53. シェーグレン症候群 Sjogren syndrome Clinical trials / Disease details


臨床試験数 : 305 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188

  
12 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-000400-26-GB
(EUCTR)
17/03/201714/12/2016A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 19.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;Italy;United Kingdom;Sweden
2NCT02631538
(ClinicalTrials.gov)
February 17, 201614/12/2015Safety and Efficacy Study of Subcutaneous Belimumab and Intravenous Rituximab Co-administration in Subjects With Primary Sjogren's SyndromeA Randomized, Double Blind (Sponsor Open), Comparative, Multicenter Study to Evaluate the Safety and Efficacy of Subcutaneous Belimumab (GSK1550188) and Intravenous Rituximab Co-administration in Subjects With Primary Sjögren's SyndromeSjogren's SyndromeDrug: Belimumab;Drug: Rituximab;Drug: Placebo belimumab;Drug: Placebo rituximabGlaxoSmithKlineNULLCompleted18 YearsN/AAll86Phase 2Argentina;Canada;France;Germany;Italy;Netherlands;Norway;Spain;Sweden;United Kingdom
3EUCTR2015-000400-26-IT
(EUCTR)
18/01/201610/11/2020A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. - NA Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MABTHERA - 1 FIALA 500 MG 50 ML
Product Name: MABTHERA
Product Code: [NA]
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: BENLYSTA - 120 MG - POLVERE PER CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 120 MG 1 FLACONCINO
Product Name: BENLYSTA
Product Code: [na]
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
Trade Name: SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML
Product Name: SOLU-MEDROL
Product Code: [na]
INN or Proposed INN: METILPREDNISOLONE
Trade Name: TACHIPIRINA - 500 MG COMPRESSE20 COMPRESSE
Product Name: Tachipirina
Product Code: [na]
INN or Proposed INN: PARACETAMOLO
Trade Name: XYZAL - 20 COMPRESSE RI
GLAXOSMITHKLINE RESEARCH AND DEVELOPMENTNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
4EUCTR2015-000400-26-NO
(EUCTR)
08/01/201623/09/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden
5EUCTR2015-000400-26-NL
(EUCTR)
28/12/201508/12/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 18.1;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Germany;Netherlands;United Kingdom;Italy;Sweden
6EUCTR2015-000400-26-SE
(EUCTR)
15/12/201508/09/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
7EUCTR2015-000400-26-DE
(EUCTR)
03/12/201501/10/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
8EUCTR2015-000400-26-FR
(EUCTR)
01/12/201524/02/2017A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren’s syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren’s syndrome. Primary Sjogrens disease
MedDRA version: 20.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline R&D LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Netherlands;Germany;United Kingdom;Italy;Sweden;Norway
9EUCTR2015-000400-26-ES
(EUCTR)
19/11/201505/10/2015A Phase 2, randomized, double blind, placebo controlled study to evaluate the safety and efficacy of belimumab and rituximab co-administration in subjects with primary Sjögren's syndromeA randomized, double blind (sponsor open), comparative, multicenter study to evaluate the safety and efficacy of subcutaneous belimumab (GSK1550188) and intravenous rituximab coadministration in subjects with primary Sjögren's syndrome. Primary Sjogrens disease
MedDRA version: 18.0;Level: PT;Classification code 10061664;Term: Autoimmune disorder;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: MabThera (Rituximab)
Product Name: MabThera (Rituximab)
INN or Proposed INN: RITUXIMAB
Other descriptive name: MABTHERA
Trade Name: Benlysta (Belimumab)
Product Name: Benlysta (Belimumab)
INN or Proposed INN: BELIMUMAB
Other descriptive name: HGS1006, LymphoStat-B, monoclonal anti-BLyS, LSB, BENLYSTA
GlaxoSmithKline, S.A.NULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;Canada;Argentina;Spain;Norway;Netherlands;Germany;United Kingdom;Italy;Sweden
10NCT01160666
(ClinicalTrials.gov)
March 20109/7/2010Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's SyndromeA Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS (BAFF) Antibody, in Subjects With Primary Sjögren's SyndromeSjögren's SyndromeDrug: BelimumabAssistance Publique - Hôpitaux de ParisHuman Genome Sciences Inc.Completed18 YearsN/ABoth20Phase 2France
11EUCTR2009-015978-35-FR
(EUCTR)
30/11/200901/10/2009Etude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISSEtude ouverte de phase 2 de 52 semaines visant à établir l'efficacité et la tolérance du Belimumab (HGS1006, LymphoStat-B), un anticorps monoclonal humanisé anti-BLys (BAFF), chez des patients atteints de syndrome de Sjögren primitif - BELISS Syndrome Sjogren's
MedDRA version: 8.1;Level: PT;Classification code 10042846;Term: Syndrome Sjogren's
Product Name: HGS1006, LymphoStat-B
INN or Proposed INN: belimumab
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2France
12NCT01008982
(ClinicalTrials.gov)
August 20095/11/2009Efficacy and Safety of Belimumab in Primary Sjögren's SyndromeA Phase 2, Proof of Concept, 52-Week Open Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects With Primary Sjögren's Syndrome.Sjögren's SyndromeDrug: LimphoStat-BUniversity of UdineAzienda Ospedaliera S. Maria della MisericordiaCompleted18 Years90 YearsBoth15Phase 2Italy