271. 強直性脊椎炎 Ankylosing spondylitis Clinical trials / Disease details
臨床試験数 : 563 / 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
| 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 | EUCTR2009-016068-35-NL (EUCTR) | 15/12/2010 | 24/06/2010 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 2 | EUCTR2010-019263-11-LT (EUCTR) | 06/09/2010 | 03/06/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: not applicable Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | |||
| 3 | EUCTR2010-019263-11-FR (EUCTR) | 02/08/2010 | 14/06/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | France;Hungary;Czech Republic;Spain;Belgium;Lithuania;Austria | ||
| 4 | EUCTR2010-019263-11-HU (EUCTR) | 14/07/2010 | 20/05/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: SAR153191 Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | |||
| 5 | EUCTR2010-019263-11-BE (EUCTR) | 08/07/2010 | 13/04/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | France;Hungary;Czech Republic;Spain;Belgium;Lithuania;Austria | ||
| 6 | EUCTR2010-019263-11-ES (EUCTR) | 28/06/2010 | 21/04/2010 | Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | Estudio de extensión multicéntrico no controlado para evaluar la seguridad y la eficacia a largo plazo de SAR153191 en pacientes con espondilitis anquilosante (EA)______________________________________________A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) | Espondilitis Anquilosante__________________________Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Phase 3 | France;Hungary;Czech Republic;Belgium;Spain;Lithuania;Austria | ||
| 7 | EUCTR2010-019263-11-CZ (EUCTR) | 03/06/2010 | 19/04/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | |||
| 8 | NCT01118728 (ClinicalTrials.gov) | June 2010 | 5/5/2010 | Extension Study for Long Term Evaluation of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis | A Multicenter Uncontrolled Extension Study Evaluating the Long Term Safety and Efficacy of SAR153191 in Patients With Ankylosing Spondylitis (AS) | Ankylosing Spondylitis | Drug: Sarilumab | Sanofi | Regeneron Pharmaceuticals | Terminated | 18 Years | N/A | All | 223 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Hungary;Lithuania;Netherlands;Poland;Spain;Czech Republic |
| 9 | EUCTR2010-019263-11-AT (EUCTR) | 19/05/2010 | 13/04/2010 | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | A multicenter uncontrolled extension study evaluating the long term safety and efficacy of SAR153191 in patients with Ankylosing Spondylitis (AS) - SUSTAIN | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 | sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 270 | Hungary;Czech Republic;Belgium;France;Spain;Austria;Lithuania | |||
| 10 | EUCTR2009-016068-35-DE (EUCTR) | 03/05/2010 | 11/12/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 11 | EUCTR2009-016068-35-FR (EUCTR) | 26/04/2010 | 14/12/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany | ||
| 12 | EUCTR2009-016068-35-CZ (EUCTR) | 25/03/2010 | 01/04/2010 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Germany;Czech Republic;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 13 | EUCTR2009-016068-35-LT (EUCTR) | 23/03/2010 | 30/12/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: not applicable Product Code: SAR153191 Product Name: not applicable Product Code: SAR153191 Product Name: not applicable Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 14 | EUCTR2009-016068-35-ES (EUCTR) | 22/02/2010 | 16/12/2009 | Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Estudio aleatorizado, doble-ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y seguridad de SAR153191 en pacientes con espondilitis anquilosante_______________________________________________A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Espondilitis anquilosante___________________________Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 15 | EUCTR2009-016068-35-BE (EUCTR) | 19/02/2010 | 30/11/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany | |||
| 16 | NCT01061723 (ClinicalTrials.gov) | February 2010 | 2/2/2010 | Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis | A Randomized Double Blind-placebo Controlled Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 in Participants With Ankylosing Spondylitis (AS) | Ankylosing Spondylitis | Drug: Sarilumab;Drug: Placebo | Sanofi | Regeneron Pharmaceuticals | Completed | 18 Years | 75 Years | All | 301 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Hungary;Lithuania;Netherlands;Poland;Spain;Turkey;Czech Republic |
| 17 | EUCTR2009-016068-35-AT (EUCTR) | 28/01/2010 | 11/01/2010 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Code: SAR153191 Product Code: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Czech Republic;Germany;Netherlands;Belgium;France;Spain;Austria;Lithuania | |||
| 18 | EUCTR2009-016068-35-HU (EUCTR) | 25/01/2010 | 14/12/2009 | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | A randomized double blind-placebo controlled dose ranging study to evaluate the efficacy and safety of SAR153191 in patients with Ankylosing Spondylitis (AS) - ALIGN | Ankylosing Spondylitis MedDRA version: 12.0;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Product Name: SAR153191 Product Code: SAR153191 Product Name: SAR153191 Product Code: SAR153191 Product Name: SAR153191 Product Code: SAR153191 | Sanofi-aventis Recherche & Développement | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 2 | France;Czech Republic;Hungary;Spain;Belgium;Lithuania;Austria;Netherlands;Germany |