TOCILIZUMAB ( DrugBank: Tocilizumab )

21 diseases

告示番号	疾患名（ページ内リンク）	臨床試験数
2	筋萎縮性側索硬化症	1
11	重症筋無力症	2
13	多発性硬化症／視神経脊髄炎	8
40	高安動脈炎	11
41	巨細胞性動脈炎	30
42	結節性多発動脈炎	2
43	顕微鏡的多発血管炎	5
44	多発血管炎性肉芽腫症	4
46	悪性関節リウマチ	416
49	全身性エリテマトーデス	1
50	皮膚筋炎／多発性筋炎	2
51	全身性強皮症	24
53	シェーグレン症候群	1
54	成人スチル病	2
55	再発性多発軟骨炎	4
56	ベーチェット病	1
86	肺動脈性肺高血圧症	2
107	若年性特発性関節炎	79
266	家族性地中海熱	4
271	強直性脊椎炎	21
331	特発性多中心性キャッスルマン病	3

2. 筋萎縮性側索硬化症

臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225

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	NCT02469896 (ClinicalTrials.gov)	November 2015	3/6/2015	A Trial of Tocilizumab in ALS Subjects	A Phase 2 Randomized, Placebo Controlled Trial of Tocilizumab in ALS Subjects	ALS;Amyotrophic Lateral Sclerosis;Lou Gehrig's Disease;Motor Neuron Disease	Drug: Tocilizumab;Other: Placebo	Barrow Neurological Institute	ALS Association;Barrow Neurological Foundation;Massachusetts General Hospital;Genentech, Inc.	Completed	18 Years	75 Years	All	22	Phase 2	United States

11. 重症筋無力症

臨床試験数 : 332 / 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127

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	NCT05067348 (ClinicalTrials.gov)	July 21, 2022	23/9/2021	Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis	A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis	Myasthenia Gravis, Generalized	Drug: Tocilizumab Injectable Product	Tang-Du Hospital	NULL	Recruiting	18 Years	80 Years	All	64	Phase 2	China
2	ChiCTR2100043273	2021-02-20	2021-02-09	Efficacy and safety of tocilizumab in the treatment of generalizaed myasthenia gravis: a single-center, prospective cohort study	Efficacy and safety of tocilizumab in the treatment of generalizaed myasthenia gravis: a single-center, prospective cohort study	Myasthenia gravis	Tocilizumab treatment group:Tocilizumab+Oral corticosteroids;Conventional immunotherapy group:Oral immunosuppressant;	Department of Neurology, The Second Affiliated Hospital of Air Force Medical University	NULL	Recruiting	18	80	Both	Tocilizumab treatment group:32;Conventional immunotherapy group:32;	N/A	China

13. 多発性硬化症／視神経脊髄炎

臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

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	NCT03350633 (ClinicalTrials.gov)	November 1, 2017	10/11/2017	Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders	Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial	Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica	Drug: Tocilizumab Injection;Drug: Azathioprine	Tianjin Medical University General Hospital	NULL	Completed	18 Years	N/A	All	118	Phase 2/Phase 3	China
2	NCT03062579 (ClinicalTrials.gov)	February 1, 2017	13/2/2017	A Longitudinal Study of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active NMOSD	Single-center, Open Label Trial of ACTEMRA® (Tocilizumab) as Monotherapy in Highly Active Neuromyelitis Optica Spectrum Disorders (NMOSD)	Neuromyelitis Optica Spectrum Disorders;Neuromyelitis Optica;Devic's Disease	Drug: Tocilizumab	Fu-Dong Shi	NULL	Completed	18 Years	N/A	All	10	Phase 1/Phase 2	China
3	JPRN-UMIN000022201	2016/01/10	04/05/2016	The efficacy and safety of tocilizumab in patients with neuromyelitis optica	The efficacy and safety of tocilizumab in patients with neuromyelitis optica - The efficacy and safety of tocilizumab in patients with neuromyelitis optica	neuromyelitis optica	Tocilizumab it to be infused every 4weeks at 8mg/kg of body weight for 2 years.	Department of Neurology, Shimane University Hospital	NULL	Complete: follow-up complete	20years-old	74years-old	Male and Female	3	Not selected	Japan
4	JPRN-UMIN000012705	2014/01/07	07/01/2014	The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis	The efficacy and safety of an anti-interluekin-6 receptor antibody in relapsing-remitting multiple sclerosis - Treatment with an anti-interleukin-6 receptor antibody for relapsing-remitting multiple sclerosis	Relapsing-remitting multiple sclerosis	Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 2 years.	Department of Immunology, National Institute of Neuroscience, NCNP	NULL	Recruiting	20years-old	65years-old	Male and Female	10	Not applicable	Japan
5	JPRN-jRCTs031180346	02/12/2013	18/03/2019	Treatment with an anti-interleukin-6 receptor antibody for multiple sclerosis	The efficacy and safety of an anti-interluekin-6 receptor antibody in multiple sclerosis	multiple sclerosis;D009103	Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight.	Yamamura Takashi	NULL	Complete	>= 20age old	<= 65age old	Both	6	N/A	Japan
6	JPRN-jRCTs031180152	04/06/2012	25/02/2019	Tocilizumab in patients with neuromyelitis optica	The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter study - Tocilizumab in patients with neuromyelitis optica	Neuromyelitis optica;D009471	Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months.	Yamamura Takashi	NULL	Complete	>= 20age old	<= 65age old	Both	20	N/A	Japan
7	JPRN-UMIN000007866	2012/05/01	01/05/2012	The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study	The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study - Tocilizumab in patients with neuromyelitis optica: Multicenter Study	neuromyelitis optica	Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 years.	Department of Immunology, National Institute of Neuroscience, NCNP	Department of Neurology, Kinki University Faculty of Mediceine	Complete: follow-up continuing	20years-old	65years-old	Male and Female	15	Not applicable	Japan
8	JPRN-UMIN000005889	2011/07/01	08/07/2011	The safety and efficacy of tocilizumab in patients with neuromyelitis optica	The safety and efficacy of tocilizumab in patients with neuromyelitis optica - Tocilizumab in patients with neuromyelitis optica	neuromyelitis optica	Tocilizumab is to be infused every 4 weeks at 8 mg/kg of body weight for 6 months.	Department of Immunology, National Institute of Neuroscience, NCNP	NULL	Complete: follow-up complete	20years-old	65years-old	Male and Female	3	Not applicable	Japan

先頭へ

40. 高安動脈炎

臨床試験数 : 24 / 薬物数 : 40 - (DrugBank : 18) / 標的遺伝子数 : 23 - 標的パスウェイ数 : 110

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	NCT05168475 (ClinicalTrials.gov)	July 14, 2021	9/12/2021	Biologics in Refractory Vasculitis	Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children	Giant Cell Arteritis;Takayasu Arteritis;Cogan Syndrome;Relapsing Polychondritis;Cryoglobulinemic Vasculitis;IgA Vasculitis;Polyarteritis Nodosa;Cutaneous Polyarteritis Nodosa;Primary Angiitis of Central Nervous System	Biological: Rituximab;Biological: Infliximab;Biological: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Recruiting	5 Years	N/A	All	140	Phase 2	United Kingdom
2	NCT04564001 (ClinicalTrials.gov)	September 2020	21/9/2020	Multicentre, Randomized, Prospective Trial Evaluating the Efficacy and Safety of Infliximab to Tocilizumab in Refractory or Relapsing Takayasu Arteritis	Multicentre, Randomized, Prospective Trial Evaluating the Efficacy and Safety of Infliximab to Tocilizumab in Refractory or Relapsing Takayasu Arteritis	Takayasu Arteritis	Drug: Infliximab;Drug: Tocilizumab	Assistance Publique - Hôpitaux de Paris	NULL	Not yet recruiting	18 Years	N/A	All	50	Phase 2	NULL
3	NCT04300686 (ClinicalTrials.gov)	March 1, 2020	5/3/2020	A Pilot Study in Severe Patients With Takayasu Arteritis.	A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort	Takayasu Arteritis;Tocilizumab;Adalimumab;Treatment	Biological: Tocilizumab;Biological: Adalimumab	Shanghai Zhongshan Hospital	NULL	Recruiting	14 Years	100 Years	All	40	Phase 4	China
4	EUCTR2018-003753-13-FR (EUCTR)	19/03/2019	13/12/2018	INTOReTAK : INfliximab and TOcilizumab in Refractory/relapsing TAKayasu arteritis	Multicentre, randomized, prospective trial comparing the efficacy and safety of Infliximab to tocilizumab in refractory or relapsing Takayasu arteritis	Patients with refractory or relapsing Takayasu Arteritis desease;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]	Trade Name: RoActemra 20mg/ml Product Name: Tocilizumab INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	50	Phase 3	France
5	JPRN-UMIN000025940	2017/02/07	07/02/2017	Clinical Research on the Safety of anti-interleukin-6 antibody (Tocilizumab) treatment for the refractory patients with Takayasu Arteritis	Clinical Research on the Safety of anti-interleukin-6 antibody (Tocilizumab) treatment for the refractory patients with Takayasu Arteritis - TOCIlizumab treatment for TAKayasu arteritis (TOCI-TAK)	Takayasu arteritis	Intravenous administration of tocilizumab (8mg/kg/month) for up to 12 months	Osaka University	National Cerebral and Cardiovascular Center	Complete: follow-up continuing	16years-old	60years-old	Male and Female	2	Not selected	Japan
6	NCT03893136 (ClinicalTrials.gov)	November 1, 2016	12/3/2019	The Registry Study of Takayasu Arteritis in East China	The Cohort Study of East Chinese Takayasu's Arteritis (ECTA-cohort Study)	Takayasu Arteritis;Mechanisms, Defense;Pregnancy Related;Treatment Refusal;Outcome	Biological: Tocilizumab;Drug: Leflunomide	Shanghai Zhongshan Hospital	NULL	Recruiting	18 Years	65 Years	All	1000		China
7	JPRN-JapicCTI-142616	02/10/2014	23/07/2014	Phase III Study of MRA-SC in Patients with Takayasu Arteritis	A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase III Study of MRA-SC in Patients with Takayasu Arteritis	Takayasu Arteritis	Intervention name : tocilizumab (MRA-SC) INN of the intervention : tocilizumab Dosage And administration of the intervention : 162mg/W, SC Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo/W, SC	Chugai Pharmaceutical Co., Ltd.	NULL	complete	12		BOTH	34	Phase 3	Japan
8	JPRN-UMIN000025943	2014/08/07	07/02/2017	Long-term Safety of treatment with tocilizumab in the refractory patients with Takayasu Arteritis	Long-term Safety of treatment with tocilizumab in the refractory patients with Takayasu Arteritis - Long-term ACTemra Investigation for remissION introduction in TAKayasu Arteritits (LACTION-TAK)	Takayasu arteritis	Intravenous administration of tocilizumab (8mg/kg/month) will be performed until December 31st, 2017.	Osaka Unversity	National Cerebral and Cardiovascular Center	Complete: follow-up continuing	16years-old	60years-old	Male and Female	9	Not selected	Japan
9	NCT02101333 (ClinicalTrials.gov)	June 10, 2014	17/2/2014	Efficacy and Tolerance of Tocilizumab In Takayasu Arteritis	Efficacy and Tolerance of First-line Treatment With Tocilizumab in Active Takayasu Arteritis French Prospective Multicenter Study	TAKAYASU ARTERITIS	Drug: Tocilizumab	Assistance Publique - Hôpitaux de Paris	Chugai Pharmaceutical	Completed	18 Years	77 Years	All	18	Phase 3	France
10	JPRN-UMIN000008812	2012/10/01	01/10/2012	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy	Rheumatoid arthritis	tocilizumab monotherapy	Department of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical Universitity	NULL	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Not selected	Japan
11	JPRN-UMIN000007845	2012/05/01	01/05/2012	Efficacy and Safety of treatment with tocilizumab in refractory patients with Takayasu Arteritis	Efficacy and Safety of treatment with tocilizumab in refractory patients with Takayasu Arteritis - ACTemra Investigation for remissiON introduction in Takayasu Arteritits (ACTION-TA)	Takayasu arteritis	Intravenous administration of tocilizumab (8mg/kg/month) for 24 months	Department of Cardiovascular Medicine Graduate School of Medicine Osaka University	NULL	Complete: follow-up continuing	16years-old	60years-old	Male and Female	15	Not selected	Japan

先頭へ

41. 巨細胞性動脈炎

臨床試験数 : 131 / 薬物数 : 139 - (DrugBank : 36) / 標的遺伝子数 : 33 - 標的パスウェイ数 : 125

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	NCT05623592 (ClinicalTrials.gov)	November 23, 2022	8/11/2022	Methotrexate as Remission Maintenance Therapy After Remission-Induction With Tocilizumab and Glucocorticoids in Giant Cell Arteritis	A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy of Methotrexate as Remission Maintenance Therapy After Remission-Induction Therapy With Tocilizumab and Glucocorticoids in Subjects With Giant Cell Arteritis	Giant Cell Arteritis	Drug: Methotrexate;Drug: Sodium chloride	University of Bonn	NULL	Recruiting	18 Years	N/A	All	40	Phase 2	Germany
2	NCT05168475 (ClinicalTrials.gov)	July 14, 2021	9/12/2021	Biologics in Refractory Vasculitis	Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children	Giant Cell Arteritis;Takayasu Arteritis;Cogan Syndrome;Relapsing Polychondritis;Cryoglobulinemic Vasculitis;IgA Vasculitis;Polyarteritis Nodosa;Cutaneous Polyarteritis Nodosa;Primary Angiitis of Central Nervous System	Biological: Rituximab;Biological: Infliximab;Biological: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Recruiting	5 Years	N/A	All	140	Phase 2	United Kingdom
3	NCT04885829 (ClinicalTrials.gov)	May 31, 2021	3/5/2021	Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers	A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers	Rheumatoid Arthritis;Giant Cell Arteritis	Drug: Tocilizumab Prefilled Syringe	Syneos Health	Dr. Reddy's Laboratories Limited	Active, not recruiting	18 Years	50 Years	All	300	Phase 1	Australia;India;New Zealand
4	NCT04888221 (ClinicalTrials.gov)	May 2021	25/3/2021	Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement	Efficacy of Tocilizumab in Association to Steroids in Giant Cell Arteritis With Cerebro-vascular Involvement (ToGiAC)	Giant Cell Arteritis;Neurovascular Disorder	Drug: Tocilizumab;Drug: Placebo	Assistance Publique - Hôpitaux de Paris	Roche Chugai;Roche Pharma AG	Not yet recruiting	60 Years	N/A	All	66	Phase 3	France
5	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom
6	NCT04239196 (ClinicalTrials.gov)	July 1, 2020	19/11/2019	Efficacy of Tocilizumab for the Treatment of Acute AION Related to GCA	Open Label Phase II Randomized Non-comparative Study of SC Tocilizumab Associated With IV Pulse Steroid Versus IV Pulse Steroid Alone for the Treatment of Acute Anterior Ischemic Optic Neuropathy Associated With Giant Cell Arteritis	Giant Cell Arteritis;Optic Ischaemic Neuropathy	Drug: tocilizumab and IV steroids combination;Other: IV steroids combination alone	Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts	Roche Chugai	Not yet recruiting	50 Years	N/A	All	58	Phase 2	France
7	NCT05394909 (ClinicalTrials.gov)	February 7, 2020	20/5/2022	Ultra-short Glucocorticosteroids and Tocilizumab Therapy in GCA Patients	Treatment Of Giant Cell Arteritis Patients With Ultra-short Glucocorticosteroids And tociliZumab: Role of Imaging in a Observational Study	GCA;TOCILIZUMAB;Glucocorticoids;PET	Drug: Tocilizumab 162Mg/0.9Ml Autoinjector	Azienda Unità Sanitaria Locale Reggio Emilia	NULL	Active, not recruiting	N/A	N/A	All	20		Italy
8	NCT03892785 (ClinicalTrials.gov)	January 27, 2020	26/3/2019	MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial	MEthotrexate Versus TOcilizumab for Treatment of GIant Cell Arteritis: a Multicenter, Randomized, Controlled Trial	Giant Cell Arteritis	Drug: Prednisone treatment;Drug: Tocilizumab treatment;Drug: Methotrexate treatment;Other: Questionnaires;Biological: Blood samples	Centre Hospitalier Universitaire Dijon	NULL	Recruiting	50 Years	N/A	All	230	Phase 3	France
9	NCT03923738 (ClinicalTrials.gov)	August 5, 2019	19/4/2019	A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).	A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis	Giant Cell Arteritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	50 Years	N/A	All	23	Phase 1	Switzerland
10	EUCTR2018-002826-22-FR (EUCTR)	07/03/2019	21/11/2018	MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA	MEthotrexate versus TOcilizumab for treatment of GIant cell Arteritis: a multicenter, randomized, controlled trial - METOGIA	MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: METOJECT Trade Name: RoActemra	CHU Dijon Bourgogne	NULL	Authorised-recruitment may be ongoing or finished			Female: no Male: no	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France
11	NCT03745586 (ClinicalTrials.gov)	December 1, 2018	6/11/2018	Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab	Giant Cell Arteritis Treatment With Ultra-short Glucocorticoids and Tocilizumab	Giant Cell Arteritis	Drug: Tocilizumab;Drug: Glucocorticoids	University Hospital Inselspital, Berne	NULL	Completed	50 Years	N/A	All	18	Phase 1/Phase 2	Switzerland;Italy
12	NCT03726749 (ClinicalTrials.gov)	November 28, 2018	30/10/2018	Tocilizumab Plus a Short Prednisone Taper for GCA	Tocilizumab Plus a Short Prednisone Taper for Giant Cell Arteritis (GCA)	Giant Cell Arteritis	Drug: Tocilizumab;Drug: Prednisone	Massachusetts General Hospital	Roche-Genentech	Recruiting	50 Years	N/A	All	30	Phase 4	United States
13	NCT03202368 (ClinicalTrials.gov)	October 25, 2017	27/6/2017	An Extension Study to Evaluate Long-Term Safety of Subcutaneous (SC) Tocilizumab in Participants With Giant Cell Arteritis (GCA)	An Extension Study to Evaluate Long Term Safety of Subcutaneous Tocilizumab in Patients With Giant Cell Arteritis Who Have Completed WA28119 Core Study in France, and Subsequently Having Flare or Persisting Disease Activity.	Giant Cell Arteritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	50 Years	N/A	All	3	Phase 3	France
14	EUCTR2016-002716-41-FR (EUCTR)	24/05/2017	04/04/2017	A STUDY TO EVALUATE LONG TERM SAFETY OF TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE	AN EXTENSION STUDY TO EVALUATE LONG TERM SAFETY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH GIANT CELL ARTERITIS WHO HAVE COMPLETED WA28119 CORE STUDY IN FRANCE, AND SUBSEQUENTLY HAVING FLARE OR PERSISTING DISEASE ACTIVITY	Giant cell arteritis (GCA) MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra 162 mg solution for injection in pre-filled syringe INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	ROCHE SAS	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 3	France
15	NCT03244709 (ClinicalTrials.gov)	January 1, 2015	1/8/2017	Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission.	Tocilizumab Dose-tapering and Interruption in Patients With Giant Cell Arteritis Achieving the Clinical Remission: a Prospective, Pilot Study.	Giant Cell Arteritis	Drug: Tocilizumab	Hospital of Prato	NULL	Recruiting	18 Years	90 Years	All	15	Phase 4	Italy
16	NCT01910038 (ClinicalTrials.gov)	November 8, 2013	17/7/2013	Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.	Evaluation of Tocilizumab as an add-on Therapy to Corticoids in Giant Cell Arteritis: Proof of Concept Study.	Giant Cell Arteritis	Drug: corticoids+ tocilizumab 8mg/Kg/4 weeks	Centre Hospitalier Universitaire Dijon	NULL	Completed	50 Years	N/A	All	20	Phase 2	France
17	EUCTR2011-006022-25-NL (EUCTR)	09/10/2013	24/05/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 17.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: TOCILIZUMAB SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Norway;Sweden
18	EUCTR2011-006022-25-BE (EUCTR)	30/09/2013	17/06/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
19	EUCTR2011-006022-25-PL (EUCTR)	09/09/2013	16/07/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 19.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
20	NCT01791153 (ClinicalTrials.gov)	July 22, 2013	12/2/2013	An Efficacy and Safety Study of Tocilizumab (RoActemra/Actemra) in Participants With Giant Cell Arteritis (GCA)	A Phase III, Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Tocilizumab in Subjects With Giant Cell Arteritis	Giant Cell Arteritis	Drug: Tocilizumab;Drug: Prednisone;Drug: Tocilizumab Placebo;Drug: Prednisone Placebo;Drug: Corticosteroids;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	50 Years	N/A	All	251	Phase 3	United States;Belgium;Canada;Denmark;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Spain;Sweden;United Kingdom;Austria
21	EUCTR2011-006022-25-ES (EUCTR)	24/06/2013	10/06/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 16.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden
22	EUCTR2011-006022-25-DK (EUCTR)	14/06/2013	14/05/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden;United States;Spain;Portugal
23	EUCTR2011-006022-25-PT (EUCTR)	07/06/2013	22/05/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Netherlands;Norway;Germany;Sweden
24	EUCTR2011-006022-25-DE (EUCTR)	06/06/2013	13/05/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000013753;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
25	EUCTR2011-006022-25-GB (EUCTR)	23/05/2013	15/05/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 19.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
26	EUCTR2011-006022-25-SE (EUCTR)	16/05/2013	07/05/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 20.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
27	EUCTR2011-006022-25-AT (EUCTR)	14/05/2013	10/05/2013	A clinical study in which neither staff at the site nor the patient nor the sponsor's team know if the patient received drug with an active ingredient or drug without an active ingredient. The aim of this study is to find out if tocilizumab is an effective and safe treatment in patients with Giant Cell Arteritis, an inflammatory disease of the blood vessels.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 17.0;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	Portugal;United States;Spain;Austria;United Kingdom;Italy;France;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Norway;Sweden
28	EUCTR2011-006022-25-IT (EUCTR)	05/05/2013	07/03/2013	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB IN SUBJECTS WITH GIANT CELL ARTERITIS	Giant cell arteritis (GCA) MedDRA version: 14.1;Level: LLT;Classification code 10018250;Term: Giant cell arteritis;System Organ Class: 100000004866;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: PredniSONE Tablets USP, 1 mg Product Code: Ro 001-9265/F02 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 2.5 mg Product Code: Ro 001-9265/F03 Other descriptive name: PREDNISONE Trade Name: PredniSONE Tablets USP, 5 mg Product Code: Ro 001-9265/F04 Other descriptive name: PREDNISONE Trade Name: Encorton Product Code: Ro 001-9265 Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	250	Phase 3	United States;Portugal;Spain;Austria;Italy;United Kingdom;France;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Norway;Sweden
29	JPRN-UMIN000008812	2012/10/01	01/10/2012	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy	Rheumatoid arthritis	tocilizumab monotherapy	Department of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical Universitity	NULL	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Not selected	Japan
30	NCT01450137 (ClinicalTrials.gov)	September 2011	3/10/2011	Tocilizumab for Patients With Giant Cell Arteritis	A Phase II, Randomized, Double-blind, Placebo Controlled Study of Tocilizumab in Patients With Giant Cell Arteritis	Giant Cell Arteritis	Drug: Tocilizumab + Glucocorticoids (GCs);Drug: Placebo + Glucocorticoids (GCs)	University Hospital Inselspital, Berne	University of Bern;Roche Pharma AG	Completed	50 Years	N/A	All	30	Phase 2	Switzerland

先頭へ

42. 結節性多発動脈炎

臨床試験数 : 15 / 薬物数 : 26 - (DrugBank : 16) / 標的遺伝子数 : 26 - 標的パスウェイ数 : 105

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	NCT05168475 (ClinicalTrials.gov)	July 14, 2021	9/12/2021	Biologics in Refractory Vasculitis	Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children	Giant Cell Arteritis;Takayasu Arteritis;Cogan Syndrome;Relapsing Polychondritis;Cryoglobulinemic Vasculitis;IgA Vasculitis;Polyarteritis Nodosa;Cutaneous Polyarteritis Nodosa;Primary Angiitis of Central Nervous System	Biological: Rituximab;Biological: Infliximab;Biological: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Recruiting	5 Years	N/A	All	140	Phase 2	United Kingdom
2	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom

43. 顕微鏡的多発血管炎

臨床試験数 : 88 / 薬物数 : 81 - (DrugBank : 21) / 標的遺伝子数 : 15 - 標的パスウェイ数 : 90

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	JPRN-UMIN000024574	2018/07/02	01/05/2017	Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis	Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ	Microscopic polyangiitis (MPA)Granulomatosis with polyangiitis (GPA)	TCZ group Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24. Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48. PSL PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day. IVCY group Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times). From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52. PSL PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.	Tokyo women's medical universityInstitute of rheumatology	Hokkaido university hospitalSaitama medical centerTokyo women's medical university hospitalKeio university hospitalJuntendo university hospitalKyorin university hospitalSt. Marianna university hospitalOkayama university hospitalKagawa university hospitalHospital of the university of occupational and environmental health, JapanTokyo Medical CenterTouhoku University HospitalKyusyu University HospitalHiroshima University Hospital	Recruiting	20years-old	85years-old	Male and Female	48	Phase 2	Japan
2	JPRN-JMA-IIA00325	01/07/2018	23/01/2018	Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis	Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis	Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA)	Intervention type:DRUG. Intervention1:remission induction therapy, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24. Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48. . Control intervention1:Cyclophosphamide (CY), Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, Intended dose regimen:Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times). From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52. PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day..	Masayoshi Harigai	NULL	Pending	>=20 YEARS	<80 YEARS	BOTH	48	Phase 2	Japan
3	JPRN-UMIN000012072	2013/12/01	01/12/2013	A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis	A prospective, open label, single arm, historical control trial of tocilizumab with corticosteroids in patients with microscopic polyangiitis - Tocilizumab with corticosteroids in microscopic polyangiitis	Microscopic polyangiitis	Tocilizumab group	Department of Rheumatology & Clinical Immunology Saitama Medical Center, Saitama Medical Universitity	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	20	Phase 3	Japan
4	JPRN-UMIN000011244	2013/09/01	01/09/2013	A prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitis	A prospective, open label, randomized, controlled trial of tocilizumab versus cyclophosphamide in patients with microscopic polyangiitis - Tocilizumab versus cyclophosphamide in microscopic polyangiitis	Microscopic polyangiitis	Tocilizumab group Cyclophosphamide group	Saitama Medical Center, Saitama Medical UniversityDepartment of Rheumatology and Clinical Immunology	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	40	Not selected	Japan
5	JPRN-UMIN000011242	2013/09/01	01/09/2013	Efficacy and safety of tocilizumab monotherapy in patients with microscopic polyangiitis	Efficacy and safety of tocilizumab monotherapy in patients with microscopic polyangiitis - Tocilizumab mono-therapy for microscopic polyangiitis	Microscopic polyangiitis	tocilizumab monotherapy	Saitama Medical Center, Saitama Medical UniversityDepartment of Rheumatology and Clinical Immunology	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	10	Not selected	Japan

先頭へ

44. 多発血管炎性肉芽腫症

臨床試験数 : 98 / 薬物数 : 108 - (DrugBank : 28) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 81

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	NCT04871191 (ClinicalTrials.gov)	March 2023	26/2/2021	Study of Salvage Therapy to Treat Patients With Granulomatosis With Polyangiitis	Salvage Therapy for Patients With Inadequate Response to Standard of Care Therapy in Granulomatosis With Polyangiitis	Granulomatosis With Polyangiitis;Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis	Drug: Rituximab;Drug: Tocilizumab;Drug: Abatacept	Assistance Publique - Hôpitaux de Paris	URC-CIC Paris Descartes Necker Cochin	Not yet recruiting	18 Years	N/A	All	42	Phase 2	France
2	EUCTR2021-000679-35-FR (EUCTR)	07/09/2021	25/06/2021	SATELITE Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis”	SATELITE Salvage Therapy for Patients with Inadequate Response to Standard of Care Therapy in Granulomatosis with Polyangiitis” - SATELITE	Granulomatosis with Polyangiitis;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]	Trade Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Trade Name: ORENCIA INN or Proposed INN: ABATACEPT Trade Name: Methotrexate Other descriptive name: METHOTREXATE Trade Name: Mycophénolate mofétil Other descriptive name: MYCOPHENOLATE MOFETIL Trade Name: Azathioprine Other descriptive name: AZATHIOPRINE	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	42	Phase 2	France
3	JPRN-UMIN000024574	2018/07/02	01/05/2017	Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis	Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis - AAVTCZ	Microscopic polyangiitis (MPA)Granulomatosis with polyangiitis (GPA)	TCZ group Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24. Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48. PSL PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day. IVCY group Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times). From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52. PSL PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day.	Tokyo women's medical universityInstitute of rheumatology	Hokkaido university hospitalSaitama medical centerTokyo women's medical university hospitalKeio university hospitalJuntendo university hospitalKyorin university hospitalSt. Marianna university hospitalOkayama university hospitalKagawa university hospitalHospital of the university of occupational and environmental health, JapanTokyo Medical CenterTouhoku University HospitalKyusyu University HospitalHiroshima University Hospital	Recruiting	20years-old	85years-old	Male and Female	48	Phase 2	Japan
4	JPRN-JMA-IIA00325	01/07/2018	23/01/2018	Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis	Clinical trial of tocilizumab versus cyclophosphamide for microscopic polyangiitis and granulomatosis with polyangiitis	Microscopic polyangiitis (MPA) Granulomatosis with polyangiitis (GPA)	Intervention type:DRUG. Intervention1:remission induction therapy, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, intended dose regimen:Week 0-16: TCZ (8mg/kg) will be administrated intravenously every 2 weeks. Week 20 and 24: TCZ (8mg/kg) will be administrated intravenously every 4 weeks. If a participant does not achieve BVAS v3=0 at week 16, he/she can receive TCZ every 2 weeks until week 24. Week 28-52: If a participant achieves complete remission at week 24, he/she will receive TCZ (8mg/kg) intravenously every 4 weeks until week 48. . Control intervention1:Cyclophosphamide (CY), Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP, Intended dose regimen:Week 0-24: CY (15mg/kg, doses will be modified for renal dysfunction) will be administrated intravenously every 4 weeks (at least 3 times, up to 6 times). From 4 weeks after the last IVCY to week 52: If a participants achieves complete remission 4 weeks after the last IVCY, he/she will take azathioprine (AZA) orally every day and continue until week 52. PSL will be prescribed by the same schedule to both treatment groups. Week 0-24: Oral PSL will be given at a dose of 0.8 mg/kg/day during first 4 weeks. And then, PSL will be tapered according to the prefixed schedule. Week 25-52: Participants continue taking oral PSL at a dose of 7.5mg per day..	Masayoshi Harigai	NULL	Pending	>=20 YEARS	<80 YEARS	BOTH	48	Phase 2	Japan

