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 | EUCTR2009-017443-34-BE (EUCTR) | 16/05/2011 | 08/10/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-5733/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Phase 2;Phase 3 | Czech Republic;Slovakia;Spain;Belgium;Lithuania;Bulgaria;Germany;Italy;United Kingdom | ||
| 2 | EUCTR2009-017488-40-BE (EUCTR) | 22/03/2011 | 01/09/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | ||
| 3 | EUCTR2009-017443-34-DE (EUCTR) | 17/01/2011 | 02/09/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-5733/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;United Kingdom;Germany;Belgium;Bulgaria;Spain;Italy;Lithuania | |||
| 4 | EUCTR2009-017443-34-BG (EUCTR) | 07/01/2011 | 24/11/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-5733/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | |||
| 5 | EUCTR2009-017488-40-ES (EUCTR) | 14/12/2010 | 06/10/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy. Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la seguridad y la reducción de los signos ysíntomas durante el tratamiento con tocilizumab (TCZ) en comparación con placebo en pacientes con espondilitis anquilosante que han tenido una respuesta insuficiente al tratamiento previo con un antagonista del TNF. | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy. Estudio aleatorizado, doble ciego, de grupos paralelos y controlado con placebo para evaluar la seguridad y la reducción de los signos ysíntomas durante el tratamiento con tocilizumab (TCZ) en comparación con placebo en pacientes con espondilitis anquilosante que han tenido una respuesta insuficiente al tratamiento previo con un antagonista del TNF. | Ankylosing SpondylitisEspondilitis Anquilosante MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Belgium;Spain;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 6 | EUCTR2009-017443-34-ES (EUCTR) | 14/12/2010 | 06/10/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy.Estudio en fase II/III ininterrumpido, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la reducción de los signos y síntomas y la inhibición de los daños estructurales durante el tratamiento con tocilizumab en comparación con placebo en pacientes con espondilitis anquilosante que no han respondido a los antiinflamatorios no esteroideos y no han recibido tratamiento previo con antagonistas del TNF. | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy.Estudio en fase II/III ininterrumpido, multicéntrico, aleatorizado, doble ciego y controlado con placebo para evaluar la reducción de los signos y síntomas y la inhibición de los daños estructurales durante el tratamiento con tocilizumab en comparación con placebo en pacientes con espondilitis anquilosante que no han respondido a los antiinflamatorios no esteroideos y no han recibido tratamiento previo con antagonistas del TNF. | Ankylosing Spondylitis (AS)Espondilitis anquilosante (EA) MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania | |||
| 7 | EUCTR2009-017488-40-BG (EUCTR) | 08/12/2010 | 22/11/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 8 | EUCTR2009-017488-40-DK (EUCTR) | 16/11/2010 | 16/09/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 9 | EUCTR2009-017488-40-LT (EUCTR) | 02/11/2010 | 19/08/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 10 | EUCTR2009-017443-34-LT (EUCTR) | 02/11/2010 | 18/08/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 13.1;Level: PT;Classification code 10002556;Term: Ankylosing spondylitis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania | |||
| 11 | EUCTR2009-017488-40-GB (EUCTR) | 01/11/2010 | 09/08/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2009-017443-34-GB (EUCTR) | 01/11/2010 | 09/08/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-5733/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | ||
| 13 | EUCTR2009-017443-34-CZ (EUCTR) | 27/10/2010 | 29/09/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-5733/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | |||
| 14 | EUCTR2009-017488-40-DE (EUCTR) | 18/10/2010 | 02/09/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 15 | EUCTR2009-017488-40-CZ (EUCTR) | 12/10/2010 | 20/09/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 16 | NCT01209689 (ClinicalTrials.gov) | October 2010 | 24/9/2010 | A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy | A Randomized, Double-blind, Parallel Group Placebo-controlled Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab (TCZ) Versus Placebo in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous TNF Antagonist Therapy | Spondylitis, Ankylosing | Drug: Tocilizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 113 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Lithuania;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom |
| 17 | EUCTR2009-017488-40-IT (EUCTR) | 22/09/2010 | 28/09/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy - ND | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy - ND | Ankylosing Spondylitis MedDRA version: 9.1;Level: LLT;Classification code 10002556 | Trade Name: RoActemra INN or Proposed INN: Tocilizumab | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;United Kingdom;Italy | |||
| 18 | EUCTR2009-017443-34-IT (EUCTR) | 22/09/2010 | 28/09/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naìve to TNF antagonist therapy | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naìve to TNF antagonist therapy | 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] - Immune System Diseases [C20] | Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy | |||
| 19 | EUCTR2009-017488-40-SK (EUCTR) | 13/09/2010 | 16/08/2010 | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | A randomized, double-blind, parallel-group placebo-controlled study of the safety and reduction of signs and symptoms during treatment with tocilizumab (TCZ) versus placebo in patients with ankylosing spondylitis who have had an inadequate response to previous TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 250 | Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom | |||
| 20 | EUCTR2009-017443-34-SK (EUCTR) | 13/09/2010 | 17/08/2010 | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | A Ph II/III seamless, multi-center, randomized, double-blind, placebo-controlled study of the reduction in signs and symptoms and inhibition of structural damage during treatment with tocilizumab versus placebo in patients with ankylosing spondylitis who have failed non-steroidal anti-inflammatory drugs and are naïve to TNF antagonist therapy | Ankylosing Spondylitis MedDRA version: 12.1;Level: LLT;Classification code 10002556;Term: Ankylosing spondylitis | Trade Name: RoActemra® Product Code: Ro 487-5733/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 502 | Czech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | |||
| 21 | NCT01209702 (ClinicalTrials.gov) | September 2010 | 24/9/2010 | A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs | A Ph II/III Seamless, Multi-center, Randomized, Double-blind, Placebo-controlled Study of the Reduction in Signs and Symptoms and Inhibition of Structural Damage During Treatment With Tocilizumab Versus Placebo in Patients With Ankylosing Spondylitis Who Have Failed Non-steroidal Anti-inflammatory Drugs and Are naïve to TNF Antagonist Therapy NSAIDs | Spondylitis, Ankylosing | Biological: tocilizumab;Drug: Placebo | Hoffmann-La Roche | NULL | Terminated | 18 Years | N/A | All | 306 | Phase 3 | United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;France;Germany;India;Italy;Lithuania;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom;Mexico;Netherlands |