 57 | NCT03436576 (ClinicalTrials.gov) | September 12, 2018 | 12/2/2018 | Efficacy of Two Concentrations of Autologous Serum for the Treatment of Severe Dry Eye | Comparison of Autologous Serum 20% and Autologous Serum 50% for the Treatment of Severe Dry Eye | Dry Eye;Keratoconjunctivitis Sicca;Sjogren's Syndrome;Corneal Diseases;Conjunctival Diseases;Keratitis;Lacrimal Apparatus Diseases | Drug: Autologous Serum 20%;Drug: Autologous Serum 50% | Pontificia Universidad Catolica de Chile | Hospital Dr Sotero del Rio | Unknown status | 18 Years | N/A | All | 20 | Phase 3 | Chile |
| 58 | EUCTR2016-003558-34-PL (EUCTR) | 19/06/2018 | 14/05/2018 | A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with Sjogren's Syndrome | A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome | Active Sjogren’s Syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Product Name: GS-9876 Product Code: GS-9876 INN or Proposed INN: GS-9876 Other descriptive name: GS-9876 Product Name: tirabrutinib Product Code: GS-4059 INN or Proposed INN: GS-4059 Other descriptive name: GS-4059 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United States;Spain;Poland;United Kingdom | ||
| 59 | NCT03540823 (ClinicalTrials.gov) | April 23, 2018 | 14/5/2018 | Evaluation of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases | Immunogenicity and Safety of Influenza A/H3N2 Vaccine in Patients With Rheumatologic Diseases | Systemic Lupus;Sjogren's Syndrome | Biological: 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 Hospital | NULL | Completed | 9 Years | N/A | All | 300 | Phase 4 | Brazil |
| 60 | NCT03319420 (ClinicalTrials.gov) | March 29, 2018 | 19/10/2017 | Evaluate the Efficacy and Safety of LO2A Eye Drops for Symptomatic Improvement of Dry Eye in Patients With Sjögren's Syndrome | A 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 Syndrome | Dry Eye Due to Sjögren's Syndrome | Drug: LO2A eye drops;Drug: Systane Ultra UD | Ocuwize LTD | NULL | Recruiting | 18 Years | 95 Years | All | 60 | Phase 4 | Israel |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 61 | NCT03430388 (ClinicalTrials.gov) | January 31, 2018 | 30/1/2018 | Yellow Fever Vaccine in Patients With Rheumatic Diseases | Evaluation of Yellow Fever Vaccine in Patients With Rheumatic Diseases Under Low Immunosuppression Level and Residing in a Risk Area | Systemic Lupus;Rheumatoid Arthritis;Spondyloarthritis;Inflammatory Myopathy;Systemic Sclerosis;Mixed Connective Tissue Disease;Takayasu Arteritis;Granulomatosis With Polyangiitis;Sjogren's Syndrome;Juvenile Idiopathic Arthritis;Juvenile Dermatomyositis | Biological: Yellow Fever vaccine (17D) | University of Sao Paulo General Hospital | NULL | Completed | 2 Years | 60 Years | All | 600 | N/A | Brazil |
| 62 | NCT03840538 (ClinicalTrials.gov) | January 1, 2018 | 12/2/2019 | Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome | Probiotics as a Prophylaxis to Prevent Clinical Manifestations of Oral Candidosis in Patients With Sjogren's Syndrome | Sjogren's Syndrome | Drug: Probiotic Product - Cap | Cairo University | NULL | Completed | 30 Years | 70 Years | All | 32 | Phase 1;Phase 2 | Egypt |
| 63 | EUCTR2016-003292-22-PL (EUCTR) | 28/09/2017 | 23/08/2017 | 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | |||
| 64 | EUCTR2016-003292-22-NL (EUCTR) | 25/07/2017 | 19/04/2017 | Study of safety and efficacy of ianalumab in patients with primarySjogren's Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 doserangingstudy to assess the safety and efficacy of multiple ianalumab dosesadministered subcutaneously in patients with moderate to severe primarySjogren's Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 65 | EUCTR2016-003292-22-BE (EUCTR) | 17/07/2017 | 26/04/2017 | 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: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 66 | EUCTR2016-003558-34-GB (EUCTR) | 03/07/2017 | 02/05/2017 | A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with Sjogren's Syndrome | A Randomized, Phase 2, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib, GS-9876 and GS-4059 in Adult Subjects with Active Sjogren’s Syndrome | Active Sjogren’s Syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Filgotinib Product Code: GS-6034 INN or Proposed INN: FILGOTINIB Product Name: GS-9876 Product Code: GS-9876 INN or Proposed INN: GS-9876 Other descriptive name: GS-9876 Product Name: tirabrutinib Product Code: GS-4059 INN or Proposed INN: GS-4059 Other descriptive name: GS-4059 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | United States;Spain;Poland;United Kingdom | ||
| 67 | NCT03226444 (ClinicalTrials.gov) | June 30, 2017 | 19/7/2017 | Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome | A 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 Syndrome | Primary Sjögren Syndrome;Dry Eye | Drug: 0.005% Lacripep;Drug: 0.01% Lacripep;Drug: Placebo | TearSolutions, Inc. | NULL | Completed | 18 Years | N/A | All | 204 | Phase 1;Phase 2 | United States |
| 68 | EUCTR2016-003292-22-HU (EUCTR) | 29/06/2017 | 20/04/2017 | Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: Not established Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Israel;Chile;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Norway;Netherlands;Germany;Japan;Sweden | ||
| 69 | EUCTR2016-003292-22-AT (EUCTR) | 19/06/2017 | 17/05/2017 | Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 70 | EUCTR2016-003292-22-FR (EUCTR) | 09/06/2017 | 11/04/2017 | Study 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 71 | EUCTR2016-003292-22-DE (EUCTR) | 06/06/2017 | 06/03/2017 | Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | |||
| 72 | EUCTR2016-003292-22-PT (EUCTR) | 05/06/2017 | 20/03/2017 | Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 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 AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | |||
| 73 | EUCTR2016-003292-22-GB (EUCTR) | 26/05/2017 | 20/03/2017 | Study of safety and efficacy of ianalumab in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of multiple ianalumab doses administered subcutaneously in patients with moderate to severe primary Sjögren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ianalumab Product Code: VAY736 INN or Proposed INN: ianalumab Other descriptive name: VAY736 antibody | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | United States;Portugal;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Belgium;Poland;Romania;Germany;Netherlands;Japan | ||
| 74 | EUCTR2016-003558-34-ES (EUCTR) | 25/05/2017 | 08/05/2017 | A clinical trial to study the safety and efficacy of filgotinib, GS-9876 and GS-4059 in subjects with Sjogren's Syndrome | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 2 | France;United States;Poland;Spain;Italy;United Kingdom | |||
| 75 | NCT03100942 (ClinicalTrials.gov) | May 1, 2017 | 31/3/2017 | Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome | A 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 | Sjogren's Syndrome | Drug: Lanraplenib;Drug: Filgotinib;Drug: Tirabrutinib;Drug: Lanraplenib placebo;Drug: Filgotinib placebo;Drug: Tirabrutinib placebo | Gilead Sciences | Galapagos NV;Ono Pharmaceutical Co. Ltd | Completed | 18 Years | 75 Years | All | 152 | Phase 2 | United States;Poland;Spain;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 76 | EUCTR2016-000101-37-GR (EUCTR) | 07/04/2017 | 15/03/2017 | Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndrome | A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome - POC H2H study | subjects with moderate to severe Sjögren's syndrome MedDRA version: 19.1;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Poland;Belgium;Romania;Peru;Denmark;South Africa;Norway;Netherlands;United States;Greece;Russian Federation;Chile;Colombia;United Kingdom;Italy;France;Hungary;Mexico | ||