46. 悪性関節リウマチ

臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228

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	NCT05725434 (ClinicalTrials.gov)	February 6, 2023	2/2/2023	A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis	A Single-arm, Open-label, Multiple-dose, Phase 3 Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: CT-P47 AI (tocilizumab);Biological: CT-P47 PFS (tocilizumab)	Celltrion	NULL	Not yet recruiting	18 Years	70 Years	All	30	Phase 3	NULL
2	NCT04885829 (ClinicalTrials.gov)	May 31, 2021	3/5/2021	Comparative Study of 3 Tocilizumab Products in Normal Healthy Volunteeers	A Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy Volunteers	Rheumatoid Arthritis;Giant Cell Arteritis	Drug: Tocilizumab Prefilled Syringe	Syneos Health	Dr. Reddy's Laboratories Limited	Active, not recruiting	18 Years	50 Years	All	300	Phase 1	Australia;India;New Zealand
3	NCT04842981 (ClinicalTrials.gov)	May 25, 2021	23/3/2021	Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis	Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid Arthritis	Arthritis, Rheumatoid;Interaction	Drug: Tocilizumab;Drug: Sarilumab	University of Southern Denmark	Odense University Hospital;Hospital of South West Jutland;King Christian X´Hospital for Rheumatic Diseases;Sygehus Lillebaelt;Odense Patient Data Explorative Network	Terminated	18 Years	75 Years	All	3	Phase 1/Phase 2	Denmark
4	JPRN-jRCTs071200107	25/05/2021	03/03/2021	Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: Comparative study with Filgotinib and Tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial	Efficacy and safety of selective JAK 1 inhibitor Filgotinib in active rheumatoid arthritis patients with inadequate response to methotrexate: Comparative study with Filgotinib and Tocilizumab examined by clinical index as well as musculoskeletal ultrasound assessment (TRANSFORM study): Study protocol for a randomized, open-label, parallel-group, multicenter, and non-inferiority clinical trial	Rheumatoid arthritis	In patients with active RA for whom continuous MTX treatment (including other concurrent csDMARDs) for at least 8 weeks is ineffective, treatment will be switched to filgotinib monotherapy or tocilizumab monotherapy. MTX (including other concomitant csDMARDs) will be discontinued at baseline. Patients who satisfy the eligibility criteria will be randomly allocated to the filgotinib treatment group or the tocilizumab group (ratio of 1:1). The patients in each group will receive each respective drug for 52 weeks. The proportion of patients who reach an American College of Rheumatology 50% improvement response (ACR50) at 12 weeks after commencement of filgotinib monotherapy or tocilizumab monotherapy will be defined as the primary endpoint, and will serve as evidence of the noninferiority of filgotinib monotherapy compared with tocilizumab monotherapy.	Kawakami Atsushi	NULL	Recruiting	>= 20age old	Not applicable	Both	400	N/A	Japan
5	EUCTR2020-005998-27-DK (EUCTR)	12/03/2021	25/01/2021	Interleukin-6 inhibitors and drug-drug interactions in patients with Rheumatoid Arthritis.	Interleukin-6 inhibitors and drug-drug interactions in patients with Rheumatoid Arthritis.	Rheumatoid arthritis MedDRA version: 23.1;Level: LLT;Classification code 10060732;Term: Rheumatoid arthritis flare up;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Product Name: Kevzara INN or Proposed INN: SARILUMAB Other descriptive name: Sarilumab Product Name: Kevzara INN or Proposed INN: SARILUMAB Other descriptive name: Sarilumab	University of Southern Denmark	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	12	Phase 1;Phase 2	Denmark
6	NCT05090410 (ClinicalTrials.gov)	March 3, 2021	30/9/2021	Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate	Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate: Comparative Study With Filgotinib and Tocilizumab Examined by Clinical Index as Well as Musculoskeletal Ultrasound Assessment	Rheumatoid Arthritis;JAK Inhibitor;IL-6 Inhibitor;Musculoskeletal Ultrasound;Biomarker	Drug: filgotinib 200mg/day;Drug: subcutaneous tocilizumab 162mg/biweekly	Atsushi Kawakami	Gilead Sciences	Recruiting	20 Years	N/A	All	400	Phase 3	Japan
7	NCT05232396 (ClinicalTrials.gov)	March 2, 2021	25/11/2021	Clinical Study of a IL-6R Injection in Patients With RA	Phase Ib Clinical Study of Safety and Tolerability , PK/PD Parameters and Preliminary Efficiency of a IL-6R Injection Monoclonal Antibody Injection in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Biological: IL-6R Monoclonal Antibody Injection 4mg/kg;Biological: IL-6R Monoclonal Antibody Injection 6mg/kg;Biological: IL-6R Monoclonal Antibody Injection 8mg/kg;Biological: Tocilizumab Injection 8mg/kg	Beijing VDJBio Co., LTD.	NULL	Completed	18 Years	70 Years	All	40	Phase 1/Phase 2	China
8	EUCTR2019-004369-42-DE (EUCTR)	15/02/2021	27/11/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Not Recruiting			Female: yes Male: yes	542	Phase 3	Serbia;United States;Czechia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Poland;Bulgaria;Georgia;Germany;Moldova, Republic of
9	EUCTR2019-004369-42-CZ (EUCTR)	01/09/2020	05/08/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Not Recruiting			Female: yes Male: yes	542	Phase 3	Serbia;Czechia;Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of
10	NCT04529863 (ClinicalTrials.gov)	August 17, 2020	25/8/2020	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tocilizumab vs Abatacept	Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines- Tocilizumab vs Abatacept	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Abatacept	Brigham and Women's Hospital	National Institute on Aging (NIA);Rutgers University;Johns Hopkins University	Completed	18 Years	N/A	All	30432		United States
11	EUCTR2019-004369-42-BG (EUCTR)	28/05/2020	07/05/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Georgia;Bulgaria;Germany;Moldova, Republic of
12	EUCTR2019-004369-42-SK (EUCTR)	12/05/2020	09/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of
13	EUCTR2019-004369-42-PL (EUCTR)	05/05/2020	23/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of
14	NCT04449224 (ClinicalTrials.gov)	April 27, 2020	7/6/2020	Comparative Effectiveness of Targeted Therapy in RA Patients	Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study	Rheumatoid Arthritis	Drug: Adalimuab, Etanercept, Tocilizumab, or Abatacept;Drug: Tofacitinib or Baricitinib	Hanyang University	Ministry of Health, Republic of Korea	Recruiting	19 Years	N/A	All	506		Korea, Republic of
15	EUCTR2019-004369-42-HU (EUCTR)	27/04/2020	03/03/2020	A study of MSB11456 compared to RoActemra in patients with moderately to severely active rheumatoid arthritis (APTURA I)	A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra® in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study) - APTURA I	Moderately to severely active Rheumatoid Arthritis MedDRA version: 21.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Code: MSB11456 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: RoActemra(R) Product Name: RoActemra (R) INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Fresenius Kabi SwissBioSim GmbH	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	542	Phase 3	United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of
16	NCT04115423 (ClinicalTrials.gov)	April 1, 2020	2/10/2019	A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab	A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database	Infection;Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)	Sungkyunkwan University	Ministry of Food and Drug Safety, Korea	Active, not recruiting	18 Years	N/A	All	9508		Korea, Republic of
17	NCT03895879 (ClinicalTrials.gov)	March 1, 2020	26/3/2019	Use of Tocilizumab Drug Levels to Optimize Treatment in RA	Concentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)	Rheumatoid Arthritis	Drug: Tocilizumab	Reade Rheumatology Research Institute	ZonMw: The Netherlands Organisation for Health Research and Development	Recruiting	18 Years	N/A	All	98	Phase 4	Netherlands
18	EUCTR2019-001754-25-NL (EUCTR)	25/11/2019	25/11/2019	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment	Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatment (ADDORA-switch): an open label randomized superiority trail - ADalimumab Dose Optimization in Rheumatoid Arthritis-switch (ADDORA-switch)	rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Enbrel, Benepali, Erelzi Product Name: Etanercepet, Rituximab, Abatacept, Tocilizumab, Sarilumab INN or Proposed INN: ETANERCEPT INN or Proposed INN: RITUXIMAB INN or Proposed INN: ABATACEPT INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB INN or Proposed INN: SARILUMAB	Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	84	Phase 4	Netherlands
19	EUCTR2017-003037-28-NL (EUCTR)	02/10/2019	22/07/2019	Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs.	Efficacy of TOcilizumab in comparison to Prednisone In Rheumatoid Arthritis patients with insufficient response to disease modifying anti-rheumatic drugs. - TOPIRA	RA patients with active RA despite treatment with DMARDs. MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Product Name: Prednisone INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE INN or Proposed INN: PREDNISOLONE Other descriptive name: Prednisolone	University Medical Center Utrecht	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	120	Phase 4	Netherlands
20	EUCTR2018-004605-57-NL (EUCTR)	06/08/2019	24/07/2019	Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients	Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patients: a randomised, multicenter, non-inferiority trial (TODORA) - Use of TOcilizumab Drug levels to Optimize treatment in RA (TODORA)	Rheumatoid arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Reade	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	98	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Netherlands
21	EUCTR2018-002202-31-BG (EUCTR)	27/03/2019	30/11/2018	A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid Arthritis	A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate	Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Code: BAT1806 INN or Proposed INN: BAT1806 Other descriptive name: TOCILIZUMAB Trade Name: RoActemra Product Name: RoActerma INN or Proposed INN: RoActemra Other descriptive name: TOCILIZUMAB	Bio-Thera Solutions, Ltd.	NULL	Not Recruiting			Female: yes Male: yes	621	Phase 3	Poland;Ukraine;Georgia;Bulgaria;China
22	ChiCTR1900021808	2019-03-08	2019-03-11	A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects	A Phase 1, Randomized, Double-Blind and Paralle, Controlled Single-dose Clinical Trial of Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of QX003S and Tocilizumab in Chinese Health Male Subjects	Active rheumatoid arthritis	1:8 mg/kg QX003S ;2:Tocilizumab, 8 mg/kg;	JiangSu Qyuns Therapeutics Co., Ltd	NULL	Recruiting	18	50	Male	1:43;2:43;	Phase 1	China
23	NCT03737708 (ClinicalTrials.gov)	February 13, 2019	8/11/2018	A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA)	Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial	Rheumatoid Arthritis (RA)	Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept	Astellas Pharma Korea, Inc.	NULL	Completed	19 Years	75 Years	All	21	Phase 4	Korea, Republic of
24	NCT03781310 (ClinicalTrials.gov)	December 2018	17/12/2018	Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid Arthritis	Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid Arthritis	Rheumatoid Arthritis;Tocilizumab	Drug: Tocilizumab	Tel-Aviv Sourasky Medical Center	Amsterdam Rheumatology and Immunology Center	Unknown status	18 Years	N/A	All	80	Phase 4	Israel
25	EUCTR2017-004079-30-PT (EUCTR)	09/08/2018	29/06/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB SC Trade Name: Enbrel Product Name: Enbrel INN or Proposed INN: ETANERCEPT	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Spain;Belgium;Italy
26	EUCTR2017-004079-30-ES (EUCTR)	10/07/2018	21/03/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rhuematoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: Rituximab Other descriptive name: Rituximab Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Belgium;Spain;Italy
27	EUCTR2017-004079-30-IT (EUCTR)	06/07/2018	10/09/2021	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 23.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	AZIENDA OSPEDALIERO UNIVERSITARIA MAGGIORE DELLA CARITà DI NOVARA	NULL	Not Recruiting			Female: yes Male: yes	207	Phase 3	Portugal;Spain;Belgium;Italy
28	NCT03100253 (ClinicalTrials.gov)	March 1, 2018	17/3/2017	Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGation	Open-label, Randomized Controlled Trial Comparing Tocilizumab to Anti-TNF Treatment and Discovery of Biomarkers for Treatment Selection in Rheumatoid Arthritis Patients With Inadequate Response to a First Anti-TNF	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab Pegol	Mario Negri Institute for Pharmacological Research	NULL	Terminated	18 Years	N/A	All	208	Phase 4	Italy
29	EUCTR2017-004079-30-BE (EUCTR)	19/02/2018	19/02/2018	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP)-EU: A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP-EU	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Not Recruiting			Female: yes Male: yes	219	Phase 3	Portugal;Spain;Belgium;Italy
30	NCT03227419 (ClinicalTrials.gov)	January 22, 2018	19/7/2017	Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate Responders	Abatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority Trial	Arthritis, Rheumatoid	Drug: Tocilizumab Prefilled Syringe;Drug: Abatacept Prefilled Syringe	Lille Catholic University	NULL	Recruiting	18 Years	N/A	All	224	Phase 4	France
31	NCT03440892 (ClinicalTrials.gov)	November 1, 2017	14/2/2018	Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis Patients	Longitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of Survivin	Rheumatoid Arthritis	Drug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinib	Vastra Gotaland Region	NULL	Recruiting	20 Years	N/A	All	2500		Sweden
32	NCT03288584 (ClinicalTrials.gov)	October 27, 2017	16/9/2017	Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid Arthritis	The Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Inflammation	Drug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents.	University of Athens	NULL	Recruiting	18 Years	80 Years	All	60		Greece
33	EUCTR2016-001987-12-IT (EUCTR)	18/08/2017	05/01/2021	Clinical study aimed to compare tocilizumab to anti-TNF treatment and to discover biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF	Open-label, randomized controlled trial comparing tocilizumab to anti-TNF treatment and discovery of biomarkers for treatment selection in rheumatoid arthritis patients with inadequate response to a first anti-TNF - RAFTING	RHEUMATOID ARTHRITIS MedDRA version: 20.0;Level: LLT;Classification code 10037738;Term: R arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10039014;Term: Rh arthritis;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA - 20 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 4ML 1 FLACONCINO Product Name: Tocilizumab Product Code: [NA] INN or Proposed INN: Tocilizumab Other descriptive name: Tocilizumab Trade Name: ENBREL - 50 MG POLV SOLUZ INIET SOTTOC. POLV. FLAC VETRO SOLV. SIRI. VET. SOLV 1 ML (50 MG/ML) 12 FLAC+12 SIRI. PRE+12 AGHI+12 ADAT PER FLAC+24 TAMP. PRE INIEZ Product Name: etanercept Product Code: [NA] INN or Proposed INN: ETANERCEPT Trade Name: REMICADE - 100 MG POLVERE PER CONCENTRATO PER INFUSIONE ENDOVENOSA 1 FLACONE VETRO 20 ML USO EV Product Name: Infliximab Product Code: [NA] INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA - 40MG/0.8ML SOLUZ. INIETTABILE- USO SOTTOCUTANEO-FLACONCINO(VETRO) 0.8ML 2 ASTUCCI:1 FLACONCINO+1SIRINGA+1AGO+1ADATT.STERILE-2TAMPONI IMBEVUTI ALCOOL Product Name: Humira Product Code: [NA] INN or Proposed INN: ADALIMUMAB Trade Name: CIMZIA - 200MG-SOLUZIONE INIETTABILE-USO SOTTOCUTANEO-SIRINGA PRERIEMPITA(VETRO) 1ML 6(3X2) SIRINGHE PRERIEMPITE+6(3X2) SALVIETTINE IMBEVUTE DI	SOCIETA' ITALIANA DI REUMATOLOGIA - SIR	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	208	Phase 4	Italy
34	EUCTR2017-000947-41-FR (EUCTR)	18/08/2017	21/06/2017	ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.	ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR	Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor. MedDRA version: 20.0;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions;System Organ Class: 100000004870;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie Trade Name: RoActemra 162 mg solution injectable en seringue préremplie	Groupement des Hôpitaux de l’Institut Catholique de Lille	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	France
35	NCT03155347 (ClinicalTrials.gov)	August 2, 2017	15/5/2017	An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy	A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	70 Years	All	340	Phase 3	China
36	NCT03215407 (ClinicalTrials.gov)	August 1, 2017	22/6/2017	The Comparative Study of Intra-articular Injection of Tocilizumab and Compound Betamethasone	The Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the Knee	Rheumatoid Arthritis of Knee	Drug: Intra-articular Tocilizumab;Drug: Intra-articular Compound Betamethasone	Chinese PLA General Hospital	NULL	Not yet recruiting	18 Years	65 Years	All	60	Phase 4	NULL
37	NCT03291457 (ClinicalTrials.gov)	March 30, 2017	20/9/2017	A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice	A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Glucocorticoid Agent	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	101		Belgium
38	NCT03112213 (ClinicalTrials.gov)	January 12, 2017	10/4/2017	Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment	CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: NSAIDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	135		Germany
39	ChiCTR-INR-16009546	2016-11-01	2016-10-21	The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis	The Efficacy and Safety of Low Dose IL-2 Conbined IL-6 Antagonist Therapy in Chinese Over-treated Patients with Rheumatoid Arthritis	rheumatoid arthritis;M05.901	IL-2 group:lL-2;IL-2 + IL-6 antagonist group:Tocilizumab;non IL-2 or IL-6 antagonist group:glucocorticoids and DMARDs;	the Second Hospital of Shanxi Medical University	NULL	Recruiting	18	65	Both	IL-2 group:15;IL-2 + IL-6 antagonist group:15;non IL-2 or IL-6 antagonist group:15;		China
40	JPRN-jRCTs041180071	13/10/2016	07/03/2019	T-ReX study	Tocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study	Rheumatoid arthritis	At week 0, the dosing frequency of MTX was decreased from weekly to biweekly without a change in dose, regardless of the initial dose. At week 12, MTX was discontinued if low disease activity was maintained. TCZ and csDMARDs other than MTX were continued at a stable dose and interval throughout the course of the study. Glucocorticoids were continued at a stable dose up to week 36, and allowed to taper after week 36. The use of oral analgesics (non-steroidal anti-inflammatory drugs, acetaminophen, pregabalin, and tramadol) was not prohibited during the study period. One or more of the following rescue treatments were performed if the CDAI score was >10 and at the discretion of the investigator and/or upon patient request: changing the dosing frequency back to weekly administration, restarting, or increasing doses of MTX; increasing doses of or adding csDMARDs other than MTX or glucocorticoids; and administering an intraarticular injection of corticosteroids, hyaluronic acid, or lidocaine.	Kojima Toshihisa	NULL	Complete	>= 20age old	Not applicable	Both	51	N/A	Japan
41	NCT02648035 (ClinicalTrials.gov)	September 22, 2016	5/1/2016	EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid Arthritis	Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Persistence to Tocilizumab SC as Monotherapy or in Combination With cDMARD Treatment in RA Patients in Greece: the EMBRACE-SC Study.	Rheumatoid Arthritis	Biological: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	200		Greece
42	EUCTR2012-002535-28-NL (EUCTR)	13/09/2016	01/09/2016	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 19.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Product Code: L01X CO2 Trade Name: RoActemra Product Name: RoActemra Product Code: L04AC07	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	144	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
43	JPRN-UMIN000021247	2016/07/22	22/07/2016	Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state	Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-state - Tocilizumab treatment with reducing and stopping methotrexate (T-ReX study)	Rheumatoid arthritis	Double the time between applications of MTX without changing dose for the first 12 weeks, and then stop MTX if CDAI<=10 is maintained.	Nagoya University Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	51	Not selected	Japan
44	NCT02765074 (ClinicalTrials.gov)	June 30, 2016	19/4/2016	Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid Arthritis	Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique Study	Rheumatoid Arthritis	Drug: subcutaneous tocilizumab	Centre Hospitalier Régional d'Orléans	Rennes University Hospital	Recruiting	18 Years	85 Years	All	60	Phase 4	France
45	NCT02797769 (ClinicalTrials.gov)	June 2, 2016	8/6/2016	A Time to Cardiovascular Event Analysis Comparing Tocilizumab to Other Biologics in Patients With Rheumatoid Arthritis (RA)	Risk of Cardiovascular Events in Patients Using Tocilizumab as Compared With Other Biologics in Multiple Large Healthcare Databases	Rheumatoid Arthritis	Drug: Other Biologics;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	48950		NULL
46	NCT02659150 (ClinicalTrials.gov)	May 18, 2016	21/12/2015	Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis	A Multicenter, Open-Label, Proof-of-Activity Study of the Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab	Massachusetts General Hospital	Brigham and Women's Hospital	Unknown status	50 Years	75 Years	Female	21	Phase 4	NULL
47	NCT02573012 (ClinicalTrials.gov)	March 29, 2016	1/10/2015	Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Participants	Prospective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Drug: Placebo matched to prednisone;Drug: Prednisone;Biological: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	314	Phase 4	France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey
48	NCT02679001 (ClinicalTrials.gov)	March 24, 2016	8/2/2016	A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.	A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT	Rheumatoid Arthritis	Drug: TNF inhibitor/TCZ	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	200		Sweden
49	NCT02682823 (ClinicalTrials.gov)	March 21, 2016	11/2/2016	Tocilizumab Real-Life Human Factors (RLHFs) Validation Study	Tocilizumab Real-Life Human Factors Validation Study	Rheumatoid Arthritis	Device: AI-1000 G2;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	91	Phase 4	United States
50	EUCTR2014-004673-16-DE (EUCTR)	12/01/2016	15/07/2015	Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.	Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients	Rheumatoid Arthritis MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: RoActemra Product Code: L04AC07 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	226	Phase 4	Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland
51	NCT02608112 (ClinicalTrials.gov)	December 31, 2015	16/11/2015	Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year	Subcutaneous Tocilizumab in Monotherapy or in Combination With csDMARD in Patients With Moderate to Severe Active Rheumatoid Arthritis and Followed by Hospital and Office Based Rheumatologists: Non Interventional Study to Describe Real-World Drug Retention Rate of the Biotherapy at 1 Year	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	291		France
52	NCT02837146 (ClinicalTrials.gov)	December 2015	7/7/2016	Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid Arthritis	Ultrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA)	Rheumatoid Arthritis	Biological: Tocilizumab (TCZ);Drug: Methotrexate (MTX)	Maria Stoenoiu	NULL	Recruiting	18 Years	75 Years	Both	45	Phase 3	Belgium
53	EUCTR2014-004673-16-FR (EUCTR)	16/11/2015	05/08/2015	Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.	Prospective, multicentre, placebo-controlled, double-blind study to compare the efficacy of maintenance treatment with tocilizumab with or without glucocorticoid discontinuation in rheumatoid arthritis patients	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg Product Code: RO001-9265/F04 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg Product Code: RO 001-9265/F02-01 INN or Proposed INN: Prednisone Other descriptive name: PREDNISONE	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	226	Phase 4	Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland
54	NCT02552940 (ClinicalTrials.gov)	October 31, 2015	16/9/2015	An Observational Study to Evaluate the Clinical Effectiveness, Quality of Life, Safety and Tolerability of Tocilizumab (TCZ) in Patients With Rheumatoid Arthritis (RA) in Daily Clinical Practice	A PROSPECTIVE, NON-INTERVENTIONAL STUDY TO EVALUATE THE CLINICAL EFFECTIVENESS, THE CONSISTENCY OF EVALUATION SCORES, QUALITY OF LIFE, SAFETY AND TOLERABILITY OF TOCILIZUMAB SUBCUTANEOUS IN PATIENTS WITH RHEUMATOID ARTHRITIS IN DAILY CLINICAL PRACTICE	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	nv Roche sa	Completed	18 Years	N/A	All	140		Belgium;Luxembourg
55	EUCTR2015-001246-28-BE (EUCTR)	19/10/2015	23/07/2015	Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study)	Ultrasound scores as imaging biomarkers of early response to subcutaneous tocilizumab in association with methotrexate in early rheumatoid arthritis (TOVERA study) - TOVERA	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: RoActemra	Cliniques Universitaires Saint-Luc, Université catholique de Louvain	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Belgium
56	EUCTR2015-000581-58-CZ (EUCTR)	14/10/2015	16/06/2015	A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra INN or Proposed INN: tocilizumabum Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB	Revmatologicky ustav Praha	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 4	Czech Republic
57	NCT02534311 (ClinicalTrials.gov)	October 13, 2015	25/8/2015	A Phase IV Study to Evaluate the Effect of Subcutaneous (SC) Tocilizumab Administered to Participants With Rheumatoid Arthritis (RA) Assessed Using Disease Activity Score (DAS28)	Prospective Evaluation of Rheumatoid Arthritis Activity Using DAS28 in Patients Treated With Subcutaneously Administered Tocilizumab on Local Level	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	60	Phase 4	Slovakia
58	NCT02778789 (ClinicalTrials.gov)	October 2015	16/5/2016	Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers	Non Randomized Parallel-group Clinical Study to Compare the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor Blockers.	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: TNF-alpha Inhibitor	University of Erlangen-Nürnberg Medical School	NULL	Completed	18 Years	N/A	All	66		Germany
59	JPRN-UMIN000027241	2015/08/31	03/05/2017	the change of IMT of carotide artery in RA with treatment of tocilizumab	the change of IMT of carotide artery in RA with treatment of tocilizumab - the change of IMT of carotide artery in RA with treatment of tocilizumab	rheumatoid arthritis	tofacitinib	hiroshima clinic	NULL	Complete: follow-up complete	18years-old	80years-old	Male and Female	50	Not applicable	Japan
60	EUCTR2014-004673-16-IT (EUCTR)	27/07/2015	04/06/2021	Randomized, blinded, controlled study to compare the efficacy of treatment with tocilizumab with or without glucocorticoids in rheumatoid arthritis.	PROSPECTIVE, MULTICENTRE, PLACEBO CONTROLLED, DOUBLE-BLIND STUDY TO COMPARE THE EFFICACY OF MAINTENANCE TREATMENT WITH TOCILIZUMAB WITH OR WITHOUT GLUCOCORTICOID DISCONTINUATION IN RHEUMATOID ARTHRITIS PATIENTS - NA	Rheumatoid Arthritis MedDRA version: 23.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE Product Name: NA Product Code: RO487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Prednisone Tablets USP, 5 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Prednisone Tablets USP, 1 mg INN or Proposed INN: PREDNISONE Other descriptive name: PREDNISONE Trade Name: Encorton, 5 mg, tablets INN or Proposed INN: PREDNISONE	F. HOFFMANN - LA ROCHE LTD.	NULL	Not Recruiting			Female: yes Male: yes	226	Phase 4	France;Serbia;Egypt;Lebanon;Turkey;Russian Federation;Germany;Switzerland;Italy
61	EUCTR2012-002535-28-ES (EUCTR)	22/07/2015	10/07/2015	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA)	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 18.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Other descriptive name: MabThera Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom
62	EUCTR2014-003012-36-BG (EUCTR)	19/06/2015	12/03/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
63	EUCTR2014-003012-36-CZ (EUCTR)	10/06/2015	05/01/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
64	EUCTR2014-003012-36-ES (EUCTR)	27/05/2015	02/02/2015	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 17.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
65	EUCTR2014-003012-36-DE (EUCTR)	21/05/2015	29/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
66	NCT02402686 (ClinicalTrials.gov)	May 20, 2015	25/3/2015	Non-Interventional Study of Tocilizumab Subcutaneous (SC) Monotherapy in Participants With Rheumatoid Arthritis (RA)	Open-Label, Multi-Center, Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab SC Monotherapy in Daily Clinical Practice (SIMPACT)	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	353		Hungary
67	EUCTR2011-004720-35-NO (EUCTR)	04/05/2015	26/01/2015	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate INN or Proposed INN: METHOTREXATE Trade Name: Metex INN or Proposed INN: METHOTREXATE Other descriptive name: METHOTREXATE DISODIUM Trade Name: Imurel INN or Proposed INN: IMUREL Other descriptive name: AZATHIOPRINE Trade Name: Arava INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN INN or Proposed INN: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Plaquenil Product Name: Plaquenil INN or Proposed INN: Plaquenil Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	800	Phase 4	Finland;Denmark;Norway;Sweden
68	NCT02404558 (ClinicalTrials.gov)	May 2015	26/3/2015	Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis	An Open-label, Randomized, Parallel Group, Single-dose Study to Describe the Safety of IL-6 Receptor Blockade With Sarilumab or Tocilizumab Monotherapy in Japanese Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab	Sanofi	Regeneron Pharmaceuticals	Completed	20 Years	N/A	Both	30	Phase 1	Japan
69	JPRN-UMIN000016950	2015/03/27	03/04/2015	Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept	Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept - Clinical outcome in patients with RA switched to TNF blocker after tocilizumab or abatacept	rheumatoid arthritis	Infliximab or adalimumab or golimumab	Osaka Medical College	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
70	EUCTR2014-003012-36-BE (EUCTR)	23/03/2015	18/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.0;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
71	EUCTR2014-003012-36-HU (EUCTR)	10/03/2015	30/12/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects with Moderate to Severe Rheumatoid Arthritis who are Intolerant to Methotrexate or for whom Continued Methotrexate Treatment is Inappropriate - A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 18.1;Level: SOC;Classification code 10021428;Term: Immune system disorders;System Organ Class: 10021428 - Immune system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: ALX-0061 Product Code: ALX-0061 INN or Proposed INN: not available Other descriptive name: ALX-0061 Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Ablynx NV	NULL	Not Recruiting			Female: yes Male: yes	228	Phase 2	Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
72	NCT02353780 (ClinicalTrials.gov)	March 2015	30/6/2013	Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept	Mechanistic Studies of B- and T-Cell Function in Rheumatoid Arthritis Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept	Rheumatoid Arthritis (RA)	Drug: TNF Antagonist (enbrel, humire, remicade, cimzia, symponi);Drug: Abatacept;Drug: Tocilizumab	Dr. Larry W. Moreland	Genentech, Inc.;Bristol-Myers Squibb	Terminated	18 Years	64 Years	All	10	Phase 4	United States
73	NCT02287922 (ClinicalTrials.gov)	March 2015	5/11/2014	A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid Arthritis	A Phase IIb Multicenter, Randomized, Double-blind Study of ALX-0061 Administered Subcutaneously as Monotherapy, in Subjects With Moderate to Severe Rheumatoid Arthritis Who Are Intolerant to Methotrexate or for Whom Continued Methotrexate Treatment is Inappropriate	Rheumatoid Arthritis	Biological: ALX-0061;Biological: Placebo;Biological: Tocilizumab	Ablynx	NULL	Completed	18 Years	74 Years	All	251	Phase 2	United States;Belgium;Bulgaria;Czechia;Georgia;Germany;Hungary;Mexico;Moldova, Republic of;North Macedonia;Poland;Romania;Serbia;Spain;Czech Republic;Macedonia, The Former Yugoslav Republic of
74	EUCTR2012-002535-28-IT (EUCTR)	16/01/2015	04/11/2014	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 17.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Portugal;Spain;Belgium;Netherlands;United Kingdom;Italy
75	EUCTR2014-003529-16-GB (EUCTR)	16/12/2014	22/06/2015	Stratification of biologic Therapies for Rheumatoid Arthritis by Pathobiology	Stratification of Biologic Therapies for RA by Pathobiology (STRAP): A randomised, open-labelled biopsy-driven stratification trial in DMARD inadequate responder patients randomised to Etanercept, Tocilizumab or Rituximab. - STRAP	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActmera Product Name: RoActmera Trade Name: Enbrel Product Name: Enbrel	Joint Research & Development Office (QMUL)	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	219	Phase 3	United Kingdom
76	JPRN-UMIN000015616	2014/11/04	10/11/2014	Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction	Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction - Biologic MateR clinical performance test for ADA and TCZ Efficacy prediction	rheumatoid arthritis	Adalimumab plus Methotrexate Tocilizumab plus Methotrexate	Biologic Mate Study Group	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	300	Not selected	Japan
77	EUCTR2011-004720-35-FI (EUCTR)	10/09/2014	09/09/2014	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment.	A multicenter, randomized, open-label, blinded-assessor, phase 4 study in patients with early rheumatoid arthritis to compare active conventional therapy versus three biologic treatments, and two de-escalation strategies in patients who respond to treatment. - NORD-STAR	Rheumatoid arthritis (RA) MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: RoActemra Other descriptive name: TOCILIZUMAB INN or Proposed INN: METHOTREXATE Trade Name: Metoject Other descriptive name: METHOTREXATE DISODIUM Other descriptive name: AZATHIOPRINE INN or Proposed INN: LEFLUNOMIDE Other descriptive name: Arava Product Name: Salazopyrin EN Other descriptive name: SULFASALAZINE Trade Name: Oxiklorin Product Code: 118-42-3 Other descriptive name: HYDROXYCHLOROQUINE SULFATE	Karolinska Institutet	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes		Phase 4	Finland;Denmark;Sweden
78	NCT01717859 (ClinicalTrials.gov)	September 2014	19/10/2012	Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab	Musculoskeletal Ultrasound in Predicting Early Dose Titration With Tocilizumab	Rheumatoid Arthritis	Drug: Tocilizumab	University of California, Los Angeles	Genentech, Inc.	Completed	18 Years	N/A	All	74	Phase 4	United States
79	NCT02234960 (ClinicalTrials.gov)	August 2014	5/9/2014	Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)	TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	102	N/A	Poland
80	JPRN-UMIN000015175	2014/07/01	17/09/2014	Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial.	Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. - STAR study	Rheumatoid Arthritis	Subcutaneous Tocilizumab 162mg every other week. Subcutaneous Abatacept 125mg every week.	St.Marianna University School of Medicine	NULL	Recruiting	20years-old	Not applicable	Male and Female	120	Not selected	Japan
81	NCT02011334 (ClinicalTrials.gov)	July 2014	4/12/2013	A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.	A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	285	Phase 3	Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay
82	EUCTR2012-002535-28-PT (EUCTR)	06/06/2014	25/02/2014	Not applicable	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera INN or Proposed INN: RITUXIMAB Trade Name: RoActemra Product Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry) - Queen Mary University London	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
83	NCT02046616 (ClinicalTrials.gov)	May 28, 2014	24/1/2014	A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)	Tocilizumab SC in Patients With Active Rheumatoid Arthritis and Inadequate Response to DMARDs. A Single-Arm, Open-Label Study to Evaluate Safety, Tolerability and Efficacy. In a Subgroup of Patients Inflammation Will Be Measured by Ultrasound.	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	133	Phase 3	Denmark;Finland;Norway;Sweden
84	NCT02087696 (ClinicalTrials.gov)	May 2014	6/3/2014	Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis	Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis and Candidates With a Biological Monotherapy	Arthritis, Rheumatoid	Drug: Tocilizumab	Spanish Foundation of Rheumatology	Roche Farma, S.A	Recruiting	18 Years	N/A	Both	122	Phase 4	Spain
85	EUCTR2012-002535-28-BE (EUCTR)	28/04/2014	28/03/2014	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActemra Product Name: RoActemra	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	160	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
86	NCT02046603 (ClinicalTrials.gov)	March 4, 2014	24/1/2014	A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent	Open-Label, Phase IIIb Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab Monotherapy or Combination Therapy With Methotrexate (MTX) or Other Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Patients With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-Tumour Necrosis Factor (Anti-TNF) Biologic Agent	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	162	Phase 3	United Kingdom
87	NCT02097524 (ClinicalTrials.gov)	March 2014	3/3/2014	Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)		Rheumatoid Arthritis	Drug: Sarilumab;Drug: Tocilizumab	Regeneron Pharmaceuticals	Sanofi	Completed	18 Years	N/A	Both	105	Phase 1	United States
88	EUCTR2013-004051-20-ES (EUCTR)	26/02/2014	27/12/2013	NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY	NOT CONTROLLED STUDY TO ASSESS THE EFFICACY OF TOCILIZUMAB IN PATIENTS WITH MODERATE OR SEVERE RHEUMATOID ARTHRITIS WHO ARE CANDIDATES TO BE TREATED WITH A BIOLOGICAL THERAPY AS MONOTHERAPY	RHEUMATOID ARTHRITIS;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra 20 mg/ml concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: ROACTEMRA	FUNDACIÓN ESPAÑOLA DE REUMATOLOGIA	NULL	Not Recruiting			Female: yes Male: yes	122	Phase 4	Spain
