Bi 655064 (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 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2012-004090-16-NL (EUCTR) | 20/08/2013 | 02/05/2013 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 | Boehringer Ingelheim B.V | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Poland;Spain;Germany;Netherlands;New Zealand | |||
| 2 | EUCTR2012-004090-16-CZ (EUCTR) | 27/06/2013 | 14/02/2013 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 INN or Proposed INN: BI 655064 | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 1;Phase 2 | Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand | ||
| 3 | EUCTR2012-004090-16-DE (EUCTR) | 23/04/2013 | 06/11/2012 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 106 | Czech Republic;Poland;Spain;Netherlands;Germany;New Zealand | |||
| 4 | EUCTR2012-004090-16-ES (EUCTR) | 19/02/2013 | 29/11/2012 | Safety, tolerability, pharmacokinetics, pharmacodynamics and clinical effects of multiple rising subcutaneous doses of BI655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy. | A randomised, double-blind, placebo-controlled trial for establishing safety, tolerability, pharmacokinetics, pharmacodynamics and clinical efficacy of multiple subcutaneous doses of BI 655064 in healthy volunteers and in rheumatoid arthritis patients with prior inadequate response to methotrexate therapy | Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Code: BI 655064 INN or Proposed INN: BI 655064 | Boehringer Ingelheim España, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 130 | Czech Republic;Spain;Australia;Netherlands;Germany;New Zealand | |||
| 5 | NCT01751776 (ClinicalTrials.gov) | December 2012 | 14/12/2012 | Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effects of Multiple Rising Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy | A Randomised, Double-blind, Placebo-controlled Trial for Establishing Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Efficacy of Multiple Subcutaneous Doses of BI 655064 in Healthy Volunteers and in Rheumatoid Arthritis Patients With Prior Inadequate Response to Methotrexate Therapy | Arthritis, Rheumatoid;Healthy | Drug: BI 655064 medium dose;Drug: BI 655064 high dose;Drug: Placebo;Drug: BI 655064 low dose | Boehringer Ingelheim | NULL | Completed | 18 Years | 70 Years | Both | 107 | Phase 1 | Czech Republic;Germany;Netherlands;New Zealand;Poland;Spain;Romania |