| 77 | EUCTR2016-003292-22-ES (EUCTR) | 06/04/2017 | 10/03/2017 | Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) | A randomized, double-blind, placebo-controlled multicenter phase 2 dose-ranging study to assess the safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome | Primary Sjogren’s syndrome MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: Not established Other descriptive name: VAY736 antibody | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 2 | Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan;Chile;Portugal;United States;Taiwan;Spain;Austria;Russian Federation | ||
| 78 | ChiCTR-INR-16009629 | 2017-04-01 | 2016-10-26 | A double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndrome | A double blinded Stratified sampling study of Jiedu Tongluo Shengjin prescription in treatment of primary Sjogren syndrome | primary Sjogren's Syndrome | low disease activity-experimental group:Jiedu Tongluo Shengjin prescription;low disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-experimental group:Jiedu Tongluo Shengjin prescription;moderate disease activity-experimental group:prednisone 10mg/d;moderate disease activity-experimental group:Hydorxychloroquine 0.2g/d;moderate disease activity-control group:Jiedu Tongluo Shengjin prescription placebo;moderate disease activity-control group:prednisone 10mg/d;moderate disease activity-control group:Hydorxychloroquine 0.2g/d; | Yueyang Hospital of Integrated Medicine affiliated to Shanghai University of Tradition Chinese Medicine | NULL | Pending | 18 | 70 | Both | low disease activity-experimental group:27;low disease activity-control group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-experimental group:27;moderate disease activity-con | China | |
| 79 | EUCTR2016-000101-37-IT (EUCTR) | 29/03/2017 | 27/02/2018 | Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Primary Sjögren's Syndrome | A Phase II, Randomized, Multi-Center, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BMS-931699 (lulizumab) or BMS-986142 in Subjects with Moderate to Severe Primary Sjögren's Syndrome - POC H2H study | subjects with moderate to severe Sjögren's syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Level: PT;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: BTK Inhibitor Product Code: BMS-986142 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: BTK Inhibitor Product Code: 1643368-58-4 INN or Proposed INN: BTK Inhibitor Other descriptive name: BMS986142 Product Name: Anti-CD28dab Product Code: BMS-931699 INN or Proposed INN: Anti-CD28dAb Other descriptive name: Anti-CD28dAb | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Greece;Russian Federation;Chile;Colombia;Italy;United Kingdom;France;Mexico;Poland;Belgium;Romania;Peru;Denmark;South Africa;Netherlands;Norway | ||
| 80 | EUCTR2015-000400-26-GB (EUCTR) | 17/03/2017 | 14/12/2016 | A 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 syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 19.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 81 | EUCTR2016-004258-14-GB (EUCTR) | 21/02/2017 | 21/12/2016 | 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. | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 22 | Phase 2 | United Kingdom | |||
| 82 | EUCTR2014-004523-51-GR (EUCTR) | 14/02/2017 | 03/01/2017 | UCB Proof of Concept Study in patients with Primary Sjogren’s Syndrome | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME | Primary Sjogren’s Syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 | UCB Celltech, UK | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | France;Greece;Spain;Italy;United Kingdom;Sweden | ||
| 83 | NCT03608761 (ClinicalTrials.gov) | February 6, 2017 | 9/7/2018 | Comparison Between Rebamipide 2% Versus Autologous Serum | Comparison 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 Study | Dry Eye Syndromes;Sjögren Syndrome | Drug: Rebamipide;Biological: autologous serum;Other: autologous serum and rebamipide 2% | Hospital Nacional Profesor Alejandro Posadas | NULL | Completed | 18 Years | N/A | Female | 21 | Phase 4 | Argentina |
| 84 | EUCTR2016-001948-19-SE (EUCTR) | 02/02/2017 | 19/10/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | ||
| 85 | JPRN-JapicCTI-173521 | 01/2/2017 | 24/02/2017 | A Phase 3 study of Abatacept in Patients with Primary Sjogrens Syndrome | A 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 Syndrome | Intervention 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. | NULL | complete | 18 | BOTH | 172 | Phase 3 | NULL | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 86 | NCT03247686 (ClinicalTrials.gov) | February 1, 2017 | 3/8/2017 | A Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome | A Phase 2, Double-blind, Placebo-controlled Study of RSLV-132 in Subjects With Primary Sjogren's Syndrome | Sjogren's Syndrome | Drug: RSLV-132;Drug: Placebo | Resolve Therapeutics | University Hospital Birmingham;Newcastle-upon-Tyne Hospitals NHS Trust | Completed | 18 Years | 70 Years | All | 28 | Phase 2 | United Kingdom |
| 87 | NCT03023592 (ClinicalTrials.gov) | February 2017 | 15/1/2017 | Study of Iguratimod in Sjögren's Syndrome | A Preliminary Efficacy Study of Iguratimod in Patients With Sjögren's Syndrome | Sjogren's Syndrome | Drug: Iguratimod | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 30 | Phase 1;Phase 2 | China |
| 88 | EUCTR2016-001948-19-CZ (EUCTR) | 28/12/2016 | 27/10/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.1;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | |||
| 89 | NCT02915159 (ClinicalTrials.gov) | December 6, 2016 | 23/9/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults With Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome | Sjogrens Disease | Biological: Abatacept;Other: Placebo | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 250 | Phase 3 | United States;Argentina;Australia;Brazil;Czechia;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Puerto Rico;Sweden;Canada;Czech Republic |
| 90 | EUCTR2016-001948-19-FR (EUCTR) | 02/12/2016 | 07/11/2016 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome | Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 19.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Sweden;Korea, Republic of | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 91 | NCT02503163 (ClinicalTrials.gov) | November 23, 2016 | 17/7/2015 | A Long-term Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome | Dry Eye With Sjögren's Syndrome | Drug: KCT-0809 ophthalmic solution | Kissei Pharmaceutical Co., Ltd. | NULL | Completed | 20 Years | N/A | All | Phase 3 | Japan | ||
| 92 | NCT02503189 (ClinicalTrials.gov) | November 23, 2016 | 17/7/2015 | A Phase III Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome | Dry Eye With Sjögren's Syndrome | Drug: KCT-0809 ophthalmic solution;Drug: Placebo | Kissei Pharmaceutical Co., Ltd. | NULL | Completed | 20 Years | N/A | All | Phase 3 | Japan | ||
| 93 | EUCTR2014-004616-12-PL (EUCTR) | 21/11/2016 | 12/10/2016 | Study 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 CDZ173 | A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome | Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Hungary;Poland;Germany | ||
| 94 | NCT02899377 (ClinicalTrials.gov) | November 18, 2016 | 23/8/2016 | A PH I Pilot Imaging Study to Evaluate Molecular Imaging Methods in HVs and pSS Pts | A Pilot Study to Evaluate Molecular Imaging Methods in Primary Sjögren's Syndrome | Autoimmune Diseases | Radiation: 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) biopsy | GlaxoSmithKline | Quintiles, Inc. | Completed | 30 Years | N/A | All | 25 | N/A | United Kingdom |
| 95 | NCT02843659 (ClinicalTrials.gov) | October 18, 2016 | 8/7/2016 | Proof of Concept Study to Evaluate the Efficacy and Safety of BMS-931699 (Lulizumab) or BMS-986142 in Primary Sjögren's Syndrome | A 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 | Sjögren's Syndrome | Drug: BMS-931699;Drug: BMS-986142;Drug: Placebo | Bristol-Myers Squibb | NULL | Terminated | 18 Years | 70 Years | All | 45 | Phase 2 | United States;Australia;Chile;Colombia;Italy;Mexico;Peru;Poland;Puerto Rico;Russian Federation;South Africa;France;Hungary |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 96 | EUCTR2016-001586-87-GB (EUCTR) | 29/09/2016 | 06/07/2016 | A Phase 2 Study of RSLV-132 in Subjects with Sjogren’s Syndrome | A 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, LLC | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | United Kingdom | |||
