53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details
臨床試験数 : 283 / 薬物数 : 320 - (DrugBank : 101) / 標的遺伝子数 : 56 - 標的パスウェイ数 : 181
| 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 | JPRN-jRCT2031210484 | 28/02/2022 | 14/12/2021 | A Study of Nipocalimab in Adults with Primary Sjogren'sSyndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome(pSS) | Sjogren's Syndrome | Placebo Placebo infusion will be administered intravenously. Nipocalimab Nipocalimab dose 1 and dose 2 infusions will be administered intravenously. Standard of Care Treatment Standard of care treatment including ophthalmic drops, artificial tears and saliva, punctum plugs, and secretagogues, and/or one immunomodulator with or without low-dose glucocorticosteroids will be administered topically/orally. | Numaguchi Hirotaka | NULL | Pending | >= 18age old | <= 65age old | Both | 150 | Phase 2 | Germany;Spain;Italy;Netherlands;Poland;Portugal;United States Of America;France;Taiwan;Japan |
| 2 | EUCTR2021-000665-32-NL (EUCTR) | 16/02/2022 | 21/10/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Germany;Netherlands;Italy;Japan | ||
| 3 | NCT05113004 (ClinicalTrials.gov) | January 5, 2022 | 2/11/2021 | New Clinical End-points in Patients With Primary Sjögren's Syndrome | NEw Clinical Endpoints in Patients With Primary Sjögren's Syndrome (pSS): an Interventional Trial Based on stratifYing Patients | Primary Sjögren's Syndrome (pSS) | Drug: Hydroxychloroquine 400mg/d;Drug: Leflunomide 20mg/d;Drug: Mycophenolate mofetil 2000mg/d;Drug: Placebo of Hydroxychloroquine 400mg/d;Drug: Placebo of Leflunomide 20mg/d;Drug: Placebo of Mycophenolate mofetil 2000mg/d | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 18 Years | N/A | All | 300 | Phase 2 | NULL |
| 4 | EUCTR2021-000665-32-DE (EUCTR) | 12/11/2021 | 27/07/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan | ||
| 5 | EUCTR2021-000665-32-IT (EUCTR) | 10/11/2021 | 08/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) - NA | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: nipocalimab Product Code: [M281] INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | JANSSEN CILAG INTERNATIONAL NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Spain;Poland;Netherlands;Germany;Japan;Italy | ||
| 6 | EUCTR2021-000665-32-PT (EUCTR) | 09/11/2021 | 16/09/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | France;United States;Portugal;Taiwan;Spain;Poland;Netherlands;Germany;Italy;Japan | ||
| 7 | NCT05085431 (ClinicalTrials.gov) | November 5, 2021 | 11/10/2021 | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome | A Study of CD19/BCMA Chimeric Antigen Receptor T Cells Therapy for Patients With Refractory Sjogren's Syndrome | Sjogren's Syndrome;Autoimmune Diseases | Biological: Assigned Interventions CD19/BCMA CAR T-cells | Zhejiang University | Yake Biotechnology Ltd. | Recruiting | N/A | N/A | All | 9 | Early Phase 1 | China |
| 8 | EUCTR2021-000665-32-ES (EUCTR) | 26/10/2021 | 27/08/2021 | A Study of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS) | Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults with Primary Sjogren's Syndrome (pSS). | Primary Sjogren's Syndrome MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Nipocalimab Product Code: M281 INN or Proposed INN: nipocalimab Other descriptive name: JNJ-80202135 | Janssen-Cilag International NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 2 | Portugal;France;United States;Taiwan;Poland;Spain;Netherlands;Germany;Italy;Japan | ||
| 9 | EUCTR2019-002470-32-IT (EUCTR) | 05/10/2021 | 27/01/2022 | Nuovi end-points clinici in pazienti con sindrome di Sjögren primaria (pSS): uno studio interventistico basato sulla stratificazione dei pazienti. | NEw Clinical End-points in patients with primary Sjögren's Syndrome (pSS): an Interventional Trial based on stratifYing patients - NECESSITY | Primary Sjögren's syndrome (pSS) MedDRA version: 21.0;Level: PT;Classification code 10040767;Term: Sjogren's syndrome;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12] | Trade Name: Arava Product Name: Leflunomide Product Code: [Leflunomide] INN or Proposed INN: LEFLUNOMIDE Trade Name: Mycophenolate mofetil TEVA Product Name: mycophenolate mofetil Product Code: [mycophenolate mofetil] INN or Proposed INN: MICOFENOLATO MOFETILE Trade Name: PLAQUENIL Product Name: Hydroxychloroquine Product Code: [Hydroxychloroquine] INN or Proposed INN: HYDROXYCHLOROQUINE SULFATE | ASSITANCE PUBLIQUE DES HOPITAUX DE PARIS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2 | France;Greece;Spain;Norway;Netherlands;United Kingdom;Italy;Sweden | ||
