OLUMIANT ( DrugBank: - )


4 diseases
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ32
49全身性エリテマトーデス22
93原発性胆汁性胆管炎2
107若年性特発性関節炎33

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005773-27-FR
(EUCTR)
09/03/202119/01/2021BARIcitinib Cognitive Emotional and Neural signaTuREBARICENTRE BARIcitinib Cognitive Emotional and Neural signaTuREBARICENTRE - BARICENTRE Patients with rheumatoid arthritis and indication of baricitinib treatment according to a rheumatologist
MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]
Trade Name: OLUMIANT 4 mg
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: OLUMIANT 4mg
Product Name: Baricitinib
INN or Proposed INN: BARICITINIB
ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
80Phase 4France
2EUCTR2018-004558-30-DK
(EUCTR)
18/12/202005/10/2020A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Ledertrexato
Product Name: Metotrexato
Product Code: Metotrexato
INN or Proposed INN: metotrexato
Other descriptive name: METHOTREXATE SODIUM
Trade Name: Metex Pen
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez DíazNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
186Phase 4Portugal;Spain;Denmark
3EUCTR2018-003351-37-FR
(EUCTR)
19/02/202028/05/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
2600Phase 3;Phase 4Russian Federation;Romania;Hungary;United States;United Kingdom;Switzerland;Spain;Greece;Austria;Czech Republic;Netherlands;Turkey;Belgium;Denmark;Poland;Italy;South Africa;Israel;Slovakia;France;Australia;Lithuania;Germany
4EUCTR2018-004558-30-PT
(EUCTR)
03/02/202021/05/2019A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response.A 3-arm, randomized, open-label, parallel active controlled, multicenter international study to compare the response of ultrasound-assessed synovitis to baricitinib, alone and combined with methotrexate versus etanercept in rheumatoid arthritis patients with inadequate response to methotrexate. Searching for synovium predictors of response. rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Ledertrexato
Product Name: Metotrexato
Product Code: Metotrexato
INN or Proposed INN: metotrexato
Other descriptive name: METHOTREXATE SODIUM
Trade Name: Metex Pen
Product Name: Methotrexate
INN or Proposed INN: Methotrexate
Other descriptive name: METHOTREXATE
Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez DíazNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
186Phase 4Portugal;Spain
5EUCTR2018-003351-37-LT
(EUCTR)
13/12/201929/08/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
6EUCTR2018-003351-37-HU
(EUCTR)
07/10/201924/07/2019A Phase 3b/4 Study in Rheumatoid Arthritis A Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
7EUCTR2018-003351-37-GR
(EUCTR)
13/09/201929/07/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Czechia;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands
8EUCTR2018-003351-37-ES
(EUCTR)
05/09/201916/09/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Lilly S.ANULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
2600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): yesUnited States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
9EUCTR2018-003351-37-PL
(EUCTR)
04/09/201909/08/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
10EUCTR2018-003351-37-NL
(EUCTR)
29/08/201908/07/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Germany;Netherlands
11EUCTR2018-003351-37-DK
(EUCTR)
29/08/201907/08/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4Russian Federation;Romania;Hungary;United States;United Kingdom;Switzerland;Spain;Greece;Austria;Czech Republic;Netherlands;Turkey;Belgium;Denmark;Poland;Italy;South Africa;Israel;Slovakia;Australia;France;Lithuania;Germany
12EUCTR2018-003351-37-IT
(EUCTR)
20/08/201915/06/2021Uno studio di fase 3b/4 sull'Artrite ReumatoideA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
Product Name: Enbrel
Product Code: [Enbrel]
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
Product Name: Humira
Product Code: [Humira]
INN or Proposed INN: ADALIMUMAB
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 4United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
13EUCTR2018-003351-37-AT
(EUCTR)
13/08/201931/07/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Czechia;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Hungary;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