| 97 | EUCTR2014-004616-12-HU (EUCTR) | 28/09/2016 | 17/08/2016 | Study 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 CDZ173 | A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome | Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Hungary;Poland;Germany | ||
| 98 | EUCTR2015-004476-30-PL (EUCTR) | 26/08/2016 | 20/07/2016 | A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s Syndrome | A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME | Primary Sjögren’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cathepsin S inhibitor Product Code: RO545-9072/F03 INN or Proposed INN: Not applicable Other descriptive name: RO5459072 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Portugal;France;United States;Poland;Germany;United Kingdom | ||
| 99 | EUCTR2014-004523-51-SE (EUCTR) | 24/08/2016 | 05/07/2016 | UCB Proof of Concept Study in patients with Primary Sjogren’s Syndrome | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME | Primary Sjogren’s Syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 | UCB Celltech, UK | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden | ||
| 100 | EUCTR2015-004476-30-DE (EUCTR) | 18/07/2016 | 18/05/2016 | A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s Syndrome | A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME | Primary Sjögren’s syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cathepsin S Inhibitor Product Code: RO545-9072/F03 INN or Proposed INN: Not applicable Other descriptive name: RO5459072 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Portugal;France;United States;Poland;Germany;Italy;United Kingdom | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 101 | NCT02701985 (ClinicalTrials.gov) | July 5, 2016 | 3/3/2016 | A Study to Assess the Efficacy of RO5459072 in Participants With Primary Sjogren's Syndrome | A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2A Study to Assess the Efficacy of RO5459072 in Patients With Primary Sjogren's Syndrome | Sjogren's Syndrome | Drug: Placebo;Drug: RO5459072 | Hoffmann-La Roche | NULL | Completed | 18 Years | 75 Years | All | 75 | Phase 2 | United States;France;Germany;Poland;Portugal;United Kingdom |
| 102 | EUCTR2015-004476-30-FR (EUCTR) | 27/06/2016 | 04/09/2017 | A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s Syndrome | A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME | Primary Sjögren’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cathepsin S Product Code: RO545-9072/F03 INN or Proposed INN: Not applicable Other descriptive name: RO5459072 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Portugal;United States;France;Poland;Germany;Italy;United Kingdom | ||
| 103 | EUCTR2015-004476-30-GB (EUCTR) | 22/06/2016 | 16/03/2016 | A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s Syndrome | A 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 Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Portugal;France;United States;Poland;Germany;United Kingdom | |||
| 104 | EUCTR2015-004476-30-PT (EUCTR) | 15/06/2016 | 18/04/2016 | A Study to Evaluate the Efficacy of RO5459072 in Participants With Primary Sjögren’s Syndrome | A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP PHASE 2A STUDY TO ASSESS THE EFFICACY OF RO5459072 IN PATIENTS WITH PRIMARY SJÖGREN’S SYNDROME | Primary Sjögren’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Cathepsin S inhibitor Product Code: RO545-9072/F03 INN or Proposed INN: Not applicable Other descriptive name: RO5459072 | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;United States;Portugal;Poland;Germany;United Kingdom | ||
| 105 | NCT03762824 (ClinicalTrials.gov) | June 14, 2016 | 3/12/2018 | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease | Combined Pneumococcal Conjugate and Polysaccharide Vaccination in Inflammatory Rheumatic Disease. Impact of Antirheumatic Treatment on Antibody Response. | Rheumatoid Arthritis;Systemic Lupus;Sjögren Syndrome;Systemic Vasculitis;Spondyloarthritis | Biological: 13-valent pneumococcal conjugate vaccine;Biological: 23-valent pneumococcal polysaccharide vaccine | Region Skane | NULL | Active, not recruiting | 18 Years | N/A | All | 300 | Phase 4 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 106 | NCT02775916 (ClinicalTrials.gov) | June 1, 2016 | 16/5/2016 | Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome | A 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 | Drug: CDZ173;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 30 | Phase 2 | Germany;Hungary |
| 107 | EUCTR2014-004616-12-DE (EUCTR) | 20/05/2016 | 17/03/2016 | Study 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 CDZ173 | A randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CDZ173 in patients with primary Sjögren’s syndrome | Primary Sjögren's syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CDZ173 INN or Proposed INN: leniolisib Other descriptive name: CDZ173 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Hungary;Poland;Germany | ||
| 108 | NCT04111341 (ClinicalTrials.gov) | May 6, 2016 | 26/9/2019 | A 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 Syndrome | Drug: TCM (Gan-Lu-Yin)GLY;Drug: PLACEBO | Chung Shan Medical University | NULL | Completed | 20 Years | 80 Years | All | 30 | Phase 2 | Taiwan |
| 109 | NCT02631538 (ClinicalTrials.gov) | February 17, 2016 | 14/12/2015 | Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's Syndrome | A 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 Syndrome | Sjogren's Syndrome | Drug: Belimumab;Drug: Rituximab;Drug: Placebo belimumab;Drug: Placebo rituximab | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 86 | Phase 2 | Argentina;Canada;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom |
| 110 | EUCTR2013-004808-19-DE (EUCTR) | 05/02/2016 | 07/12/2015 | Study 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 CFZ533 | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's | primary Sjögren’s syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 INN or Proposed INN: Not yet established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | United States;Hungary;Germany;United Kingdom;Switzerland | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 111 | EUCTR2015-000400-26-IT (EUCTR) | 18/01/2016 | 10/11/2020 | A 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 syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. - NA | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: MABTHERA Product Code: [NA] INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO Product Name: BENLYSTA Product Code: [na] INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: SOLU-MEDROL Product Code: [na] INN or Proposed INN: METILPREDNISOLONE Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [na] INN or Proposed INN: PARACETAMOLO Trade Name: XYZAL - 20 COMPRESSE RI | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 112 | EUCTR2015-000400-26-NO (EUCTR) | 08/01/2016 | 23/09/2015 | A 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 syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 113 | EUCTR2015-000400-26-NL (EUCTR) | 28/12/2015 | 08/12/2015 | A 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 syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 18.1;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 114 | EUCTR2015-000400-26-SE (EUCTR) | 15/12/2015 | 08/09/2015 | A 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 syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 115 | NCT02614716 (ClinicalTrials.gov) | December 10, 2015 | 24/11/2015 | A 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 Syndrome | Sjögren's Syndrome | Drug: LY3090106;Drug: Placebo | Eli Lilly and Company | NULL | Completed | 18 Years | 65 Years | All | 32 | Phase 1 | United States;Bulgaria;Georgia;Romania |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 116 | EUCTR2015-000400-26-DE (EUCTR) | 03/12/2015 | 01/10/2015 | A 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 syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 117 | EUCTR2015-000400-26-FR (EUCTR) | 01/12/2015 | 24/02/2017 | A 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 syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;Norway | ||
