LY2127399 ( DrugBank: - )


3 diseases
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica9
46Malignant rheumatoid arthritis50
49Systemic lupus erythematosus21

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,342 Drugs : 2,355 - (DrugBank : 406) / Drug target genes : 269 - Drug target pathways : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2008-007459-28-BG
(EUCTR)
30/04/201029/04/2010Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
245France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany
2EUCTR2008-007459-28-DE
(EUCTR)
08/10/200923/12/2008Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
245France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany
3EUCTR2008-007459-28-BE
(EUCTR)
21/09/200907/01/2009Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
500France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany
4EUCTR2008-007459-28-CZ
(EUCTR)
22/07/200905/05/2009Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
245Hungary;Finland;Germany;Czech Republic;Denmark;Belgium;Bulgaria;France
5EUCTR2008-007459-28-DK
(EUCTR)
09/07/200929/05/2009Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
245France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany
6EUCTR2008-007459-28-FR
(EUCTR)
01/07/200915/05/2009Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
500Phase 2France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany
7EUCTR2008-007459-28-HU
(EUCTR)
01/07/200927/04/2009Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
500Finland;Hungary;Czech Republic;Germany;Denmark;Belgium;Bulgaria;France
8EUCTR2008-007459-28-FI
(EUCTR)
25/06/200918/03/2009Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple SclerosisMultiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects with Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: N/a
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
245France;Czech Republic;Hungary;Finland;Belgium;Denmark;Bulgaria;Germany
9NCT00882999
(ClinicalTrials.gov)
April 200916/4/2009A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years64 YearsAll245Phase 2United States;Bulgaria;Czechia;France;Germany;Hungary;Israel;Poland;Romania;Russian Federation;Serbia;Slovakia;Ukraine;Belgium;Canada;Czech Republic;Denmark;Finland;Switzerland

46. Malignant rheumatoid arthritis


Clinical trials : 4,325 Drugs : 2,671 - (DrugBank : 417) / Drug target genes : 187 - Drug target pathways : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-001618-40-PL
(EUCTR)
04/01/201331/10/2012Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate.Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tabalumab
Product Code: LY2127399
Other descriptive name: TABALUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
180United States;Czech Republic;Argentina;Poland;Russian Federation
2EUCTR2012-001618-40-CZ
(EUCTR)
05/11/201203/08/2012Evaluation of the blood concentration of Tabalumab after the administration of Tabalumab using prefilled syringe or auto-injector in patients with Rheumathoid Arthritis that have not responded correctly to treatment with Methotrexate.Pharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled syringe or Auto-Injector in Patients with Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate. Rheumatoid Arthritis
MedDRA version: 14.1;Level: LLT;Classification code 10042952;Term: Systemic rheumatoid arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: tabalumab
Product Code: LY2127399
Other descriptive name: TABALUMAB
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
180United States;Czech Republic;Argentina;Poland;Russian Federation
3NCT01576549
(ClinicalTrials.gov)
May 201210/4/2012A Study of LY2127399 in Rheumatoid ArthritisAn Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial BiopsiesRheumatoid ArthritisDrug: LY2127399Eli Lilly and CompanyNULLTerminated18 YearsN/AAll2Phase 2United States
4EUCTR2010-022208-36-PL
(EUCTR)
05/12/201108/04/2011An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P) A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P) 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: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1505Phase 3Germany;Malaysia;France;Bulgaria;Brazil;Australia;South Africa;New Zealand;Peru;Korea, Republic of;United States;Greece;Croatia;Poland;Hungary;Colombia;Italy;Lithuania;India;Russian Federation;Slovakia;Ukraine;Taiwan;Sri Lanka;Argentina;Mexico;Romania;Spain;Japan
