Humanised anti-CD4 IgG1 monoclonal ( 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
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2010-018485-24-HU
(EUCTR)
29/06/201202/05/2012To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritisA multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
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] - Immune System Diseases [C20]
Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
216Czech Republic;Hungary;Spain;Latvia;Germany
2EUCTR2010-018485-24-LV
(EUCTR)
15/06/201214/05/2012To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritisA multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
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] - Immune System Diseases [C20]
Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
176Phase 2Hungary;Czech Republic;Spain;Germany;Latvia
3EUCTR2010-018485-24-DE
(EUCTR)
18/05/201128/01/2011To investigate the efficacy and safety of SC BT061 in patients with activerheumatoid arthritisA multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
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] - Immune System Diseases [C20]
Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
176Hungary;Czech Republic;Spain;Latvia;Germany
4EUCTR2010-018485-24-ES
(EUCTR)
12/04/201104/11/2010A multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RAA multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
176Phase 2Hungary;Czech Republic;Spain;Latvia;Germany
5EUCTR2010-018485-24-CZ
(EUCTR)
20/10/201024/08/2010To investigate the efficacy and safety of SC BT061 in patients with active rheumatoid arthritisA multi-center, double-blind, randomized, placebo-controlled, dose-finding study in patients with active rheumatoid arthritis incompletely controlled on stable MTX doses to investigate efficacy and safety of SC BT061 - BT061 plus MTX in RA Patients with active rheumatoid arthritis incompletely controlled on stable MTX doses.
MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: BT061
Product Code: BT061
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
INN or Proposed INN: Humanised anti-CD4 IgG1 monoclonal
Biotest AGNULLNot RecruitingFemale: yes
Male: yes
128Hungary;Czech Republic;Spain;Latvia;Germany