| 118 | EUCTR2015-000400-26-ES (EUCTR) | 19/11/2015 | 05/10/2015 | A 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 syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. | Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;Sweden | ||
| 119 | NCT02610543 (ClinicalTrials.gov) | October 2015 | 18/11/2015 | UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome | A Randomized, Double-blind, Placebo-controlled, Proof-of-concept Study to Evaluate the Efficacy of UCB5857 Over 12 Weeks in Subjects With Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: UCB5857;Drug: Placebo | UCB Celltech | PRA Health Sciences | Terminated | 18 Years | 75 Years | All | 27 | Phase 2 | France;Italy;Spain;Sweden;United Kingdom;Greece |
| 120 | EUCTR2014-003140-12-NL (EUCTR) | 21/09/2015 | 26/08/2015 | Leflunomide and Hydroxychloroquine combination therapy for primary Sjogren's Syndrome | Optimizing DMARD-therapy for primary Sjogren's Syndrome - Leflunomide and Hydroxychloroquine combination therapy for patients with primary Sjogren's Syndrome - LEF-HCQ combination therapy in pSS | Sjogren's Syndrome MedDRA version: 18.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 18.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;Classification code 10042846;Term: Syndrome Sjogren's;Classification code 10040765;Term: Sjogren's;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Leflunomide Mylan Product Name: Leflunomide mylan INN or Proposed INN: LEFLUNOMIDE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: HYDROXYCHLOROQUINE | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | Netherlands | ||||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 121 | EUCTR2014-004523-51-ES (EUCTR) | 14/09/2015 | 01/06/2015 | UCB Proof of Concept Study in patients with Primary Sjogren?s Syndrome | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN?S SYNDROME | Primary Sjogren?s Syndrome MedDRA version: 18.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 | UCB Celltech, UK | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden | ||
| 122 | EUCTR2014-004523-51-IT (EUCTR) | 25/08/2015 | 15/12/2017 | UCB PROOF OF CONCEPT STUDY IN PATIENTS WITH PRIMARY SJ?GREN'S SYNDROME | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OFCONCEPTSTUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJ?GREN'S SYNDROME - NA | Primary Sj?gren's Syndrome MedDRA version: 20.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 | UCB CELLTECH (UK BRANCH OF UCB PHARMA SA) | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | France;Greece;Spain;Netherlands;United Kingdom;Italy;Sweden | ||
| 123 | JPRN-UMIN000019009 | 2015/08/19 | 14/09/2015 | The multicenter randomized open controlled trials of impact on clinical effect and oxidative stress markers of Mucosta ophthalmic solution that targets the dry eye patients complicated with Sjogren's syndrome | The dry eye patients complicated with Sjogren's syndrome | Mucosta ophthalmic suspensionUD2%, q.i.d. and Soft Santear, t.d. for 4weeks in both eyes Soft Santear, q.i.d. for 4weeks | Kyoto Prefectural University of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | |
| 124 | NCT02503176 (ClinicalTrials.gov) | August 2015 | 17/7/2015 | An Extension Study of KCT-0809 in Dry Eye Patients With Sjögren's Syndrome | Dry Eye With Sjögren's Syndrome | Drug: KCT-0809 ophthalmic solution | Kissei Pharmaceutical Co., Ltd. | NULL | Terminated | 20 Years | N/A | All | Phase 3 | Japan | ||
| 125 | JPRN-UMIN000018376 | 2015/07/22 | 22/07/2015 | Efficacy and safety of rituximab for patients with severe rheumatic disease | Efficacy 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 Pediatrics | NULL | Complete: follow-up complete | 2years-old | Not applicable | Male and Female | 20 | Not selected | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 126 | NCT02334306 (ClinicalTrials.gov) | June 8, 2015 | 12/12/2014 | A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome | A 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 Syndrome | Primary Sjögren's Syndrome | Biological: AMG 557/MEDI5872;Other: Placebo | MedImmune LLC | Amgen | Completed | 18 Years | 75 Years | All | 32 | Phase 2 | United States;France;Sweden;United Kingdom |
| 127 | NCT02464319 (ClinicalTrials.gov) | June 1, 2015 | 30/5/2015 | A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome | Safety and Efficiency Study of Low-dose IL-2 Treatment in Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: hrIL-2 active;Drug: hrIL-2 placebo | Peking University People's Hospital | Monash University;Beijing ShuangLu Pharmaceutical Co., Ltd. | Completed | 18 Years | 65 Years | All | 60 | Phase 2 | China |
| 128 | EUCTR2014-004523-51-FR (EUCTR) | 28/05/2015 | 20/07/2015 | UCB Proof of Concept Study in patients with Primary Sjogren’s Syndrome | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME | Primary Sjogren’s Syndrome MedDRA version: 18.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 | UCB Celltech, UK | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | France;Greece;Spain;Netherlands;Italy;United Kingdom;Sweden | ||
| 129 | EUCTR2014-004523-51-GB (EUCTR) | 18/05/2015 | 01/04/2015 | UCB Proof of Concept Study in patients with Primary Sjogren’s Syndrome | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF-OF-CONCEPT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF UCB5857 OVER 12 WEEKS IN SUBJECTS WITH PRIMARY SJOGREN’S SYNDROME | Primary Sjogren’s Syndrome MedDRA version: 19.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 Product Name: UCB5857 Product Code: UCB5857 INN or Proposed INN: UCB5857 Other descriptive name: UCB5857 | UCB Celltech, UK | NULL | Not Recruiting | Female: yes Male: yes | 58 | Phase 2 | France;Greece;Spain;Italy;United Kingdom;Sweden | ||
| 130 | EUCTR2014-003896-41-GB (EUCTR) | 27/03/2015 | 05/02/2015 | MedImmune Sjogren's Syndrome Study | A 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, LLC | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | France;United States;United Kingdom;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 131 | ChiCTR-IPR-15005990 | 2015-03-23 | 2015-02-10 | Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Cyclosporine A in the Treatment of Interstitial Pneumonitis associated with Sjogren’s syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Sjogren's syndrome | Treatment group:glucocorticoid+CsA;Control group:glucocorticoid+placebo; | Peking University People's Hospital | NULL | Pending | 18 | 75 | Both | Treatment group:120;Control group:120; | China | |
| 132 | NCT02370550 (ClinicalTrials.gov) | March 2015 | 18/2/2015 | Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome | Cyclosporine A in the TReatment of Interstitial Pneumonitis Associated With Sjogren's Syndrome(CTRIPS): A Prospective, Randomized, Multicenter, Double-Blind Placebo-Controlled Trial | Sjogren's Syndrome | Drug: Cyclosporin A;Drug: Prednisone;Drug: Placebo;Drug: Calcium carbonate D | Peking University People's Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 240 | Phase 4 | China |
| 133 | NCT02633332 (ClinicalTrials.gov) | February 2015 | 30/11/2015 | Use 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 Treatments | Rheumatoid Arthritis;Autoimmune Diseases;Disorder of Synovium;Sjogren's Syndrome;Acute and Chronic Inflammation;Disorder of Pleura and Pleural Cavity;Felty's Syndrome;Rheumatoid Nodules | Drug: Vitamin D3;Drug: Lipitor®;Drug: Acycloguanosine;Drug: Tetracycline;Drug: methotrexate;Drug: etanercept | Università Popolare Homo & Natura | NULL | Completed | 18 Years | 75 Years | Both | 15 | Phase 1 | Italy |