| 10 | NCT04968912 (ClinicalTrials.gov) | September 21, 2021 | 9/7/2021 | A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS) | A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS) | Sjogren's Syndrome | Other: Placebo;Drug: Nipocalimab;Drug: Standard of Care Treatment | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | 75 Years | All | 150 | Phase 2 | United States;France;Germany;Italy;Japan;Netherlands;Poland;Portugal;Spain;Taiwan |
| 11 | NCT04252209 (ClinicalTrials.gov) | August 2021 | 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 |
| 12 | EUCTR2020-003298-22-ES (EUCTR) | 06/07/2021 | 09/02/2021 | A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s Syndrome | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active 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: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Greece;Poland;Spain;Ukraine;Netherlands;Germany;United Kingdom | ||
| 13 | NCT04835623 (ClinicalTrials.gov) | June 21, 2021 | 5/4/2021 | CEQUA for Sjogren's Syndrome Dry Eye | Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome | Dry Eye;Dry Eye Syndromes;Sjogren's Syndrome | Drug: Cyclosporine 0.09% Ophthalmic Solution | Center for Ophthalmic and Vision Research, LLC | Sun Pharma Global FZE | Recruiting | 18 Years | 70 Years | All | 50 | Phase 4 | United States |
| 14 | EUCTR2019-002205-22-NL (EUCTR) | 15/06/2021 | 11/02/2020 | 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;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 | France;United States;Mexico;Argentina;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom | ||
| 15 | NCT04496960 (ClinicalTrials.gov) | May 18, 2021 | 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 Sj(SqrRoot)(Delta)Gren s Syndrome; a 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 | Recruiting | 18 Years | 75 Years | All | 30 | Phase 1/Phase 2 | United States |
| 16 | EUCTR2021-001414-10-NL (EUCTR) | 30/03/2021 | 24/03/2021 | Response to corona vaccination in patients with primary Sjögren's syndrome | Vaccine response against SARS-CoV-2 in patients with primary Sjögren’s syndrome - VaccineSS | Primary Sjögren's syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Comirnaty concentrate for dispersion for injection Trade Name: COVID-19 Vaccine AstraZeneca suspension for injection COVID-19 Vaccine (ChAdOx1-S [recombinant]) Trade Name: COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant]) | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 4 | Netherlands | ||
| 17 | EUCTR2020-003298-22-DE (EUCTR) | 26/02/2021 | 26/11/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s Syndrome | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active 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: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Greece;Spain;Poland;Ukraine;Germany;United Kingdom | ||
| 18 | NCT04839315 (ClinicalTrials.gov) | February 15, 2021 | 5/4/2021 | COVID-19 Vaccination in Rheumatic Disease Patients | Immunological Consequences of COVID-19 Vaccination in Patients With Rheumatic Diseases | Systemic Lupus Erythematosus;Sjogren's Syndrome;Inflammatory Myositis;Psoriatic Arthritis;Gout;Ankylosing Spondylitis;Arthritis of Multiple Sites Associated With Inflammatory Bowel Disease (Diagnosis);Osteoarthritis | Biological: mRNA COVD19 vaccine | Mayo Clinic | NULL | Recruiting | 18 Years | N/A | All | 100 | Early Phase 1 | United States |
| 19 | EUCTR2020-003298-22-HU (EUCTR) | 10/02/2021 | 30/11/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s Syndrome | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active 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: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Poland;Ukraine;Netherlands;Germany;United Kingdom;France;Hungary;Greece;Spain | ||
| 20 | EUCTR2020-003298-22-GR (EUCTR) | 02/02/2021 | 13/12/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s Syndrome | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active 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: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Greece;Spain;Poland;Ukraine;Netherlands;Germany;United Kingdom | ||
| 21 | NCT04700280 (ClinicalTrials.gov) | January 28, 2021 | 6/1/2021 | A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 12 Weeks in Adults With Active Primary Sjögren's Syndrome | A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orally Administered GLPG3970 for 12 Weeks in Adult Subjects With Active Primary Sjögren's Syndrome | Primary Sjögren Syndrome | Drug: GLPG3970;Drug: Placebo | Galapagos NV | NULL | Active, not recruiting | 18 Years | 74 Years | All | 31 | Phase 2 | France;Germany;Greece;Hungary;Poland;Spain;Ukraine |
