271. Ankylosing spondylitis
531 clinical trials,   343 drugs   (DrugBank: 66 drugs),   41 drug target genes,   141 drug target pathways

Searched query = "Ankylosing spondylitis", "Spondylarthritis ankylopoietica"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
21 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-017443-34-BE
(EUCTR)
16/05/201108/10/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
502Phase 2;Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Bulgaria;Germany;Italy;United Kingdom
2EUCTR2009-017488-40-BE
(EUCTR)
22/03/201101/09/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
3EUCTR2009-017443-34-DE
(EUCTR)
17/01/201102/09/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;United Kingdom;Germany;Belgium;Bulgaria;Spain;Italy;Lithuania
4EUCTR2009-017443-34-BG
(EUCTR)
07/01/201124/11/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
5EUCTR2009-017443-34-ES
(EUCTR)
14/12/201006/10/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2009-017488-40-ES
(EUCTR)
14/12/201006/10/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Belgium;Spain;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
7EUCTR2009-017488-40-BG
(EUCTR)
08/12/201022/11/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
8EUCTR2009-017488-40-DK
(EUCTR)
16/11/201016/09/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
9EUCTR2009-017443-34-LT
(EUCTR)
02/11/201018/08/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Germany;United Kingdom;Belgium;Bulgaria;Spain;Italy;Lithuania
10EUCTR2009-017488-40-LT
(EUCTR)
02/11/201019/08/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2009-017488-40-GB
(EUCTR)
01/11/201009/08/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
250Phase 3Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
12EUCTR2009-017443-34-GB
(EUCTR)
01/11/201009/08/2010A 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 therapyA 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
F. Hoffmann-La Roche Ltd.NULLNot Recruiting Female: yes
Male: yes
502Phase 2;Phase 3Czech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
13EUCTR2009-017443-34-CZ
(EUCTR)
27/10/201029/09/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
14EUCTR2009-017488-40-DE
(EUCTR)
18/10/201002/09/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
15EUCTR2009-017488-40-CZ
(EUCTR)
12/10/201020/09/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT01209689
(ClinicalTrials.gov)
October 201024/9/2010A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist TherapyA 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 TherapySpondylitis, AnkylosingDrug: Tocilizumab;Drug: PlaceboHoffmann-La RocheNULLTerminated18 YearsN/AAll113Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;Denmark;France;Germany;India;Italy;Lithuania;Netherlands;Poland;Slovakia;South Africa;Spain;United Kingdom
17EUCTR2009-017488-40-IT
(EUCTR)
22/09/201028/09/2010A 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 - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;United Kingdom;Italy
18EUCTR2009-017443-34-IT
(EUCTR)
22/09/201028/09/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Belgium;Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
19EUCTR2009-017488-40-SK
(EUCTR)
13/09/201016/08/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
250Czech Republic;Slovakia;Spain;Belgium;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
20EUCTR2009-017443-34-SK
(EUCTR)
13/09/201017/08/2010A 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 therapyA 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.NULLNot RecruitingFemale: yes
Male: yes
502Czech Republic;Slovakia;Belgium;Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21NCT01209702
(ClinicalTrials.gov)
September 201024/9/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDsA 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 NSAIDsSpondylitis, AnkylosingBiological: tocilizumab;Drug: PlaceboHoffmann-La RocheNULLTerminated18 YearsN/AAll306Phase 3United States;Australia;Belgium;Brazil;Bulgaria;Canada;Czech Republic;France;Germany;India;Italy;Lithuania;Poland;Russian Federation;Slovakia;South Africa;Spain;United Kingdom;Mexico;Netherlands