| 134 | NCT02257957 (ClinicalTrials.gov) | November 2014 | 24/9/2014 | Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye | Platelet -Rich Plasma (PRP) Injection for the Treatment of Severe Dry Eye | Dry Eye;Sjogren Syndrome | Drug: PRP injection;Drug: Standard care Hyaluronic acid eye drops | Universidad Nacional de Colombia | NULL | Not yet recruiting | 18 Years | N/A | Both | 30 | Phase 3 | NULL |
| 135 | NCT02291029 (ClinicalTrials.gov) | October 22, 2014 | 4/11/2014 | Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome | A 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 | Primary Sjögren's Syndrome | Drug: 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 3 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 69 | Phase 2 | United States;Germany;Hungary;Switzerland;United Kingdom |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 136 | NCT02067910 (ClinicalTrials.gov) | August 2014 | 14/2/2014 | Efficacy and Safety of Abatacept in Patients With Primary Sjögren's Syndrome | Randomized, 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 Syndrome | Drug: Abatacept SC | University Medical Center Groningen | Bristol-Myers Squibb | Completed | 18 Years | N/A | All | 80 | Phase 3 | Netherlands |
| 137 | EUCTR2013-004808-19-GB (EUCTR) | 23/07/2014 | 07/03/2014 | Study 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 CFZ533 | A 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 AG | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | United States;Hungary;Germany;Switzerland;United Kingdom | |||
| 138 | EUCTR2013-004808-19-HU (EUCTR) | 02/07/2014 | 06/05/2014 | Study 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 CFZ533 | A multi-center, randomized, double-blind, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of CFZ533 in patients with primary Sjögren’s syndrome - Safety, pharmacokinetics and preliminary efficacy study of CFZ533 in patients with primary Sjögren's | primary Sjögren’s syndrome MedDRA version: 18.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: CFZ533 INN or Proposed INN: Not yet established Product Code: CFZ533 INN or Proposed INN: Not yet established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 42 | Phase 2 | Hungary;Germany;United Kingdom;Switzerland | ||
| 139 | EUCTR2014-000417-31-NL (EUCTR) | 01/07/2014 | 20/03/2014 | Abatacept treatment in primary Sjögrens Syndrome | Randomized, double-blind, placebo-controlled phase III study (ASAP III study) to assess the efficacy and safety of Abatacept treatment in patients with primary Sjögren’s syndrome(ASAP III study = Abatacept Sjögren Active Patients phase III study) - ASAPIII | Primary Sjögren's syndrome (pSS) MedDRA version: 16.1;Level: LLT;Classification code 10042846;Term: Syndrome Sjogren's;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Orencia Product Name: Abatacept Product Code: BMS-188667 | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 140 | NCT02112019 (ClinicalTrials.gov) | June 2014 | 8/4/2014 | Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome | Endoscopic Treatment of Salivary Glands Affected by Sjögren's Syndrome; A Randomised Controlled Pilot Study | Sjögren's Syndrome | Procedure: Sialoendoscopy;Drug: saline;Drug: hydrocortisone | Derk Jan Jager | NULL | Active, not recruiting | 18 Years | 70 Years | All | 50 | N/A | Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 141 | NCT02149420 (ClinicalTrials.gov) | May 23, 2014 | 9/9/2013 | PD of VAY736 in Patients With Primary Sjögren's Syndrome | A 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 | Primary Sjögren's Syndrome | Drug: VAY736;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 75 Years | All | 27 | Phase 2 | Germany;France;Netherlands;United States |
| 142 | EUCTR2013-000250-22-DE (EUCTR) | 11/04/2014 | 16/10/2013 | A single dose study to assess the effect of VAY736 in patients with primary Sjögren’s syndrome | A single dose, double-blind, placebo-controlled, parallel study to assess the pharmacodynamics, pharmacokinetics and safety and tolerability of VAY736 in patients with primary Sjögren’s syndrome - CVAY736X2201 | Seropositive primary Sjögren’s syndrome MedDRA version: 19.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: VAY736 INN or Proposed INN: VAY736 Other descriptive name: VAY736 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | Germany | ||
| 143 | JPRN-UMIN000013234 | 2014/04/01 | 01/04/2014 | Effect 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 syndrome | Diquafosol sodium and rebamipide ophthalmic solution Artifical tears, vitamin A ophthalmic solution, or/and sodium hyaluronate ophthalmic solution | Keio University School of Medicine | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 20 | Not applicable | Japan | |
| 144 | NCT02110446 (ClinicalTrials.gov) | February 2014 | 1/4/2014 | Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome | Evaluation of the Efficacy and the Mechanism of Chinese Herbal Formula SS-1 for Sjögren's Syndrome - A Randomized Control Trial | Sjögren's Syndrome | Drug: SS-1;Drug: Placebo | Chang Gung Memorial Hospital | Chang Gung University;National Science Council, Taiwan;China Medical University, China;China Medical University Hospital | Recruiting | 20 Years | 75 Years | Both | 60 | Phase 2 | Taiwan |
| 145 | NCT01716312 (ClinicalTrials.gov) | January 8, 2014 | 23/10/2012 | Omalizumab for Lupus | A 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 Syndrome | Drug: Omalizumab | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | National Institute of Arthritis and Musculasketal and Skin Diseases | Completed | 18 Years | 100 Years | All | 17 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 146 | NCT01782235 (ClinicalTrials.gov) | July 24, 2013 | 30/1/2013 | Efficacy 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: Placebo | University Hospital, Strasbourg, France | NULL | Completed | 18 Years | 80 Years | All | 110 | Phase 2;Phase 3 | France |
| 147 | JPRN-UMIN000010796 | 2013/06/01 | 24/05/2013 | Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers | Sjogren's syndrome | single oral administration of pilocarpine. salagen (KISSEI PHARMACEUTICAL CO.,LTD.) 5mg 1Tablet. | Oita University Faculty of Medicine | NULL | Pending | 20years-old | Not applicable | Male and Female | 30 | Not applicable | Japan | |
| 148 | JPRN-UMIN000010710 | 2013/05/15 | 15/05/2013 | Effective treatment of rebamipide on xerostomia in Sjogrens syndrome patients:a pilot study -a double-blind placebo-controlled trial- | Xerostomia in Sjogrens syndrome | Rebamipide 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 center | NULL | Complete: follow-up complete | 20years-old | 80years-old | Male and Female | 60 | Phase 2 | Japan | |
| 149 | JPRN-UMIN000004237 | 2013/03/31 | 19/09/2010 | Efficacy and safety of mizoribine for patients with Sjogren's syndrome in pediatric age | Sjogren's syndrome in pediatric age | Mizoribine 10 mg/kg (up to 500 mg) will be administered once daily twice a week. | Graduate School of Medicine, Chiba University | NULL | Complete: follow-up complete | 10years-old | 20years-old | Male and Female | 5 | Phase 2 | Japan | |
| 150 | NCT02147509 (ClinicalTrials.gov) | March 2013 | 13/5/2014 | Evaluation of Therapeutic Effect of Bandage Contact Lenses ( BCL) on Dry Eye Caused by Sjogren's Syndrome | Evaluation of the Therapeutic Effect of Bandage Contact Lenses on Dry Eye Caused by Sjogren's Syndrome | Sjögren's Syndrome Patients With Severe Dry Eye | Drug: 0.02% Fm, SH;Drug: 0.02% Fm, SH, 0.05% CsA;Other: 0.02% Fm, SH, tBCL;Drug: 0.02% Fm, SH, AS | Jinyang Li | NULL | Completed | 18 Years | 70 Years | Both | 64 | N/A | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 151 | NCT03578900 (ClinicalTrials.gov) | January 1, 2013 | 18/5/2018 | Quality of Life and Sjögren Syndrome | Quality of Life in a Portuguese Population With Primary Sjögren Syndrome | Xerostomia;Hyposalivation;Quality of Life;Sjogren's Syndrome | Drug: Xeros;Drug: Citric Acid based Mouthwash | Grupo de Investigação em Bioquímica e Biologia Oral | University of Lisbon;Portuguese Institute of Rheumatology;Dentaid SL | Completed | 18 Years | N/A | All | 289 | Phase 4 | NULL |