5EUCTR2010-022206-40-PL
(EUCTR)
26/07/201111/04/2011A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) 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: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
6EUCTR2010-022207-22-PL
(EUCTR)
22/07/201111/04/2011A Study in Patients With Rheumatoid Arthritis(FLEX-V)A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors (FLEX-V) 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: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
555Phase 3Germany;Colombia;Malaysia;Italy;Australia;Brazil;Russian Federation;New Zealand;Argentina;Mexico;Taiwan;Korea, Republic of;Spain;Japan;Greece;United States;Poland
7EUCTR2010-022205-17-PL
(EUCTR)
19/07/201108/04/2011A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy(FLEX-M) 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: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: n/a
Trade Name: Boostrix®
Product Name: Boostrix®
Product Code: -
Other descriptive name: DIPHTHERIA TOXOID
Other descriptive name: TETANUS TOXOID
Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE
Trade Name: PNEUMOVAX® 23
Product Name: PNEUMOVAX® 23
Product Code: -
Other descriptive name: pneumococcal serotypes
Eli Lilly and CompanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
990Phase 3Hungary;Colombia;Malaysia;Bulgaria;South Africa;Australia;Brazil;Lithuania;India;Slovakia;Russian Federation;Ukraine;New Zealand;Peru;Taiwan;Sri Lanka;Mexico;Argentina;Romania;Korea, Republic of;Japan;United States;Croatia;Poland
8EUCTR2010-022208-36-GR
(EUCTR)
21/06/201116/05/2011An Open Label Study for Patients With Rheumatoid Arthritis A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) Rheumatoid Arthritis
MedDRA version: 13.1;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: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3United States;Taiwan;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;Malaysia;Australia;Peru;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Croatia;Bulgaria;Germany;New Zealand;Japan
9EUCTR2010-022207-22-DE
(EUCTR)
08/06/201103/12/2010A Study in Patients With Rheumatoid Arthritis (FLEX-V)A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors (FLEX-V) Rheumatoid Arthritis
MedDRA version: 14.0;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: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Other descriptive name: not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Other descriptive name: not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
555Phase 3United States;Taiwan;Greece;Spain;Russian Federation;Colombia;Italy;Mexico;Argentina;Poland;Brazil;Malaysia;Australia;Germany;New Zealand;Japan;Korea, Republic of
10EUCTR2010-022208-36-DE
(EUCTR)
08/06/201103/12/2010A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
11NCT01215942
(ClinicalTrials.gov)
June 20115/10/2010An Open Label Study for Participants With Rheumatoid ArthritisA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: LY2127399Eli Lilly and CompanyNULLTerminated18 YearsN/AAll1086Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;France;Germany;Greece;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Sri Lanka;Taiwan;Ukraine;Italy;Peru
12EUCTR2010-022206-40-LT
(EUCTR)
01/04/201128/12/2010A Rheumatoid Arthritis Study in Patients(FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) Rheumatoid Arthritis
MedDRA version: 14.0;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: LY2127399
Product Code: LY2127399
INN or Proposed INN: not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Australia;Peru;South Africa;Bulgaria;Japan;New Zealand
13EUCTR2010-022205-17-LT
(EUCTR)
01/04/201128/12/2010A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate(FLEX-M)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M) Rheumatoid Arthritis
MedDRA version: 14.0;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: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
990Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
14EUCTR2010-022208-36-LT
(EUCTR)
01/04/201128/12/2010A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
15EUCTR2010-022206-40-BG
(EUCTR)
30/03/201124/02/2011A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) Rheumatoid Arthritis