89	EUCTR2013-002007-34-SE (EUCTR)	20/02/2014	23/01/2014	Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.	Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	137	Phase 3	Finland;Denmark;Sweden
90	EUCTR2013-002007-34-FI (EUCTR)	10/02/2014	14/11/2013	Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.	Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound. - TOZULTRA	Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	137	Phase 3	Finland;Denmark;Sweden
91	JPRN-JapicCTI-142505	01/2/2014		Phase III study of MRA-SC 162 mg/week	A Randomized, Double-blind, Parallel-group, Phase III Study of MRA-SC in Rheumatoid Arthritis Patients with Inadequate Response to Tocilizumab Subcutaneous Injection 162 mg every 2 weeks	Rheumatoid arthritis	Intervention name : MRA-SC INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg QW Control intervention name : MRA-SC INN of the control intervention : tocilizumab Dosage And administration of the control intervention : 162 mg Q2W	Chugai Pharmaceutical Co., Ltd.	NULL		20		BOTH	50	Phase 3	NULL
92	NCT01987479 (ClinicalTrials.gov)	January 30, 2014	8/11/2013	A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis	Multi-Center, Open Label, Single Arm Phase IIIB Study on Safety and Efficacy of Subcutaneous Tocilizumab in Monotherapy or in Combination With Methotrexate or Other Non-Biologic Disease Modifying Antirheumatic Drugs in Rheumatoid Arthritis Patients With an Inadequate Response to Non-Biologic DMARDs - OSCAR	Rheumatoid Arthritis	Drug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	150	Phase 3	Netherlands
93	NCT01988012 (ClinicalTrials.gov)	January 2014	31/10/2013	A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis.	An Open-label, Multicenter Study to Evaluate Disease Activity and Safety of Treatment With Actemra (Tocilizumab) Administered as Subcutaneous Injection in Adult RA Patients.	Rheumatoid Arthritis	Biological: tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	100	Phase 3	Israel
94	NCT02001987 (ClinicalTrials.gov)	January 2014	29/11/2013	A Study of Tocilizumab (RoActemra) in Tocilizumab-Naive Participants With Rheumatoid Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Antirheumatic Drugs (DMARDs) and/or Biologic Therapy	A Multi-Center Open-Label Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Tocilizumab in Tocilizumab-Naive Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARD and/or Biologic Therapy	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Methotrexate;Drug: csDMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	139	Phase 3	France
95	NCT02031471 (ClinicalTrials.gov)	January 2014	16/12/2013	TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment	TOSCARA: An Open-label, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	57	Phase 3	Belgium;Luxembourg
96	JPRN-UMIN000012690	2013/12/28	27/12/2013	Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment	Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment - STARR-SMARRT	Rheumatoid Arthritis	tocilizumab+tacrolimus+Bucillamine tocilizumab	National hospital organization Chiba east national hospital Clinical Research Center	NULL	Complete: follow-up complete	20years-old	99years-old	Male and Female	60	Not applicable	Japan
97	EUCTR2013-002150-79-BE (EUCTR)	16/12/2013	24/10/2013	A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patients	TOSCARA: An open-label, single-arm study to evaluate the efficacy, safety and tolerability of tocilizumab (TCZ) subcutaneous in TCZ-naïve patients with active rheumatoid arthritis - TOSCARA	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-02 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	N.V. Roche S.A.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 3	Belgium
98	EUCTR2013-002007-34-DK (EUCTR)	09/12/2013	09/12/2013	Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.	Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	137	Phase 3	Finland;Denmark;Sweden
99	NCT01668966 (ClinicalTrials.gov)	December 9, 2013	16/8/2012	A Long Term Extension Study of WA19926 (NCT01007435) of Tocilizumab (RoActemra/Actemra) in Participants With Early, Moderate to Severe Rheumatoid Arthritis (RA)	A Multicenter, Open-Label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Months	N/A	All	23	Phase 3	Brazil
100	JPRN-UMIN000012073	2013/12/01	21/10/2013	Effects of Subcutaneous Actemura and MTX Blending in RA	Effects of Subcutaneous Actemura and MTX Blending in RA - eSCRAMBLE	rheumatoid arthritis	Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to continue methotrexate with the addition of tocilizumab (MTX+TCZ) 162mg/body every other week for 52 weeks. Adults with active RA (DAS28 >3.2) despite methotrexate prescription were randomly assigned to switch to tocilizumab (TCZ) 162mg/body every other week for 52 weeks.	Department of Orthopaedic Surgery,Graduate School of Medicine, Osaka City University Medical School	NULL	Complete: follow-up complete	20years-old	85years-old	Male and Female	100	Phase 4	Japan
101	NCT01941095 (ClinicalTrials.gov)	November 20, 2013	30/8/2013	A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid Arthritis	Multicenter, Open Label, Phase IIIb Study to Evaluate the Safety and Tolerability of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Methotrexate or Other Non-Biologic Disease-Modifying Antirheumatic Drugs in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	100	Phase 3	Greece
102	NCT01980836 (ClinicalTrials.gov)	November 2013	4/11/2013	Effect of Tocilizumab to the Cellular Immune Response to Influenza Vaccine	The Effect of Tocilizumab on the Cellular Immune Response to Seasonal Influnza Vaccine in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis;Cellular Immune Response	Biological: Seasonal influenza vaccine	Tel-Aviv Sourasky Medical Center	NULL	Not yet recruiting	18 Years	N/A	Both	40	Phase 4	Israel
103	NCT01855789 (ClinicalTrials.gov)	November 2013	14/5/2013	A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate in Participants With Moderate to Severe Active Rheumatoid Arthritis		Rheumatoid Arthritis	Drug: Placebo;Drug: Tocilizumab;Drug: methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	718	Phase 3	United States
104	NCT01951170 (ClinicalTrials.gov)	November 2013	23/9/2013	An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis	An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute)	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	52	Phase 3	Australia
105	EUCTR2013-002341-11-GB (EUCTR)	25/10/2013	26/07/2013	This is a study in healthy subjects to look at the effect of tocilizumab (RoActemra) on a type of white blood cell	A SINGLE BLIND PHASE IV PHARMACODYNAMIC STUDY TO EVALUATE NEUTROPHIL DISTRIBUTION KINETICS AND FUNCTION FOLLOWING SINGLE-DOSE TOCILIZUMAB TREATMENT IN HEALTHY SUBJECTS	healthy volunteers (intended indication: Rheumatoid Arthritis) MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: no Male: yes		Phase 4	United Kingdom
106	EUCTR2013-000342-19-NL (EUCTR)	24/10/2013	08/10/2013	A clinical trial where patients with Rheumatoid Arthritis are treated with the study drug tocilizumab, subcutaneous (injection in the skin), with or without other non-biological anti-rhematic drugs, to study the safety and efficacy of the drug.	MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Roche Nederland B.V.	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Netherlands
107	EUCTR2013-002429-52-IE (EUCTR)	23/10/2013	15/08/2013	STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS	A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab SC Other descriptive name: TOCILIZUMAB SC	Roche Farma S.A	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Spain;Ireland
108	EUCTR2013-002429-52-PT (EUCTR)	21/10/2013	08/08/2013	STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS	A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Roche Farma S.A.	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Spain;Ireland
109	EUCTR2013-000054-22-GB (EUCTR)	01/10/2013	07/08/2013	OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT	OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT - ACT-MOVE	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R	Roche Products Limited	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	United Kingdom
110	EUCTR2013-000359-42-GR (EUCTR)	12/09/2013	27/08/2013	Not applicable	Multicenter, open label, phase IIIb study to evaluate the safety and tolerability of subcutaneous tocilizumab as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs in patients with Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04	ROCHE HELLAS S.A.	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Greece
111	NCT01941940 (ClinicalTrials.gov)	September 5, 2013	2/9/2013	A Study to Evaluate Efficacy of Tocilizumab Administered as Monotherapy or in Combination With Methotrexate and/or Other Disease Modifying Antirheumatic Drugs (DMARDs) in Rheumatoid Arthritis (RA) Participants	A National, Open-Label, Single-Arm, Phase IIIb Study to Evaluate the Efficacy of Weekly Tocilizumab Subcutaneous, Administered as Monotherapy or in Combination With Methotrexate and/or Other DMARDs in Rheumatoid Arthritis (RA) Patients	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	227	Phase 3	Italy
112	NCT01995201 (ClinicalTrials.gov)	September 2013	1/11/2013	A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid Arthritis	A Phase IIIb Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous (SC) Tocilizumab (TCZ) Given as Monotherapy or in Combination With Methotrexate (MTX) or Other Non Biologics DMARDs in Subjects With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Active, not recruiting	18 Years	N/A	Both	401	Phase 3	Ireland;Portugal;Spain
113	EUCTR2013-002429-52-ES (EUCTR)	23/08/2013	12/07/2013	STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS	A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Roche Farma S.A	NULL	Not Recruiting			Female: yes Male: yes	420	Phase 3	Portugal;Spain;Ireland
114	EUCTR2013-001569-17-IT (EUCTR)	02/08/2013	04/06/2013	A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients.	A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	Roche S.p.A.	NULL	Not Recruiting			Female: yes Male: yes	225	Phase 3	Italy
115	EUCTR2012-004482-40-ES (EUCTR)	18/06/2013	16/05/2013	Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapies	Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis (RA) in persistent clinical remission in treatment with biological therapies: open, controlled study and randomized.	Evaluation of the clinical utility of a standardized protocol of strategies for the reduction of doses in patients with rheumatoid arthritis in clinical remission at treatment with biologic therapies;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Infliximab INN or Proposed INN: INFLIXIMAB Trade Name: HUMIRA Product Name: Adalimumab INN or Proposed INN: ADALIMUMAB Trade Name: ENBREL Product Name: Etanercept INN or Proposed INN: ETANERCEPT Trade Name: CIMZIA Product Name: Certolizumab Pegol INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: SIMPONI Product Name: Golimumab INN or Proposed INN: GOLIMUMAB Trade Name: ORENCIA Product Name: Abatacept INN or Proposed INN: ABATACEPT Trade Name: RoActemra Product Name: Tocilizumab INN or Proposed INN: TOCILIZUMAB Product Name: Infliximab INN or Proposed INN: INFLIXIMAB	FRANCISCO J. BLANCO GARCÍA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Spain
116	EUCTR2012-003536-23-PL (EUCTR)	05/06/2013	22/04/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden
117	NCT01878318 (ClinicalTrials.gov)	June 2013	6/6/2013	A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs	Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs	Rheumatoid Arthritis	Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Withdrawn	18 Years	N/A	Both	0	Phase 4	Venezuela
118	EUCTR2012-003536-23-GB (EUCTR)	21/05/2013	15/03/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
119	EUCTR2012-003536-23-NL (EUCTR)	01/05/2013	22/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		Mexico;Argentina;Poland;Belgium;Brazil;Romania;Norway;Netherlands;Sweden;United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary
120	NCT04157010 (ClinicalTrials.gov)	May 2013	15/4/2014	Tocilizumab REMission in Early RA	Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the Changes in Expression of Janus Kinase/Signal Transducers and Activators of Transcription (JAK-STAT) and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients With Early Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Methotrexate	University of Leeds	Hoffmann-La Roche	Completed	18 Years	N/A	All	20	Phase 4	United Kingdom
121	EUCTR2012-003536-23-NO (EUCTR)	09/04/2013	12/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Germany;Sweden
122	EUCTR2012-003536-23-SE (EUCTR)	08/04/2013	07/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
123	EUCTR2011-004017-17-GB (EUCTR)	08/04/2013	11/01/2013	Tocilizumab and Remission in early rheumatoid arthritis	Prospective, Single-centre, Open-Label, Randomised, Pilot Study Assessing the changes in expression of JAK-STAT and Speed & Depth of Remission Induced by Tocilizumab & Methotrexate Combination and Tocilizumab Monotherapy in Patients with Early Rheumatoid Arthritis (TREMERA). - TREMERA	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RoActemra	The University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	20	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
124	EUCTR2012-003536-23-BE (EUCTR)	04/04/2013	07/01/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Netherlands;Germany;Norway;Sweden
125	EUCTR2012-003536-23-ES (EUCTR)	01/04/2013	04/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
126	EUCTR2012-003536-23-IT (EUCTR)	29/03/2013	05/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200	Phase 3	United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
127	EUCTR2012-003536-23-FI (EUCTR)	13/03/2013	19/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
128	EUCTR2012-003536-23-EE (EUCTR)	13/03/2013	12/02/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Netherlands;Norway;Sweden
129	EUCTR2012-003536-23-HU (EUCTR)	07/03/2013	16/01/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
130	NCT02843789 (ClinicalTrials.gov)	March 2013	19/7/2016	Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy	Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy	Arthritis, Rheumatoid	Drug: Tocilizumab	Centre Hospitalier Universitaire de Besancon	NULL	Completed	18 Years	80 Years	All	109	Phase 4	France
131	NCT01768572 (ClinicalTrials.gov)	March 2013	11/1/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists	Rheumatoid Arthritis	Drug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placebo	Sanofi	Regeneron Pharmaceuticals	Completed	18 Years	N/A	All	202	Phase 3	United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic
132	EUCTR2012-003536-23-CZ (EUCTR)	20/02/2013	03/01/2013	To Evaluate The Safety of SAR153191 (REGN88) and Tocilizumab Added to Other RA Drugs in Patients With RA Who Are Not Responding to or Intolerant of Anti-TNF Therapy (SARIL-RA-ASCERTAIN)	A Randomized, Double-Blind, Double-Dummy Study Assessing The Safety and Tolerability of Sarilumab and Tocilizumab In Patients With Rheumatoid Arthritis Who Are Inadequate Responders to or Intolerant of TNF Antagonists - ASCERTAIN	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Product Name: Sarilumab Product Code: SAR153191 (REGN88) INN or Proposed INN: Sarilumab Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	sanofi-aventis recherche & développement	NULL	Not Recruiting			Female: yes Male: yes	200		United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden
133	JPRN-UMIN000010033	2013/02/14	14/02/2013	To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy	To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy - To investigate the efficacy of tocilizumab in RA patients with moderate disease activity	Rheumatoid Arthritis	Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks.	Daihei Kida	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	20	Not selected	Japan
134	EUCTR2012-002535-28-GB (EUCTR)	21/01/2013	14/12/2012	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	A Randomised, open labelled study in anti-TNFa inadequate responders to investigate the mechanisms for Response - Resistance to Rituximab versus Tocilizumab in RA (R4-RA) - R4-RA	Rheumatoid Arthritis MedDRA version: 20.0;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: MabThera Product Name: MabThera Trade Name: RoActemra Product Name: RoActemra	Joint Research & Development Office (Barts and The London School of Medicine & Dentistry)	NULL	Not Recruiting			Female: yes Male: yes	160	Phase 4	Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
135	NCT01715831 (ClinicalTrials.gov)	January 15, 2013	25/10/2012	A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488	A Multicenter, Open-Label, Single-Arm Extension Study to Describe the Safety of Tocilizumab Treatment In Brazilian Patients With DMARDs Refractory Rheumatoid Arthritis Which Completed Studies ML21530 and MA21488 and Presenting an Indication of Maintaining the Tocilizumab Treatment	Arthritis, Rheumatoid	Drug: DMARDs;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	26	Phase 4	Brazil
136	NCT01772316 (ClinicalTrials.gov)	December 2012	17/1/2013	A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis	A Multicenter, Open-label, Long-term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	47	Phase 3	Spain
137	EUCTR2012-001760-30-IT (EUCTR)	05/11/2012	25/07/2012	Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.	Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;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 Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB	OSSERVATORIO EPIDEMIOLOGICO GISEA	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			Italy
138	NCT01741688 (ClinicalTrials.gov)	October 26, 2012	30/11/2012	An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis	A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab	Rheumatoid Arthritis	Biological: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	16	N/A	Peru
139	JPRN-UMIN000008812	2012/10/01	01/10/2012	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR)	Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) - Treatment of LVV and PMR by tocilizumab mono-therapy	Rheumatoid arthritis	tocilizumab monotherapy	Department of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical Universitity	NULL	Complete: follow-up complete	16years-old	80years-old	Male and Female	40	Not selected	Japan
140	NCT01730456 (ClinicalTrials.gov)	October 2012	15/11/2012	A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926	A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	13	Phase 3	Macedonia, The Former Yugoslav Republic of
141	NCT01734993 (ClinicalTrials.gov)	October 2012	19/11/2012	A Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA).	A Multicenter, Open-Label Long-Term Extension Study of WA22762 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	11	Phase 3	France
142	NCT01661140 (ClinicalTrials.gov)	September 2012	7/8/2012	A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate Dosage	Randomized, Phase IV, Placebo-controlled, Comparative Study to Evaluate the Efficacy and Safety of Tapering Methotrexate (MTX) Dosage Versus Maintaining the Dosage in Patients With Severe Active Rheumatoid Arthritis (RA) Who Have Demonstrated an Inadequate Response (IR) to Prior Disease-modifying Anti-rheumatic Drugs (DMARDs) Treatment and Have Initiated RoActemra (RoActemra, TCZ) in Combination With MTX	Rheumatoid Arthritis	Drug: Methotrexate (stable dose);Drug: Tocilizumab;Drug: Methotrexate (tapering dose)	Hoffmann-La Roche	NULL	Terminated	18 Years	N/A	All	427	Phase 4	United Kingdom
143	NCT01662063 (ClinicalTrials.gov)	August 2012	30/7/2012	A Long-Term Extension Study of WA22762 and NA25220 of Subcutaneous (SC) Tocilizumab (TCZ) in Moderate to Severe Rheumatoid Arthritis (RA)	A Multicenter Open-Label, Long-Term Extension Study of WA22762 and NA25220 to Evaluate Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab	Genentech, Inc.	NULL	Completed	18 Years	N/A	All	218	Phase 3	United States;Puerto Rico
144	NCT01705730 (ClinicalTrials.gov)	July 31, 2012	10/10/2012	A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy	Mon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in Monotherapy	Rheumatoid Arthritis	Drug: tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	71		Belgium
145	JPRN-UMIN000008404	2012/07/01	12/07/2012	Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria.	Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria. - Extension of Tocilizumab Dose Intervals in Patients with Rheumatoid Arthritis using IL-6 Serum Level Criteria.	rheumatoid arthritis	Extension of Tocilizumab Dose Intervals	Japan Labour Health and Welfare Organization,Yokohama Rosai Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	50	Not selected	Japan
146	NCT01665430 (ClinicalTrials.gov)	July 2012	13/8/2012	A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid Arthritis	A Multicenter, Open-Label, Single Arm, Long-Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Terminated	18 Years	N/A	All	38	Phase 3	Poland
147	NCT01649804 (ClinicalTrials.gov)	July 2012	23/7/2012	A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid Arthritis	A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG-TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	12	Phase 3	Hungary
148	EUCTR2011-005260-20-GB (EUCTR)	28/06/2012	10/05/2012	RoActemra® (tocilizumab) plus methotrexate (MTX) in stable dosage in comparison with RoActemra® plus reducing (tapering) MTX dosages in patients with severe rheumatoid arthritis (RA) that have inadequate responded to a trial of two disease modifying anti-rheumatic drugs (DMARDs), including MTX and have not been previously treated with a biologic agent, such as a TNF inhibitor.	Randomised, Phase IV, placebo-controlled, comparative study to evaluate the efficacy and safety of tapering methotrexate (MTX) dosage versus maintaining the dosage in patients with severe active rheumatoid arthritis (RA) who have demonstrated an inadequate response to prior conventional disease-modifying anti-rheumatic drugs (DMARDs) treatment and have initiated RoActemra® (tocilizumab, TCZ) in combination with MTX. - ACT-TAPER	Adult Rheumatoid Arthritis (RA) MedDRA version: 20.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium Trade Name: Methotrexate 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	Roche Products Limited	NULL	Not Recruiting			Female: yes Male: yes	618	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	United Kingdom
149	EUCTR2011-005204-15-AT (EUCTR)	20/06/2012	15/05/2012	Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?	Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop	biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0;Level: LLT;Classification code 10039076;Term: Rheumatoid arthritis and other inflammatory polyarthropathies;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Enbrel INN or Proposed INN: ETANERCEPT Trade Name: Humira INN or Proposed INN: ADALIMUMAB Trade Name: Cimzia INN or Proposed INN: CERTOLIZUMAB PEGOL Trade Name: Simponi INN or Proposed INN: GOLIMUMAB Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Orncia INN or Proposed INN: ABATACEPT	Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie	NULL	Not Recruiting			Female: yes Male: yes	110	Phase 4	Austria
150	NCT01664104 (ClinicalTrials.gov)	June 2012	7/8/2012	A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting	CRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With Tocilizumab	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	151	N/A	Italy
151	EUCTR2011-006040-79-DK (EUCTR)	25/05/2012	25/05/2012	A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arth	The efficacy and safety of adding tocilizumab to methotrexate and intra-articular glucocorticosteroid treatment in early rheumatoid arthritis.A randomized, double-blinded, placebo-controlled trial. - DanACT Early	Adult Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra®	Aarhus University Hospital, Department of Rheumatology U	NULL	Not Recruiting			Female: yes Male: yes	180	Phase 4	Denmark
152	EUCTR2012-000139-21-AT (EUCTR)	14/05/2012	23/04/2012	Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action	A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: Remicade Product Name: Remicade INN or Proposed INN: INFLIXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB Trade Name: Mabthera Product Name: Mabthera INN or Proposed INN: RITUXIMAB Trade Name: Orencia Product Name: Orencia INN or Proposed INN: ABATACEPT Trade Name: Ro-Actemra Product Name: Ro Actemra Other descriptive name: TOCILIZUMAB	Medizinische Universität Wien, Universitätsklinik für Innere Medizin III	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
153	EUCTR2011-006125-14-HU (EUCTR)	04/05/2012	08/03/2012	A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE	A MULTICENTER, OPEN-LABEL, SINGLE ARM, LONG TERM EXTENSION STUDY OF WA19926 TO DESCRIBE SAFETY DURING TREATMENT WITH TOCILIZUMAB IN PATIENTS WITH EARLY, MODERATE TO SEVERE RHEUMATOID ARTHRITIS - FUNCTION LTE	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: RoActemra Product Code: RO4877533	Roche (Magyarország) Kft.	NULL	Not Recruiting			Female: yes Male: yes	241		Hungary
154	JPRN-UMIN000014484	2012/05/01	01/12/2014	Saitama Actemra study for QOL in patients with Rheumatoid arthritis	Saitama Actemra study for QOL in patients with Rheumatoid arthritis - SAQRA study	rheumatoid arthritis	Treatment with Tocilizumab	Juntendo University, Juntendo Koshigaya Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	40	Not selected	Japan
155	NCT01664598 (ClinicalTrials.gov)	May 2012	10/8/2012	An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis	A Multicenter, Open-label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	49	Phase 3	Russian Federation
156	NCT01617005 (ClinicalTrials.gov)	May 2012	8/6/2012	A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)	Non-interventional Local Study to Describe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	50	N/A	Montenegro
157	NCT01579006 (ClinicalTrials.gov)	May 2012	16/4/2012	Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis	A Multi National, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (Actemra)	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	Clalit Health Services	Completed	18 Years	N/A	All	184	N/A	Israel
158	JPRN-UMIN000007380	2012/04/01	01/05/2012	Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis	Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis - Comparison of tocilizumab and high-dose methotrexate on rheumatoid arthritis	rheumatoid arthritis	tocilizumab + methotrexate (10mg/week) high-dose methotrexate (stepwisely increased to 16mg/week)	Kinki University Faculty of Medicine, Division of Hematology and Rheumatology	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	40	Not selected	Japan
159	NCT01557374 (ClinicalTrials.gov)	April 2012	16/3/2012	TOward the Lowest Effective DOse of Abatacept or Tocilizumab	Tapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering Strategy	Rheumatoid Arthritis	Drug: Tocilizumab, Abatacept;Drug: Decrease Tocilizumab, Abatacept	Assistance Publique - Hôpitaux de Paris	Ministry of Health, France	Completed	18 Years	N/A	All	232	Phase 4	France
160	NCT01655381 (ClinicalTrials.gov)	April 2012	30/7/2012	A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid Arthritis	A Multicenter, Open-label, Single Arm, Long-term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	15	Phase 3	France
161	JPRN-UMIN000017230	2012/03/01	22/04/2015	Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)	Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies) - Correlation between efficacy of the biological therapy (tocilizumab) and levels of oxidative stress markers in Japanese patients with rheumatoid arthritis (inadequate responders to existing therapies)	Rheumatoid arthritis	Biologic treatment (tocilizumab)	Kyushu University	NULL	Recruiting	20years-old	Not applicable	Male and Female	60	Not selected	Japan
162	NCT01670045 (ClinicalTrials.gov)	March 2012	17/8/2012	A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis	A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	43	N/A	Indonesia;Greece
163	JPRN-UMIN000007019	2012/02/01	01/02/2012	Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease	Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease - Treatment of AOSD by tocilizumab mono-therapy	Rheumatoid arthritis	tocilizumab monotherapy	Department of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical Universitity	NULL	Complete: follow-up complete	16years-old	70years-old	Male and Female	40	Not selected	Japan
164	NCT01562327 (ClinicalTrials.gov)	February 2012	21/3/2012	A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis	A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	50	N/A	Argentina
165	NCT01587989 (ClinicalTrials.gov)	February 2012	12/3/2012	A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate	A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) Versus Tocilizumab Monotherapy in Patients With Mild to Moderate Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 < 4,5 and >2,6)	Rheumatoid Arthritis	Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	77	Phase 3	Austria
166	NCT01474291 (ClinicalTrials.gov)	January 2012	15/11/2011	An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice	Evaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLO	Rheumatoid Arthritis	Biological: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	608	N/A	France;Monaco
167	EUCTR2010-020065-24-GR (EUCTR)	05/12/2011	04/11/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Greece;Ecuador;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
168	NCT01326962 (ClinicalTrials.gov)	November 30, 2011	7/3/2011	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNF	Tocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNF	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	28	Phase 3	Saudi Arabia
169	NCT01251120 (ClinicalTrials.gov)	November 2011	30/11/2010	A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid Arthritis	A Pragmatic, Randomized, Parallel Group Study of the Effect on Disease Remission, Work Productivity and Tolerability of Tocilizumab in Combination With DMARDs and Individually Designed Best Practice DMARD Therapy in Patients With Early, Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: DMARD	Hoffmann-La Roche	NULL	Terminated	18 Years	N/A	All	2	Phase 4	Finland
170	NCT01468077 (ClinicalTrials.gov)	November 2011	7/11/2011	A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) Treatment	Multicenter, Randomized, Parallel Group Study to Compare the Incidence of Tocilizumab Related Infusion Reactions in Patients With Moderate to Severe Active RA, When Infusion is Given Over 31 Minutes Compared to 1 Hour	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	47	Phase 2	Denmark;Iceland
171	EUCTR2010-019912-18-BG (EUCTR)	03/10/2011	25/08/2011	A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
172	EUCTR2010-020065-24-BE (EUCTR)	26/09/2011	16/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	United States;Serbia;Philippines;Greece;Ecuador;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Croatia;Germany
173	EUCTR2010-020065-24-DE (EUCTR)	06/09/2011	30/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
174	EUCTR2010-023587-40-NL (EUCTR)	06/09/2011	11/05/2011	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700		Germany;Netherlands;Italy;Sweden;Greece;Finland;Spain
175	NCT01245439 (ClinicalTrials.gov)	September 2011	17/11/2010	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis	Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	65	Phase 3	Turkey
176	NCT01462162 (ClinicalTrials.gov)	September 2011	27/10/2011	A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis	A Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical Practice	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	122	N/A	Spain
177	NCT01399697 (ClinicalTrials.gov)	September 2011	20/7/2011	A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate	A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2)	Rheumatoid Arthritis	Drug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	261	Phase 4	Spain
178	EUCTR2010-020065-24-NL (EUCTR)	31/08/2011	06/07/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
179	EUCTR2010-019912-18-HU (EUCTR)	31/08/2011	08/06/2011	A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa	Adult Rheumatoid Arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand
180	EUCTR2010-020065-24-ES (EUCTR)	25/08/2011	01/07/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Anticuerpo monoclonal anti-humano recombinante humanizado, receptor de IL-6R. Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Serbia;Philippines;Ecuador;Greece;Spain;Israel;Russian Federation;Chile;Italy;India;France;Malaysia;Denmark;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Romania;Croatia;Germany
181	EUCTR2011-002363-15-IS (EUCTR)	17/08/2011	22/06/2011	A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.	Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST	Adult Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra®	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	56		Denmark;Iceland
182	EUCTR2011-002363-15-DK (EUCTR)	16/08/2011	27/07/2011	A clinical trial with the aim to explore infusion reactions from Tocilizumab given either in 31 or 60 minutes to patients with moderate to severe rheumatoid arthritis.	Multicenter, randomized, parallel group study to compare the incidence of Tocilizumab related infusion reactions in patients with moderate to severe active RA, when infusion is given over 31 minutes compared to 1 hour. - ACT FAST	Adult Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	Roche a/s	NULL	Not Recruiting			Female: yes Male: yes	56		Denmark;Iceland
183	EUCTR2010-020065-24-GB (EUCTR)	15/08/2011	08/04/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
184	NCT01331837 (ClinicalTrials.gov)	August 2, 2011	7/4/2011	A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk Factors	A Clinical Outcomes Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) in Comparison With Etanercept (ETA) on the Rate of Cardiovascular Events in Patients With Moderate to Severe Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Etanercept;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	50 Years	N/A	All	3080	Phase 4	United States;Argentina;Austria;Belgium;Bosnia and Herzegovina;Canada;Chile;Croatia;Czechia;Ecuador;France;Germany;Greece;Hungary;India;Israel;Italy;Latvia;Lithuania;Malaysia;Mexico;Netherlands;Philippines;Poland;Romania;Russian Federation;Serbia;South Africa;Spain;Turkey;United Kingdom;Brazil;China;Czech Republic
185	JPRN-UMIN000013750	2011/07/31	21/04/2014	Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis	Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis - Study on effects of cytokine targeted therapy on periodontal condition in patients with rheumatoid arthritis	Rheumatoid arthritis, Periodontitis	IL-6 receptor inhibition group: Tocilizumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later. TNF inhibition group: Infliximab, Etanercept, and Adalimumab will be infused in 20 patients, and its effectiveness will be evaluated at 3 and 6 months later.	Division of Periodontology, Niigata University Graduate School of Medical and Dental Sciences	NULL	Complete: follow-up complete	Not applicable	Not applicable	Male and Female	80	Not selected	Japan
186	EUCTR2010-020065-24-AT (EUCTR)	28/07/2011	17/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
187	EUCTR2011-001863-39-AT (EUCTR)	28/07/2011	15/06/2011	A study of saftey and efficacy of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab Monotherapy in patients with mild to moderate rheumatoid arthritis, who have not adequately responded to their current treatment with MTX.	A multi-center study of the safety and effect on disease activity of Tocilizumab (TCZ) in combination with Methotrexate (MTX) versus Tocilizumab monotheraphy in patients with mild to moderate rheumatoid arthritis, with inadequate response to MTX (defined as DAS 28 = 4,5 and > 2,6) - OPTIMISE	Mild to moderate rheumatoid arthritis MedDRA version: 16.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexat Lederle 2.5mg tablets Product Name: Methotrexat Product Code: RO0029893 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	Roche Austria GmbH	NULL	Not Recruiting			Female: yes Male: yes			Austria
188	EUCTR2010-020065-24-CZ (EUCTR)	26/07/2011	27/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 19.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
189	EUCTR2010-020065-24-LT (EUCTR)	25/07/2011	25/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080		Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
190	EUCTR2010-020065-24-HU (EUCTR)	15/06/2011	02/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
191	EUCTR2010-023587-40-DE (EUCTR)	14/06/2011	02/03/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700		United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
192	EUCTR2010-020065-24-LV (EUCTR)	08/06/2011	11/05/2011	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel (etanercept) in Patients With Rheumatoid Arthritis and Increased Risk for Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptor blockade with tocilizumab (TCZ) in comparison with etanercept (ETA) on the rate of cardiovascular events in patients with moderate to severe rheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 18.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	3080	Phase 4	Serbia;United States;Philippines;Ecuador;Greece;Spain;Russian Federation;Chile;Israel;Italy;India;France;Malaysia;South Africa;Netherlands;Latvia;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Germany
193	EUCTR2011-000215-79-FR (EUCTR)	07/06/2011	24/02/2011	Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA	Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA	Polyarthrite rhumatoïde	Trade Name: Roactemra Other descriptive name: TOCILIZUMAB	CHU de Clermont Ferrand	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France
194	JPRN-UMIN000005590	2011/06/01	12/05/2011	Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis	Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis - Maintenance of remission by tocilizumab mono-therapy	Rheumatoid arthritis	Cessation of MTX (tocilizumab monotherapy) Continue MTX with tocilizumab	Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	40	Not selected	Japan
195	EUCTR2010-020839-39-BE (EUCTR)	10/05/2011	25/11/2010	Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapy	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: CDP6038 Product Code: CDP6038 Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB	UCB Biosciences, Inc. A Member of the UCB Group of Companies	NULL	Not Recruiting			Female: yes Male: yes	220	Phase 2	United States;Belgium;United Kingdom
