49. 全身性エリテマトーデス
[臨床試験数:827,薬物数:638(DrugBank:168),標的遺伝子数:108,標的パスウェイ数:191

Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
9 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-005667-25-RO
(EUCTR)
21/06/201321/07/2014Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 17.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5000Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
2EUCTR2011-005672-42-GB
(EUCTR)
11/06/201327/03/2013Efficacy and Safety of Belimumab in Black Race Patients With Systemic Lupus Erythematosus (SLE) (EMBRACE)A Phase 3/4, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) in Adult Subjects of Black Race With Systemic Lupus Erythematosus (SLE) - EMBRACE Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.1;Level: LLT;Classification code 10025134;Term: Lupus erythematosus;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
501Phase 3;Phase 4United States;France;Martinique;Brazil;South Africa;Colombia;United Kingdom
3EUCTR2011-005667-25-BG
(EUCTR)
24/04/201331/01/2013Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
4000Phase 4United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
4EUCTR2011-005667-25-PT
(EUCTR)
05/04/201317/01/2013Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 21.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
4000Phase 4Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand;United States;Serbia;Portugal;Philippines;Taiwan;Hong Kong;Estonia;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Turkey;Lithuania;Czech Republic;Hungary;Mexico;Canada
5EUCTR2011-005667-25-IT
(EUCTR)
21/03/201314/01/2013Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Study to Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 15.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 15.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
INN or Proposed INN: BELIMUMAB
HUMAN GENOME SCIENCES INCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5000Portugal;United States;Philippines;Estonia;Taiwan;Hong Kong;Spain;Thailand;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Australia;Peru;China;Korea, Republic of;Korea, Democratic People's Republic of;Lithuania;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Brazil;Croatia;Bulgaria;New Zealand
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-005667-25-ES
(EUCTR)
14/02/201321/12/2012Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5000Serbia;Portugal;United States;Philippines;Hong Kong;Estonia;Taiwan;Slovakia;Spain;Thailand;Ukraine;Indonesia;Israel;Russian Federation;Chile;Colombia;Italy;Switzerland;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Croatia;Romania;Bulgaria;Norway;New Zealand
7EUCTR2011-005667-25-CZ
(EUCTR)
30/01/201304/12/2012Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 19.0;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5000Phase 4Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
8EUCTR2011-005667-25-HU
(EUCTR)
22/01/201322/11/2012Belimumab Assessment of Safety in SLE (BASE)A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab Lupus Erythematosus
MedDRA version: 17.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusion
Product Name: Belimumab
Product Code: L04AA26
INN or Proposed INN: BELIMUMAB
Other descriptive name: Benlysta
Human Genome Sciences Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5000Serbia;Portugal;United States;Philippines;Taiwan;Estonia;Hong Kong;Slovakia;Thailand;Spain;Ukraine;Indonesia;Russian Federation;Chile;Israel;Colombia;Switzerland;Italy;India;Malaysia;Peru;Australia;China;Korea, Republic of;Lithuania;Turkey;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Norway;New Zealand
9EUCTR2007-007648-85-NL
(EUCTR)
07/04/200919/12/2008A Continuation Trial for Subjects With Lupus That Completed Protocol HGS1006-C1056 or HGS1006-C1057A Multi-Center, Continuation Trial of Belimumab (HGS1006, LymphoStat-B™), a Fully Human Monoclonal Anti-BLyS Antibody, in Subjects with Systemic Lupus Erythematosus (SLE) who Completed the Phase 3 Protocol HGS1006-C1056 or HGS1006-C1057 - NA Systemic lupus erythematosus (SLE)
MedDRA version: 14.1;Level: PT;Classification code 10042945;Term: Systemic lupus erythematosus;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Trade Name: Benlysta 400 mg powder for concentrate for solution for infusions
Product Name: Belimumab
Product Code: HGS1006
INN or Proposed INN: Belimumab
Other descriptive name: LymphoStat-B; Benlysta
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)NULLNot RecruitingFemale: yes
Male: yes
1620Phase 3United States;Philippines;Taiwan;Hong Kong;Slovakia;Spain;Austria;Chile;Israel;Colombia;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Peru;Germany;Netherlands;Sweden;Korea, Republic of