FKB327 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
46悪性関節リウマチ11

46. 悪性関節リウマチ


臨床試験数 : 4,356 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1JPRN-jRCT2071200057
08/07/201725/11/2020Bioequivalence study of FKB327 and adalimumab in healthy adult male subjects; Multicenter studyA Phase I, Randomized, Single-Blind, Multicenter, Parallel-Group, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-006 Study Rheumatoid arthritis;D001172Experimental: FKB327 (Adalimumab biosimilar)
Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1.
Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Active Comparator: US licenced Adalimumab
Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1.
Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug
Yazawa RieNULLComplete>= 20age old< 45age oldMale130Phase 1Japan
2JPRN-jRCT2071200058
21/12/201525/11/2020Bioequivalence study of FKB327 and adalimumab in healthy adult male subjectsA Phase I, Randomized, Single-Blind, Single-Dose Study to Compare Pharmacokinetic Characteristics and Safety of FKB327 with those of Humira in Healthy Adult Male Subjects - FKB327-004 Study Rheumatoid arthritis;D001172Experimental: FKB327 (Adalimumab biosimilar)
Intervention Description: Single-dose 40 mg of FKB327 administered subcutaneously injection on day 1.
Drug: FKB327 provided as a prefilled syringe contain 40 mg / 0.8 mL of drug

Active Comparator: US licenced Adalimumab
Single-dose 40 mg administered of US licenced Adalimumab subcutaneously injection on day 1.
Drug: US licenced Adalimumab provided as a prefilled syringe contain 40 mg / 0.8 mL of drug
Yonemura TakumaNULLComplete>= 20age old< 45age oldMale130Phase 1Japan
3EUCTR2014-000110-61-DE
(EUCTR)
15/10/201504/05/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE 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] - Immune System Diseases [C20]
Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
4EUCTR2014-000110-61-ES
(EUCTR)
06/07/201501/06/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE 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] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
5NCT02405780
(ClinicalTrials.gov)
June 10, 201517/3/2015A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis PatientsAn Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant MethotrexateArthritis, RheumatoidDrug: FKB327;Drug: Humira®Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLCompleted18 YearsN/AAll645Phase 3United States;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Bulgaria;Czech Republic
6EUCTR2014-000110-61-CZ
(EUCTR)
11/05/201504/05/2015Study to assess the long-term efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients with Rheumatoid Arthritis on Concomitant Methotrexate - ARABESC-OLE Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327 PFS
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Product Code: FKB327 AI
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3Bulgaria;Germany;United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru
7EUCTR2014-000109-11-DE
(EUCTR)
22/01/201508/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
730Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
8EUCTR2014-000109-11-BG
(EUCTR)
21/01/201510/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
730Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
9EUCTR2014-000109-11-CZ
(EUCTR)
18/12/201409/10/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. - ARABESC Rheumatoid Arthritis
MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
680Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
10EUCTR2014-000109-11-ES
(EUCTR)
09/12/201404/11/2014Study to assess the efficacy and safety of FKB327 compared with Humira®, when each is administered in combination with Methotrexate in patients with Rheumatoid Arthritis.A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety with the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate. 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] - Immune System Diseases [C20]
Product Code: FKB327
INN or Proposed INN: ADALIMUMAB
Trade Name: Humira
Product Name: Humira
INN or Proposed INN: ADALIMUMAB
Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;Serbia;Spain;Ukraine;Chile;Russian Federation;Czech Republic;Canada;Poland;Romania;Peru;Bulgaria;Germany
11NCT02260791
(ClinicalTrials.gov)
December 201429/7/2014A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis PatientsA Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on MethotrexateArthritis, RheumatoidDrug: FKB327;Drug: Humira®Fujifilm Kyowa Kirin Biologics Co., Ltd.NULLCompleted18 YearsN/AAll728Phase 3United States;Bulgaria;Canada;Chile;Czechia;Germany;Peru;Poland;Romania;Russian Federation;Spain;Ukraine;Czech Republic;Serbia