MedDRA version: 14.0;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: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
16EUCTR2010-022205-17-BG
(EUCTR)
29/03/201124/02/2011A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate (FLEX-M)A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy (FLEX-M) Rheumatoid Arthritis
MedDRA version: 14.0;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: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Trade Name: Boostrix®
Product Name: Boostrix®
Product Code: -
Other descriptive name: DIPHTHERIA TOXOID
Other descriptive name: TETANUS TOXOID
Other descriptive name: PERTUSSIS TOXOID ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS FILAMENTOUS HAEMAGGLUTININ ADSORBED ON ALUMINIUM HYDROXIDE
Other descriptive name: PERTUSSIS PERTACTIN ADSORBED ON ALUMINIUM HYDROXIDE
Trade Name: PNEUMOVAX® 23
Product Name: PNEUMOVAX® 23
Product Code: -
Other descriptive name: pneumococcal serotypes
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
990Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Malaysia;Brazil;Poland;Croatia;Romania;Australia;Peru;Bulgaria;South Africa;Japan;New Zealand;Korea, Republic of
17EUCTR2010-022208-36-BG
(EUCTR)
24/03/201124/02/2011An Open Label Study for Patients With Rheumatoid Arthritis (FLEX-P) A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) (FLEX-P) 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: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: Not available
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3United States;Taiwan;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Sri Lanka;Italy;India;France;Malaysia;Peru;Australia;South Africa;Korea, Republic of;Lithuania;Hungary;Mexico;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
18EUCTR2010-022207-22-ES
(EUCTR)
21/03/201129/12/2010A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfaA Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacyand Safety of LY2127399 in Patients with Moderateto Severe Rheumatoid Arthritis (RA) who had anInadequate Response to one or more TNF-alphaInhibitorsEstudio de fase 3, multicéntrico, aleatorizado,doble ciego, controlado con placebo de evaluaciónde la eficacia y la seguridad de LY2127399 enpacientes con artritis reumatoide (AR) moderada ointensa que no han obtenido una respuestasuficiente con uno o varios inhibidores del TNF-alfa Rheumatoid Arthritis Artritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
555Phase 3Greece;Poland;Spain;Germany;Italy
19EUCTR2010-022208-36-ES
(EUCTR)
21/03/201129/12/2010A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)Estudio en fase 3b, multicéntrico y abierto paraevaluar la seguridad y la eficacia a largo plazo deLY2127399 en pacientes con artritis reumatoide(AR) Rheumatoid ArthritisArtritis Reumatoide
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
20EUCTR2010-022207-22-GR
(EUCTR)
15/03/201120/01/2011A Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a InhibitorsA Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
555Phase 3Greece;Poland;Spain;Germany;Italy
21EUCTR2010-022207-22-IT
(EUCTR)
24/02/201103/02/2011A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors - NDA Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to one or more TNF-a Inhibitors - ND Rheumatoid Arthritis
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
555Phase 3Greece;Poland;Spain;Germany;Italy
22EUCTR2010-022206-40-HU
(EUCTR)
23/02/201126/11/2010A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) TherapyA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3Hungary;Poland;Lithuania;Bulgaria
23EUCTR2010-022205-17-HU
(EUCTR)
18/02/201115/12/2010A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate TherapyA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients with Moderate to Severe Rheumatoid Arthritis (RA) who had an Inadequate Response to Methotrexate Therapy Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
990Phase 3Hungary;Poland;Lithuania;Bulgaria
24EUCTR2010-022208-36-HU
(EUCTR)
18/02/201126/11/2010A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) Rheumatoid Arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
25EUCTR2010-022208-36-IT
(EUCTR)
10/01/201108/02/2011A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis(RA) - NDA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis(RA) - ND Rheumatoid Arthritis.