196	EUCTR2010-023587-40-GR (EUCTR)	10/05/2011	16/05/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700		United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
197	EUCTR2010-023587-40-SE (EUCTR)	04/05/2011	14/03/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor	A randomized, open-label, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	96		United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
198	NCT01347983 (ClinicalTrials.gov)	May 2011	3/5/2011	Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients	Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients	Rheumatoid Arthritis	Drug: Tocilizumab+Methotrexate(MTX)	Chugai Pharma Taiwan	NULL	Completed	20 Years	75 Years	Both	72	Phase 3	Taiwan
199	NCT01283971 (ClinicalTrials.gov)	May 2011	25/1/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor	A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folate	Hoffmann-La Roche	NULL	Terminated	18 Years	N/A	All	96	Phase 4	United States;Denmark;Finland;France;Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;United Kingdom
200	EUCTR2010-020065-24-IT (EUCTR)	29/04/2011	20/03/2012	A Study of RoActemra/Actemra (tocilizumab) in Comparison to Enbrel(etanercept) in Patients With Rheumatoid Arthritis and Increased Riskfor Heart Disease.	A clinical outcomes study to evaluate the effects of IL-6 receptorblockade with tocilizumab (TCZ) in comparison with etanercept (ETA) onthe rate of cardiovascular events in patients with moderate to severerheumatoid arthritis (RA). - ENTRACTE	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: TOCILIZUMAB Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal Trade Name: Enbrel® INN or Proposed INN: ETANERCEPT Other descriptive name: Etanercept	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	2800	Phase 4	United States;Philippines;Greece;Ecuador;Spain;Chile;Russian Federation;Israel;Italy;India;Malaysia;South Africa;Netherlands;Latvia;China;Bosnia and Herzegovina;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Germany
201	EUCTR2010-023587-40-DK (EUCTR)	28/04/2011	12/04/2011	A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One TNF-Inhibitor	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	United States;European Union;Greece;Finland;Spain;Denmark;Russian Federation;Netherlands;Germany;Italy;Sweden
202	EUCTR2010-019912-18-GR (EUCTR)	18/04/2011	01/04/2011	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis	Rheumatoid arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Product Name: tocilizumab 162mg/0.9ml SC PFS SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600		Hungary;Greece;Spain;Bulgaria
203	EUCTR2010-023587-40-FI (EUCTR)	15/04/2011	24/02/2011	A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	A randomized, open-label double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	96		Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
204	EUCTR2010-023587-40-ES (EUCTR)	13/04/2011	17/02/2011	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor.Estudio randomizado, doble ciego, de grupos paralelos de la reducción de los signos y síntomas durante el tratamiento con tocilizumab versus con adalimumab, ambos asociados con MTX, en pacientes con artritis reumatoide activa moderada a severa y respuesta inadecuada al tratamiento con sólo un inhibidor de TNF.	Adult Rheumatoid Arthritis (RA)Artritis reumatoide del adulto (AR) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700	Phase 4	Greece;Finland;Spain;Denmark;Netherlands;Germany;Italy;Sweden
205	EUCTR2010-023587-40-IT (EUCTR)	10/03/2011	27/04/2011	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - ND	A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - ND	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra INN or Proposed INN: tocilizumab Trade Name: Humira INN or Proposed INN: Adalimumab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	700		Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
206	NCT01353859 (ClinicalTrials.gov)	March 2011	13/5/2011	A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs	An Open Label, Local, Multicenter , Phase IIIb Interventional Study to Assess the Efficacy of Tocilizumab (TCZ) in Combination With Methotrexate (MTX) in Indonesian Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	39	Phase 3	Indonesia;Greece
207	NCT01232569 (ClinicalTrials.gov)	March 2011	1/11/2010	A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Double-blind, Parallel Group Study of Safety and the Effect on Clinical Outcome of Tocilizumab Subcutaneous (sc) Versus Placebo sc in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab 162 mg;Drug: Placebo	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	656	Phase 3	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;Greece;Guatemala;Hungary;Israel;Malaysia;Mexico;New Zealand;Panama;Philippines;Poland;Russian Federation;South Africa;Spain;Switzerland;Thailand;Peru
208	NCT01332994 (ClinicalTrials.gov)	March 2011	18/3/2011	A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid Arthritis	Efficacy and Safety Study of a Sequential Therapy of Tocilizumab (TCZ) and, if Initially Inadequately Responded to Tocilizumab (TCZ), Followed by Rituximab (RTX) in DMARD-IR Patients With Rheumatoid Arthritis (MIRAI)	Rheumatoid Arthritis	Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	519	Phase 3	Germany
209	EUCTR2010-020839-39-GB (EUCTR)	25/02/2011	12/10/2010	Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapy	A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY WITHAN ACTIVE COMPARATOR TO EVALUATE THE EFFICACY AND SAFETY OF CDP6038 ADMINISTERED SUBCUTANEOUSLY FOR 12 WEEKS TO SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS HAVING PREVIOUSLY FAILED TNF-BLOCKER THERAPY - RA0056	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: Olikizumab Product Code: CDP6038 INN or Proposed INN: Olokizumab Other descriptive name: Recombinant human Mab of IgG4 subtype Trade Name: RoActemra 20 mg/ml concentrate for solution for infusion. Product Name: Tocilizumab INN or Proposed INN: RoActemra® Other descriptive name: TOCILIZUMAB	UCB Biosciences, Inc	NULL	Not Recruiting			Female: yes Male: yes	220		United Kingdom;United States
210	NCT01254331 (ClinicalTrials.gov)	February 2011	3/12/2010	An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment	Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	51	Phase 3	Tunisia
211	NCT01235507 (ClinicalTrials.gov)	February 2011	15/10/2010	A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) (ALABASTER)	Actemra - Local Bosnian Open, Multicentric, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis After Inadequate Response to DMARDs	Rheumatoid Arthritis	Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	71	Phase 3	Bosnia and Herzegovina
212	EUCTR2010-019912-18-ES (EUCTR)	17/01/2011	19/01/2011	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	Rheumatoid arthritis (RA)Artritis Reumatoide (AR) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml SC PFS SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6;	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	600	Phase 3	Hungary;Greece;Spain;Bulgaria
213	EUCTR2010-022049-88-DE (EUCTR)	05/01/2011	11/11/2010	Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI	Efficacy and safety study of a sequential therapy of tocilizumab (TCZ) and, if initially inade-quately responded to tocilizumab (TCZ), followed by rituximab (RTX) in DMARD-IR patients with rheumatoid arthritis (MIRAI) - MIRAI	Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra 20 mg/ml Concentrate for solution for infusion Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: Tocilizumab Trade Name: Mabthera 500 mg Concentrate for solution for infusion Product Name: Rituximab Product Code: RO045-2294 INN or Proposed INN: RITUXIMAB	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes			Germany
214	NCT01219933 (ClinicalTrials.gov)	January 2011	11/10/2010	A Study of Glucocorticoid Use to Evaluate Systematic Methylprednisolone Reduction in Patients With Rheumatoid Arthritis on Background RoActemra/Actemra (Tocilizumab) (ACT-ALONE)	An Open-label, Single-arm Study to Describe Glucocorticoid Use in Rheumatoid Arthritis Patients Treated With Tocilizumab in Daily Clinical Practice and to Evaluate Systematic Glucocorticoid Dose Reduction Once Low Disease Activity is Reached (ACT-ALONE)	Rheumatoid Arthritis	Drug: methylprednisolone;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	68	Phase 4	Belgium
215	NCT01258712 (ClinicalTrials.gov)	December 2010	8/12/2010	Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients	Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients	Rheumatoid Arthritis (RA)	Drug: Tocilizumab + methotrexate(MTX);Drug: Tocilizumab placebo + methotrexate(MTX)	Chugai Pharma Taiwan	NULL	Completed	20 Years	75 Years	Both	86	Phase 3	Taiwan
216	EUCTR2010-018375-22-BG (EUCTR)	25/11/2010	23/09/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand
217	JPRN-UMIN000004412	2010/11/01	20/10/2010	Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid	Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid - CARAT study	rheumatoid arthritis	tocilizumab	General Internal Medicine, Tenri Hospital	NULL	Recruiting	16years-old	80years-old	Male and Female	25	Not applicable	Japan
218	NCT01242488 (ClinicalTrials.gov)	November 2010	15/11/2010	Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) Therapy	Randomized, Double-blind, Placebo-controlled, Dose Ranging Study With an Active Comparator to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Subjects With Rheumatoid Arthritis Having Previously Failed TNF-blocker Therapy	Rheumatoid Arthritis	Biological: CDP6038;Biological: Tocilizumab (Actemra or RoActemra);Other: Placebo sc;Other: Placebo iv	UCB Pharma	NULL	Completed	18 Years	N/A	Both	221	Phase 2	United States;Belgium;United Kingdom
219	EUCTR2008-006924-68-AT (EUCTR)	28/10/2010	12/01/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy
220	NCT01362062 (ClinicalTrials.gov)	October 26, 2010	26/5/2011	Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Participants With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Non-Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) and/or Anti-tumor Necrosis Factor (Anti-TNF) Therapy	A Study to Observe the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti TNF Therapy.	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	110	N/A	India
221	EUCTR2010-018375-22-LT (EUCTR)	11/10/2010	16/08/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand
222	EUCTR2010-018375-22-DE (EUCTR)	05/10/2010	14/07/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1200		United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand
223	EUCTR2009-015845-21-GR (EUCTR)	04/10/2010	04/10/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
224	EUCTR2009-015845-21-PT (EUCTR)	01/10/2010	22/07/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Finland;Portugal;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
225	NCT01214733 (ClinicalTrials.gov)	October 2010	4/10/2010	A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis	An Open Label Study of the Safety During Treatment With Tocilizumab (TCZ), in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	30	Phase 3	South Africa
226	NCT01149057 (ClinicalTrials.gov)	October 2010	22/6/2010	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDS	An Open-Label Study to Evaluate the Efficacy and Safety Of Tocilizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-biologic DMARDs and/or Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	Clalit Health Services	Completed	18 Years	N/A	All	145	Phase 4	Israel
227	EUCTR2010-019694-15-BE (EUCTR)	28/09/2010	28/07/2010	Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone	Act-Alone : An open-label, single-arm study to describe glucocorticoid use in rheumatoid arthritis patients treated with Tocilizumab in daily clinical practice and to evaluate systematic glucocorticoid dose reduction once low disease activity is reached - ACT-Alone	Rheumatoid Arthritis in adult MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: Medrol 4 mg tablets Other descriptive name: METHYLPREDNISOLONE Trade Name: Medrol A 16 mg tablets Other descriptive name: METHYLPREDNISOLONE	N.V. Roche S.A.	NULL	Not Recruiting			Female: yes Male: yes		Phase 4	Belgium
228	EUCTR2010-019935-37-FI (EUCTR)	15/09/2010	02/07/2010	A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis	A pragmatic, randomized, parallel group study of the effect on disease remission, work productivity, and tolerability of tocilizumab in combination with DMARDs and individually designed best practice DMARD therapy in patients with early, moderate to severe Rheumatoid Arthritis	Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term:	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 Other descriptive name: TOCILIZUMAB	Roche Oy	NULL	Not Recruiting			Female: yes Male: yes	160		Finland
229	EUCTR2010-018375-22-GB (EUCTR)	14/09/2010	29/06/2010	A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA	Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand
230	NCT01194414 (ClinicalTrials.gov)	September 2010	1/9/2010	A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab SC;Drug: tocilizumab IV;Drug: placebo to tocilizumab SC;Drug: placebo to tocilizumab IV;Drug: Disease-modifying antirheumatic drugs (DMARDs)	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1262	Phase 3	United States;Argentina;Australia;Brazil;Bulgaria;Canada;Colombia;France;Germany;Guatemala;Hong Kong;Italy;Lithuania;Mexico;New Zealand;Peru;Philippines;Poland;Puerto Rico;Romania;Russian Federation;Singapore;South Africa;Spain;Thailand;United Kingdom
231	NCT01163747 (ClinicalTrials.gov)	September 2010	14/7/2010	A Study of the Effects of RoActemra/Actemra on Vaccination in Patients With Rheumatoid Arthritis on Background Methotrexate (VISARA)	A Randomized, Parallel-group, Open-label, Multicenter Study to Evaluate the Effects of Tocilizumab on Vaccination in Subjects With Active Rheumatoid Arthritis Receiving Background Methotrexate	Rheumatoid Arthritis	Biological: tocilizumab;Drug: methotrexate;Biological: 23-Valent Pneumococcal Polysaccharide Vaccine;Biological: Tetanus Toxoid Adsorbed Vaccine	Genentech, Inc.	NULL	Completed	18 Years	64 Years	All	91	Phase 4	United States
232	EUCTR2010-018375-22-ES (EUCTR)	03/08/2010	04/06/2010	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa.	Rheumatoid arthritisArtritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml jeringa SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab 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	1200	Phase 3	Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
233	NCT01195272 (ClinicalTrials.gov)	August 2010	2/9/2010	A Study of the Effects of RoActemra/Actemra (Tocilizumab) on Neutrophils in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic and/or Non-biologic DMARDs.	A 52 Week, Single Center, Open-label Study to Evaluate Neutrophil Function and Survival Effects of Tocilizumab (TCZ) in Patients With Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	21	Phase 4	United Kingdom
234	EUCTR2010-018375-22-IT (EUCTR)	29/07/2010	05/07/2010	A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND	A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND	Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Trade Name: RoActemra INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1200		Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
235	EUCTR2009-015845-21-DE (EUCTR)	22/07/2010	18/03/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Finland;Czech Republic;United Kingdom;Germany;Belgium;Spain;Greece;Sweden
236	EUCTR2009-012759-12-CZ (EUCTR)	16/07/2010	22/02/2010	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Denmark;Germany;Sweden
237	EUCTR2009-015845-21-CZ (EUCTR)	16/07/2010	26/03/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
238	EUCTR2009-015845-21-SE (EUCTR)	06/07/2010	10/05/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
239	EUCTR2009-015845-21-FI (EUCTR)	16/06/2010	30/04/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300		Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
240	EUCTR2009-012759-12-GR (EUCTR)	15/06/2010	13/11/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
241	EUCTR2009-015845-21-BE (EUCTR)	08/06/2010	04/05/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
242	EUCTR2010-019873-13-BE (EUCTR)	07/06/2010	14/04/2010	Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA	Comparative study of the clinical response and cardiorespiratory endurance in early rheumatoid arthritis patients treated with Tociluzimab or MethotrexateAddendum protocol : Global gene expression profiles in synovial biopsies from early rheumatoid arthritis patients treated with Tocilizumab or Methotrexate - TOMERA	early rheumatoid arthritis MedDRA version: 12.1;Level: HLT;Classification code 10039075;Term: Rheumatoid arthritis and associated conditions	Trade Name: RoActemra Product Name: Tocilizumab	UCL Cliniques Universitaires Saint Luc	NULL	Not Recruiting			Female: yes Male: yes		Phase 2	Belgium
243	EUCTR2009-015845-21-GB (EUCTR)	13/05/2010	17/03/2010	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Humira® Product Code: RO 551-6922 INN or Proposed INN: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
244	EUCTR2010-018331-18-GB (EUCTR)	12/05/2010	18/03/2010	A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	A 52 week, Single center, Open-label Study to Evaluate Neutrophil function and survival effects of Tocilizumab (TCZ) in Patients with Active Rheumatoid Arthritis (RA) on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Adult Rheumatoid Arthritis (RA) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes			United Kingdom
245	EUCTR2009-015845-21-ES (EUCTR)	12/05/2010	12/01/2012	A comparison of tocilizumab and adalimumab in patients withrheumatoid arthritis looking at improvement in joint pain, joint swellingand general disease activity.	A multi-center, randomized, blinded, parallel-group study of the reduction of signs and symptoms during monotherapy treatment with tocilizumab 8 mg/kg intravenously versus adalimumab 40 mg subcutaneously in patients with rheumatoid arthritis.	Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: HUMIRA 40 mg solución inyectable en jeringa precargada INN or Proposed INN: ADALIMUMAB Other descriptive name: ADALIMUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	300	Phase 4	United States;Portugal;Greece;Finland;Spain;Turkey;United Kingdom;Switzerland;Czech Republic;Mexico;Belgium;Brazil;Australia;Germany;Sweden
246	NCT01119859 (ClinicalTrials.gov)	May 2010	1/4/2010	A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis	A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Adalimumab;Drug: Placebo to tocilizumab;Drug: Placebo to adalimumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	326	Phase 4	United States;Australia;Belgium;Brazil;Czech Republic;Finland;Germany;Greece;Mexico;Portugal;Spain;Sweden;Switzerland;Turkey;United Kingdom;Norway
247	NCT01245452 (ClinicalTrials.gov)	May 2010	19/11/2010	Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or Methotrexate	Comparative Study of the Clinical Response and Cardiorespiratory Endurance in Early Rheumatoid Arthritis Patients Treated With Tocilizumab or Methotrexate Addendum Protocol : Global Gene Expression Profiles in Synovial Biopsies	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Methotrexate	Patrick Durez	NULL	Completed	18 Years	70 Years	Both	30	N/A	Belgium
248	EUCTR2010-018696-21-FR (EUCTR)	14/04/2010	15/02/2010	Etude de l’évolution de la réponse immunitaire Th17 chez des patients atteints de polyarthrite rhumatoïde et traités par tocilizumab après échec des autres thérapies - TOCI 17	Etude de l’évolution de la réponse immunitaire Th17 chez des patients atteints de polyarthrite rhumatoïde et traités par tocilizumab après échec des autres thérapies - TOCI 17	Polyarthrite rhumatoïde MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoACTEMRA Product Name: TOCILIZUMAB	CHU DIJON	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes			France
249	EUCTR2009-012759-12-HU (EUCTR)	17/03/2010	25/01/2010	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
250	NCT01256736 (ClinicalTrials.gov)	March 2010	28/10/2010	To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis	Prospective, Open-labeled, 1 Year Extension Study of the Efficacy and the Safety During Treatment of Tocilizumab in Patients With Active RA Completing Treatment CWP-TCZ301 Study	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: DMARDs	JW Pharmaceutical	NULL	Completed	18 Years	N/A	Both	89	Phase 3	Korea, Republic of
251	NCT01610791 (ClinicalTrials.gov)	March 2010	31/5/2012	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs (REMISSION)	A Single Arm, Open Label Study to Assess the Safety, Tolerability and Efficacy of Tocilizumab in Active Rheumatoid Arthritis Patients With Inadequate Response to the DMARDs (REMISSION Study)	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	121	Phase 3	Morocco
252	NCT01034397 (ClinicalTrials.gov)	March 2010	16/12/2009	A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDs	A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	54	Phase 4	Portugal
253	NCT02010216 (ClinicalTrials.gov)	March 2010	4/12/2013	A Study of RoActemra/Actemra (Tocilizumab) in Adult Patients With Rheumatoid Arthritis (SVOBODA Programme)	Non-Randomized Phase IV Trial on Efficacy and Safety of Actemra in the Treatment of Adult Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	23	Phase 4	Kazakhstan
254	NCT01063062 (ClinicalTrials.gov)	February 28, 2010	3/2/2010	A Study With Tocilizumab [RoActemra/Actemra] Monotherapy or in Combination With Methotrexate in Patients With Rheumatoid Arthritis (PICTURE)	A Single-arm, Open-label, Multicenter Study of Tocilizumab Monotherapy or in Combination With Methotrexate to Assess Safety and the Efficacy in Reducing Disease Activity in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDs (PICTURE)	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	107	Phase 3	Egypt
255	EUCTR2009-012759-12-IE (EUCTR)	26/01/2010	05/11/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
256	EUCTR2009-012759-12-SE (EUCTR)	12/01/2010	17/11/2009	A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
257	EUCTR2009-012759-12-PT (EUCTR)	12/01/2010	21/10/2009	A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Australia;Denmark;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
258	NCT01034137 (ClinicalTrials.gov)	January 2010	16/12/2009	A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid Arthritis	U-ACT-EARLY: A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Evaluate Remission in DMARD and Biological naïve Early Rheumatoid Arthritis (RA) Subjects Treated With Tocilizumab (TCZ) Plus Tight Control Methotrexate (MTX) , TCZ Monotherapy or Tight Control MTX Monotherapy	Rheumatoid Arthritis	Drug: methotrexate;Drug: placebo MTX;Drug: placebo TCZ;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	317	Phase 3	Netherlands
259	NCT01089023 (ClinicalTrials.gov)	January 2010	8/3/2010	A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	95	Phase 4	Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates
260	NCT01000441 (ClinicalTrials.gov)	December 23, 2009	22/10/2009	Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis	Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumab	University Hospital, Strasbourg, France	NULL	Completed	18 Years	N/A	All	300	Phase 4	France;Monaco
261	EUCTR2009-012759-12-FI (EUCTR)	21/12/2009	28/09/2009	A 2 year, global, randomized, phase III clinical trial stuying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with methotrexate and methotrexate only, in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	United States;Portugal;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Peru;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Germany;New Zealand;Sweden
262	EUCTR2009-012759-12-DK (EUCTR)	07/12/2009	03/11/2009	A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;United States;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Peru;Denmark;Australia;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Germany;New Zealand;Sweden
263	EUCTR2009-012759-12-ES (EUCTR)	01/12/2009	23/09/2009	Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Estudio multicéntrico, doble ciego, randomizado, con grupos de tratamiento paralelos, para evaluar la seguridad, la remisión de la enfermedad y la prevención del daño estructural articular durante el tratamiento con tocilizumab (TCZ) en monoterapia y en combinación con metotrexato (MTX), frente a metotrexato en monoterapia, en pacientes con artritis reumatoide precoz, moderada a severa. A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Artritis ReumatoideRheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
264	NCT01044498 (ClinicalTrials.gov)	December 2009	7/1/2010	A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis	An Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Ortho-Novum® 1/35	Hoffmann-La Roche	NULL	Completed	18 Years	44 Years	Female	46	Phase 3	United States
265	EUCTR2009-012185-32-IT (EUCTR)	23/11/2009	25/06/2009	Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND	Open label, multicentric phase IIIb study to evaluate the effect of tocilizumab in combination with DMARDs in the inhibition of progression of synovitis, bone marrow edema, and erosions evaluated by dedicated magnetic resonance imaging (MRI) in the hand of patients with rheumatoid arthritis (RA) - ND	Moderate to severe active rheumatoid arthritis (RA), who are inadequate responders to DMARDs. MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: Ro487-7533 INN or Proposed INN: RoActemra	ROCHE	NULL	Not Recruiting			Female: yes Male: yes		Phase 3	Italy
266	EUCTR2009-012759-12-FR (EUCTR)	13/11/2009	09/10/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
267	EUCTR2009-012759-12-DE (EUCTR)	13/11/2009	25/08/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128		Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
268	EUCTR2009-012759-12-IT (EUCTR)	12/11/2009	17/11/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - ND	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - ND	Rheumatoid Arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab Trade Name: RoActemra INN or Proposed INN: Tocilizumab Trade Name: RoActemra INN or Proposed INN: Tocilizumab Trade Name: Methotrexate ``Lederle`` 2.5mg tablets INN or Proposed INN: Methotrexate	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden
269	EUCTR2008-006924-68-HU (EUCTR)	11/11/2009	02/09/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Portugal;Hungary;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
270	EUCTR2009-013316-12-NL (EUCTR)	10/11/2009	21/10/2009	A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early	A multi-center, randomized, double blind, placebo controlled study to evaluate remission in DMARD and biological naïve early reumatoid arthritis (RA) subjects treated with tocilizumab (TCZ) plus tight control methotrexate (MTX) treatment, TCZ monotherapy or tight control MTX monotherapy. - U-Act-Early	Rheumatoid Arthritis MedDRA version: 15.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: RoActemra Trade Name: Methotrexate 'Lederle' 2,5mg tablets	Roche Nederland B.V.	NULL	Not Recruiting			Female: yes Male: yes			Netherlands
271	JPRN-UMIN000002744	2009/11/01	10/11/2009	Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation	Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation - Surprise study	rheumatoid arthritis	tocilizumab plus methotrexate tocilizumab	Keio University	NULL	Complete: follow-up complete	20years-old	75years-old	Male and Female	300	Not selected	Japan
272	NCT00996203 (ClinicalTrials.gov)	October 31, 2009	15/10/2009	A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.	Local Open-label Multicenter Study to Evaluate the Quality of Life in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to DMARDs When Adding Tocilizumab (TCZ)	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: DMARDs (disease-modifying antirheumatic drugs)	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	201	Phase 4	Russian Federation
273	NCT00951275 (ClinicalTrials.gov)	October 31, 2009	30/7/2009	A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis	A Single Arm, Open-label Study of Early Improvement of Anemia and Fatigue During Treatment With Tocilizumab (TCZ) in Combination With DMARDs, in Adult Patients With Moderate to Severe Active Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	105	Phase 3	Italy
274	NCT01007435 (ClinicalTrials.gov)	October 31, 2009	3/11/2009	A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis	A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Placebo to tocilizumab;Drug: Methotrexate;Drug: Placebo to methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1162	Phase 3	United States;Argentina;Australia;Austria;Brazil;Canada;China;Colombia;Denmark;Finland;France;Germany;Greece;Guatemala;Hong Kong;Hungary;Ireland;Israel;Italy;Macedonia, The Former Yugoslav Republic of;Mexico;New Zealand;Panama;Peru;Philippines;Poland;Portugal;Puerto Rico;Russian Federation;Singapore;South Africa;Spain;Sweden;Thailand;Turkey;United Kingdom;Czech Republic
275	EUCTR2009-012759-12-GB (EUCTR)	14/10/2009	17/08/2009	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
276	EUCTR2009-012218-30-PT (EUCTR)	06/10/2009	12/08/2009	A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT	A randomized, double-blind, placebo-controlled study to assess the efficacy of tocilizumab (TCZ) + non-biological DMARD in reducing synovitis as measured by magnetic resonance imaging (MRI) at 12 weeks after initiation of treatment in patients with moderate to severe rheumatoid arthritis (RA) with inadequate response to non-biological DMARDs - PORTRAIT	Men and women > 18 years of age with RA who are currently experiencing an inadequate clinical response to a stable dose of non-biologic DMARDs (at least 12 weeks) and with MRI documented synovitis of dominant hand.	Trade Name: RoActemra	Roche Farmacêutica Química, Lda.	NULL	Not Recruiting			Female: yes Male: yes			Portugal
277	NCT01120366 (ClinicalTrials.gov)	October 2009	6/5/2010	Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation	Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After Discontinuation	Rheumatoid Arthritis	Drug: Tocilizumab plus methotrexate;Drug: Tocilizumab	SURPRISE Study Group	NULL	Completed	20 Years	75 Years	Both	233	Phase 4	Japan
278	NCT00996606 (ClinicalTrials.gov)	October 2009	15/10/2009	A Study of Tocilizumab in Combination With Disease-Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs	Open Label, Multicentric Phase IIIb Study to Evaluate the Effect of Tocilizumab in Combination With DMARDs in the Inhibition of Progression of Synovitis, Bone Marrow Edema, and Erosions Evaluated by Dedicated Magnetic Resonance Imaging (MRI) in the Hand of Patients With Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: DMARDs;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	58	Phase 3	Italy
279	NCT01211834 (ClinicalTrials.gov)	October 2009	29/9/2010	Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and the Safety During Treatment With Tocilizumab vs Placebo in Combination With Traditional DMARD Therapy in Patients With Moderate to Severe Active RA and an Inadequate Response to Current DMARD Therapy	Rheumatoid Arthritis	Drug: tocilizumab;Drug: DMARDs;Drug: Placebo	JW Pharmaceutical	NULL	Completed	18 Years	N/A	Both	90	Phase 3	Korea, Republic of
280	EUCTR2009-012759-12-AT (EUCTR)	14/09/2009	21/08/2009	A 2 year, global, randomized, phase III clinical trial studying the safety, disease remission and prevention of joint damage with Tocilizumab only, Tocilizumab with Methotrexate and Methotrexate only, in patients with early, moderate to severe, rheumatoid arthritis.	A multi-center, randomized, double-blind, parallel group study of the safety, disease remission and prevention of structural joint damage during treatment with tocilizumab (TCZ), as a monotherapy and in combination with methotrexate (MTX), versus methotrexate in patients with early, moderate to severe rheumatoid arthritis. - FUNCTION	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1128	Phase 3	United States;Portugal;Philippines;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Colombia;Italy;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Peru;South Africa;China;Panama;Finland;Guatemala;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Germany;New Zealand;Sweden
281	EUCTR2008-001847-20-DE (EUCTR)	08/09/2009	03/06/2009	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Germany;Latvia;Netherlands;Norway;Sweden
282	JPRN-UMIN000002340	2009/08/01	20/08/2009	Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET)	Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) - cHAMLET	Rheumatoid Arthritis	Treatment with higher dosages of infliximab (3-10 mg/Kg) Every 2 months Follow-up to 54 weeks Treatment with one of other biologics (etanercept, adalimumab, tocilizumab) in standard protocol Follow-up to 54 weeks	Department of Rheumatosurgery, Osaka City University Medical School	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	60	Phase 4	Japan
283	NCT00965653 (ClinicalTrials.gov)	August 2009	18/8/2009	A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid Arthritis	Open-label, Multicenter, Randomized, Parallel Study to Investigate pk, pd, Efficacy and Safety of Tocilizumab (TCZ, RO4877533) Following Subcutaneous Administration of TCZ 162 mg Weekly or Every Other Week in Combination With Methotrexate in Patients With Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: folic acid;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	Both	29	Phase 1	Canada;New Zealand;Spain;United Kingdom
284	EUCTR2008-005525-11-GR (EUCTR)	20/07/2009	17/11/2009	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
285	EUCTR2008-006924-68-GR (EUCTR)	03/06/2009	19/11/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
286	NCT00977106 (ClinicalTrials.gov)	June 2009	18/8/2009	TORPEDO Study: A Study on Rapid Effect of Tocilizumab in Patients With Rheumatoid Arthritis With an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs) or Anti-TNF	Comparative Double Blind Placebo Controlled Clinical Study on Tocilizumab Rapid Efficacy on Patients Relief in rheumatoïd Arthritis With an Inadequate Response to DMARDs or Anti TNF :TORPEDO	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: placebo	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	103	Phase 3	France
287	NCT01010503 (ClinicalTrials.gov)	June 2009	9/11/2009	A Study of Tocilizumab With or Without Methotrexate in Patients With Rheumatoid Arthritis.	Evaluation of Adherence and Persistence to Tocilizumab in Combination With Methotrexate or Tocilizumab Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis in Local Environment.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	32	Phase 4	Slovakia
288	NCT00947492 (ClinicalTrials.gov)	June 2009	27/7/2009	Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs	Monitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).	Rheumatoid Arthritis	Biological: Venous blood sample	Assistance Publique Hopitaux De Marseille	NULL	Active, not recruiting	18 Years	N/A	Both	60	N/A	France
289	EUCTR2008-006924-68-PT (EUCTR)	18/05/2009	17/03/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		France;Portugal;Hungary;Czech Republic;Spain;Netherlands;United Kingdom;Italy
290	EUCTR2009-011105-17-IT (EUCTR)	17/05/2009	27/03/2009	A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue	A single-arm, open-label study of early improvement of anemia and fatigue during treatment with tocilizumab (TCZ) in combination with non biologic DMARDs, in adult patients with moderate to severe active rheumatoid arthritis. - Anemia Fatigue	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: Ro 487-7533 INN or Proposed INN: RoActemra	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Italy
291	EUCTR2009-011520-53-SK (EUCTR)	04/05/2009	17/03/2009	Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment	Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environment	moderate to severe active rheumatoid arthritis	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: RoActemra	Roche Slovensko s.r.o.	NULL	Not Recruiting			Female: yes Male: yes			Slovakia
292	NCT00887341 (ClinicalTrials.gov)	May 2009	22/4/2009	A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis	Phase II Multi-centre, Randomized, Parallel Group, Pilot Trial to Compare the Incidence of Tocilizumab Related Infusion Reactions in Moderate to Severe RA Patients When Infusion is Made Over 1 Hour Against 31 Minutes	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	76	Phase 2	Spain
293	NCT00891020 (ClinicalTrials.gov)	May 2009	29/4/2009	A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)	Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choice	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	886	Phase 3	United States;Puerto Rico;United Kingdom
294	EUCTR2008-006924-68-CZ (EUCTR)	28/04/2009	12/02/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
295	EUCTR2008-008309-23-FR (EUCTR)	24/04/2009	31/03/2009	Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO	Etude clinique comparative en double aveugle versus placebo sur la rapidité d’action du tocilizumab sur le soulagement des patients atteints de polyarthrite rhumatoïde active avec réponse inadéquate aux DMARDs et/ou aux biothérapies. - TORPEDO	Polyarthrite rhumatoïde active modérée à sévère de moins de 10 ans d'ancienneté, avec réponse inadéquate au méthotrexate (MTX) et/ou à un autre DMARD et/ou à au moins un anti-TNF MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Code: RO487-7533/F01-F05 INN or Proposed INN: tolicizumab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	118	Phase 4	France
296	EUCTR2008-005525-11-DE (EUCTR)	24/04/2009	09/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81		United Kingdom;Germany;Netherlands;France;Spain
297	EUCTR2008-006924-68-FR (EUCTR)	06/04/2009	19/03/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Code: RO4877533/F04-F05 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Portugal;France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
298	EUCTR2008-006924-68-IT (EUCTR)	03/04/2009	23/03/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - extension to study MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - extension to study MA21573	Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs) or anti-TNF therapies. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: TOCILIZUMAB	F. Hoffmann-La Roche	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
299	EUCTR2008-006924-68-NL (EUCTR)	02/04/2009	09/02/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
300	EUCTR2008-005525-11-NL (EUCTR)	31/03/2009	12/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81		France;Spain;Germany;Netherlands;United Kingdom
301	EUCTR2008-003011-12-GB (EUCTR)	30/03/2009	27/04/2009	Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA	Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA	Rheumatoid Arthritis	Trade Name: RoActemra®EV Product Code: PRD82321 Product Name: Tocilizumab Product Code: RO4877533	University of Leeds	NULL	Not Recruiting			Female: yes Male: yes	30	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