14EUCTR2018-003351-37-GB
(EUCTR)
08/08/201916/05/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Slovakia;Greece;Spain;Lithuania;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
15EUCTR2018-003351-37-DE
(EUCTR)
02/08/201924/07/2019A Phase 3b/4 Study in Rheumatoid ArthritisA Randomized, Active Controlled, Parallel Group, Phase 3b/4 Study of Baricitinib in Patients with Rheumatoid Arthritis. - RA-BRIDGE Rheumatoid Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
INN or Proposed INN: ETANERCEPT
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2600Phase 3;Phase 4United States;Czechia;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Italy;Switzerland;France;Hungary;Belgium;Poland;Romania;Denmark;Australia;South Africa;Germany;Netherlands
16EUCTR2018-004558-30-ES
(EUCTR)
16/05/201911/04/2019Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response.Synovial ultrasound as primary outcome in a 3-arm, randomized, open-label, parallel active controlled, multicenter international study comparing baricitinib, alone and combined with MTX versus TNF-alfa inhibitor in rheumatoid arthritis patients: Searching for synovium predictors of response. rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
INN or Proposed INN: BARICITINIB
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: ETANERCEPT
Fundación Instituto de Investigación Sanitaria de la Fundación Jiménez DíazNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
186 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain
17EUCTR2019-000505-72-NL
(EUCTR)
13/05/201918/02/2019Baricitinib in patients suffering from Rheumatoid ArthritisPragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT) Pragmatic trial baricitinib versus First biological in Tight Control” Patients suffering from Rheumatoid Arthritis (PERFECT);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Trade Name: Olumiant
Product Name: baricitinib
Transparency in HealthcareNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesNetherlands
18NCT03755466
(ClinicalTrials.gov)
November 21, 201821/11/2018Examination of Efficacy and Safety of Baricitinib in RA PatientsEfficacy and Safety of Baricitinib in Rheumatoid Arthritis Patients Compared With Those Treated by Biologics or TofacitinibRheumatoid ArthritisDrug: Baricitinib, olumiant®;Drug: Biologics;Drug: Tofacitinib 5 MG [Xeljanz]Shinshu UniversityNULLRecruiting20 YearsN/AAll90Phase 2Japan
19EUCTR2012-003686-17-SI
(EUCTR)
17/06/201403/04/2014A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
20EUCTR2012-003686-17-GR
(EUCTR)
18/03/201416/01/2014A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
21EUCTR2012-003686-17-LT
(EUCTR)
31/12/201321/11/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
22EUCTR2012-003686-17-HR
(EUCTR)
05/12/201301/09/2014A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
23EUCTR2012-003686-17-SE
(EUCTR)
02/12/201305/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
24EUCTR2012-003686-17-GB
(EUCTR)
24/10/201306/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
25EUCTR2012-003686-17-LV
(EUCTR)
24/07/201305/07/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
26EUCTR2012-003686-17-PL
(EUCTR)
24/07/201304/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Romania;Croatia;Germany;Japan;Sweden
27EUCTR2012-003686-17-BE
(EUCTR)
18/07/201331/05/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden;United States;Portugal;Taiwan;Slovakia
28EUCTR2012-003686-17-DK
(EUCTR)
04/07/201307/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
29EUCTR2012-003686-17-DE
(EUCTR)
04/07/201313/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden
30EUCTR2012-003686-17-CZ
(EUCTR)
17/06/201331/05/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
31EUCTR2012-003686-17-PT
(EUCTR)
12/06/201314/06/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3350Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Germany;Japan;Sweden
32EUCTR2012-003686-17-SK
(EUCTR)
05/06/201302/05/2013A Phase 3 Study in Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis - RA-BEYOND Rheumatoid arthritis
MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3000Phase 3Croatia;Germany;Japan;Sweden;Canada;Argentina;Brazil;Belgium;Poland;Romania;United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;Italy;India;France;Denmark;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico

49. 全身性エリテマトーデス


臨床試験数 : 993 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-005028-11-NL
(EUCTR)
23/09/202002/07/2020A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
2EUCTR2017-005028-11-HR
(EUCTR)
05/06/202023/11/2020A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
3EUCTR2017-005028-11-GR
(EUCTR)
20/05/202026/11/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Israel;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
4EUCTR2017-005028-11-IT
(EUCTR)
19/12/201922/01/2021A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) - NA Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: [LY3009104]
INN or Proposed INN: Baricitinib
Other descriptive name: Baricitinib
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: [LY3009104]
INN or Proposed INN: Baricitinib
Other descriptive name: Baricitinib
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;United States;Philippines;Taiwan;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;Netherlands;China;Korea, Republic of;Czechia;Korea, Democratic People's Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
5EUCTR2017-005028-11-GB
(EUCTR)
24/10/201918/03/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Spain;Chile;Russian Federation;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan
6EUCTR2017-005026-37-HR
(EUCTR)
24/10/201920/01/2020A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
7EUCTR2017-005026-37-NL
(EUCTR)
06/08/201913/05/2019A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Czechia;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Germany;Netherlands;China
8EUCTR2017-005026-37-GR
(EUCTR)
26/07/201903/05/2019A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Germany;Netherlands;China
9EUCTR2017-005028-11-RO
(EUCTR)
22/07/201915/03/2022A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
10EUCTR2017-005028-11-PL
(EUCTR)
05/07/201923/04/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-TermSafety and Efficacy of Baricitinib in Patients with Systemic LupusErythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
11EUCTR2017-005028-11-AT
(EUCTR)
02/06/201928/03/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;United States;Philippines;Taiwan;Greece;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
12EUCTR2017-005028-11-ES
(EUCTR)
30/05/201931/05/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
13EUCTR2017-005028-11-HU
(EUCTR)
20/05/201902/04/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
14EUCTR2017-005028-11-DE
(EUCTR)
10/05/201928/03/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3China;United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;Korea, Republic of;Czechia;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
15EUCTR2017-005028-11-CZ
(EUCTR)
08/04/201928/03/2019A study of Baricitinib in patients with LupusA Phase 3, Double-Blind, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;Netherlands;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan
16EUCTR2017-005026-37-GB
(EUCTR)
27/03/201919/09/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
17EUCTR2017-005027-25-IT
(EUCTR)
20/12/201822/01/2021A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus - - Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant - EU/1/16/1170/009-016
Product Name: Baricitinib
Product Code: [LY3009104]
INN or Proposed INN: Baricitinib
Trade Name: Olumiant - EU/1/16/1170/001-008
Product Name: Baricitinib
Product Code: [LY3009104]
INN or Proposed INN: Baricinitib
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
825Phase 3Serbia;United States;Philippines;Spain;Chile;Colombia;Italy;India;France;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of
18EUCTR2017-005026-37-AT
(EUCTR)
18/12/201825/09/2018A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Brazil;Belgium;Croatia;Australia;Netherlands;Germany;China
19EUCTR2017-005026-37-BE
(EUCTR)
17/12/201825/09/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
750Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
20EUCTR2017-005026-37-HU
(EUCTR)
19/11/201825/09/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
21EUCTR2017-005026-37-CZ
(EUCTR)
12/11/201826/10/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 21.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
22EUCTR2017-005027-25-ES
(EUCTR)
21/09/201824/09/2018A study of Baricitinib in patients with LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3Study of Baricitinib in Patients with Systemic Lupus Erythematosus Systemic Lupus Erythematosus (SLE)
MedDRA version: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
750Phase 3Serbia;United States;Philippines;Spain;Chile;Colombia;Argentina;Poland;Romania;South Africa;Japan;Korea, Republic of;Italy;India;France

93. 原発性胆汁性胆管炎


臨床試験数 : 298 薬物数 : 252 - (DrugBank : 59) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 115
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003365-34-GB
(EUCTR)
02/05/201911/02/2019A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCAA Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA Primary Biliary Cholangitis
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
52 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Italy;United Kingdom
2EUCTR2018-003365-34-IT
(EUCTR)
18/04/201903/08/2021A Study of Baricitinib (LY3009104) in Participants With Primary Biliary Cholangitis Who do Not Respond or Cannot Take UDCA.A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA. - na Primary Biliary Cholangitis
MedDRA version: 20.0;Level: PT;Classification code 10008604;Term: Cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
Other descriptive name: baricitinib
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLNot RecruitingFemale: yes
Male: yes
52Phase 2United States;United Kingdom;Italy

107. 若年性特発性関節炎


臨床試験数 : 447 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 標的パスウェイ数 : 146
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000119-10-DE
(EUCTR)
20/01/202025/06/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Spain;Germany;United Kingdom;Italy
2EUCTR2017-004495-60-PL
(EUCTR)
12/12/201923/10/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
103Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Germany;China;Japan
3EUCTR2017-004495-60-DK
(EUCTR)
20/11/201921/11/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
103Phase 3Argentina;Russian Federation;Japan;United Kingdom;India;Spain;Austria;Czech Republic;Turkey;Belgium;China;Denmark;Brazil;Poland;Italy;Mexico;Israel;France;Germany
4EUCTR2017-004471-31-FR
(EUCTR)
15/10/201905/08/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
5EUCTR2019-000119-10-IT
(EUCTR)
08/10/201917/06/2021A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Trade Name: SUB180983
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: [Humira]
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: [L04AB04]
INN or Proposed INN: ADALIMUMAB
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;European Union;Germany;United Kingdom;Italy
6EUCTR2017-004518-24-FR
(EUCTR)
03/10/201905/08/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
7EUCTR2017-004495-60-FR
(EUCTR)
24/09/201910/07/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
97Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China;Japan
8EUCTR2017-004495-60-IT
(EUCTR)
16/09/201917/06/2021A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less Than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: OLUMIANT
Product Name: OLUMIANT
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Trade Name: OLUMIANT
Product Name: OLUMIANT
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Product Name: OLUMIANT
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Product Name: OLUMIANT
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
103Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Germany;China;Japan
9EUCTR2017-004495-60-GB
(EUCTR)
19/08/201911/07/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
103Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China
10EUCTR2019-000119-10-FR
(EUCTR)
14/08/201929/05/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Germany;United Kingdom
11EUCTR2017-004471-31-BE
(EUCTR)
09/08/201906/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Belgium;Brazil;Poland;Denmark;Australia;Germany;China;Japan
12EUCTR2019-000119-10-GB
(EUCTR)
06/08/201917/04/2019A study of Baricitinib in children and young adults with JIA associated eye inflammationAn Open-label, Active-Controlled, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Active Juvenile Idiopathic Arthritis-Associated Uveitis or Chronic Anterior Antinuclear Antibody Positive Uveitis - JUVE-BRIGHT Juvenile Idiopathic Arthritis Associated Uveitis or Anterior Antinuclear Antibody-Positive Uveitis
MedDRA version: 20.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
Product Code: L04AB04
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 3France;Germany;United Kingdom
13EUCTR2017-004471-31-DE
(EUCTR)
17/07/201903/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
236 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
14EUCTR2017-004518-24-BE
(EUCTR)
16/07/201914/08/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
15EUCTR2017-004518-24-PL
(EUCTR)
09/07/201927/06/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
16EUCTR2017-004471-31-PL
(EUCTR)
02/07/201919/06/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
17EUCTR2017-004518-24-DE
(EUCTR)
27/06/201903/05/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
18EUCTR2017-004518-24-DK
(EUCTR)
13/06/201930/04/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Germany;Japan;China
19EUCTR2017-004471-31-DK
(EUCTR)
13/06/201901/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Germany;Japan;China
20EUCTR2017-004471-31-GB
(EUCTR)
29/05/201913/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
21EUCTR2017-004471-31-ES
(EUCTR)
27/05/201929/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
236 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
22EUCTR2017-004471-31-CZ
(EUCTR)
27/05/201903/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
23EUCTR2017-004518-24-CZ
(EUCTR)
27/05/201902/05/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) - JUVE-BASIS Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Germany;China;Japan
24EUCTR2017-004518-24-AT
(EUCTR)
22/05/201907/05/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
225Phase 3Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
25EUCTR2017-004518-24-ES
(EUCTR)
22/05/201927/05/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
225 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
26EUCTR2017-004471-31-IT
(EUCTR)
21/05/201915/06/2021A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) - NA Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: olumiant
Product Code: [LY3009104]
Trade Name: Olumiant
Product Name: OLUMIANT
Product Code: [LY3009104]
Product Name: olumiant
Product Code: [LY3009104]
Product Name: Olumiant
Product Code: [LY3009104]
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
27EUCTR2017-004518-24-IT
(EUCTR)
17/05/201917/06/2021A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) - na Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: olumiant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: oluminant
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: Baricitinib
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: [LY3009104]
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
ELI LILLY & COMPANY, LILLY CORPORATE CENTERNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Australia;Denmark;Germany;China;Japan
28EUCTR2017-004518-24-GB
(EUCTR)
23/04/201907/02/2019A study of Baricitinib compared to placebo in children with Juvenile Idiopathic Arthritis (JIA)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 2 Years to Less Than 18 Years Old with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
225Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Germany;Japan;China
29EUCTR2017-004495-60-AT
(EUCTR)
05/08/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
103Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Denmark;Germany;China;Japan
30EUCTR2017-004495-60-DE
(EUCTR)
01/08/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
103Phase 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;China;Japan
31EUCTR2017-004495-60-BE
(EUCTR)
14/08/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNA Female: yes
Male: yes
103 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSpain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China
32EUCTR2017-004495-60-CZ
(EUCTR)
02/09/2019A study of Baricitinib in children and young adults with Juvenile Idiopathic Arthritis (jia)A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients from 1 Year to Less than 18 Years Old with Systemic Juvenile Idiopathic Arthritis (sJIA) - JUVE-BALM Systemic Juvenile Idiopathic Arthritis (sJIA)
MedDRA version: 20.0;Level: LLT;Classification code 10079454;Term: Systemic juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: ly3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
103Phase 3Czechia;Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China
33EUCTR2017-004471-31-AT
(EUCTR)
08/05/2019A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients from 1 Year to <18 Years of Age with Juvenile Idiopathic Arthritis (JIA) Juvenile Idiopathic Arthritis
MedDRA version: 23.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Trade Name: Olumiant
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Product Name: Olumiant
Product Code: LY3009104
INN or Proposed INN: BARICITINIB
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
236Phase 3Czechia;Spain;Turkey;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Australia;Germany;China;Japan