MedDRA version: 9.1;Level: PT;Classification code 10039073
Product Name: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1505Phase 3Hungary;Greece;Poland;Spain;Lithuania;Bulgaria;Germany;Italy
26NCT01202760
(ClinicalTrials.gov)
January 201114/9/2010A Rheumatoid Arthritis Study in ParticipantsA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients With Rheumatoid Arthritis (RA) With or Without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX O)Rheumatoid ArthritisDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 YearsN/AAll1004Phase 3United States;Argentina;Australia;Bulgaria;Colombia;Croatia;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Sri Lanka;Taiwan;Ukraine;Peru
27NCT01202773
(ClinicalTrials.gov)
January 201114/9/2010A Study in Participants With Rheumatoid ArthritisA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to One or More TNF-a Inhibitors (FLEX V)Rheumatoid ArthritisDrug: LY2127399;Drug: Placebo Q4W;Drug: Placebo Q2WEli Lilly and CompanyNULLTerminated18 YearsN/AAll456Phase 3United States;Argentina;Australia;Brazil;Colombia;France;Germany;Greece;Italy;Japan;Korea, Republic of;Malaysia;Mexico;New Zealand;Poland;Russian Federation;South Africa;Spain;Taiwan
28EUCTR2010-022206-40-SK
(EUCTR)
13/12/201027/04/2016A Rheumatoid Arthritis Study in Patients (FLEX-O)A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of LY2127399 in Patients with Rheumatoid Arthritis (RA) with or without Background Disease-Modifying Anti-rheumatic Drug (DMARD) Therapy (FLEX-O) Rheumatoid Arthritis
MedDRA version: 19.0;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: LY2127399
Product Code: LY2127399
Product Name: LY2127399
Product Code: LY2127399
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1002Phase 3United States;Taiwan;Slovakia;Ukraine;Lithuania;Russian Federation;Colombia;Sri Lanka;India;Hungary;Mexico;Argentina;Poland;Malaysia;Romania;Croatia;Peru;Australia;South Africa;Bulgaria;New Zealand;Japan;Korea, Republic of
29NCT01198002
(ClinicalTrials.gov)
December 20108/9/2010A Rheumatoid Arthritis Study in Participants on a Background Treatment of MethotrexateA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis (RA) Who Had an Inadequate Response to Methotrexate Therapy (FLEX M)Rheumatoid ArthritisDrug: LY2127399;Drug: Placebo Q2W;Drug: Placebo Q4W;Drug: MethotrexateEli Lilly and CompanyNULLTerminated18 YearsN/AAll1041Phase 3United States;Argentina;Australia;Brazil;Bulgaria;Colombia;Croatia;Hungary;India;Japan;Korea, Republic of;Lithuania;Malaysia;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Sri Lanka;Taiwan;Ukraine;Peru
30NCT01253291
(ClinicalTrials.gov)
May 20101/12/2010A Study of Japanese Rheumatoid Arthritis ParticipantsAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With MethotrexateRheumatoid ArthritisDrug: LY2127399Eli Lilly and CompanyNULLCompleted20 Years75 YearsAll26Phase 1Japan
31EUCTR2008-004894-16-HU
(EUCTR)
03/12/200917/11/2008Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and Company limitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Czech Republic;Hungary;Poland;Germany
32NCT01253226
(ClinicalTrials.gov)
September 20091/12/2010A Study for Japanese Participants With Rheumatoid Arthritis (RA)Multiple-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With MethotrexateRheumatoid ArthritisDrug: LY2127399 (Tabalumab);Drug: PlaceboEli Lilly and CompanyNULLCompleted20 Years75 YearsAll32Phase 1Japan
33EUCTR2008-004875-23-HU
(EUCTR)
08/07/200911/05/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
198Hungary;Germany;Belgium;France;Austria;Poland
34EUCTR2008-004875-23-AT
(EUCTR)
26/06/200930/04/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236Hungary;Germany;Belgium;France;Poland;Austria
35EUCTR2008-001105-42-PL
(EUCTR)
03/06/200917/04/2009A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Germany;Belgium;France;Austria;Poland
36EUCTR2008-004875-23-DE
(EUCTR)
26/05/200909/03/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236Poland;Austria;France;Belgium;Germany;Hungary
37EUCTR2008-004875-23-BE
(EUCTR)
18/05/200907/01/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236France;Hungary;Poland;Belgium;Austria;Germany
38EUCTR2008-004875-23-PL
(EUCTR)
22/04/200925/02/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Product Code: NA
