56. ベーチェット病 Behcet disease Clinical trials / Disease details
臨床試験数 : 76 / 薬物数 : 110 - (DrugBank : 32) / 標的遺伝子数 : 36 - 標的パスウェイ数 : 116
| 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 | EUCTR2009-013901-33-DE (EUCTR) | 21/06/2010 | 03/03/2010 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy (SHIELD Study) - C2303E1, SHIELD Study | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy (SHIELD Study) - C2303E1, SHIELD Study | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 112 | France;Greece;Spain;Austria;Germany | |||
| 2 | EUCTR2009-013901-33-GR (EUCTR) | 15/06/2010 | 22/02/2011 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 102 | Germany;France;Spain;Greece;Austria | |||
| 3 | EUCTR2009-013901-33-FR (EUCTR) | 07/04/2010 | 16/02/2010 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy | Adjunctive therapy to standard-of-care for the treatment of intermediate uveitis, posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis MedDRA version: 12.1;Classification code 10022557;Term: Intermediate uveitis MedDRA version: 12.1;Classification code 10033687;Term: Panuveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 146 | France;Greece;Spain;Austria;Germany | |||
| 4 | EUCTR2009-013901-33-ES (EUCTR) | 18/02/2010 | 18/01/2010 | Extensión de 38 semanas del estudio aleatorizado multicéntrico con doble enmascaramiento y controlado con placebo de 24 semanas de duración con el objetivo de evaluar la diferencia en el índice de recurrencia de exacerbaciones en pacientes con uveítis posterior o panuveítis secundaria a Behçet tratados con AIN457 o placebo de forma aditiva al tratamiento inmunosupresor de base - C2303E1 | Extensión de 38 semanas del estudio aleatorizado multicéntrico con doble enmascaramiento y controlado con placebo de 24 semanas de duración con el objetivo de evaluar la diferencia en el índice de recurrencia de exacerbaciones en pacientes con uveítis posterior o panuveítis secundaria a Behçet tratados con AIN457 o placebo de forma aditiva al tratamiento inmunosupresor de base - C2303E1 | terapia adyuvante de los agentes inmunosupresores de base para el tratamiento de la uveítis posterior o de la panuveítis secundaria a la enfermedad de Behçet MedDRA version: 9;Level: LLT;Classification code 10004212;Term: Behcet's disease | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: AIN457 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 159 | Germany;France;Spain;Greece;Austria | |||
| 5 | EUCTR2009-011237-27-DE (EUCTR) | 17/11/2009 | 06/08/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy (SHIELD Study) - C2303 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy (SHIELD Study) - C2303 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 112 | Hungary;Germany;France;Spain;Italy;Greece;Austria | |||
| 6 | EUCTR2009-013901-33-AT (EUCTR) | 12/11/2009 | 13/10/2009 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1 | A 38-week extension to a 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303E1 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 112 | Germany;France;Spain;Greece;Austria | |||
| 7 | EUCTR2009-011237-27-FR (EUCTR) | 23/10/2009 | 06/08/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10033687;Term: Panuveitis MedDRA version: 12.0;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: Not available Other descriptive name: rhumAb to Il-17A (IgG1-k-class) | Novartis Pharma Services Ag | NULL | Not Recruiting | Female: yes Male: yes | 102 | France;Hungary;Greece;Spain;Austria;Germany;Italy | |||
| 8 | EUCTR2009-011237-27-ES (EUCTR) | 20/10/2009 | 05/08/2009 | Estudio aleatorizado multicéntrico, con doble enmascaramiento y controlado con placebo de 24 semanas de duración con el objetivo de evaluar la diferencia en el índice de recurrencia de exacerbaciones en pacientes con uveitis posterior o panuveitis secundaria a Behçet tratados con AIN457 o placebo de forma aditiva al tratamiento inmunosupresor de base. - C2303 | Estudio aleatorizado multicéntrico, con doble enmascaramiento y controlado con placebo de 24 semanas de duración con el objetivo de evaluar la diferencia en el índice de recurrencia de exacerbaciones en pacientes con uveitis posterior o panuveitis secundaria a Behçet tratados con AIN457 o placebo de forma aditiva al tratamiento inmunosupresor de base. - C2303 | Tratamiento de uveítis posterior o panuveítis secundaria a Behçet de forma aditiva al tratamiento inmunosupresor de base MedDRA version: 9;Level: LLT;Classification code 10004212;Term: Behcet's disease | Product Name: AIN457 Product Code: AIN457 INN or Proposed INN: AIN457 | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 102 | Phase 3 | France;Hungary;Greece;Spain;Austria;Germany;Italy | ||
| 9 | EUCTR2009-011237-27-HU (EUCTR) | 15/10/2009 | 29/07/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease MedDRA version: 12.0;Level: LLT;Classification code 10036370;Term: Posterior uveitis | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services Ag | NULL | Not Recruiting | Female: yes Male: yes | 112 | France;Hungary;Greece;Spain;Austria;Germany;Italy | |||
| 10 | EUCTR2009-011237-27-AT (EUCTR) | 14/10/2009 | 18/09/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 112 | Hungary;Germany;France;Spain;Italy;Greece;Austria | |||
| 11 | NCT00995709 (ClinicalTrials.gov) | October 2009 | 13/10/2009 | Phase III Study in Refractory Behcet's Disease | A 24 Week Multicenter, Randomized, Double-masked, Placebo Controlled Study to Assess the Difference in the Rate of Recurrent Exacerbations in Behçet¿s Patients With Posterior or Panuveitis Treated With AIN457 vs Placebo Adjunctive to Standard-of-care Immunosuppressive Therapy | Behcet Disease | Drug: AIN457;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 118 | Phase 3 | United States;Egypt;France;Germany;Greece;Hong Kong;India;Israel;Italy;Jordan;Korea, Republic of;Singapore;Spain;Switzerland;Taiwan;Tunisia;Turkey;Austria;Brazil;Hungary;Saudi Arabia |
| 12 | EUCTR2009-011237-27-GR (EUCTR) | 22/09/2009 | 07/10/2009 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | A 24 week multicenter, randomized, double-masked, placebo controlled study to assess the difference in the rate of recurrent exacerbations in Behçet’s patients with posterior or panuveitis treated with AIN457 vs placebo adjunctive to standard-of-care immunosuppressive therapy - C2303 | Adjunctive therapy to standard-of-care for the treatment of posterior uveitis or panuveitis secondary to Behçet's disease | Product Name: AIN457 Product Code: AIN457 | Novartis Pharma Services Ag | NULL | Not Recruiting | Female: yes Male: yes | 112 | Hungary;Germany;France;Spain;Italy;Greece;Austria |