| 152 | NCT02004067 (ClinicalTrials.gov) | January 2013 | 3/12/2013 | Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease | Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease | Primary Sjogren Syndrome;Secondary Sjogren Syndrome;Aqueous Deficient Dry Eye Disease;Evaporative Dry Eye Disease | Drug: Restasis;Drug: Refresh Endura | Federal University of São Paulo | Allergan | Completed | 18 Years | 65 Years | All | 100 | Phase 4 | Brazil |
| 153 | JPRN-UMIN000008427 | 2012/07/13 | 13/07/2012 | Evaluation 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 University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
| 154 | NCT01552681 (ClinicalTrials.gov) | July 2012 | 9/3/2012 | Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome | A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Baminercept, a Lymphotoxin-beta Receptor Fusion Protein, for the Treatment of Primary Sjögren's Syndrome (ASJ02) | Primary Sjögren's Syndrome | Biological: Baminercept;Other: Placebo | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence;Biogen | Terminated | 18 Years | 75 Years | All | 52 | Phase 2 | United States |
| 155 | EUCTR2011-006196-19-DK (EUCTR) | 28/02/2012 | 30/01/2012 | Clinical Trials with lozenge as local anaesthesia as treatment for oral pain of patients with burning mouth syndrome and Sjögrens syndrom | Clinical 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 Hospital | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Denmark | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 156 | NCT01601028 (ClinicalTrials.gov) | July 2011 | 29/4/2012 | Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome | Phase 3 Study of Hydroxychloroquine Treatment of Dry Eyes in Patients With Primary Sjögren's Syndrome | Autoimmune Diseases;Sjogren's Syndrome;Dry Eye | Drug: Hydroxychloroquine;Drug: Placebo | Seoul National University Hospital | NULL | Completed | 19 Years | N/A | Both | 39 | Phase 3 | Korea, Republic of |
| 157 | NCT01316770 (ClinicalTrials.gov) | May 1, 2011 | 15/3/2011 | Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects | A Randomized Within-Subject, Double-Blind, Placebo-Controlled Study of Dexamethasone Irrigation of the Parotid Glands in Primary Sjögren's Syndrome Subjects | Sjögren's Syndrome;Xerostomia | Drug: Dexamethasone Parotid Irrigation;Drug: Placebo Parotid Irrigation | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Terminated | 18 Years | N/A | Female | 14 | Phase 2 | United States |
| 158 | NCT01357447 (ClinicalTrials.gov) | May 2011 | 18/5/2011 | Pulmozyme for Sjogren's Associated Cough | A Double-blind, Placebo-controlled Cross-over Trial of Pulmozyme for Sjogren's Associated Cough | Sjogren's Syndrome;Cough | Drug: Dornase alfa;Drug: Saline | UConn Health | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 1 | United States |
| 159 | NCT01393132 (ClinicalTrials.gov) | March 2011 | 7/7/2011 | Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye | Comparative Study of Thymosin Beta 4 Eye Drops or Vehicle in the Treatment of Patients With Ocular Surface Defects Due to Severe Dry Eye | Dry Eye;Sjogren's Syndrome;Graft vs. Host Disease | Drug: Thymosin Beta 4 eye drops;Drug: Vehicle Control | Michigan Cornea Consultants, PC | Kresge Eye Institute | Completed | 18 Years | 90 Years | All | 9 | Phase 2 | United States |
| 160 | NCT01647737 (ClinicalTrials.gov) | March 2011 | 14/5/2012 | Green Tea Lozenges for the Management of Dry Mouth | A Natural Formulation for Patients Diagnosed With Xerostomia | Xerostomia;Sjogren Syndrome;Dry Mouth | Dietary Supplement: MighTeaFlow;Dietary Supplement: Xylitol | Augusta University | GlaxoSmithKline | Completed | 18 Years | 75 Years | All | 60 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 161 | EUCTR2010-021430-64-GB (EUCTR) | 03/12/2010 | 04/11/2010 | A clinical trial to show whether there is an improvment in symptoms after the administration of rituximab in patients with primary Sjögren’s syndrome. | A randomised double blind placebo controlled clinical trial of anti B-cell therapy in patients with primary Sjögren’s syndrome. - TRACTISS (Rituximab / Placebo in Sjogren's Syndrome) Version 1.0 | Primary Sjögren’s syndrome (PSS). MedDRA version: 14.1;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: MabThera (rituximab) Product Name: MabThera (Rituximab) Product Code: N/A INN or Proposed INN: Rituximab Other descriptive name: Rituxan (US, Canada, Japan), MabThera (rest of world) | University of Leeds | NULL | Not Recruiting | Female: yes Male: yes | 110 | United Kingdom | |||
| 162 | JPRN-UMIN000004477 | 2010/11/01 | 01/11/2010 | Efficacy 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 syndrome | Hydroxychloroquine 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 Science | NULL | Complete: follow-up complete | 20years-old | 75years-old | Male and Female | 10 | Not applicable | Japan | |
| 163 | NCT01369589 (ClinicalTrials.gov) | November 2010 | 6/6/2011 | An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness | An Evaluation of the Impact of a Single Dose of P-552 on Oral Mucosal Wetness in Subjects With Xerostomia Related to Sjogren's Syndrome | Xerostomia;Sjogren's Syndrome | Drug: P-552;Drug: Placebo | Parion Sciences | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1;Phase 2 | United States |
| 164 | EUCTR2009-015558-40-NL (EUCTR) | 28/07/2010 | 23/12/2009 | Abatacept treatment in patients with primary Sjögren’s syndrome | Abatacept treatment in patients with primary Sjögren’s syndrome | Sjögren’s syndrome (SS) is a chronic, systemic, lymphoproliferative autoimmune disease affecting the exocrine glands. The salivary and lacrimal glands are most commonly affected, resulting in dry mouth and dry eyes. Extraglandular involvement can occur in SS, and includes, amongst others, pulmonary disease, renal disease and vasculitis. Moreover, almost all patients suffer from restricting fatigue. MedDRA version: 12.0;Level: LLT;Classification code 10040767;Term: Sjogren's syndrome | Trade Name: Orencia | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Netherlands | |||
| 165 | NCT01151644 (ClinicalTrials.gov) | April 2010 | 25/6/2010 | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Safety and Efficacy of Anti-Pandemic H1N1 Vaccination in Rheumatic Diseases | Rheumatoid 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 DM | Biological: Anti-pandemic H1N1 influenza vaccine | University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo | Active, not recruiting | N/A | N/A | Both | 5000 | Phase 4 | Brazil |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 166 | NCT01081184 (ClinicalTrials.gov) | March 2010 | 3/3/2010 | Neurotrophins Implications in Primary Sjögren Syndrome | Neurotrophins Implications in Primary Sjögren Syndrome | Primary Sjögren Syndrome | Biological: blood sample | University Hospital, Limoges | NULL | Completed | 18 Years | N/A | Both | 40 | N/A | France |
| 167 | NCT01160666 (ClinicalTrials.gov) | March 2010 | 9/7/2010 | Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome | A 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 Syndrome | Sjögren's Syndrome | Drug: Belimumab | Assistance Publique - Hôpitaux de Paris | Human Genome Sciences Inc. | Completed | 18 Years | N/A | Both | 20 | Phase 2 | France |
| 168 | NCT01693393 (ClinicalTrials.gov) | March 2010 | 14/9/2012 | Low Dose Cyclosporin A in Primary Sjögren Syndrome | A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome | Sjögren´s Syndrome | Drug: Cyclosporine A | Charite University, Berlin, Germany | NULL | Completed | 18 Years | 75 Years | Both | 30 | Phase 2 | Germany |