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236Hungary;Germany;Belgium;France;Austria;Poland
39EUCTR2008-004894-16-CZ
(EUCTR)
14/04/200926/11/2008Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyPhase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and Company limitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Germany;Czech Republic;Poland
40EUCTR2008-004875-23-FR
(EUCTR)
31/03/200916/04/2009An Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid ArthritisAn Open-Label Extension Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
236Phase 2France;Hungary;Poland;Belgium;Austria;Germany
41EUCTR2008-004894-16-DE
(EUCTR)
12/02/200911/11/2008Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyPhase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and Company limitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Czech Republic;Germany;Poland
42NCT00837811
(ClinicalTrials.gov)
February 20093/2/2009An Open Label Extension Study in Participants With Rheumatoid ArthritisAn Open Label Extension Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Rheumatoid Arthritis.Rheumatoid ArthritisBiological: LY2127399Eli Lilly and CompanyNULLCompleted18 YearsN/AAll182Phase 2United States;Australia;Austria;Belgium;Brazil;Canada;Chile;Germany;Hungary;India;Mexico;Poland;Puerto Rico;Romania;Argentina;Czech Republic;France;Slovakia;Ukraine
43EUCTR2008-004894-16-PL
(EUCTR)
15/01/200918/12/2008Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyPhase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: LY2127399
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and Company limitedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2Hungary;Czech Republic;Germany;Poland
44EUCTR2008-001105-42-AT
(EUCTR)
11/11/200806/08/2008A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: NA
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Austria;Poland;France;Belgium;Germany
45EUCTR2008-001105-42-DE
(EUCTR)
16/10/200804/08/2008A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2Germany;Belgium;France;Poland;Austria
46EUCTR2008-001105-42-FR
(EUCTR)
10/10/200828/08/2008A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Poland;Belgium;Austria;Germany
47NCT00785928
(ClinicalTrials.gov)
October 20083/11/2008A Study for Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyPhase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate TherapyRheumatoid ArthritisBiological: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years75 YearsAll158Phase 2United States;Argentina;Australia;Chile;Germany;Hungary;India;Mexico;Poland;Romania;Slovakia;Ukraine;Brazil;Canada;Czech Republic
48EUCTR2008-001105-42-BE
(EUCTR)
16/09/200814/07/2008A Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDGA Phase 2 Study of Multiple Intravenous Doses of LY2127399, an Anti-BAFF Human Antibody, in Patients with Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor Therapy - BCDG Rheumatoid arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Code: LY2127399
INN or Proposed INN: N/A
Other descriptive name: Anti LP40 antibody, subclass IgG4 LA294
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
100Phase 2France;Poland;Belgium;Austria;Germany
49NCT00689728
(ClinicalTrials.gov)
June 20082/6/2008A Study for Patients With Rheumatoid Arthritis on Methotrexate (MTX) With an Inadequate Response to TNFa Inhibitor TherapyA Phase 2 Study of Multiple Intravenous Doses of LY2127399 in Patients With Rheumatoid Arthritis on Concomitant Methotrexate and an Inadequate Response to TNFa Inhibitor TherapyArthritis, RheumatoidBiological: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years75 YearsAll100Phase 2United States;Argentina;Austria;Belgium;Brazil;Canada;Germany;Mexico;Poland;Puerto Rico;France
50NCT00308282
(ClinicalTrials.gov)
March 28, 200628/3/2006A Multi-Site Study to Evaluate the Safety and Effect of Study Drug on Participants With Rheumatoid ArthritisPhase II Study of Safety and Efficacy of Intravenous LY2127399 in Patients With Rheumatoid Arthritis Treated With MethotrexateArthritis, RheumatoidDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLCompleted18 Years75 YearsAll136Phase 2Romania

49. Systemic lupus erythematosus


Clinical trials : 946 Drugs : 722 - (DrugBank : 186) / Drug target genes : 117 - Drug target pathways : 199