| 22 | EUCTR2020-003298-22-FR (EUCTR) | 15/01/2021 | 19/11/2020 | A study evaluating the effects of GLPG3970 given as an oral treatment for 12 weeks in adults with active primary Sjögren’s Syndrome | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of orally administered GLPG3970 for 12 weeks in adult subjects with active 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: GLPG3970 Product Code: G1567970 INN or Proposed INN: Not applicable Other descriptive name: GLPG3970 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | France;Hungary;Greece;Spain;Poland;Ukraine;Netherlands;Germany;United Kingdom | ||
| 23 | NCT04615455 (ClinicalTrials.gov) | November 3, 2020 | 3/11/2020 | Mesenchymal Stem Cell Therapy of Dry Eye Disease in Patients With Sjögren's Syndrome | A Randomized Clinical Trial Evaluating Allogeneic Adipose-derived MesenchymAl Stem Cells as a Treatment of Dry Eye Disease in Patients With Sjögren's Syndrome | Keratoconjunctivitis Sicca, in Sjogren's Syndrome | Drug: ASCs;Drug: Cryostor CS10 | Rigshospitalet, Denmark | NULL | Active, not recruiting | 18 Years | N/A | All | 40 | Phase 2 | Denmark |
| 24 | 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 | Netherlands;Germany;United Kingdom;Belgium;Poland;Spain;Argentina;Mexico;France;United States | ||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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;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 | France;United States;Mexico;Argentina;Spain;Belgium;Poland;Netherlands;Germany;United Kingdom | ||
| 30 | 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 | Portugal;United States;Slovenia;Greece;Turkey;Austria;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Germany;Netherlands;Japan;Sweden;Korea, Republic of | ||
| 31 | 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 | 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;Korea, Republic of;Sweden | ||
| 32 | 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 | ||
| 33 | 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 | 75 Years | All | 185 | Phase 2 | United States;Argentina;Belgium;France;Germany;Mexico;Netherlands;Poland;Spain;United Kingdom;Australia |
| 34 | 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;Chile;Israel;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of | ||
| 35 | 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;Argentina;Australia;Austria;Brazil;Canada;Chile;Colombia;France;Germany;Greece;Hungary;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Romania;Russian Federation;Slovenia;Sweden;Turkey;United Kingdom |
| 36 | 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 | ||
| 37 | 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 | ||
| 38 | 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 | Not Recruiting | Female: yes Male: yes | 260 | Phase 2 | Hungary;Canada;Argentina;Brazil;Romania;Australia;Netherlands;Germany;Japan;Sweden;Korea, Republic of;United States;Portugal;Slovenia;Greece;Turkey;Austria;Russian Federation;Chile;Israel;Colombia;United Kingdom;Italy;France | ||
| 39 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | 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 | ||
| 40 | EUCTR2018-004476-35-FR (EUCTR) | 13/08/2019 | 20/06/2019 | 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: 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: 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 | ||
| 41 | 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 | ||
| 42 | 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 | ||
| 43 | NCT03700138 (ClinicalTrials.gov) | June 19, 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 |
| 44 | 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] | Trade Name: Privigen 100 mg/ml, solution pour perfusion | Hôpitaux Universitaires de Strasbourg | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France | ||
| 45 | 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 |
| 46 | 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 | ||
| 47 | NCT03434106 (ClinicalTrials.gov) | February 10, 2018 | 9/2/2018 | Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction | Sjögren's Syndrome Is Associated With Meibomian Gland Dysfunction | Meibomian Gland Dysfunction;Sjögren's Syndrome | Drug: liposic;Drug: Tears Naturale Forte | LanZhou University | NULL | Unknown status | 45 Years | 60 Years | Female | 60 | N/A | China |
