46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details


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

  
6 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Secondary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1EUCTR2012-005733-37-GB
(EUCTR)
18/09/201323/07/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
2EUCTR2012-005733-37-CZ
(EUCTR)
16/08/201315/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
3EUCTR2012-005733-37-LV
(EUCTR)
02/08/201322/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
4NCT01936181
(ClinicalTrials.gov)
August 20132/9/2013A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisDrug: Remicade (infliximab);Drug: SB2 (proposed biosimilar to infliximab)Samsung Bioepis Co., Ltd.NULLCompleted18 Years75 YearsAll584Phase 3Bulgaria;Lithuania
5EUCTR2012-005733-37-LT
(EUCTR)
11/07/201320/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of
6EUCTR2012-005733-37-BG
(EUCTR)
10/07/201321/05/2013A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid ArthritisA Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy 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: SB2 (infliximab biosimilar)
Product Code: SB2
INN or Proposed INN: INFLIXIMAB
Trade Name: Remicade®
Product Name: Remicade
INN or Proposed INN: INFLIXIMAB
Samsung Bioepis Co., Ltd.NULLNot RecruitingFemale: yes
Male: yes
584Phase 3Philippines;Ukraine;Lithuania;United Kingdom;India;Czech Republic;Mexico;Poland;Romania;Bulgaria;Latvia;Bosnia and Herzegovina;Korea, Republic of