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-022101-18-HR
(EUCTR)
31/03/201417/10/2014Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
2NCT02041091
(ClinicalTrials.gov)
January 201417/1/2014A Study of Tabalumab (LY2127399) Using Two Different Injection Methods in Participants With LupusPharmacokinetic Evaluations of Tabalumab Following Subcutaneous Administration by Prefilled Syringe or Auto Injector in Patients With Systemic Lupus ErythematosusLupus Erythematosus, SystemicDrug: Tabalumab Auto-Injector;Drug: Tabalumab Prefilled SyringeEli Lilly and CompanyNULLTerminated18 YearsN/AAll226Phase 3United States;Korea, Republic of;Puerto Rico;Mexico
3EUCTR2010-022101-18-IT
(EUCTR)
13/05/201303/09/2012Non disponibileA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 15.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
ELI LILLY AND COMPANYNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3United States;Belarus;Philippines;Taiwan;Ecuador;Spain;Thailand;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Singapore;Croatia;Bulgaria;Germany;Japan;New Zealand
4EUCTR2010-022101-18-DE
(EUCTR)
20/03/201310/12/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3United States;Belarus;Serbia;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Australia;Peru;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
5EUCTR2010-022101-18-GB
(EUCTR)
21/12/201228/11/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
INN or Proposed INN: Not available
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3United States;Belarus;Serbia;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Australia;Peru;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Croatia;Bulgaria;Germany;Japan;New Zealand
6EUCTR2010-022101-18-BG
(EUCTR)
28/08/201229/08/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
7EUCTR2010-022101-18-HU
(EUCTR)
17/08/201217/05/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand;Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia
8EUCTR2010-022101-18-LV
(EUCTR)
10/08/201228/05/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand
9EUCTR2010-022101-18-ES
(EUCTR)
25/05/201221/05/2012A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X)A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3Serbia;United States;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Israel;Russian Federation;Chile;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Latvia;Tunisia;Korea, Democratic People's Republic of;Guatemala;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Croatia;Romania;Bulgaria;Germany;Japan;New Zealand
10EUCTR2010-022101-18-AT
(EUCTR)
14/05/201211/04/2012Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-X) - ILLUMINATE-X Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4; Anti BAFF (B cell activating factor)
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1276Phase 3United States;Serbia;Belarus;Philippines;Taiwan;Ecuador;Thailand;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Macedonia, the former Yugoslav Republic of;Malaysia;Peru;Australia;South Africa;Tunisia;Latvia;Guatemala;Korea, Democratic People's Republic of;Turkey;Austria;United Kingdom;Egypt;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Croatia;Bulgaria;Germany;New Zealand;Japan
11NCT01488708
(ClinicalTrials.gov)
January 20126/12/2011On Open-Label Study in Participants With Systemic Lupus ErythematosusA Phase 3b, Multicenter, Open-Label Study to Evaluate the Long-Term Safety and Efficacy of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE) (Illuminate-X)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: LY2127399;Drug: PlaceboEli Lilly and CompanyNULLTerminated18 YearsN/AAll1518Phase 3United States
12EUCTR2010-022099-29-DE
(EUCTR)
04/07/201114/12/2010Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Canada;Macedonia, the former Yugoslav Republic of;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of
13EUCTR2010-022099-29-BG
(EUCTR)
16/06/201124/02/2011Study investigating a new medicine, LY2127399, in patients diagnosed with Systemic Lupus Erythematosus (SLE).A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3United States;Belarus;Philippines;Thailand;Guatemala;Ukraine;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of
14EUCTR2010-022099-29-IT
