HA20 (IMMU-106) ( 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5

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
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2010-022378-15-GB
(EUCTR)
18/08/201110/02/2011A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET 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: Veltuzumab solution 75mg/ml
Product Code: hA20 (IMMU-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
2EUCTR2010-022378-15-DE
(EUCTR)
25/05/201109/02/2011A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET 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: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
3EUCTR2010-022378-15-ES
(EUCTR)
19/05/201121/02/2011A clinical study to explore the therapeutic effects of different doses ofthe new drug veltuzumab, a drug of biologic origin, and placebo, inpatients with rheumatoid arthritis.VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET 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: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom
4EUCTR2010-022378-15-HU
(EUCTR)
08/04/201121/02/2011VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVETVELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET Rheumatoid arthritis
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: Veltuzumab solution 75mg/ml
Product Code: hA20 (Immu-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Czech Republic;Hungary;Spain;Germany;United Kingdom
5EUCTR2010-022378-15-CZ
(EUCTR)
16/03/201121/02/2011A clinical study to explore the therapeutic effects of different doses of the new drug veltuzumab, a drug of biologic origin, and placebo, in patients with rheumatoid arthritis.VELVET (Veltuzumab various doses exploratory trial), a randomized, double blind, placebo controlled, multicentre, multinational phase II dose range finding trial in subjects with moderate to severe rheumatoid arthritis insufficiently controlled with either methotrexate alone or methotrexate plus anti-tumour necrosis factor biological treatment, comparing 3 different subcutaneous dosages of anti-CD20 monoclonal antibody veltuzumab to placebo as an add-on therapy to methotrexate. - VELVET 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: Veltuzumab solution 75mg/ml
Product Code: hA20 (IMMU-106)
INN or Proposed INN: Veltuzumab
Other descriptive name: humanised anti-CD 20 antibody
Nycomed GmbHNULLNot RecruitingFemale: yes
Male: yes
300Phase 2United States;Hungary;Czech Republic;Mexico;Canada;Argentina;Spain;Germany;United Kingdom