302	EUCTR2008-000587-17-DE (EUCTR)	26/03/2009	17/12/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
303	EUCTR2008-000587-17-IT (EUCTR)	12/03/2009	20/03/2009	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background No-Biologic DMARDs who have an Inadequate Response to Current Non-Biologic DMARD and/or Anti-TNF Therapy - ND	Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti-TNF therapies MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 INN or Proposed INN: tocilizumab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
304	EUCTR2008-006924-68-GB (EUCTR)	06/03/2009	29/04/2009	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - this is an extension study to MA21573	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Italy;United Kingdom
305	NCT02721004 (ClinicalTrials.gov)	March 2009	2/3/2016	Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid Arthritis	Documentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	N/A	N/A	Both	592	N/A	Austria
306	NCT00883753 (ClinicalTrials.gov)	March 2009	17/4/2009	An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy	An Extension Phase of the Multi-National Open-Label Study (MA21573) to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	934	Phase 3	Australia;Canada;Czech Republic;France;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;United Kingdom;Austria;Turkey
307	NCT00810199 (ClinicalTrials.gov)	March 2009	16/12/2008	A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment	Randomized Placebo-controlled Study of Two Treatment Strategies Based on Tocilizumab (TCZ) With or Without Methotrexate (MTX) and Possible Addition of Other Disease-modifying Anti-rheumatic Drugs (DMARDs) in Patients...	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate;Drug: placebo	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	556	Phase 3	United States;Brazil;Croatia;Denmark;Estonia;France;Germany;Greece;Israel;Italy;Latvia;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Sweden;Thailand;United Kingdom;Monaco
308	NCT00845832 (ClinicalTrials.gov)	March 2009	17/2/2009	A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to Methotrexate	A Randomized, Active Controlled, Double-blind, Study to Compare the Safety and Reduction in Disease Activity With the Combination of Rituximab (MabThera®)and Tocilizumab (RoActemra®) Versus Tocilizumab in Patients With Active Rheumatoid Arthritis With an Incomplete Response to Methotrexate	Rheumatoid Arthritis	Drug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Terminated	18 Years	65 Years	All	24	Phase 2	France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden
309	EUCTR2008-000587-17-HU (EUCTR)	27/02/2009	28/11/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
310	EUCTR2008-006443-39-ES (EUCTR)	23/02/2009	09/12/2008	Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos.	Estudio piloto de fase II multicéntrico, aleatorizado, en grupos paralelos para comparar la incidencia de las reacciones a la infusión de Tocilizumab en pacientes con AR moderada a grave cuando la infusión se realiza en 1 hora frente a 31 minutos.	Pacientes adultos con artritis reumatoide (AR) activa moderada o grave que son respondedores inadecuados a los tratamientos con FAMEs no biológicos o con anti-TNFs. MedDRA version: 9;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO04877533 INN or Proposed INN: Tocilizumab Other descriptive name: RoActemra	Roche Farma, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain
311	EUCTR2008-001847-20-GR (EUCTR)	17/02/2009	06/03/2009	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Rheumatoid Arthritis	Trade Name: RoActemra® Product Code: L04AC07 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
312	EUCTR2008-006924-68-ES (EUCTR)	13/02/2009	19/01/2009	Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573	Fase de extensión del estudio abierto multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy. - extension MA21573	Artritis reumatoide/Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1200		Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
313	EUCTR2008-005525-11-FR (EUCTR)	06/02/2009	13/03/2009	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and reduction in disease activity with the combination of rituximab (MabThera®) and tocilizumab (RoActemra®) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera Product Code: RO452294/V02 INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533/F01 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
314	EUCTR2008-001847-20-SE (EUCTR)	02/02/2009	23/10/2008	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
315	NCT00754572 (ClinicalTrials.gov)	February 2009	17/9/2008	A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis	A Single-arm, Open-label Study of the Safety and Reduction of Signs and Symptoms During Treatment With Tocilizumab in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	418	Phase 3	Argentina;Brazil;Chile;Colombia;Costa Rica;Ecuador;Mexico;Peru;Uruguay;Venezuela
316	EUCTR2008-005525-11-ES (EUCTR)	29/01/2009	09/12/2008	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Estudio randomizado, controlado con placebo, doble ciego y con grupos paralelos para comparar la seguridad y la reducción de la actividad de la enfermedad con la combinación de rituximab (MabThera) y tocilizumab (RoActemra) frente al tratamiento con tocilizumab en pacientes con artritis reumatoide activa con respuesta incompleta a metotrexato.A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Artritis reumatoideRheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MABTHERA 500 mg concentrado para solución para perfusión INN or Proposed INN: RITUXIMAB Other descriptive name: RITUXIMAB Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Phase 2	France;Greece;Spain;Netherlands;Germany;United Kingdom
317	EUCTR2008-001847-20-IT (EUCTR)	18/01/2009	18/12/2008	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo-controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ND	Adult patients with active moderate to severe (DAS28 > 4.4) rheumatoid arthritis (RA) who have inadequately responded to prior conventional MTX treatment and have not been treated with any biologic agent before. MedDRA version: 9.1;Level: LLT;Classification code 10003268;Term: Arthritis rheumatoid	Product Name: Tocilizumab Product Code: RO04877533 Trade Name: Methotrexate Lederle 2.5 mg Tablets INN or Proposed INN: Methotrexate Product Name: Tocilizumab Product Code: RO04877533	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;United Kingdom;Italy;Sweden
318	EUCTR2008-000587-17-GR (EUCTR)	13/01/2009	30/01/2009	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Adult patients with moderate to severe active rheumatoid arthritis (RA) who are inadequate responders to DMARDs or anti- TNF therapies MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab	F. Hoffmann- La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
319	NCT02809833 (ClinicalTrials.gov)	January 2009	20/6/2016	Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine	Tocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical Routine	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	850	N/A	Germany
320	NCT00848120 (ClinicalTrials.gov)	December 31, 2008	19/2/2009	A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis	An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	29	Phase 3	Philippines
321	EUCTR2008-005525-11-GB (EUCTR)	29/12/2008	16/12/2008	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	A randomized, placebo controlled, double-blind, parallel group study to compare the safety and efficacy of the combination of rituximab (MabThera) and tocilizumab (Actemra) versus tocilizumab therapy in patients with active rheumatoid arthritis with an incomplete response to methotrexate.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: MabThera 500mg Product Name: rituximab INN or Proposed INN: Rituximab Product Name: tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	81	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Greece;Spain;Netherlands;Germany;United Kingdom
322	EUCTR2008-001847-20-GB (EUCTR)	19/12/2008	09/09/2008	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate.	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
323	EUCTR2008-001847-20-LV (EUCTR)	19/12/2008	29/12/2008	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Latvia;Germany;Netherlands;Norway;Sweden
324	EUCTR2008-001847-20-DK (EUCTR)	10/12/2008	21/10/2008	Safety and efficacy of tocilizumab in combination with placebo compared with tocilizumab in combination with methotrexate, with possible addition of other disease-modifying antirheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis who are not responding adequately to their current therapy with methotrexate	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT RAY	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra® INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate Disodium Other descriptive name: Methotrexate as methotrexate disodium	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
325	EUCTR2008-001847-20-NL (EUCTR)	10/12/2008	23/10/2008	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAY	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment. - ACT-RAY	Rheumatoid Arthritis	Product Name: Tocilizumab Product Code: RO04877533 Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
326	NCT00810277 (ClinicalTrials.gov)	November 30, 2008	16/12/2008	A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs	An Open Label Study to Evaluate the Safety and Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARDs.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	14	Phase 3	Finland
327	EUCTR2008-001847-20-EE (EUCTR)	28/11/2008	13/10/2008	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Rheumatoid Arthritis	Trade Name: RoActemra® Product Code: L04AC07 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets	F Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
328	EUCTR2008-001847-20-FR (EUCTR)	17/11/2008	21/10/2008	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Randomized placebo-controlled study to evaluate the safety and efficacy of adding tocilizumab (TCZ) to methotrexate (MTX) versus switching to TCZ (placebo controlled), with possible addition of other disease-modifying anti-rheumatic drugs (DMARDs), in patients with active rheumatoid arthritis who have inadequately responded to prior MTX treatment.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO04877533/F05/F04 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: Methotrexate	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	470	Phase 3	France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
329	NCT00773461 (ClinicalTrials.gov)	October 31, 2008	15/10/2008	A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.	A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo	Hoffmann-La Roche	NULL	Completed	18 Years	70 Years	All	209	Phase 3	China
330	EUCTR2008-001847-20-ES (EUCTR)	17/10/2008	11/08/2008	Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX.	Estudio aleatorizado, controlado con placebo, para evaluar la seguridad y eficacia de añadir tocilizumab (TCZ) a metotrexato (MTX) frente al cambio a TCZ (controlado con placebo), con la posibilidad de añadir otros fármacos antirreumáticos modificadores de la enfermedad (FAMEs), en pacientes con artritis reumatoide activa que tienen una respuesta inadecuada al tratamiento previo con MTX.	Artritis reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: RO04877533 INN or Proposed INN: tocilizumab Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Name: Methotrexate 'Lederle' 2.5mg Tablets INN or Proposed INN: METOTREXATO SODIO Other descriptive name: METHOTREXATE SODIUM	F Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	470		France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
331	EUCTR2008-000587-17-BE (EUCTR)	13/10/2008	19/08/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-Sure	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-Sure	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece
332	EUCTR2008-000587-17-DK (EUCTR)	22/09/2008	04/07/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
333	EUCTR2008-000587-17-CZ (EUCTR)	15/09/2008	20/06/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Greece
334	EUCTR2008-000587-17-IE (EUCTR)	11/09/2008	05/06/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid Arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab (Actemra) Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
335	EUCTR2008-004126-16-FI (EUCTR)	05/09/2008	15/07/2008	Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs	Local Open-Label Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARDs	Rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: tocilizumab Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	Roche Oy	NULL	Not Recruiting			Female: yes Male: yes			Finland
336	NCT00750880 (ClinicalTrials.gov)	September 2008	10/9/2008	An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.	International Multi-Center Open Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have An Inadequate Response to Current Non-Biologic DMARD or Anti-TNF Therapy.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1681	Phase 3	Australia;Austria;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;India;Ireland;Italy;Luxembourg;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States
337	EUCTR2008-000587-17-FI (EUCTR)	20/08/2008	05/06/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
338	EUCTR2008-000105-11-DE (EUCTR)	19/08/2008	16/05/2008	Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis	Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid Arthritis	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: tocilizumab	Roche Pharma AG	NULL	Not Recruiting			Female: yes Male: yes			Germany
339	EUCTR2008-000587-17-NL (EUCTR)	12/08/2008	10/09/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
340	EUCTR2008-000587-17-FR (EUCTR)	12/08/2008	16/07/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tolicizumab Roche Product Code: RO4877533/F04-F05 INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
341	EUCTR2008-000587-17-PT (EUCTR)	08/08/2008	06/06/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
342	NCT00754559 (ClinicalTrials.gov)	August 2008	17/9/2008	A Study to Assess Efficacy With Respect to Clinical Improvement in Disease Activity and Safety of Tocilizumab in Patients Wtih Active Rheumatoid Arthritis.	Effectiveness After Four and Twentyfour Weeks and Safety of Tocilizumab in Patients With Active RA	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	286	Phase 3	Germany
343	EUCTR2008-000587-17-ES (EUCTR)	22/07/2008	26/05/2008	Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Estudio abierto, multinacional para evaluar la seguridad, tolerabilidad y eficacia de tocilizumab en pacientes con artritis reumatoide activa en tratamiento con FAMEs no biológicos que tienen una respuesta inadecuada al tratamiento actual con FAMEs no biológicos y/o terapia anti-TNF.Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Artritis reumatoideRheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500	Phase 3	Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
344	EUCTR2008-000587-17-SE (EUCTR)	03/07/2008	21/05/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
345	JPRN-UMIN000001240	2008/07/01	10/07/2008	The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial	The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial - The efficacy of tocilizumab to RA patients refractory to anti-TNF agents	rheumatoid arthritis	Tocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 years	Division of Rheumatology & Clinical Immunology, Jichi Medical University	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	20	Not selected	Japan
346	JPRN-UMIN000002421	2008/07/01	04/09/2009	Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis	Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis - Comparative study of tocilizumab therapy versus conventional therapy for the treatment of rheumatoid arthritis complicating AA amyloidosis	rheumatoid arthritis	tocilizumab Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab	AA amyloidosis clinical research conference	NULL	Recruiting	20years-old	Not applicable	Male and Female	40	Not selected	Japan
347	EUCTR2008-000587-17-AT (EUCTR)	19/06/2008	09/05/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy - ACT-SURE	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
348	EUCTR2008-000587-17-GB (EUCTR)	18/06/2008	18/04/2008	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic DMARDs who have an Inadequate Response to Current Non-biologic DMARD and/or Anti-TNF Therapy	Rheumatoid arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	1500		Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
349	EUCTR2007-001114-17-GB (EUCTR)	12/12/2007	13/02/2008	A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA).	A Mechanism of Action study to evaluate the effects of IL-6receptor blockade with tocilizumab (TCZ) on lipids, arterialstiffness, and markers of atherogenic risk in patients withmoderate to severe active rheumatoid arthritis (RA).	Rheumatoid Arthritis (RA)	Product Name: Actemra Product Code: RO4877533 (TCZ)	F. Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	120		United Kingdom
350	NCT00535782 (ClinicalTrials.gov)	October 31, 2007	24/9/2007	A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid Arthritis	A Mechanism of Action Study to Evaluate the Effects of IL-6 Receptor Blockade With Tocilizumab (TCZ) on Lipids, Arterial Stiffness, and Markers of Atherogenic Risk in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA).	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Placebo;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	All	132	Phase 3	United States;Canada;Puerto Rico;United Kingdom
351	NCT00531817 (ClinicalTrials.gov)	October 2007	18/9/2007	A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis	A Randomized, Double-blind, Parallel-group Study to Evaluate the Safety and Efficacy of Tocilizumab (TCZ) Versus Placebo in Combination With Disease Modifying Antirheumatic Drugs (DMARDs) in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Placebo;Drug: Permitted DMARDs	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	619	Phase 3	United States;Puerto Rico
352	EUCTR2005-002909-23-PT (EUCTR)	08/03/2007	03/01/2007	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden
353	EUCTR2005-002909-23-IS (EUCTR)	08/05/2006	25/04/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Germany;Iceland;Italy;United Kingdom;Sweden
354	NCT00380601 (ClinicalTrials.gov)	May 2006	25/9/2006	Phase?Open-label Study of MRA for Rheumatoid Arthritis(RA)	An Open-label, Phase? Study to Evaluate the Efficacy and Safety of MRA in Patients With RA	Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	20 Years	N/A	Both	20	Phase 3	Japan
355	EUCTR2005-002909-23-FI (EUCTR)	19/04/2006	23/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
356	EUCTR2005-002909-23-IT (EUCTR)	11/04/2006	14/03/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra INN or Proposed INN: Ro Actemra	F. Hoffmann - La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	2420		Sweden;Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;United Kingdom;Italy
357	EUCTR2005-002909-23-NO (EUCTR)	30/03/2006	11/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Norway;Germany;Iceland;Sweden
358	EUCTR2005-002909-23-GB (EUCTR)	27/03/2006	13/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
359	EUCTR2005-002909-23-SI (EUCTR)	16/03/2006	20/02/2006	A long-term 5-year study investigation whethetr tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		United States;Portugal;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden
360	EUCTR2005-002909-23-CZ (EUCTR)	13/03/2006	13/01/2006	A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2420		France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Norway;Germany;Sweden;Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland
361	EUCTR2005-002909-23-LT (EUCTR)	07/03/2006	11/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: tocilizumab	F Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden
362	EUCTR2005-002909-23-DK (EUCTR)	21/02/2006	23/01/2006	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA	Rheumatoid arthritis	Trade Name: RoActemra INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
363	EUCTR2005-002909-23-SE (EUCTR)	09/02/2006	23/12/2005	A long-term 5-year study investigating whether tocilizumab (study drug) continues to be safe and effective in patients with moderate to severe rheumatoid arthritis (RA) who have completed participation in one of the tocilizumab short-term core studies	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - GROWTH96	Rheumatoid arthritis MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;United States;Hong Kong;Thailand;Spain;Costa Rica;Israel;Russian Federation;Italy;Switzerland;France;Peru;Australia;Denmark;South Africa;Netherlands;China;Panama;Slovenia;Finland;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Iceland;Germany;Norway;Sweden
364	EUCTR2005-002909-23-DE (EUCTR)	10/01/2006	07/10/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.	Rheumatoid arthritis	Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
365	EUCTR2005-002423-13-HU (EUCTR)	19/12/2005	05/11/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Germany;Bulgaria;Italy
366	EUCTR2004-005210-37-FI (EUCTR)	17/11/2005	14/03/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200		Finland;Czech Republic;Germany;Spain;Sweden
367	EUCTR2005-002423-13-SK (EUCTR)	18/10/2005	20/09/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Austria;Bulgaria;Germany;Italy
368	EUCTR2005-001138-33-PT (EUCTR)	29/09/2005	21/09/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Denmark;Slovenia;Norway;Spain;Italy
369	EUCTR2005-001138-33-IT (EUCTR)	28/09/2005	01/02/2007	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate MTX monotherapy, in patients with active rheumatoid arthritis.	rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: Tocilizumab Product Code: Ro 48-77533 Trade Name: METHOTREXATE*25CPR 2,5MG INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Denmark;Slovenia;Norway;Spain;Italy
370	EUCTR2005-002423-13-IT (EUCTR)	28/09/2005	04/11/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822	Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra INN or Proposed INN: RoActemra	F.Hoffmann La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Bulgaria;Germany;Italy
371	EUCTR2005-002909-23-ES (EUCTR)	21/09/2005	08/09/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.Estudio de extensión, a largo plazo, de la seguridad durante el tratamiento con tocilizumab (MRA) en pacientes con artritis reumatoide que hayan terminado el tratamiento en estudios trocales con MRA	Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab	F Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	2420		Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
372	EUCTR2005-002423-13-DE (EUCTR)	06/09/2005	05/07/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Rheumatoid arthritis	Trade Name: RoActemra Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Germany;Bulgaria;Italy
373	NCT00720798 (ClinicalTrials.gov)	September 2005	22/7/2008	An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies	Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies	Rheumatoid Arthritis	Drug: Tocilizumab;Drug: Disease-modifying anti-rheumatic drugs;Drug: Non-steroidal anti-inflammatory drugs;Drug: Oral corticosteroids	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	2067	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;China;Costa Rica;Czech Republic;Denmark;Finland;France;Germany;Hong Kong;Iceland;Israel;Italy;Lithuania;Mexico;Netherlands;Norway;Panama;Peru;Portugal;Puerto Rico;Russian Federation;Serbia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;United Kingdom
374	EUCTR2005-001138-33-DK (EUCTR)	23/08/2005	20/06/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Slovenia;Denmark;Norway;Spain;Italy
375	EUCTR2005-002423-13-AT (EUCTR)	22/08/2005	18/07/2005	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822	Rheumatoid arthritis	Trade Name: RoActemra Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Slovakia;Austria;Bulgaria;Germany;Italy
376	EUCTR2005-000884-25-SE (EUCTR)	11/08/2005	07/06/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	450		United Kingdom;Germany;Iceland;Italy;Sweden
377	NCT00721123 (ClinicalTrials.gov)	August 2005	22/7/2008	A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid Arthritis	Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822	Rheumatoid Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	538	Phase 3	Argentina;Australia;Austria;Brazil;Bulgaria;Canada;France;Germany;Hong Kong;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;China
378	EUCTR2005-001138-33-LT (EUCTR)	14/07/2005	30/05/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
379	EUCTR2005-000884-25-GB (EUCTR)	11/07/2005	19/04/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	450	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	Iceland;Germany;Italy;United Kingdom;Sweden
380	EUCTR2005-001138-33-NO (EUCTR)	06/07/2005	06/06/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 3	Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
381	EUCTR2005-001138-33-ES (EUCTR)	05/07/2005	16/05/2006	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650	Phase 3	Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
382	EUCTR2004-005210-37-CZ (EUCTR)	01/07/2005	30/06/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200		Finland;Germany;Czech Republic;Spain;Sweden
383	NCT00109408 (ClinicalTrials.gov)	July 2005	27/4/2005	A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis	A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: Methotrexate;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	673	Phase 3	United States;Argentina;Australia;Canada;China;Denmark;France;Israel;Italy;Lithuania;Mexico;Norway;Peru;Portugal;Serbia;Slovenia;South Africa;Spain;Croatia;Former Serbia and Montenegro
384	EUCTR2005-000884-25-IS (EUCTR)	27/06/2005	27/04/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	450	Phase 3	Germany;Iceland;Italy;United Kingdom;Sweden
385	EUCTR2004-003741-40-SK (EUCTR)	16/06/2005	07/12/2004	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	630	Phase 3	Hungary;Slovakia;Austria;Germany;Italy
386	EUCTR2005-000884-25-DE (EUCTR)	14/06/2005	13/04/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche AG	NULL	Not Recruiting			Female: yes Male: yes	450		United Kingdom;Germany;Iceland;Italy;Sweden
387	EUCTR2004-005210-37-DE (EUCTR)	04/05/2005	10/03/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200		Finland;Czech Republic;Germany;Spain;Sweden
388	EUCTR2005-000884-25-IT (EUCTR)	02/05/2005	22/06/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combionation with methotrexate in patients with moderate to severe active rheumatoid arthritis and an inadequate response to previous anti-TNF therapy.	rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: Tocilizumab Product Code: Ro 48-77533 Trade Name: METHOTREXATE2,5MG 25CPR INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE7,5MG/ML 4SIR. INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE10MG/1,33ML 4S INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE20MG/2,66ML 4S INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE*15MG/2ML 4SIR INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	570		United Kingdom;Germany;Iceland;Italy;Sweden
389	NCT00106522 (ClinicalTrials.gov)	May 2005	25/3/2005	A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy	A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to Anti-TNF Therapy	Rheumatoid Arthritis	Drug: Methotrexate;Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	499	Phase 3	United States;Australia;Belgium;Canada;France;Germany;Iceland;Italy;Mexico;Netherlands;Puerto Rico;Sweden;Switzerland;United Kingdom
390	EUCTR2004-005210-37-SE (EUCTR)	26/04/2005	10/03/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200		Finland;Czech Republic;Germany;Spain;Sweden
391	EUCTR2004-003741-40-HU (EUCTR)	15/04/2005	07/02/2005	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Germany;Italy
392	NCT00106574 (ClinicalTrials.gov)	April 2005	25/3/2005	A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Double-blind Study of the Effect of Tocilizumab on Reduction in Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis and Inadequate Response to DMARD Therapy	Rheumatoid Arthritis	Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	1220	Phase 3	United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand
393	EUCTR2004-005210-37-ES (EUCTR)	29/03/2005	04/11/2005	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	A randomized, double-blind, placebo-controlled, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with traditional DMARD therapy in patients with moderate to severe active rheumatoid arthritis and an inadequate response to current DMARD therapy.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1200	Phase 3	Czech Republic;Finland;Spain;Germany;Sweden
394	EUCTR2004-003733-14-FI (EUCTR)	23/03/2005	17/11/2004	A study investigating whether tocilizumab (study drug) prevents joint damage, and how safe it is, in patients with moderate to severe rheumatoid arthritis randomly divided to groups receiving treatment with tocilizumab and methotrexate or methotrexate and placebo.	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis. - LITHE	Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: Tocilizumab Product Code: RO4877533 INN or Proposed INN: Tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1170	Phase 3	United States;Greece;Finland;Spain;Italy;France;Mexico;Brazil;Poland;Australia;Denmark;South Africa;Norway;China
395	NCT00144586 (ClinicalTrials.gov)	March 2005	2/9/2005	Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JP	An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA220JP or MRA221JP	Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	20 Years	75 Years	Both	42	Phase 3	NULL
396	EUCTR2004-003741-40-DE (EUCTR)	28/02/2005	01/12/2004	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Germany;Italy
397	NCT00144560 (ClinicalTrials.gov)	February 2005	2/9/2005	Drug-Drug Interaction Study of MRA in Patient With Rheumatoid Arthritis (RA)	An Open-Label, Clinical Pharmacology Study to Investigate Drug-Drug Interaction in Patients With RA	Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	20 Years	75 Years	Both	31	N/A	NULL
398	EUCTR2004-003733-14-ES (EUCTR)	28/01/2005	07/12/2005	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	1170		Finland;Denmark;Spain;Italy
399	EUCTR2004-003733-14-DK (EUCTR)	26/01/2005	07/12/2004	A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safetyand prevention of structural joint damage during treatment withMRA versus placebo, in combination with methotrexate, inpatients with moderate to severe active rheumatoid arthritis.	Rheumatoid arthritis	Trade Name: RoActemra® Product Name: Tocilizumab Roche Product Code: RO4877533 INN or Proposed INN: Tocilizumab Roche Other descriptive name: MRA, Actemra	F Hoffmann La-Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	1170		Finland;Spain;Denmark;Italy
400	NCT00365001 (ClinicalTrials.gov)	January 2005	15/8/2006	A Drug Interaction Study Between Tocilizumab, Methotrexate and Simvastatin on Patients With Rheumatoid Arthritis.	A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate;Drug: Simvastatin	Hoffmann-La Roche	NULL	Completed	18 Years	75 Years	Both	23	Phase 1	United States;New Zealand
401	NCT00144573 (ClinicalTrials.gov)	January 2005	2/9/2005	Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment	An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment	Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	20 Years	75 Years	Both	14	N/A	NULL
402	NCT00106535 (ClinicalTrials.gov)	January 2005	25/3/2005	A Study to Assess the Effect of Tocilizumab + Methotrexate on Prevention of Structural Joint Damage in Patients With Moderate to Severe Active Rheumatoid Arthritis (RA)	A Randomized, Double-blind Study of Safety and Prevention of Structural Joint Damage During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	1196	Phase 3	United States;Australia;Brazil;China;Denmark;Finland;France;Greece;Italy;Mexico;Norway;Poland;Puerto Rico;South Africa;Spain;Switzerland
403	NCT00106548 (ClinicalTrials.gov)	January 2005	25/3/2005	A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis	A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis	Rheumatoid Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Methotrexate	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	623	Phase 3	Argentina;Australia;Austria;Brazil;Bulgaria;Canada;China;France;Germany;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;Spain
404	EUCTR2004-003741-40-AT (EUCTR)	26/11/2004	22/10/2004	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: Tocilizumab Other descriptive name: MRA	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Austria;Germany;Italy
405	EUCTR2004-003733-14-IT (EUCTR)	09/11/2004	18/05/2005	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and prevention of structural joint damage during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	active rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: Tocilizumab Product Code: RO 487-7533 INN or Proposed INN: Tocilizumab Other descriptive name: NA Trade Name: METHOTREXATE2,5MG 25CPR Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE10MG/1,33ML 4S Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE15MG/2ML 4SIR Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE20MG/2,66ML 4S Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	1170		Finland;Denmark;Spain;Italy
406	EUCTR2004-003741-40-IT (EUCTR)	28/10/2004	21/09/2005	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	A randomized, double-blind, parallel group study of the safety and reduction of signs and symptoms during treatment with MRA versus placebo, in combination with methotrexate, in patients with moderate to severe active rheumatoid arthritis.	Active rheumatoid arthritis. MedDRA version: 6.1;Level: PT;Classification code 10039073	Product Name: Tocilizumab Product Code: RO 487-7533 INN or Proposed INN: Tocilizumab Trade Name: METHOTREXATE2,5MG 25CPR Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE10MG/1,33ML 4S Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE15MG/2ML 4SIR Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate Trade Name: METHOTREXATE20MG/2,66ML 4S Product Name: NA Product Code: NA INN or Proposed INN: Methotrexate	ROCHE	NULL	Not Recruiting			Female: yes Male: yes			Hungary;Germany;Italy
407	NCT00144534 (ClinicalTrials.gov)	June 2004	2/9/2005	Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP	An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JP	Rheumatoid Arthritis	Drug: MRA (Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	20 Years	75 Years	Both	115	Phase 3	NULL
408	NCT00144547 (ClinicalTrials.gov)	April 2004	2/9/2005	Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JP	An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP	Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	20 Years	N/A	Both	241	Phase 3	NULL
409	NCT00144521 (ClinicalTrials.gov)	February 2004	2/9/2005	Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)	A Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA	Rheumatoid Arthritis	Drug: MRA(Tocilizumab);Drug: MRA placebo;Drug: MTX;Drug: MTX placebo	Chugai Pharmaceutical	NULL	Completed	20 Years	75 Years	Both	127	Phase 3	NULL
410	NCT00144508 (ClinicalTrials.gov)	March 2003	2/9/2005	Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)	An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA	Rheumatoid Arthritis	Drug: MRA (Tocilizumab);Other: current treatment	Chugai Pharmaceutical	NULL	Completed	20 Years	N/A	Both	306	Phase 3	NULL
411	NCT00144651 (ClinicalTrials.gov)	August 2001	2/9/2005	Study of MRA in Patients With Rheumatoid Arthritis (RA)	An Open-label, Extension, Phase II Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Were Participated in Study MRA009JP	Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	20 Years	N/A	Both	135	Phase 2	NULL
412	EUCTR2005-001138-33-SI (EUCTR)		13/06/2005	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	A randomized, double-blind, double-dummy, parallel group study of the safety and efficacy of MRA monotherapy, versus methotrexate (MTX) monotherapy, in patients with active rheumatoid arthritis.	Rheumatoid Arthritis	Product Name: MRA Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: MRA Trade Name: Methotrexate sodium tablets 2.5 mg Product Name: Methotrexate sodium INN or Proposed INN: Methotrexate sodium	F. Hoffmann La-Roche AG	NULL	Not Recruiting			Female: yes Male: yes	650		Portugal;Denmark;Slovenia;Norway;Spain;Italy
413	JPRN-JapicCTI-050018		02/09/2005	Double-blind, parallel-group, controlled Phase 3 study of MRA in rheumatoid arthritis(RA)	Double-blind, parallel-group, controlled Phase 3 study of MRA in rheumatoid arthritis(RA)	RA	Intervention name : MRA (tocilizumab) Dosage And administration of the intervention : Intravenous infusion	Chugai Pharmaceutical Co., Ltd.	NULL		20	74			Phase 3	NULL
414	EUCTR2005-002423-13-BG (EUCTR)		03/08/2010	Study of safety and efficacy of long-term treatment with tocilizumab in adult patients with rheumatoid arthritis.	Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - GROWTH95	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann La-Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	630		Hungary;Germany;Switzerland;Bulgaria;France;Italy;Singapore;Hong Kong;Austria;Australia;Brazil;Israel;Slovakia;Canada;Mexico;Argentina;Thailand
415	JPRN-JapicCTI-050016		02/09/2005	A controlled, randomized trial of MRA monotherapy in patients with rheumatoid arthritis(RA)	A controlled, randomized trial of MRA monotherapy in patients with rheumatoid arthritis(RA)	RA	Intervention name : MRA (tocilizumab) Dosage And administration of the intervention : Intravenous infusion	Chugai Pharmaceutical Co., Ltd.	NULL		20				Phase 3	NULL
416	EUCTR2011-001626-15-ES (EUCTR)		20/10/2011	A study of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with rheumatoid arthritis with inadequate response to prior treatment with methotrexate and low disease activity with the combination de RoActemra/Actemra y methotrexate.	A multi-centre, randomized, double-blind study of the safety and efficacy of tocilizumab (TCZ) in combination with methotrexate (MTX), versus TCZ (placebo controlled) in patients with active rheumatoid arthritis (RA) with inadequate response to prior MTX treatment and low disease activity (DAS 28 ? 3.2) with the combination TCZ and MTX.	Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: Methotrexate 'Lederle' 2.5mg Tablets Product Code: Ro 002-9893/F02 INN or Proposed INN: Methotrexate Disodium	Roche Farma, S.A.	NULL	Not Recruiting			Female: yes Male: yes			Spain