| 48 | 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 |
| 49 | EUCTR2016-003292-22-IT (EUCTR) | 20/11/2017 | 25/05/2021 | 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. - Study of safety and efficacy of VAY736 in patients with primary Sjogren’s Syndrome (pSS) | 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 | NOVARTIS PHARMA AG | NULL | Not Recruiting | 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;Germany;Netherlands;Japan | ||
| 50 | EUCTR2016-003292-22-PL (EUCTR) | 28/09/2017 | 23/08/2017 | Study of safety and efficacy of ianalumab in patients with primarySjogren'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] | 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;Poland;Belgium;Romania;Germany;Netherlands;Japan | ||
| 51 | EUCTR2016-001948-19-IT (EUCTR) | 05/09/2017 | 25/05/2021 | A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sj¿grens Syndrome | A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sj¿grens Syndrome - - | Adults with moderately to severely Active Primary Sjogrens Syndrome MedDRA version: 20.1;Level: PT;Classification code 10048676;Term: Sjogren-Larsson syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 21.0;Level: LLT;Classification code 10040766;Term: Sjogren's disease;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 21.0;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: Orencia INN or Proposed INN: 00305800 | BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 288 | Phase 3 | Czechia;Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Germany;Norway;Japan;Korea, Republic of;Sweden | ||
| 52 | 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 | Not Recruiting | 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 | ||
| 53 | 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 | 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 | ||
| 54 | 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 | ||
| 55 | 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 |
| 56 | 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 | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;Norway;Japan;Sweden;United States;Portugal;Taiwan | ||
| 57 | EUCTR2016-003292-22-AT (EUCTR) | 19/06/2017 | 17/05/2017 | 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 | 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 | ||
| 58 | 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] | Product Code: VAY736 INN or Proposed INN: Not established 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 | ||
| 59 | 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] | 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 | Portugal;United States;Taiwan;Spain;Austria;Russian Federation;Chile;Israel;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 60 | 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 dosesadministered 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 | Portugal;United States;Taiwan;Spain;Austria;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Hungary;Argentina;Poland;Belgium;Romania;Netherlands;Germany;Japan | ||
| 61 | 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 | ||
| 62 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Poland;Spain;Italy;United Kingdom | ||
| 63 | NCT03060005 (ClinicalTrials.gov) | May 1, 2017 | 23/1/2017 | Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ? | Is Sjögren's Syndrome Associated With Meibomian Gland Dysfunction ? | Sjögren's Syndrome;Meibomian Gland Dysfunction | Drug: Tears Naturale Forte;Drug: liposic | Tung Wah Hospital | NULL | Recruiting | 50 Years | 60 Years | Female | 80 | N/A | China |
| 64 | 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 |
| 65 | 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 | 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 | ||
| 66 | 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 |
| 67 | 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 | ||
| 68 | 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] | Trade Name: Orencia INN or Proposed INN: ABATACEPT | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 288 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Italy;France;Czech Republic;Mexico;Canada;Argentina;Brazil;Australia;Denmark;Norway;Germany;Japan;Sweden;Korea, Republic of | ||
| 69 | 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 |
| 70 | 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 | ||
| 71 | 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 | ||
| 72 | 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 | ||