| 169 | NCT01850979 (ClinicalTrials.gov) | February 2010 | 1/5/2013 | Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops | Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops: Prospective Double-Blind Randomized Study | Sjogren Syndrome;Dry Eye Syndrome | Drug: Tacrolimus;Drug: Olive Oil | University of Sao Paulo General Hospital | NULL | Completed | 40 Years | 60 Years | Both | 24 | Phase 4 | Brazil |
| 170 | EUCTR2009-015978-35-FR (EUCTR) | 30/11/2009 | 01/10/2009 | Etude 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 | Etude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISS | Syndrome Sjogren's MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's | Product Name: HGS1006, LymphoStat-B INN or Proposed INN: belimumab | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | France | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 171 | NCT01008982 (ClinicalTrials.gov) | August 2009 | 5/11/2009 | Efficacy and Safety of Belimumab in Primary Sjögren's Syndrome | A 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 Syndrome | Drug: LimphoStat-B | University of Udine | Azienda Ospedaliera S. Maria della Misericordia | Completed | 18 Years | 90 Years | Both | 15 | Phase 2 | Italy |
| 172 | JPRN-UMIN000029307 | 2009/02/01 | 27/09/2017 | Efficacy and safety of pilocarpine / sodium alginate formulation for dry mouth in Sjogren's syndrome patients | Sjogren's syndrome | Pilocarpine / sodium alginate solution (0.32 mL, pilocarpine 0.96 mg) is administered intra-orally 3 times a day for 7 days. | Teikyo University | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 50 | Not selected | Japan | |
| 173 | NCT00852839 (ClinicalTrials.gov) | February 2009 | 26/2/2009 | A Safety and Efficacy Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome | A Randomized, Double-Blind, Vehicle-Controlled, Parallel Arm Study of 552-02 in Subjects With Dry Mouth Associated With Sjogren's Syndrome | Dry Mouth Associated With Sjogren's Syndrome;Xerostomia | Drug: Placebo;Drug: 552-02 | Parion Sciences | NULL | Completed | 18 Years | 80 Years | All | 140 | Phase 2 | United States |
| 174 | EUCTR2007-001377-28-PT (EUCTR) | 09/01/2009 | 25/08/2008 | Phase 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 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 175 | JPRN-UMIN000001460 | 2008/10/01 | 29/10/2008 | The efficacy and safety of pirocarpine hydrochloride for juvenile Sjogren's syndrome | Sjogren's syndrome | Oral pilocarpine hydrochloride for 4 weeks. | Department of Pediatrics, Graduate School of Medicine, Chiba Univerity | NULL | Complete: follow-up complete | 6years-old | 16years-old | Male and Female | 10 | Not selected | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 176 | EUCTR2007-003537-16-NL (EUCTR) | 04/09/2008 | 09/08/2007 | Estetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept Study | Estetrol Therapy in Sjogren's Syndrome: An Open Proof of Concept Study | Primary Sjogren's Syndrome MedDRA version: 9.1;Level: LLT;Classification code 10040767;Term: Sjogren's syndrome | Product Name: estetrol Product Code: E4 | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: no | Netherlands | ||||
| 177 | EUCTR2007-001377-28-DE (EUCTR) | 01/09/2008 | 15/05/2008 | Phase 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 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 178 | EUCTR2007-001377-28-NL (EUCTR) | 15/07/2008 | 29/05/2008 | Phase 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 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 179 | EUCTR2007-001377-28-AT (EUCTR) | 26/06/2008 | 27/05/2008 | Phase 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 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| 180 | EUCTR2007-001377-28-FR (EUCTR) | 11/06/2008 | 29/02/2008 | Phase 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 | Phase IV, one-day, single blood sampling study to investigate severe thrombocytopenia and autoimmune diseases in psoriasis subjects previously treated with RAPTIVA® (efalizumab) in the framework of the European Observational Safety Study 25878 (CLEAREST™) - CLEAREST™-TRAIL | Adult patients with moderate to severe chronic plaque psoriasis -- who have failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA, -- AND who have been treated with Raptiva (efalizumab) previously,-- AND who developed adverse events (AEs) corresponding to pre-specified newlydiagnosed autoimmune disorders OR who developed severe thrombocytopenia. MedDRA version: 9.1;Level: LLT;Classification code 10061664;Term: Autoimmune disorder MedDRA version: 9.1;Classification code 10025139;Term: Lupus erythematosus systemic MedDRA version: 9.1;Classification code 10047888;Term: Wegener's granulomatosis MedDRA version: 9.1;Classification code 10002817;Term: Antiphospholipid syndrome MedDRA version: 9.1;Classification code 10040767;Term: Sjogren's syndrome MedDRA version: 9.1;Classification code 10039073;Term: Rheumatoid arthritis MedDRA version: 9.1;Classification code 10028245;Term: Multiple sclerosis MedDRA version: 9.1;Classification code 10045228;Term: Type I diabetes mellitus MedDRA version: 9.1;Classification code 10011401;Term: Crohn's disease MedDRA version: 9.1;Classification code 10009900;Term: Colitis ulcerative MedDRA version: 9.1;Classification code 10003827;Term: Autoimmune hepatitis MedDRA version: 9.1;Classification code 10049046;Term: Autoimmune thyroiditis MedDRA version: 9.1;Classification code 10003822;Term: Autoimmune haemolytic anaemia NOS MedDRA version: 9.1;Classification code 10034697;Term: Pernicious anemia MedDRA version: 9.1;Classification code 10028417;Term: Myasthenia gravis MedDRA version: 9.1;Classification code 10018620;Term: Goodpasture's syndrome MedDRA version: 9.1;Classification code 10 | Trade Name: Raptiva 100 mg/ml powder and solvent for solution for injection INN or Proposed INN: Efalizumab Other descriptive name: EFALIZUMAB | Merck Serono International S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 92 | Phase 4 | Portugal;Germany;Netherlands;France;Austria | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 181 | NCT00632866 (ClinicalTrials.gov) | March 2008 | 29/2/2008 | Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome | Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome | Primary Sjögren's Syndrome | Drug: Hydroxychloroquine;Drug: Placebo | Assistance Publique - Hôpitaux de Paris | Sanofi | Completed | 18 Years | N/A | Both | 120 | Phase 3 | France |
| 182 | EUCTR2007-001708-19-GB (EUCTR) | 21/02/2008 | 01/08/2007 | 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. | 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 SA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United Kingdom | |||
| 183 | NCT00637793 (ClinicalTrials.gov) | February 2008 | 11/3/2008 | Study of NGX267 Oral Capsules in Patients With Xerostomia Associated With Sjorgren's Syndrome | A 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 Syndrome | Xerostomia;Sjogren's Syndrome | Drug: NGX267 | TorreyPines Therapeutics | NULL | Completed | 21 Years | 55 Years | Both | 24 | Phase 2 | United States |
| 184 | NCT00631358 (ClinicalTrials.gov) | February 2008 | 29/2/2008 | Assessment of Inflammatory Biomarkers Expressed in a Sjogren's Population: Effect of a Topical Steroid Intervention | Sjogren's Syndrome | Drug: Maxidex;Other: No treatment | Alcon Research | NULL | Completed | 17 Years | N/A | All | 97 | Phase 4 | Canada | |
| 185 | JPRN-UMIN000000997 | 2008/01/01 | 28/01/2008 | The 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 syndrome | It 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 Hospital | National Institute of Public Health | Complete: follow-up complete | 20years-old | 90years-old | Male and Female | 12 | Phase 1 | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 186 | EUCTR2007-001708-19-FR (EUCTR) | 23/08/2007 | 06/08/2007 | 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. | A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial. | treatment on bilateral moderate dry eye syndrome due to Sjögren's syndrome or diagnosed as a primary syndrome MedDRA version: 9.1;Level: LLT;Classification code 10013774;Term: Dry eye | Product Name: SVS20 Product Code: SVS20 INN or Proposed INN: sodium hyaluronate Trade Name: Lacryvisc INN or Proposed INN: carbomer 974P Product Name: SALINE INN or Proposed INN: sodium chloride | TRB CHEMEDICA INTERNATIONAL SA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 3 | United Kingdom;France | ||