先頭へ

49. 全身性エリテマトーデス

臨床試験数 : 993 / 薬物数 : 702 - (DrugBank : 184) / 標的遺伝子数 : 116 - 標的パスウェイ数 : 200

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	NCT05155345 (ClinicalTrials.gov)	January 11, 2022	10/12/2021	A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus	A Phase Ib, Multicenter, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus	Systemic Lupus Erythematosus	Drug: Mosunetuzumab;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Recruiting	18 Years	75 Years	All	50	Phase 1	United States;Georgia;Moldova, Republic of;Poland;Ukraine

50. 皮膚筋炎／多発性筋炎

臨床試験数 : 194 / 薬物数 : 244 - (DrugBank : 89) / 標的遺伝子数 : 50 - 標的パスウェイ数 : 151

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	EUCTR2018-000391-15-IT (EUCTR)	05/06/2018	27/02/2018	Multicentric, prospective open-label study to assess the efficacy and safety of Tocilizumab in subjects with refractory myositis	Multicentric, open-label, prospective study of subcutaneous tocilizumab in adult patients with refractory myositis - ToReMy	Myositis (dermatomyositis [DM] or polymyositis [PM]) MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10028653;Term: Myositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0;Classification code 10036102;Term: Polymyositis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra 162 mg soluzione iniettabile in siringa preriempita Product Name: RoActemra 162 mg soluzione iniettabile in siringa preriempita Product Code: NA INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia	NULL	Not Recruiting			Female: yes Male: yes	16	Phase 2	Italy
2	NCT02043548 (ClinicalTrials.gov)	October 1, 2014	17/1/2014	Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis	Tocilizumab in the Treatment of Refractory Polymyositis and Dermatomyositis	Dermatomyositis;Polymyositis	Drug: tocilizumab;Drug: placebo	Chester Oddis	Genentech, Inc.	Completed	18 Years	N/A	All	36	Phase 2	United States

51. 全身性強皮症

臨床試験数 : 525 / 薬物数 : 565 - (DrugBank : 148) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 217

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	JPRN-JapicCTI-173760	10/11/2017	07/11/2017	Tocilizumab LTE study in patients with SSc	A PHASE III, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF TOCILIZUMAB IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic sclerosis	Intervention name : tocilizumab INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg/week, SC Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -	CHUGAI PHARMACEUTICAL CO., LTD	NULL	complete	18		BOTH	18	Phase 3	Japan
2	EUCTR2015-000424-28-IE (EUCTR)	17/10/2016	19/08/2016	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
3	JPRN-UMIN000022624	2016/07/01	06/06/2016	Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD	Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD - Clinical trial of long term efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD	The patients with systemic sclerosis or sclerodermatous chronic GVHD.	treatment with tocilizumab duration: 116 weeks dosage: 8mg/kg times: 6 times Frequency: every 4 weeks	Kanazawa University Hospital	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	5	Not selected	Japan
4	EUCTR2015-000424-28-GR (EUCTR)	26/01/2016	30/12/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
5	JPRN-JapicCTI-152963	08/1/2016	09/07/2015	Phase III Study of Tocilizumab in Patients with Systemic Sclerosis	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis	Intervention name : Tocilizumab INN of the intervention : tocilizumab Dosage And administration of the intervention : 162 mg/W, SC Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : Placebo/W, SC	Chugai Pharmaceutical Co., Ltd.	F.Hoffmann-La Roche Ltd	complete	18		BOTH	210	Phase 3	Japan, North America, Europe, 25 countries including Japan, US, UK, Germany etc.
6	EUCTR2015-000424-28-NL (EUCTR)	22/12/2015	21/09/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
7	EUCTR2015-000424-28-HR (EUCTR)	18/12/2015	01/02/2016	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
8	NCT02453256 (ClinicalTrials.gov)	November 20, 2015	21/5/2015	A Study of the Efficacy and Safety of Tocilizumab in Participants With Systemic Sclerosis (SSc)	A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy and Safety of Tocilizumab Versus Placebo in Patients With Systemic Sclerosis	Systemic Sclerosis	Drug: Placebo;Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	212	Phase 3	United States;Argentina;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Italy;Japan;Lithuania;Mexico;Netherlands;Poland;Portugal;Puerto Rico;Romania;Spain;Switzerland;United Kingdom;Brazil;Croatia;South Africa
9	EUCTR2015-000424-28-DE (EUCTR)	02/11/2015	27/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
10	EUCTR2015-000424-28-LT (EUCTR)	14/10/2015	29/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
11	JPRN-UMIN000020389	2015/10/01	06/01/2016	Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD	Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD - Clinical trial of efficacy for tocilizumab in systemic sclerosis and sclerodermatous chronic GVHD	The patients with systemic sclerosis or sclerodermatous chronic GVHD.	treatment with tocilizumab duration: 20 weeks dosage: 8mg/kg times: 6 times Frequency: every 4 weeks	Kanazawa University Hospital, Department of dermatology	NULL	Complete: follow-up complete	20years-old	Not applicable	Male and Female	5	Not selected	Japan
12	EUCTR2015-000424-28-HU (EUCTR)	22/09/2015	11/08/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - FOCUSSCED	Systemic Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
13	EUCTR2015-000424-28-DK (EUCTR)	10/09/2015	17/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000171021 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
14	EUCTR2015-000424-28-IT (EUCTR)	07/09/2015	30/09/2021	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,PARALLEL-GROUP STUDY TO ASSESS THEEFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS - NA	Systemic Sclerosis MedDRA version: 21.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: ROACTEMRA - 162 MG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - SIRINGA PRERIEMPITA 0,9ML (VETRO) - 4 SIRINGHE PRERIEMPITE Product Name: tocilizumab Product Code: [RO487-7533/F10-04] INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB	F. HOFFMANN - LA ROCHE LTD.	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Japan;United States;Portugal;Greece;Spain;Ireland;Italy;Switzerland
15	EUCTR2015-000424-28-BE (EUCTR)	07/09/2015	28/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;China;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;Japan
16	EUCTR2015-000424-28-ES (EUCTR)	07/08/2015	04/08/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Portugal;Greece;Spain;Ireland;Switzerland;Italy;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
17	EUCTR2015-000424-28-PT (EUCTR)	31/07/2015	30/07/2015	A study to assess the efficacy and safety of tocilizumab versus placebo in patients with Systemic Sclerosis.	A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF TOCILIZUMAB VERSUS PLACEBO IN PATIENTS WITH SYSTEMIC SCLEROSIS	Systemic Sclerosis MedDRA version: 20.0;Level: LLT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra 162 mg Product Code: RO487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	210	Phase 3	Portugal;United States;Greece;Spain;Ireland;Italy;Switzerland;France;Denmark;South Africa;Netherlands;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Brazil;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;Japan
18	JPRN-UMIN000015495	2014/04/01	22/10/2014	Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)	Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka) - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis (Ver. Osaka)	Systemic sclerosis	Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies	Osaka University	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	5	Not applicable	Japan
19	JPRN-jRCTs031180370	12/11/2013	18/03/2019	Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis	Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fibrosis in systemic sclerosis	Systemic sclerosis	Administrate 8 mg/kg of tocilizumab once every four weeks for six months	Yoshizaki Ayumi	Sato Shinichi	Complete	>= 20age old	< 80age old	Both	5	Phase 2	Japan
20	JPRN-UMIN000012214	2013/11/05	05/11/2013	Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis	Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis - Clinical trial of tocilizumab for skin fobrosis in systemic sclerosis	Systemic sclerosis	Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies Continue existing conventional therapies	The University of Tokyo	NULL	Complete: follow-up complete	20years-old	80years-old	Male and Female	5	Not applicable	Japan
21	NCT01532869 (ClinicalTrials.gov)	March 2012	10/2/2012	A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis	A Phase II/III, Multicenter, Randomized, Double-blind, Placebo-controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis	Sclerosis, Systemic	Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	All	87	Phase 3	United States;Canada;France;Germany;United Kingdom
22	EUCTR2011-001460-22-GB (EUCTR)	19/01/2012	17/10/2011	A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.	A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A	Systemic Sclerosis (SSc) MedDRA version: 17.0;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS) Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	86	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	France;United States;Canada;Germany;United Kingdom
23	EUCTR2011-001460-22-DE (EUCTR)	28/11/2011	20/10/2011	A clinical study conducted at many clinical sites. In this study patients will be randomly assigned to one of two treatments. Neither staff at the site nor the patient nor the sponsor’s team will know if the patient received drug with an active ingredient or drug without an active ingredient. The goal is to see if the drug improves the progression of the disease in patients with systemic sclerosis and what the side effects are.	A Phase II/III, Multicenter, Randomized, Double Blind, Placebo-Controlled Study To Assess The Efficacy And Safety Of Tocilizumab Versus Placebo In Patients With Systemic Sclerosis - N/A	Systemic Sclerosis (SSc) MedDRA version: 18.1;Level: PT;Classification code 10042953;Term: Systemic sclerosis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]	Trade Name: RoActemra Product Name: tocilizumab SC 162 mg/0.9 ml prefilled syringe with safety device (PFS) Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	86	Phase 2/3	France;United States;Canada;Germany;United Kingdom
24	JPRN-UMIN000005550	2011/06/01	23/05/2011	Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis	Randomized, open-label, multicenter trial to assess humanized anti-IL-6 receptor antibody, tocilizumab, for the treatment of systemic sclerosis - The assessment of tocilizumab for the treatment of systemic sclerosis	Systemic sclerosis	Administrate 8 mg/kg of tocilizumab once every four weeks for six months with existing conventional therapies Continue existing conventional therapies	Respiratory Medicine, Allergy and Rheumatic Diseases, Osaka University Graduate School of Medicine	Rheumatology Keio University,Rheumatology Tokyo Women's Medical University,Dermatology Osaka University	Complete: follow-up complete	20years-old	65years-old	Male and Female	24	Phase 2	Japan