| 73 | 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 | ||
| 74 | 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 | ||
| 75 | 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 |
| 76 | 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 | ||
| 77 | 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] | 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 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;France;United States;Poland;Germany;United Kingdom | ||
| 78 | 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 | ||
| 79 | 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 |
| 80 | 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 | ||
| 81 | NCT03411850 (ClinicalTrials.gov) | May 2016 | 30/6/2016 | Sjogrens Syndrome Measured by Ultrasound | Disease Modification in Sjogrens Syndrome Measured by Ultrasound: A Pilot Study | Sjogren's Syndrome | Biological: Orencia;Other: Placebo | Arthritis & Rheumatism Associates, P.C. | Bristol-Myers Squibb | Active, not recruiting | 18 Years | 65 Years | All | 20 | Phase 2 | United States |
| 82 | 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 | ||
| 83 | 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 |
| 84 | NCT02495129 (ClinicalTrials.gov) | December 2015 | 8/7/2015 | Study of Pharmacodynamic Effects of VAY736 in Patients With Primary Sjögren's Syndrome | A Three-part, Partially Open Label and Double-blind, Randomized Study to Assess the Pharmacodynamic Effects, Safety, Tolerability and Preliminary Efficacy of VAY736 in Patients With Primary Sjögren's Syndrome Using [Zr-89]-Rituximab PET/CT | Primary Sjögren's Syndrome | Drug: VAY736 lower dose;Drug: VAY736 higher dose | Novartis Pharmaceuticals | NULL | Withdrawn | N/A | N/A | All | 0 | Phase 1/Phase 2 | Netherlands |
| 85 | 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 | |
| 86 | 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 |
| 87 | 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 |
| 88 | 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 |
| 89 | 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] | Product Code: CFZ533 INN or Proposed INN: Not yet established | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Germany;Switzerland;United Kingdom | ||
| 90 | 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 | ||
| 91 | 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 | |||
| 92 | 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 |
| 93 | 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 | ||
| 94 | NCT02027298 (ClinicalTrials.gov) | November 2013 | 18/11/2013 | Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study | Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study | Primary Sjogren's Syndrome;Secondary Sjogren's Syndrome;Inflammatory Arthritis;Rheumatoid Arthritis | Drug: Abatacept | The Cleveland Clinic | Bristol-Myers Squibb | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| 95 | 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 |
| 96 | 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 | |
| 97 | 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 |
| 98 | 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 | ||
| 99 | 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 |
| 100 | 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 |
| 101 | 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 | ||
| 102 | 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 |
| 103 | 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 |
| 104 | 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 | Product Name: SVS20 Product Code: SVS20 Trade Name: carbomer Trade Name: 0.9% sodium chloride | TRB CHEMEDICA INTERNATIONAL SA | NULL | Not Recruiting | Female: yes Male: yes | 300 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United Kingdom | ||
| 105 | 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 |
| 106 | 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 | |
| 107 | EUCTR2007-005218-38-FR (EUCTR) | 31/01/2008 | 20/11/2007 | Essai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUER | Essai prospectif Randomisé contre placebo en double aveugle de l’hydroxychloroQUine dans le traitement du syndrome de sJOgren primitif (JOQUER) - JOQUER | Syndrome de Sjögren primitif MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's | Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Sulfate d'hydroxychloroquine | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 108 | 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 | ||
| 109 | 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 |