(EUCTR)
01/06/201107/02/2011A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) - NDA Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) - ND Systemic Lupus Erythematosus (SLE)
MedDRA version: 9.1;Level: PT;Classification code 10042945
Product Name: LY2127399
Product Code: LY2127399
ELI LILLYNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3Austria;Bulgaria;Germany;Italy
15EUCTR2010-022100-42-GB
(EUCTR)
28/04/201119/01/2011Not availableA Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - (ILLUMINATE-2) Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3United States;Serbia;Taiwan;Ecuador;Spain;Russian Federation;Israel;United Kingdom;India;France;Hungary;Mexico;Canada;Brazil;Malaysia;Romania;Australia;South Africa;Tunisia;Latvia;New Zealand
16EUCTR2010-022100-42-ES
(EUCTR)
20/04/201115/02/2011Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE)Estudio de Fase 3, multicéntrico, aleatorizado, doble ciego y controlado con placebo, para evaluar la eficacia y la seguridad de LY2127399 subcutáneo en pacientes con lupus sistémico eritematoso (LSE)//A Phase 3, Multicenter, Randomized, Double-Blind,Placebo-Controlled Study to Evaluate the Efficacy andSafety of Subcutaneous LY2127399 in Patients withSystemic Lupus Erythematosus (SLE) Lupus Eritematoso Sistémico (LES) //Systemic Lupus Erythematosus (SLE)
MedDRA version: 12.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: Anti LP40 anticuerpo, subclase IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3Hungary;Spain;Latvia;United Kingdom
17EUCTR2010-022100-42-LV
(EUCTR)
08/04/201113/01/2011A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2 Systemic Lupus Erythematosus (SLE)
MedDRA version: 16.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand
18EUCTR2010-022100-42-HU
(EUCTR)
23/02/201113/01/2011A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-2) - ILLUMINATE-2 Systemic Lupus Erythematosus (SLE)
MedDRA version: 14.1;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3Serbia;United States;Taiwan;Ecuador;Spain;Israel;Russian Federation;United Kingdom;India;France;Hungary;Mexico;Canada;Malaysia;Brazil;Romania;Australia;South Africa;Latvia;Tunisia;New Zealand
19EUCTR2010-022099-29-AT
(EUCTR)
27/01/201128/12/2010Study investigating a new medicine, LY2127399, in patients diagnosedwith Systemic Lupus Erythematosus (SLE).A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients with Systemic Lupus Erythematosus (SLE) (ILLUMINATE-1) - ILLUMINATE-1 Systemic Lupus Erythematosus (SLE)
MedDRA version: 17.0;Level: LLT;Classification code 10025139;Term: Lupus erythematosus systemic;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: LY2127399
Product Code: LY2127399
Other descriptive name: LA294; Anti LP40 antibody, subclass IgG4
Eli Lilly and CompanyNULLNot RecruitingFemale: yes
Male: yes
1140Phase 3United States;Belarus;Philippines;Thailand;Ukraine;Guatemala;Turkey;Austria;Chile;Colombia;Italy;Egypt;Macedonia, the former Yugoslav Republic of;Canada;Argentina;Poland;Singapore;Croatia;Peru;Bulgaria;Germany;Japan;Korea, Republic of
20NCT01205438
(ClinicalTrials.gov)
January 201117/9/2010A Study of LY2127399 in Participants With Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Patients With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeksEli Lilly and CompanyNULLCompleted18 YearsN/AAll1124Phase 3United States;Australia;Brazil;Canada;Ecuador;France;Hungary;India;Israel;Latvia;Malaysia;Mexico;New Zealand;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Tunisia;United Kingdom
21NCT01196091
(ClinicalTrials.gov)
December 20103/9/2010A Study of LY2127399 in Participants With Systemic Lupus ErythematosusA Phase 3, Multicenter, Randomized, Double Blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Subcutaneous LY2127399 in Participants With Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus;Connective Tissue Disease;Autoimmune DiseaseDrug: LY2127399;Drug: Placebo every 2 weeks;Drug: Placebo every 4 weeks;Drug: Standard of CareEli Lilly and CompanyNULLCompleted18 YearsN/AAll1164Phase 3United States;Argentina;Austria;Belarus;Bulgaria;Canada;Chile;Colombia;Croatia;Egypt;Germany;Guatemala;Italy;Japan;Korea, Republic of;Macedonia, The Former Yugoslav Republic of;Peru;Philippines;Poland;Puerto Rico;Singapore;Thailand;Ukraine;Turkey