271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 574 / 薬物数 : 359 - (DrugBank : 68) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 146
| 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 | EUCTR2009-011591-30-GB (EUCTR) | 21/09/2010 | 20/10/2009 | An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 | An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 | Ankylosing spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA). MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;Netherlands;United Kingdom | ||
| 2 | EUCTR2009-011591-30-NL (EUCTR) | 17/05/2010 | 18/11/2009 | Safety and tolerability of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitis | An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 | Ankylosing spondylitis MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | United States;Germany;Netherlands;United Kingdom | |||
| 3 | EUCTR2009-011591-30-DE (EUCTR) | 03/03/2010 | 08/12/2009 | An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 | An open-label non-randomized extension study to evaluate the safety and tolerability of AIN457 (anti interleukin-17 monoclonal antibody) in patients with moderate to severe ankylosing spondylitis - A2209E1 | Ankylosing spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA). MedDRA version: 14.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Netherlands;Germany;United Kingdom | |||
| 4 | EUCTR2008-002631-33-NL (EUCTR) | 23/02/2009 | 17/09/2008 | Efficacy of AIN457 in adults (18-65 years) with moderate to severe ankylosing spondylitis | Randomized, double-blind, placebo-controlled, multi-center, phase II, proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 | ankylosing spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Germany;United Kingdom;Netherlands | ||
| 5 | EUCTR2008-002631-33-GB (EUCTR) | 14/01/2009 | 25/07/2008 | Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209 | Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - CAIN457A2209 | Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA). MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Germany;United Kingdom;Netherlands | ||
| 6 | EUCTR2008-002631-33-DE (EUCTR) | 15/12/2008 | 20/08/2008 | Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 | Randomized, placebo controlled, double blind, multi-center phase II proof-of-concept study to assess the efficacy of AIN457 in patients with moderate to severe ankylosing spondylitis - A2209 | Ankylosing Spondylitis (AS), which belongs to seronegative spondyloarthropathies (SpA). MedDRA version: 9.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: AIN457 Product Code: AIN457 Other descriptive name: Recombinant human monoclonal antibody to Il-17 of the IgG1-k-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | United Kingdom;Germany;Netherlands |