| 187 | NCT00426543 (ClinicalTrials.gov) | January 2007 | 23/1/2007 | Effect of B-cell Depletion in Patients With Primary Sjögren's Syndrome | Phase 1 Study of B-cell Depletion With Rituximab on Oral, Ocular and General Disease Manifestations in Patients With Primary Sjögren's Syndrome | Primary Sjögren's Syndrome;Xerostomia;Hyposalivation;Keratoconjunctivitis Sicca;Fatigue | Drug: MabThera (rituximab);Drug: Rituximab, Mabthera | University of Copenhagen | Rigshospitalet, Denmark | Completed | 18 Years | 70 Years | Female | 21 | Phase 2 | Denmark |
| 188 | NCT00438048 (ClinicalTrials.gov) | November 2006 | 20/2/2007 | A Comparison of Orally Pilocarpine and Artificial Saliva in Xerostomy Treatment | Xerostomy Treatment in Patients With Sjogren's Syndrome in Chile :A Double Blind Control Trial Comparing Orally Pilocarpine Drops and Artificial Saliva | Primary Sjogren;Secondary Sjogren;Xerostomia | Procedure: pilocarpine;Drug: Artificial Saliva | Pontificia Universidad Catolica de Chile | Formulario MAgistral Farmacias Ahumada | Completed | 18 Years | N/A | Both | 76 | Phase 4 | Chile |
| 189 | NCT00363350 (ClinicalTrials.gov) | August 2006 | 10/8/2006 | Rituximab Treatment in Sjogren's Syndrome | Rituximab for the Treatment of Primary Sjögren's Syndrome: a Double Blinded Randomized Placebo-Controlled Trial | Sjogren's Syndrome | Drug: rituximab (anti-CD20) | University Medical Centre Groningen | Hoffmann-La Roche | Completed | 18 Years | 85 Years | Both | 30 | Phase 1;Phase 2 | Netherlands |
| 190 | NCT00344448 (ClinicalTrials.gov) | June 2006 | 23/6/2006 | Pilot Study of Raptiva to Treat Sjogren's Syndrome | A Randomized, Placebo Controlled, Proof of Concept, Study of Raptiva, a Humanized Anti-CD-11a Monoclonal Antibody, in Patients With Sjogren's Syndrome | Sjogren's Syndrome | Drug: Raptiva | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Terminated | 18 Years | N/A | All | 10 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 191 | NCT00542763 (ClinicalTrials.gov) | April 2005 | 10/10/2007 | Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome | Mycophenolate Sodium Treatment in Patients With Primary Sjogren's Syndrome - An Open Label Pilot Trial | Primary Sjogren's Syndrome | Drug: Mycophenolate sodium | University Hospital Muenster | Novartis | Completed | 18 Years | 75 Years | Both | 12 | Phase 1 | Germany |
| 192 | NCT04470479 (ClinicalTrials.gov) | March 1, 2005 | 7/7/2020 | Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome | Oral Pilocarpine in the Treatment of the Dry Eye of Patients With Sjogrens Syndrome | Dry Eye | Drug: Pilocarpine Hydrochloride;Drug: Placebo | Federal University of São Paulo | NULL | Completed | 18 Years | 65 Years | All | 32 | Phase 3 | Brazil |
| 193 | NCT00233363 (ClinicalTrials.gov) | March 2005 | 4/10/2005 | Exploratory Study for Dry Mouth in Patients With Sjögren’s Syndrome | An Exploratory Study of Rebamipide to Evaluate Efficacy and Safety in the Treatment of Dry Mouth in Patients With Sjögren’s Syndrome | Xerostomia;Sjogren's Syndrome | Drug: Rebamipide | Otsuka Pharmaceutical Co., Ltd. | NULL | Completed | 20 Years | N/A | Both | 100 | Phase 2 | Japan |
| 194 | NCT00873496 (ClinicalTrials.gov) | January 2005 | 31/3/2009 | Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients | Effects of Hydroxychloroquine on Oral Complaints of Sjögren Patients: a Prospective Sample Study. | Sjögren's Syndrome;Xerostomia | Drug: Hydroxychloroquine | Ege University | NULL | Completed | N/A | N/A | Female | 30 | N/A | Turkey |
| 195 | NCT00101829 (ClinicalTrials.gov) | April 2004 | 13/1/2005 | Anti-CD20 Antibody Therapy for Sjogren's Syndrome | An Open-Label, One Arm, Phase I Safety Study of Anti-CD20 Antibody (Rituximab, Rituxan) Therapy in the Treatment of Primary Sjogren's Syndrome | Sjogren's Syndrome | Drug: Rituximab | National Institute of Allergy and Infectious Diseases (NIAID) | Autoimmunity Centers of Excellence | Completed | 18 Years | 75 Years | All | 12 | Phase 1 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 196 | NCT00025818 (ClinicalTrials.gov) | May 2001 | 26/10/2001 | Six Month Clinical Research Study for Patients With Moderate or Severe Dry Eye Syndrome | Keratoconjunctivitis Sicca;Sjogren's Syndrome;Lupus Erythematosus, Systemic;Arthritis, Rheumatoid;Scleroderma, Systemic | Drug: Ophthalmic Emulsion | Allergan | NULL | Completed | 18 Years | N/A | Both | 290 | Phase 3 | United States | |
| 197 | NCT00391924 (ClinicalTrials.gov) | May 2000 | 24/10/2006 | Dehydroepiandrosterone Administration in Women With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome | Fatigue and General Well-Being in Patients With Systemic Lupus Erythematosus or Primary Sjögren's Syndrome: Effects of Dehydroepiandrosterone Administration | Lupus Erythematosus, Systemic;Sjogren's Syndrome | Drug: Dehydroepiandrosterone | UMC Utrecht | University Medical Centre Groningen;Dutch Arthritis Association | Completed | 18 Years | N/A | Female | 120 | Phase 2 | Netherlands |
| 198 | NCT00001954 (ClinicalTrials.gov) | December 1999 | 18/1/2000 | Etanercept Therapy for Sjogren's Syndrome | Etanercept Therapy for Sjogren's Syndrome | Sjogren's Syndrome | Drug: Etanercept | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Completed | N/A | N/A | Both | 28 | Phase 2 | United States |
| 199 | NCT00001731 (ClinicalTrials.gov) | November 1997 | 3/11/1999 | Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops | A Double-Masked, Randomized, Vehicle-Controlled Pilot Study of the Treatment of Keratoconjunctivitis Sicca With Topical Cyclosporin A 0.1% Emulsion | Keratoconjunctivitis Sicca;Sjogren's Syndrome | Drug: Cyclosporin A | National Eye Institute (NEI) | NULL | Completed | N/A | N/A | Both | 30 | Phase 2 | United States |
| 200 | NCT00001599 (ClinicalTrials.gov) | May 1997 | 3/11/1999 | Pilot Study of Thalidomide to Treat Sjogren's Syndrome | Pilot Study of Thalidomide for Sjogren's Syndrome | Sjogren's Syndrome;Xerostomia | Drug: Thalidomide | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Completed | N/A | N/A | Female | 28 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 201 | NCT00001598 (ClinicalTrials.gov) | May 1997 | 3/11/1999 | DHEA Treatment for Sjogren's Syndrome | Dehydroepiandrosterone (DHEA) Treatment for Sjogren's Syndrome | Lacrimal Apparatus Disease;Salivary Gland Disease;Sjogren's Syndrome;Xerostomia | Drug: Dehydroepiandrosterone | National Institute of Dental and Craniofacial Research (NIDCR) | NULL | Completed | N/A | N/A | Female | 28 | Phase 2 | United States |
| 202 | JPRN-JapicCTI-050036 | 06/09/2005 | Exploratory study of rebamipide to evaluate the efficacy and safety in treatment of dry mouth in patients with Sjogren's syndrome | Exploratory 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 syndrome | Intervention name : Rebamipide Dosage And administration of the intervention : Oral | Otsuka Pharmaceutical Co., Ltd. | NULL | 20 | BOTH | Phase 2 | NULL | ||||
| 203 | EUCTR2009-013976-38-DE (EUCTR) | 07/12/2009 | Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - Cypress | Phase II Trial of low-dose Sandimmun Optoral ® (Cyclosporine A) for the treatment of primary Sjögren's syndrome (pSS) - Cypress | Primary Sjögren's Syndrome MedDRA version: 12.1;Level: LLT;Classification code 10059142;Term: Sjoegren's syndrome | Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN Trade Name: Sandimmun Optoral Product Name: Sandimmun Optoral INN or Proposed INN: CICLOSPORIN | Charité Berlin, Department of rheumatology | Charité Berlin, department of rheumatology;Charité Berlin, department of rheumatology | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Germany |