53. Sjogren syndrome Clinical trials / Disease details
Clinical trials : 305 / Drugs : 325 - (DrugBank : 104) / Drug target genes : 58 - Drug target pathways : 188
| 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 | EUCTR2015-000400-26-GB (EUCTR) | 17/03/2017 | 14/12/2016 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 19.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 2 | EUCTR2015-000400-26-IT (EUCTR) | 18/01/2016 | 10/11/2020 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. - NA | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML Product Name: MABTHERA Product Code: [NA] INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO Product Name: BENLYSTA Product Code: [na] INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML Product Name: SOLU-MEDROL Product Code: [na] INN or Proposed INN: METILPREDNISOLONE Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE Product Name: Tachipirina Product Code: [na] INN or Proposed INN: PARACETAMOLO Trade Name: XYZAL - 20 COMPRESSE RI | GLAXOSMITHKLINE RESEARCH AND DEVELOPMENT | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 3 | EUCTR2015-000400-26-NO (EUCTR) | 08/01/2016 | 23/09/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden | ||
| 4 | EUCTR2015-000400-26-NL (EUCTR) | 28/12/2015 | 08/12/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 18.1;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 5 | EUCTR2015-000400-26-SE (EUCTR) | 15/12/2015 | 08/09/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 6 | EUCTR2015-000400-26-DE (EUCTR) | 03/12/2015 | 01/10/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 7 | EUCTR2015-000400-26-FR (EUCTR) | 01/12/2015 | 24/02/2017 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. | Primary Sjogrens disease MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline R&D Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;Norway | ||
| 8 | EUCTR2015-000400-26-ES (EUCTR) | 19/11/2015 | 05/10/2015 | A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndrome | A randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. | Primary Sjogrens disease MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: MabThera (Rituximab) Product Name: MabThera (Rituximab) INN or Proposed INN: RITUXIMAB Other descriptive name: MABTHERA Trade Name: Benlysta (Belimumab) Product Name: Benlysta (Belimumab) INN or Proposed INN: BELIMUMAB Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden |