Baricitinib    (DrugBank: Baricitinib)

9 diseases
告示番号疾患名(ページ内リンク)臨床試験数
41巨細胞性動脈炎1
46悪性関節リウマチ94
49全身性エリテマトーデス28
50皮膚筋炎/多発性筋炎2
93原発性胆汁性胆管炎2
107若年性特発性関節炎[全身型若年性特発性関節炎(~2018.3)]9
265脂肪萎縮症2
268中條・西村症候群1
325遺伝性自己炎症疾患4

41. 巨細胞性動脈炎 [臨床試験数:108,薬物数:111(DrugBank:32),標的遺伝子数:33,標的パスウェイ数:121
Searched query = "Giant cell arteritis", "Temporal arteritis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 108 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03026504
(ClinicalTrials.gov)
March 9, 201717/1/2017Baricitinib in Relapsing Giant Cell ArteritisBaricitinib in Relapsing Giant Cell Arteritis (GCA): A Phase II, Single-institution, Open-label Pilot StudyArteritis, Giant CellDrug: BaricitinibMatthew J KosterEli Lilly and CompanyActive, not recruiting50 YearsN/AAll15Phase 2United States

46. 悪性関節リウマチ [臨床試験数:4,183,薬物数:2,538(DrugBank:401),標的遺伝子数:183,標的パスウェイ数:219
Searched query = "Malignant rheumatoid arthritis", "Rheumatoid arthritis", "Rheumatoid arthritis with vasculitis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
94 / 4,183 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-UMIN000040094
2020/07/0101/07/2020Development of chronotherapeutics in rheumatoid arthritisDevelopment of chronotherapeutics in rheumatoid arthritis - Development of chronotherapeutics in rheumatoid arthritis rheumatoid arthritisbaricitinib 4mg morning
baricitinib 4mg evening
baricitinib 2mg evening
Division of Diabetes, Endocrinology and Clinical Immunology, Department of Internal Medicine, Hyogo college of MedicineNULLPending18years-old100years-oldMale and Female90Not applicableJapan
2NCT04449224
(ClinicalTrials.gov)
April 27, 20207/6/2020Comparative Effectiveness of Targeted Therapy in RA PatientsComparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational StudyRheumatoid ArthritisDrug: Adalimuab, Etanercept, Tocilizumab, or Abatacept;Drug: Tofacitinib or BaricitinibHanyang UniversityMinistry of Health, Republic of KoreaRecruiting19 YearsN/AAll506Korea, Republic of
3JPRN-jRCT1041190125
09/03/202009/03/2020PRECIOUS-B studyPatient REported, Clinical, and Imaging OUtcomes of tapering methotrexate in patients with rheumatoid arthritis in Stable low disease activity with Baricitinib - PRECIOUS-B study Rheumatoid arthritis1) MTX*
Week 0 to 12
- Reduced after registration.
- The dosing frequency of MTX is decreased from weekly to biweekly without a change in dose, regardless of the initial dose.
- The dosing frequency of folic acid is decreased from weekly to biweekly without a change in dose if concomitantly used.
Week 12 to 52
- Discontinued if low disease activity was maintained.
- Folic acid is discontinued if concomitantly used.
*The allowable range of adherence is -20% to +20%.

2) BAR
- Continued at a stable dose and interval throughout the course of the study.

3) csDMARDs other than MTX
- Continued at a stable dose and interval throughout the course of the study.

4) Glucocorticoids
- Continued at a stable dose up to week 36, and allowed to taper after week 36.

5) Rescue treatments
One or more of the following rescue treatments are performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request
- Changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX.
- Increasing doses of or adding csDMARDs other than MTX.
- Increasing doses of or adding glucocorticoids.
- Drainage of synovial fluid.
- Administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.
Takahashi NobunoriNULLPending>= 20age oldNot applicableBoth51N/AJapan
4EUCTR2018-003351-37-FR
(EUCTR)
19/02/202028/05/2019A 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]
Eli Lilly and CompanyNULLNot Recruiting 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
5NCT04086745
(ClinicalTrials.gov)
February 14, 202010/9/2019A Study of Baricitinib in Participants With Rheumatoid ArthritisA Randomized, Controlled Pragmatic Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Baricitinib;Drug: TNF InhibitorEli Lilly and CompanyIncyte CorporationRecruiting18 YearsN/AAll1300Phase 4United States
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-004558-30-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
7EUCTR2018-003351-37-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: 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;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
8EUCTR2018-003351-37-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]
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
9EUCTR2018-003351-37-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: 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;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Romania;Australia;Denmark;South Africa;Netherlands;Germany
10EUCTR2018-003351-37-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]
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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2018-003351-37-PL
(EUCTR)
04/09/201909/08/2019A 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: 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]
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
12EUCTR2018-003351-37-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 4United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Denmark;Australia;South Africa;Germany;Netherlands
13EUCTR2018-003351-37-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
14EUCTR2018-003351-37-AT
(EUCTR)
13/08/201931/07/2019A 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: 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]
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
15EUCTR2018-003351-37-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2018-003351-37-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: 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 4South Africa;Germany;Netherlands;United States;Slovakia;Greece;Spain;Turkey;Lithuania;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Australia;Denmark
17EUCTR2018-004558-30-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]
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
18EUCTR2019-000505-72-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]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
19NCT03915964
(ClinicalTrials.gov)
April 25, 201912/4/2019A Study of Baricitinib (LY3009104) in Participants With Rheumatoid ArthritisA Randomized, Active-Controlled, Parallel-Group, Phase 3b/4 Study of Baricitinib in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Baricitinib;Drug: TNF InhibitorEli Lilly and CompanyIncyte CorporationActive, not recruiting18 YearsN/AAll2600Phase 4United States;Australia;Austria;Belgium;Czechia;Denmark;France;Germany;Greece;Hungary;Israel;Italy;Lithuania;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Turkey;United Kingdom
20NCT03755466
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03701789
(ClinicalTrials.gov)
September 11, 20184/10/2018Effect of Baricitinib Treatment on Peripheral Bone in RAEvaluation of Bone Quality in Patients With Rheumatoid Arthritis Treated With Baricitinib: Single Centre, Mode of Action Study (BARE BONE)Rheumatoid Arthritis;Bone Density;Finger JointsDrug: BaricitinibUniversity of Erlangen-Nürnberg Medical SchoolNULLRecruiting18 Years74 YearsAll15Phase 3Germany
22NCT03440892
(ClinicalTrials.gov)
November 1, 201714/2/2018Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis PatientsLongitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of SurvivinRheumatoid ArthritisDrug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinibVastra Gotaland RegionNULLRecruiting20 YearsN/AAll2500Sweden
23NCT02265705
(ClinicalTrials.gov)
October 201413/10/2014A Study of Baricitinib (LY3009104) in Participants With Rheumatoid Arthritis (RA)A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate TherapyRheumatoid ArthritisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll290Phase 3Argentina;Brazil;China
24EUCTR2012-003686-17-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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3350Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;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;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
25EUCTR2012-003686-17-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 3Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Germany;Japan;Sweden;United Kingdom;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2012-003686-17-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
27EUCTR2012-003686-17-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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
28EUCTR2012-003686-17-SE
(EUCTR)
02/12/201305/06/2013A Phase 3 Study in Rheumatoid Arthritis A 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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
3350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;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;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
29EUCTR2012-003686-17-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
30EUCTR2012-003686-17-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: 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3350Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;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;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2012-003686-17-LV
(EUCTR)
24/07/201305/07/2013A Phase 3 Study in Rheumatoid Arthritis A 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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
3350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;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;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
32EUCTR2012-003686-17-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 3Germany;Japan;Sweden;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;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania
33EUCTR2012-002323-15-HR
(EUCTR)
17/07/201330/03/2015A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
34EUCTR2012-003686-17-HU
(EUCTR)
11/07/201307/06/2013A 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: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
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
35EUCTR2012-003686-17-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2012-003686-17-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
37EUCTR2012-003686-17-ES
(EUCTR)
04/07/201326/06/2013A 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: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Lilly S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3000Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Italy;Switzerland;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;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
38NCT01885078
(ClinicalTrials.gov)
June 27, 201319/6/2013An Extension Study in Participants With Moderate to Severe Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll2089Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;China;Croatia;Czechia;Denmark;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Taiwan;Turkey;United Kingdom;Czech Republic
39EUCTR2012-003686-17-NL
(EUCTR)
26/06/201325/06/2013A 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: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3000Phase 3Italy;India;France;Denmark;Australia;South Africa;Netherlands;Latvia;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;Greece;Spain;Russian Federation;Israel;Switzerland
40EUCTR2012-003686-17-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2012-003686-17-PT
(EUCTR)
12/06/201314/06/2013A Phase 3 Study in Rheumatoid Arthritis A 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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
3350 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;Switzerland;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;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
42EUCTR2012-003686-17-AT
(EUCTR)
11/06/201307/06/2013A 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: 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]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
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
43EUCTR2012-003686-17-FR
(EUCTR)
07/06/201321/09/2015A 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: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
3000Phase 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;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Germany;Japan;Sweden
44EUCTR2012-003686-17-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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3000Phase 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
45EUCTR2012-003686-17-IT
(EUCTR)
29/05/201304/04/2013A 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: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3000Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;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;Belgium;Brazil;Romania;Croatia;Germany;Japan;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2012-002339-27-ES
(EUCTR)
16/05/201316/05/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
47EUCTR2012-002322-73-LT
(EUCTR)
16/04/201328/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
48EUCTR2012-002323-15-GR
(EUCTR)
15/04/201329/03/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3Study Evaluating the Efficacy and Safety of Baricitinib(LY3009104) in Patients with Moderately to Severely ActiveRheumatoid Arthritis Who Have Had an InadequateResponse to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of
49EUCTR2012-002324-32-SE
(EUCTR)
27/03/201320/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
50EUCTR2012-002322-73-SI
(EUCTR)
26/03/201319/03/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2012-002323-15-GB
(EUCTR)
21/03/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
525 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Turkey;Austria;Israel;Italy;United Kingdom;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
52EUCTR2012-002339-27-DE
(EUCTR)
21/03/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
53EUCTR2012-002339-27-GB
(EUCTR)
21/03/201304/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
660 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Romania;Germany;Japan;Korea, Republic of
54EUCTR2012-002322-73-DE
(EUCTR)
21/03/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
55EUCTR2012-002324-32-GR
(EUCTR)
12/03/201326/02/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3United States;Portugal;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Sweden;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2012-002339-27-BE
(EUCTR)
11/03/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany;Japan;Korea, Republic of
57EUCTR2012-002324-32-BE
(EUCTR)
25/02/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
58EUCTR2012-002322-73-ES
(EUCTR)
20/02/201306/03/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
59EUCTR2012-002322-73-GB
(EUCTR)
15/02/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
1280 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
60EUCTR2012-002339-27-CZ
(EUCTR)
13/02/201304/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;United Kingdom;Italy;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2012-002322-73-SK
(EUCTR)
12/02/201305/02/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
62EUCTR2012-002339-27-SK
(EUCTR)
12/02/201305/02/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
63EUCTR2012-002323-15-DK
(EUCTR)
08/02/201308/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Netherlands;Germany;Japan;Korea, Republic of
64EUCTR2012-002324-32-IT
(EUCTR)
06/02/201311/01/2013A phase 3 study in moderate to severe rheumatoid arthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Trade Name: Maxtrex
INN or Proposed INN: METHOTREXATE
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Trade Name: Maxtrex
INN or Proposed INN: METHOTREXATE
ELI LILLY AND COMPANYNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
65EUCTR2012-002339-27-PT
(EUCTR)
01/02/201302/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2012-002324-32-GB
(EUCTR)
31/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Eli Lilly and CompanyNULLNot Recruiting Female: yes
Male: yes
550 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Portugal;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Brazil;Belgium;South Africa;Germany;Japan;Korea, Republic of;Sweden
67EUCTR2012-002323-15-BE
(EUCTR)
28/01/201320/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
68EUCTR2012-002323-15-PL
(EUCTR)
25/01/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;Switzerland;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
69EUCTR2012-002322-73-GR
(EUCTR)
24/01/201313/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Switzerland;France;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
70EUCTR2012-002324-32-DE
(EUCTR)
23/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2012-002322-73-CZ
(EUCTR)
22/01/201304/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
72EUCTR2012-002322-73-BE
(EUCTR)
21/01/201319/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
73EUCTR2012-002324-32-PT
(EUCTR)
18/01/201302/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Other descriptive name: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;Italy;United Kingdom;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
74EUCTR2012-002322-73-PT
(EUCTR)
18/01/201302/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Other descriptive name: Humira
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
75EUCTR2012-002323-15-NL
(EUCTR)
17/01/201317/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Denmark;Australia;Germany;Netherlands;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2012-002322-73-NL
(EUCTR)
17/01/201317/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 17.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: baricitinib
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3Portugal;United States;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
77EUCTR2012-002322-73-HU
(EUCTR)
14/01/201327/11/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Russian Federation;Israel;Switzerland;France;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan
78EUCTR2012-002339-27-HU
(EUCTR)
14/01/201322/11/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Russian Federation;Italy;United Kingdom;India;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany;Japan;Korea, Republic of
79EUCTR2012-002323-15-AT
(EUCTR)
14/01/201308/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
80EUCTR2012-002324-32-AT
(EUCTR)
14/01/201309/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have HadLimited or No Treatment with Disease-Modifying Antirheumatic Drugs - RA - BEGIN Moderately to severely active rheumatoid arthritis
MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexat HEXAL® 2,5 mg Tabletten
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5mg Tablets
INN or Proposed INN: METHOTREXATE
Trade Name: Methotrexate 2.5 mg tablets
INN or Proposed INN: METHOTREXATE
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
550Phase 3Portugal;United States;Greece;Austria;Russian Federation;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Brazil;South Africa;Germany;Japan;Korea, Republic of;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2012-002322-73-LV
(EUCTR)
11/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid Arthritis.A Randomized, Double-Blind, Placebo- and Active Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy. - RA-BEAM Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
Other descriptive name: baricitinib
Trade Name: Humira
INN or Proposed INN: ADALIMUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1280Phase 3United States;Portugal;Taiwan;Slovakia;Greece;Spain;Israel;Russian Federation;Switzerland;France;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Slovenia;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Germany;Japan
82EUCTR2012-002323-15-ES
(EUCTR)
09/01/201309/01/2013A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Product Name: baricitinib
Product Code: LY3009104
INN or Proposed INN: N/A
Other descriptive name: baricitinib
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;Italy;Switzerland;United Kingdom;India;France;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Australia;Denmark;Netherlands;Germany;Japan;Korea, Republic of
83EUCTR2012-002339-27-IT
(EUCTR)
07/01/201321/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs with Moderately to Severely Active Rheumatoid Arthritis - RA - BUILD Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
ELI LILLY AND COMPANYNULLNot RecruitingFemale: yes
Male: yes
660Phase 3Portugal;Taiwan;Slovakia;Spain;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Germany;Japan;Korea, Republic of
84NCT01721044
(ClinicalTrials.gov)
January 20131/11/2012A Moderate to Severe Rheumatoid Arthritis StudyA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor InhibitorsRheumatoid ArthritisDrug: Placebo;Drug: Baricitinib;Drug: cDMARDEli Lilly and CompanyNULLCompleted18 YearsN/AAll527Phase 3United States;Argentina;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Greece;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Poland;Puerto Rico;Spain;Switzerland;Turkey;United Kingdom;Croatia;India
85EUCTR2012-002323-15-IT
(EUCTR)
18/12/201219/12/2012A Phase 3 Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors - RA - BEACON Moderately to severely active rheumatoid arthritis
MedDRA version: 14.1;Level: SOC;Classification code 10028395;Term: Musculoskeletal and connective tissue disorders;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
Product Name: BARICITINIB
Product Code: LY3009104
Other descriptive name: Baricitinib
ELI LILLY AND COMPANYNULLNot RecruitingFemale: yes
Male: yes
525Phase 3United States;Greece;Spain;Turkey;Austria;Israel;United Kingdom;Italy;India;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Australia;Netherlands;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86NCT01721057
(ClinicalTrials.gov)
December 20121/11/2012A Study in Moderate to Severe Rheumatoid Arthritis ParticipantsA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Placebo;Drug: Baricitinib;Drug: cDMARDEli Lilly and CompanyNULLCompleted18 YearsN/AAll684Phase 3United States;Argentina;Australia;Belgium;Canada;Croatia;Czechia;Germany;Hungary;India;Italy;Japan;Korea, Republic of;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Spain;Taiwan;United Kingdom;Czech Republic
87NCT01711359
(ClinicalTrials.gov)
November 201218/10/2012A Study in Participants With Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic DrugsRheumatoid ArthritisDrug: Baricitinib;Drug: Methotrexate;Drug: Baricitinib Placebo;Drug: MTX Placebo;Drug: Folic AcidEli Lilly and CompanyNULLCompleted18 YearsN/AAll588Phase 3United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Greece;India;Italy;Japan;Korea, Republic of;Mexico;Portugal;Puerto Rico;Russian Federation;South Africa;Sweden;United Kingdom
88NCT01710358
(ClinicalTrials.gov)
October 201217/10/2012A Study in Moderate to Severe Rheumatoid ArthritisA Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate TherapyRheumatoid ArthritisDrug: Adalimumab;Drug: Baricitinib;Drug: Methotrexate;Drug: Adalimumab Placebo;Drug: Baricitinib PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll1307Phase 3United States;Argentina;Belgium;Canada;China;Croatia;Czechia;France;Germany;Greece;Hungary;Japan;Korea, Republic of;Latvia;Lithuania;Mexico;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Slovakia;Slovenia;South Africa;Spain;Switzerland;Taiwan;United Kingdom;Czech Republic;Netherlands
89NCT01469013
(ClinicalTrials.gov)
November 20118/11/2011Oral Baricitinib (LY3009104)Treatment in Japanese Participants With Active Rheumatoid Arthritis on Background Methotrexate TherapyA Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Parallel-Group, Phase 2 Study of Baricitinib (LY3009104) in Japanese Patients With Active Rheumatoid Arthritis on Background Methotrexate TherapyArthritis, RheumatoidDrug: Placebo;Drug: Baricitinib;Drug: MethotrexateEli Lilly and CompanyNULLCompleted20 Years75 YearsAll145Phase 2Japan
90JPRN-JapicCTI-132125
14/05/2013A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate TherapyA Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy Rheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous injection every 2 weeks through Week 50
Control intervention name : Adalimumab
Dosage And administration of the control intervention : Adalimumab administered by SC injection every 2 weeks through Week 50
Eli Lilly Japan K.K.NULL18BOTHPhase 3NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91JPRN-JapicCTI-132138
28/05/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid ArthritisA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis Rheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Eli Lilly Japan K.K.NULL18BOTHPhase 3NULL
92JPRN-JapicCTI-132134
23/05/2013A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic DrugsA Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment with Disease-Modifying Antirheumatic Drugs Rheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 52.
Control intervention name : Placebo
Dosage And administration of the control intervention : Baricitinib placebo administered orally once daily through Week 52 and MTX placebo administered orally once weekly through Week 52.
Control intervention name : Methotrexate
Dosage And administration of the control intervention : Methotrexate (MTX) administered orally once weekly with dose ranging from 7.5 to 12.5 mg per week through Week 52.
Eli Lilly Japan K.K.NULLcomplete18BOTHPhase 3NULL
93JPRN-JapicCTI-142405
06/01/2014A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid ArthritisA Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis Rheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily
Intervention name : placebo
Dosage And administration of the intervention : Placebo administered orally once daily
Eli Lilly Japan K.K.NULLother18BOTHPhase 3NULL
94JPRN-JapicCTI-132156
12/06/2013A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor InhibitorsA Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors Rheumatoid ArthritisIntervention name : Baricitinib
Dosage And administration of the intervention : Baricitinib administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally once daily through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Eli Lilly Japan K.K.NULLrecruiting18BOTHPhase 3NULL

49. 全身性エリテマトーデス [臨床試験数:827,薬物数:638(DrugBank:168),標的遺伝子数:108,標的パスウェイ数:191
Searched query = "Systemic lupus erythematosus", "SLE"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
28 / 827 trials found
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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: 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-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
5EUCTR2017-005026-37-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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
825Phase 3United States;Taiwan;Greece;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;Hungary;Czech Republic;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT03843125
(ClinicalTrials.gov)
September 9, 201914/2/2019A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)A 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 ErythematosusDrug: BaricitinibEli Lilly and CompanyIncyte CorporationRecruiting18 YearsN/AAll1100Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Chile;China;Colombia;Croatia;Czechia;France;Germany;Greece;Hungary;India;Israel;Italy;Japan;Korea, Republic of;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Switzerland;Taiwan;United Kingdom
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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: 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-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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3Serbia;United States;Philippines;Taiwan;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan
10EUCTR2017-005028-11-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: 20.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Philippines;Taiwan;Spain;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2017-005028-11-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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Philippines;Taiwan;Spain;Ukraine;Russian Federation;Chile;Colombia;Switzerland;Italy;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Romania;Germany;Japan
12EUCTR2017-005028-11-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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Philippines;Taiwan;Spain;Russian Federation;Chile;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
13EUCTR2017-005028-11-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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1100Phase 3United States;Serbia;Philippines;Taiwan;Spain;Chile;Russian Federation;Colombia;Italy;Switzerland;India;France;Australia;South Africa;China;Korea, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Germany;Japan
14EUCTR2017-005026-37-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
15EUCTR2017-005026-37-AT
(EUCTR)
18/12/201825/09/2018A 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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
825Phase 3United States;Czechia;Taiwan;Greece;Ukraine;Austria;Russian Federation;United Kingdom;Switzerland;Czech Republic;Hungary;Mexico;Belgium;Brazil;Croatia;Australia;Netherlands;Germany;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2017-005026-37-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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
750 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Taiwan;Greece;Ukraine;Austria;Russian Federation;Switzerland;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Brazil;Australia;Netherlands;Germany;China
17EUCTR2017-005026-37-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 CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: 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
18EUCTR2017-005026-37-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 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
19EUCTR2017-005027-25-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
20NCT03616912
(ClinicalTrials.gov)
August 2, 20181/8/2018A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyIncyte CorporationRecruiting18 YearsN/AAll809Phase 3United States;Australia;Austria;Belgium;Brazil;China;Croatia;Czechia;Germany;Greece;Hungary;Israel;Mexico;Netherlands;Russian Federation;Switzerland;Taiwan;United Kingdom;Ukraine
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT03616964
(ClinicalTrials.gov)
August 2, 20181/8/2018A Study of Baricitinib in Participants With Systemic Lupus ErythematosusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study of Baricitinib in Patients With Systemic Lupus ErythematosusSystemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyIncyte CorporationActive, not recruiting18 YearsN/AAll750Phase 3United States;Argentina;Chile;Colombia;France;India;Italy;Japan;Korea, Republic of;Philippines;Poland;Romania;Serbia;South Africa;Spain
22EUCTR2015-004404-35-ES
(EUCTR)
29/04/201604/04/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Lilly S.A.NULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of
23EUCTR2015-004404-35-PL
(EUCTR)
12/04/201631/03/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Taiwan;Mexico;Argentina;Spain;Poland;Romania;Austria;Japan;United Kingdom;Korea, Republic of
24EUCTR2015-004404-35-FR
(EUCTR)
12/04/201604/05/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 19.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;France;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;United Kingdom;Korea, Republic of
25EUCTR2015-004404-35-AT
(EUCTR)
06/04/201624/03/2016A study in LupusA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (SLE) Patients with Systemic Lupus Erythematosus (SLE)
MedDRA version: 18.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
300Phase 2France;United States;Taiwan;Mexico;Argentina;Poland;Spain;Romania;Austria;Japan;Korea, Republic of
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT02708095
(ClinicalTrials.gov)
March 24, 201610/3/2016A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)A Randomized, Double-Blind, Placebo-Controlled, Parallel- Group, Phase 2 Study of Baricitinib in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus ErythematosusDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll314Phase 2United States;Argentina;Austria;France;Japan;Korea, Republic of;Mexico;Poland;Puerto Rico;Romania;Spain;Taiwan
27JPRN-JapicCTI-163359
01/3/2016A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHHA Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)-I4V-MC-JAHH Systemic Lupus Erythematosus (SLE)Intervention name : Baricitinib
INN of the intervention : Baricitinib
Dosage And administration of the intervention : Baricitinib given orally once a day for 24 weeks
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo given orally once a day for 24 weeks
Eli Lilly Japan K.K.NULL18BOTHPhase 2NULL
28JPRN-JapicCTI-184095
03/09/2018A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA)A Randomized, Double Blind, Placebo Controlled, Parallel Group, Phase 3 Study of Baricitinib in Patients with Systemic Lupus Erythematosus (I4V-MC-JAIA) Systemic Lupus ErythematosusIntervention name : LY3009104
INN of the intervention : Baricitinib
Dosage And administration of the intervention : High Dose or Low Dose. Baricitinib administered orally. Placebo administered orally to maintain the blind.
Control intervention name : Placebo
Dosage And administration of the control intervention : Placebo administered orally.
Eli Lilly Japan K.K.NULLrecruiting18BOTHPhase 3NULL

50. 皮膚筋炎/多発性筋炎 [臨床試験数:157,薬物数:207(DrugBank:76),標的遺伝子数:47,標的パスウェイ数:142
Searched query = "Dermatomyositis", "Polymyositis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 157 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01724580
(ClinicalTrials.gov)
June 20095/11/2012Compassionate Use Protocol for the Treatment of Autoinflammatory SyndromesCompassionate Use Treatment Protocol I4V-MC-JAGA: Treatment of Conditions Expected to Benefit From JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI and Severe Juvenile DermatomyositisChronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature (CANDLE);Juvenile Dermatomyositis (JDM);Stimulator of Interferon Genes (STING)-Associated Vasculopathy With Onset During Infancy (SAVI);Aicardi-Goutières Syndrome (AGS)Drug: BaricitinibEli Lilly and CompanyNULLNo longer available6 MonthsN/AAllUnited States;United Kingdom
2EUCTR2015-003424-31-GB
(EUCTR)
07/12/2015Treatment of autoinflammatory diseasesTreatment of Conditions Expected to Benefit from JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis - JAGA CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis, Aicardi-Goutieres Syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
INN or Proposed INN: baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
60Phase 2France;United States;United Kingdom

93. 原発性胆汁性胆管炎 [臨床試験数:230,薬物数:215(DrugBank:51),標的遺伝子数:34,標的パスウェイ数:107
Searched query = "Primary biliary cholangitis", "Primary biliary cirrhosis", "PBC"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 230 trials found
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]
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
2NCT03742973
(ClinicalTrials.gov)
March 28, 201914/11/2018A 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 UDCAPrimary Biliary CholangitisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLTerminated18 YearsN/AAll2Phase 2United States;Puerto Rico;Italy;United Kingdom

107. 若年性特発性関節炎[全身型若年性特発性関節炎(~2018.3)] [臨床試験数:151,薬物数:75(DrugBank:13),標的遺伝子数:16,標的パスウェイ数:90
Searched query = "Juvenile idiopathic arthritis [Systemic juvenile idiopathic arthritis (~Mar 2018)]", "Systemic-onset juvenile idiopathic arthritis", "JIA", "SJIA"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
9 / 151 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04088396
(ClinicalTrials.gov)
February 12, 202011/9/2019A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With sJIARandomized, 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 ArthritisSystemic Juvenile Idiopathic ArthritisDrug: Baricitinib;Drug: PlaceboEli Lilly and CompanyNULLRecruiting1 Year17 YearsAll103Phase 3Argentina;Austria;Belgium;Brazil;Czechia;Denmark;France;Germany;India;Israel;Italy;Japan;Mexico;Poland;Russian Federation;Spain;Turkey;United Kingdom
2EUCTR2017-004495-60-DE
(EUCTR)
13/01/202001/08/2019A 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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished 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
3EUCTR2017-004495-60-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 3Spain;Turkey;Austria;Russian Federation;Israel;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Denmark;Germany;Japan;China
4EUCTR2017-004495-60-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]
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finished 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
5EUCTR2017-004495-60-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2017-004495-60-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
7EUCTR2017-004495-60-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]
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
8EUCTR2017-004495-60-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]
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
9EUCTR2017-004495-60-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;Israel;Russian Federation;United Kingdom;Italy;India;France;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Denmark;Germany;China;Japan

265. 脂肪萎縮症 [臨床試験数:109,薬物数:164(DrugBank:59),標的遺伝子数:26,標的パスウェイ数:94
Searched query = "Lipodystrophy", "Berardinelli-Seip syndrome", "Lawrence syndrome", "Barraquer-Simons syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
2 / 109 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04517253
(ClinicalTrials.gov)
October 27, 202017/8/2020A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGSA Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients With NNS/CANDLE, SAVI, and AGSNakajo-Nishimura Syndrome;Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome;STING-Associated Vasculopathy With Onset in Infancy;Aicardi Goutieres SyndromeDrug: BaricitinibEli Lilly and CompanyNULLRecruiting6 MonthsN/AAll5Phase 2/Phase 3Japan
2NCT01724580
(ClinicalTrials.gov)
June 20095/11/2012Compassionate Use Protocol for the Treatment of Autoinflammatory SyndromesCompassionate Use Treatment Protocol I4V-MC-JAGA: Treatment of Conditions Expected to Benefit From JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI and Severe Juvenile DermatomyositisChronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature (CANDLE);Juvenile Dermatomyositis (JDM);Stimulator of Interferon Genes (STING)-Associated Vasculopathy With Onset During Infancy (SAVI);Aicardi-Goutières Syndrome (AGS)Drug: BaricitinibEli Lilly and CompanyNULLNo longer available6 MonthsN/AAllUnited States;United Kingdom

268. 中條・西村症候群 [臨床試験数:1,薬物数:1(DrugBank:1),標的遺伝子数:2,標的パスウェイ数:33
Searched query = "Nakajo-Nishimura syndrome", "Autoinflammation, lipodystrophy, and dermatosis syndrome", "CANDLE syndrome", "JMP syndrome", "Nakajo syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 1 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04517253
(ClinicalTrials.gov)
October 27, 202017/8/2020A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGSA Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients With NNS/CANDLE, SAVI, and AGSNakajo-Nishimura Syndrome;Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome;STING-Associated Vasculopathy With Onset in Infancy;Aicardi Goutieres SyndromeDrug: BaricitinibEli Lilly and CompanyNULLRecruiting6 MonthsN/AAll5Phase 2/Phase 3Japan

325. 遺伝性自己炎症疾患 [臨床試験数:6,薬物数:10(DrugBank:6),標的遺伝子数:2,標的パスウェイ数:33
Searched query = "Hereditary autoinflammatory syndrome", "NLRC4 abnormality", "Adenosine deaminase 2 deficiency", "ADA2 deficiency", "Aicardi-Goutieres syndrome", "A20 haploinsufficiency"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
4 / 6 trials found
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PhaseCountries
1NCT04517253
(ClinicalTrials.gov)
October 27, 202017/8/2020A Study of Baricitinib (LY3009104) in Adult and Pediatric Japanese Participants With NNS/CANDLE, SAVI, and AGSA Phase 2/3, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Baricitinib in Adult and Pediatric Japanese Patients With NNS/CANDLE, SAVI, and AGSNakajo-Nishimura Syndrome;Chronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature Syndrome;STING-Associated Vasculopathy With Onset in Infancy;Aicardi Goutieres SyndromeDrug: BaricitinibEli Lilly and CompanyNULLRecruiting6 MonthsN/AAll5Phase 2/Phase 3Japan
2NCT03921554
(ClinicalTrials.gov)
June 3, 20193/4/2019JAK Inhibitor Treatment in AGSJanus Kinase Inhibitor (Baricitinib) for Aicardi Goutières SyndromeAicardi Goutieres SyndromeDrug: BaricitinibAdeline Vanderver, MDEli Lilly and CompanyActive, not recruiting1 MonthN/AAll100Phase 2United States
3NCT01724580
(ClinicalTrials.gov)
June 20095/11/2012Compassionate Use Protocol for the Treatment of Autoinflammatory SyndromesCompassionate Use Treatment Protocol I4V-MC-JAGA: Treatment of Conditions Expected to Benefit From JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI and Severe Juvenile DermatomyositisChronic Atypical Neutrophilic Dermatosis With Lipodystrophy and Elevated Temperature (CANDLE);Juvenile Dermatomyositis (JDM);Stimulator of Interferon Genes (STING)-Associated Vasculopathy With Onset During Infancy (SAVI);Aicardi-Goutières Syndrome (AGS)Drug: BaricitinibEli Lilly and CompanyNULLNo longer available6 MonthsN/AAllUnited States;United Kingdom
4EUCTR2015-003424-31-GB
(EUCTR)
07/12/2015Treatment of autoinflammatory diseasesTreatment of Conditions Expected to Benefit from JAK 1/2 Inhibition: CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis - JAGA CANDLE, CANDLE-Related Conditions, SAVI, and Severe Juvenile Dermatomyositis, Aicardi-Goutieres Syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Baricitinib
Product Code: LY3009104
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
INN or Proposed INN: Baricitinib
Other descriptive name: BARICITINIB
INN or Proposed INN: baricitinib
Other descriptive name: BARICITINIB
Eli Lilly and CompanyNULLNAFemale: yes
Male: yes
60Phase 2France;United States;United Kingdom