先頭へ

53. シェーグレン症候群

臨床試験数 : 305 / 薬物数 : 325 - (DrugBank : 104) / 標的遺伝子数 : 58 - 標的パスウェイ数 : 188

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	NCT01782235 (ClinicalTrials.gov)	July 24, 2013	30/1/2013	Efficacy of Tocilizumab in Primary Sjögren's Syndrome.	A Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy of Tocilizumab for the Treatment of Primary Sjögren's Syndrome.	Primary Sjögren's Syndrome (pSS)	Drug: Tocilizumab;Drug: Placebo	University Hospital, Strasbourg, France	NULL	Completed	18 Years	80 Years	All	110	Phase 2/Phase 3	France

54. 成人スチル病

臨床試験数 : 2 / 薬物数 : 1 - (DrugBank : 1) / 標的遺伝子数 : 1 - 標的パスウェイ数 : 12

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	JPRN-UMIN000001457	2008/10/01	28/10/2008	The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial	The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial - Efficacy assessment of tocilizumab to steroid-resistant patients with adult Still's disease	Adult Still's disease and systemic juvenile idiopathic arthritis	Tocilizumab is to be infused every 2 to 4 weeks at 8 mg/kg of body weight	Division of Rheumatology & Clinical Immunology, Jichi Medical University	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	10	Not selected	Japan
2	JPRN-UMIN000001250	2008/07/01	16/07/2008	Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial	Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial - Effects of tocilizumab-addition to steroid-dependent patients with adult Still's disease	Adult Still's disease or systemic juvenile idiopathic arthritis	Tocilizumab (8 mg/kg of body weight) is to be infused every 2 to 4 weeks.	Division of Rheumatology & Clinical Immunology, Jichi Medical University	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	10	Not selected	Japan

55. 再発性多発軟骨炎

臨床試験数 : 8 / 薬物数 : 10 - (DrugBank : 9) / 標的遺伝子数 : 12 - 標的パスウェイ数 : 101

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	NCT05168475 (ClinicalTrials.gov)	July 14, 2021	9/12/2021	Biologics in Refractory Vasculitis	Biologics in Refractory Vasculitis (BIOVAS): A Pragmatic, Randomised, Double-blind, Placebo-controlled, Modified-crossover Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis in Adults and Children	Giant Cell Arteritis;Takayasu Arteritis;Cogan Syndrome;Relapsing Polychondritis;Cryoglobulinemic Vasculitis;IgA Vasculitis;Polyarteritis Nodosa;Cutaneous Polyarteritis Nodosa;Primary Angiitis of Central Nervous System	Biological: Rituximab;Biological: Infliximab;Biological: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Recruiting	5 Years	N/A	All	140	Phase 2	United Kingdom
2	EUCTR2019-003964-30-GB (EUCTR)	22/10/2020	31/07/2020	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory vasculitis in adults and children.	Biologics in refractory vasculitis (BIOVAS): A pragmatic, randomised, double-blind, placebo-controlled, modified-crossover trial of biologic therapy for refractory primary non-ANCA associated vasculitis in adults and children - Biologics in refractory vasculitis (BIOVAS)	Non-ANCA associated vasculitides: 1.Giant cell arteritis (GCA)2.Takayasu’s arteritis (TA)3.Polyarteritis nodosa (PAN) or cutaneous polyarteritis unrelated to hepatitis B (CPAN)4.Relapsing polychondritis (RP)5.IgA vasculitis (IgAV)6.Cogan’s syndrome7.Non-infective cryoglobulinaemia8.Primary angiitis of central nervous system (PACNS) MedDRA version: 21.1;Level: PT;Classification code 10047115;Term: Vasculitis;System Organ Class: 10047065 - Vascular disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Product Name: Infliximab Product Code: N/A INN or Proposed INN: Infliximab Trade Name: Rituximab Product Name: Rituximab INN or Proposed INN: Rituximab Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: N/A INN or Proposed INN: Tocilizumab	Cambridge University Hospitals NHS Foundation Trust	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 2	United Kingdom
3	NCT01104480 (ClinicalTrials.gov)	May 2010	13/4/2010	Tocilizumab for Relapsing Polychondritis	Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis	Relapsing Polychondritis	Drug: Tocilizumab	McMaster Children's Hospital	NULL	Withdrawn	12 Years	15 Years	Male	0	Phase 2	Canada
4	NCT01041248 (ClinicalTrials.gov)	January 2010	30/12/2009	Single Patient Study to Treat Relapsing Polychondritis With Tocilizumab	Efficacy of Tocilizumab in a Patient With Relapsing Polychondritis	Relapsing Polychondritis	Drug: Tocilizumab	Children's Hospital of Eastern Ontario	NULL	Completed	N/A	N/A	Male	1	N/A	Canada

56. ベーチェット病

臨床試験数 : 81 / 薬物数 : 107 - (DrugBank : 30) / 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	NCT03554161 (ClinicalTrials.gov)	May 10, 2018	21/4/2018	Tocilizumab for the Treatment of Refractory Behcet's Uveitis	Efficacy and Safety of Tocilizumab in the Treatment of Refractory Uveitis in Patients With Behcet's Disease	Behcet Syndrome;Uveitis	Biological: Tocilizumab (TCZ)	Wenjie Zheng	NULL	Terminated	18 Years	65 Years	All	3	Phase 2	China

86. 肺動脈性肺高血圧症

臨床試験数 : 1,205 / 薬物数 : 684 - (DrugBank : 124) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 193

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	NCT02676947 (ClinicalTrials.gov)	January 2016	21/12/2015	A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension	A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension	Pulmonary Arterial Hypertension	Drug: Tocilizumab	Papworth Hospital NHS Foundation Trust	Roche Pharma AG;National Institute for Health Research, United Kingdom	Completed	18 Years	70 Years	All	29	Phase 2	United Kingdom
2	EUCTR2015-002799-26-GB (EUCTR)	27/10/2015	21/09/2015	A therapeutic trial of blockade of interleukin-6 using the drug Tocilizumab in pulmonary arterial hypertension	TRANSFORM-UK: A Therapeutic Open Label Study of Tocilizumab in the Treatment of Pulmonary Arterial Hypertension - An open label study of Tocilizumab in PAH	Pulmonary arterial hypertension;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]	Trade Name: RoActemra INN or Proposed INN: Tocilizumab Other descriptive name: n/a	Papworth Hospital NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	26	Phase 2	United Kingdom

107. 若年性特発性関節炎

臨床試験数 : 447 / 薬物数 : 297 - (DrugBank : 57) / 標的遺伝子数 : 52 - 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	NCT05609630 (ClinicalTrials.gov)	March 15, 2023	7/11/2022	Study of Oral Upadacitinib and Subcutaneous/Intravenous Tocilizumab to Evaluate Change in Disease Activity, Adverse Events and How Drug Moves Through the Body of Pediatric and Adolescent Participants With Active Systemic Juvenile Idiopathic Arthritis.	A Multicenter, Randomized Open-Label Study to Assess the Efficacy, Safety, and Pharmacokinetics of Upadacitinib With a Tocilizumab Reference Arm in Subjects From 1 Year to Less Than 18 Years Old With Active Systemic Juvenile Idiopathic Arthritis	Juvenile Idiopathic Arthritis	Drug: Upadacitinib;Drug: Tocilizumab	AbbVie	NULL	Not yet recruiting	1 Year	17 Years	All	90	Phase 3	NULL
2	NCT03301883 (ClinicalTrials.gov)	April 26, 2018	21/9/2017	A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)	A Phase IV, Multicenter, Single-Arm, Open-Label Study to Assess the Efficacy and Safety of Tocilizumab in Chinese Patients With Systemic Juvenile Idiopathic Arthritis	Juvenile Idiopathic Arthritis	Drug: Tocilizumab;Drug: NSAIDs;Drug: CSs;Drug: MTX	Hoffmann-La Roche	NULL	Completed	2 Years	17 Years	All	62	Phase 4	China
3	ChiCTR-OPB-17013704	2017-12-20	2017-12-05	A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis	A phase IV, multicenter single-arm, open-label study to assess the efficecy and safety of Tocilizumab in Chinese patients with systemic juvenile idiopathic arthritis	systemic juvenile idiopathic arthritis	Case series:Tocilizumab;	Children's Hospital of Chongqing Medical University	NULL	Recruiting	2	17	Both	Case series:65;	Phase 4	China
4	ChiCTR-INR-17011829	2017-08-01	2017-07-02	Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab	Multiple center's clinical treatment of systemic onset juvenile idiopathic arthritis with tocilizumab	Systemic onset juvenile idiopathic arthritis	Case:Tocilizumab;Control:Conventional Treatment;	Shenzhen Children's Hospital	NULL	Pending			Both	Case:75;Control:75;		China
5	NCT02840175 (ClinicalTrials.gov)	May 18, 2017	19/7/2016	Treatment Tapering in JIA With Inactive Disease	Treatment Tapering in Oligoarticular or Rheumatoid Factor Negative Polyarticular Juvenile Idiopathic Arthritis With Inactive Disease on Biologic Therapy	Juvenile Idiopathic Arthritis	Drug: etanercept;Drug: adalimumab;Drug: Abatacept;Drug: Tocilizumab	Assistance Publique - Hôpitaux de Paris	NULL	Completed	2 Years	17 Years	All	62	Phase 3	France
6	JPRN-UMIN000024178	2016/09/28	28/09/2016	Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis	Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis - Efficacy and safety of combination therapy of tocilizumab and abatacept in patients with refractory systemic-onset juvenile idiopathic arthritis	Systemic-onset juvenile idiopathic arthritis(sJIA)	Tocilizumab 8mg/kg every 2 weeks, and Abatacept 10 mg/kg every 4 weeks	Yokohama City University Hospital Department of Pediatrics	NULL	Recruiting	2years-old	Not applicable	Male and Female	5	Not selected	Japan
7	ChiCTR-OPC-17011391	2016-09-01	2017-05-12	The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China	The efficacy and safety of tocilizumab for refractory systemic juvenile idiopathic arthritis in China	systemic juvenile idiopathic arthritis	tocilizumab group:tocilizumab;glucocorticoid group:glucocorticoid;	Children's Hospital of Chongqing Medical University	NULL	Completed	2	16	Both	tocilizumab group:36;glucocorticoid group:24;		China
8	EUCTR2016-000312-15-FR (EUCTR)	12/08/2016	17/06/2016	Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM	Treatment tapering in oligoarticular or rheumatoid factor negative polyarticular Juvenile Idiopathic Arthritis with inactive disease on biologic therapy - AJIBIOREM	Patients with oligoarticular onset or rheumatoid factor negative polyarticular JIA followed in tertiary care center for paediatric rheumatology. MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders	Trade Name: ENBREL Product Name: ENBREL INN or Proposed INN: Etanercept Other descriptive name: Etanercept Trade Name: HUMIRA Product Name: HUMIRA INN or Proposed INN: adalimumab Other descriptive name: adalimumab Trade Name: ROACTEMRA Product Name: ROACTEMRA INN or Proposed INN: tocilizumab Other descriptive name: tocilizumab Trade Name: ORENCIA Product Name: ORENCIA INN or Proposed INN: abatacept Other descriptive name: abatacept	ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)	NULL	Not Recruiting			Female: yes Male: yes	230	Phase 3	France
9	EUCTR2015-000435-33-GB (EUCTR)	18/08/2015	17/07/2015	A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis.	A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	10	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
10	EUCTR2015-000435-33-BE (EUCTR)	12/08/2015	19/06/2015	A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis.	A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 1	France;Hungary;Poland;Spain;Belgium;Russian Federation;Germany;Italy;United Kingdom
11	EUCTR2015-000435-33-DE (EUCTR)	07/08/2015	10/06/2015	A study to assess the pharmacokinetics and safety of tocilizumab in patients less than 2 years old with Active Systemic Juvenile Idiopathic Arthritis.	A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 1	France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
12	EUCTR2015-000435-33-HU (EUCTR)	27/07/2015	10/06/2015	A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis.	A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 1	France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
13	EUCTR2015-000435-33-PL (EUCTR)	07/07/2015	03/07/2015	A study to assess the pharmacokinetics and safety of tocilizumab inpatients less than 2 years old with Active Systemic Juvenile IdiopathicArthritis.	A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 19.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 1	France;Hungary;Belgium;Spain;Poland;Russian Federation;Germany;Italy;United Kingdom
14	EUCTR2015-001323-23-GB (EUCTR)	03/07/2015	01/05/2015	A study of Tocilizumab in patients with JIA associated Uveitis who have not responded to treatment with an anti-TNF.	A phase II trial of Tocilizumab in anti-TNF refractory patients with JIA associated uveitis. - APTITUDE	Juvenile Idiopathic Arthritis with Associated Uveitis MedDRA version: 18.0;Level: PT;Classification code 10046851;Term: Uveitis;System Organ Class: 10015919 - Eye disorders MedDRA version: 18.0;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11]	Trade Name: Tocilizumab Product Name: Tocilizumab Product Code: Ro 487-7533/F10 INN or Proposed INN: Tocilizumab Other descriptive name: RoActemra	University Hospitals Bristol NHS Foundation Trust	NULL	Not Recruiting			Female: yes Male: yes	22	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United Kingdom
15	EUCTR2015-000435-33-ES (EUCTR)	26/06/2015	29/06/2015	A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis.	A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	Roche Farma S.A en nombre de F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	10	Phase 1	France;Hungary;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
16	NCT02165345 (ClinicalTrials.gov)	July 16, 2014	13/6/2014	Extension Study Evaluating the Safety and Efficacy of Subcutaneous Tocilizumab (RoActemra/Actemra) Administration in Systemic and Polyarticular-Course Juvenile Idiopathic Arthritis	Long-Term Extension Study to Evaluate the Safety and Efficacy of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis	Juvenile Idiopathic Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	2 Years	18 Years	All	82	Phase 1	United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom
17	EUCTR2013-005212-98-IT (EUCTR)	09/07/2014	20/05/2014	Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.	LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 1	United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
18	EUCTR2013-005212-98-DE (EUCTR)	30/06/2014	19/05/2014	Long Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis	LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	104	Phase 1	United States;France;Mexico;Canada;Argentina;Spain;Brazil;Australia;Russian Federation;Germany;United Kingdom;Italy
19	EUCTR2013-005212-98-ES (EUCTR)	16/06/2014	09/06/2014	Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.	LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC	Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	96	Phase 1	United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
20	EUCTR2013-005212-98-GB (EUCTR)	21/05/2014	20/05/2014	Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.	LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	104	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
21	NCT01603355 (ClinicalTrials.gov)	November 2013	18/5/2012	Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Uveitis	An Open-label Trial to Assess the Efficacy and Safety of Tocilizumab in the Management of Juvenile Idiopathic Arthritis Associated Vision-threatening Uveitis That is Refractory to Other Modes of Systemic Immunosuppression	Juvenile Idiopathic Arthritis Associated Uveitis	Drug: Tocilizumab	Eric B. Suhler	Genentech, Inc.	Terminated	2 Years	17 Years	All	3	Phase 1/Phase 2	United States
22	EUCTR2012-003486-18-PL (EUCTR)	19/08/2013	02/07/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 1	United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Australia;Peru;Germany
23	NCT01904292 (ClinicalTrials.gov)	August 15, 2013	14/6/2013	A Study of Subcutaneously Administered Tocilizumab in Participants With Systemic Juvenile Idiopathic Arthritis	A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Systemic Juvenile Idiopathic Arthritis	Juvenile Idiopathic Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	1 Year	17 Years	All	52	Phase 1	United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom
24	EUCTR2012-003490-26-DE (EUCTR)	08/08/2013	05/06/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 1	France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
25	EUCTR2012-003486-18-DE (EUCTR)	08/08/2013	05/06/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 1	France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany;United States;Spain;Russian Federation;United Kingdom;Italy
26	NCT01904279 (ClinicalTrials.gov)	July 2013	14/6/2013	A Study of Subcutaneously (SC) Administered Tocilizumab (TCZ) in Participants With Polyarticular-Course Juvenile Idiopathic Arthritis (pJIA)	A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis	Juvenile Idiopathic Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	1 Year	17 Years	All	52	Phase 1	United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico;Russian Federation;Spain;United Kingdom;Peru;Poland
27	EUCTR2012-003486-18-ES (EUCTR)	28/06/2013	26/06/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 1	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany
28	EUCTR2012-003490-26-ES (EUCTR)	26/06/2013	26/06/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 16.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 1	France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
29	EUCTR2012-003486-18-GB (EUCTR)	14/06/2013	20/06/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with polyarticular-course juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;Russian Federation;United Kingdom;Italy;France;Canada;Argentina;Brazil;Poland;Australia;Peru;Germany
30	EUCTR2012-003490-26-GB (EUCTR)	14/06/2013	20/06/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;Italy;United Kingdom
31	EUCTR2012-003486-18-IT (EUCTR)	11/06/2013	05/06/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 1	United States;Spain;Russian Federation;Italy;United Kingdom;France;Canada;Argentina;Poland;Brazil;Peru;Australia;Germany
32	EUCTR2012-003490-26-IT (EUCTR)	11/06/2013	05/06/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	48	Phase 1	France;United States;Mexico;Canada;Argentina;Brazil;Spain;Australia;Russian Federation;Germany;United Kingdom;Italy
33	NCT01734382 (ClinicalTrials.gov)	June 10, 2013	22/11/2012	A Study of Decreased Dose Frequency in Participants With Systemic Juvenile Arthritis Who Experience Laboratory Abnormalities During Treatment With RoActemra/Actemra (Tocilizumab)	A Phase IV Study to Evaluate Decreased Dose Frequency in Patients With Systemic Juvenile Arthritis (SJIA) Who Experience Laboratory Abnormalities During Treatment With Tocilizumab	Juvenile Idiopathic Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	2 Years	17 Years	All	35	Phase 4	United States;Argentina;Canada;Germany;Israel;Italy;Mexico;Russian Federation;Spain;United Kingdom;Australia;Norway;Sweden
34	NCT01727986 (ClinicalTrials.gov)	March 2013	8/11/2012	An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study	Extension, Open-label, Interventional, Long-term Study to Evaluate the Safety of Tocilizumab Treatment in Patients From Brazil With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global Multinational Trial (WA19977)	Juvenile Idiopathic Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	9 Years	18 Years	Both	11	Phase 3	Brazil
35	EUCTR2012-000444-10-IT (EUCTR)	22/01/2013	11/01/2013	A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB	A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB	Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: TOCILIZUMAB	F. HOFFMANN - LA ROCHE LTD.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Mexico;Canada;Spain;Australia;Germany;Norway;United Kingdom;Italy;Sweden
36	EUCTR2012-000444-10-DE (EUCTR)	30/11/2012	28/09/2012	A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab	A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB	Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	43	Phase 4	Sweden;Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom
37	EUCTR2012-000444-10-ES (EUCTR)	22/11/2012	14/09/2012	A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab	A STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB	Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 15.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Mexico;Canada;Spain;Australia;Germany;Norway;Italy;United Kingdom;Sweden
38	EUCTR2012-000444-10-GB (EUCTR)	09/11/2012	21/08/2012	A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab	A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB	Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 21.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	43	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes	Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;Italy;United Kingdom;Sweden
39	EUCTR2012-000444-10-SE (EUCTR)	01/11/2012	04/10/2012	A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab	A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB	Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 20.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	43	Phase 4	Mexico;Canada;Spain;Australia;Russian Federation;Israel;Norway;Germany;United Kingdom;Italy;Sweden
40	NCT01455701 (ClinicalTrials.gov)	October 26, 2012	18/10/2011	A Study to Evaluate Pharmacokinetics and Safety of Tocilizumab (RoActemra/Actemra) in Participants Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)	A Phase I Pharmacokinetic and Safety Study of Tocilizumab (TCZ) in Patients Less Than 2 Years Old With Active Systemic Juvenile Idiopathic Arthritis (sJIA)	Juvenile Idiopathic Arthritis	Drug: Tocilizumab	Hoffmann-La Roche	NULL	Completed	N/A	24 Months	All	11	Phase 1	United States;Argentina;Belgium;Canada;Germany;Hungary;Poland;Spain;France;Russian Federation;United Kingdom
41	NCT01575769 (ClinicalTrials.gov)	March 2012	10/4/2012	An Extension Study to WA19977 in Patients With Active Polyarticular-Course Juvenile Idiopathic Arthritis	Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From Poland and Russia Who Completed the Global, Multinational Trial (WA19977).	Juvenile Idiopathic Arthritis	Drug: RoActemra/Actemra (tocilizumab)	Hoffmann-La Roche	NULL	Terminated	2 Years	N/A	All	41	Phase 3	Poland;Russian Federation
42	NCT01673919 (ClinicalTrials.gov)	February 2012	23/8/2012	A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis From France Who Completed WA19977 Core Study	Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis From France Who Completed the Global, Multinational Trial (WA19977)	Juvenile Idiopathic Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	4 Years	N/A	All	7	Phase 3	France
43	NCT01667471 (ClinicalTrials.gov)	January 2012	15/8/2012	A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Juvenile Idiopathic Arthritis Who Completed WA19977 Core Study	Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global, Multinational Trial (WA19977)	Juvenile Idiopathic Arthritis	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	9 Years	18 Years	All	6	Phase 3	Germany
44	EUCTR2011-001097-25-DE (EUCTR)	19/10/2011	21/09/2011	Tocilizumab i.v. monthly in patients with pcJIA	Long-term, interventional, open label extension study evaluating the safety of tocilizumab treatment in patients with polyarticular-course juvenile idiopathic arthritis from Germany who completed the global, multinational trial (WA19977)	Polyarticular-course juvenile idiopathic arthritis MedDRA version: 14.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: Ro-Actemra Product Code: RO4877533 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB	Roche Pharma AG	NULL	Not Recruiting			Female: no Male: no			Germany
45	EUCTR2009-011593-15-NL (EUCTR)	09/02/2010	30/09/2009	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis	polyarticular-course juvenile idiopathic arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	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	185		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy
46	NCT00988221 (ClinicalTrials.gov)	November 30, 2009	1/10/2009	A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis	A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis	Juvenile Idiopathic Arthritis	Drug: Tocilizumab;Drug: Placebo	Hoffmann-La Roche	NULL	Completed	2 Years	17 Years	All	188	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;France;Germany;Italy;Mexico;Peru;Poland;Russian Federation;Spain;United Kingdom;Netherlands
47	EUCTR2009-011593-15-FR (EUCTR)	12/11/2009	04/12/2009	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis	polyarticular-course juvenile idiopathic arthritis MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Trade Name: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab	F. Hoffmann-La Roche Ltd	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	185		Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy
48	EUCTR2009-011593-15-ES (EUCTR)	27/10/2009	29/07/2009	Ensayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis	Ensayo clínico de retirada de 24 semanas de duración, doble ciego, randomizado y controlado frente a placebo, con una fase abierta de introducción de 16 semanas y 64 semanas de seguimiento abierto, para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis Idiopática Juvenil activa de curso poliarticular.A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis	Artritis idiopática juvenil activa de curso poliarticular/Polyarticular-course juvenile idiopathic arthritis. MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB Trade Name: ROACTEMRA	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	185	Phase 3	France;Belgium;Spain;Netherlands;Germany;Italy;United Kingdom
49	EUCTR2009-011593-15-BE (EUCTR)	19/10/2009	23/09/2009	A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH	Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	185	Phase 3	Canada;Argentina;Belgium;Poland;Brazil;Peru;Australia;Netherlands;Germany;Mexico;United States;Spain;Russian Federation;Italy;United Kingdom;France
50	EUCTR2009-011593-15-IT (EUCTR)	11/09/2009	28/07/2009	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis. - ND	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis. - ND	Polyarticular-course JIA (pcJIA) consisting of RF-positive, RF-negative, and extended oligoarticular subsets. MedDRA version: 12.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Trade Name: RoActemra Trade Name: RoActemra Trade Name: RoActemra	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	185		France;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy
51	EUCTR2009-011593-15-DE (EUCTR)	08/09/2009	20/07/2009	A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH	Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	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	185		United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Belgium;Brazil;Poland;Australia;Peru;Germany;Netherlands
52	EUCTR2009-011593-15-GB (EUCTR)	20/08/2009	06/07/2009	A two year study to evaluate the effect of tocilizumab in children who have arthritis in several joints	A 24 week randomized double-blind, placebo controlled withdrawal trial with a 16 week open label lead-in phase, and 64 week open label follow-up, to evaluate the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis - CHERISH	Polyarticular-course juvenile idiopathic arthritis MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Code: Ro 487-7533/F01 INN or Proposed INN: Tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	185	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Spain;Russian Federation;Italy;United Kingdom;France;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Peru;Australia;Netherlands;Germany
53	NCT00868751 (ClinicalTrials.gov)	March 2009	24/3/2009	Single Patient Use of Tocilizumab in Systemic Onset Juvenile Idiopathic Arthritis	Single Patient Use of Tocilizumab for Treatment of Steroid Dependent, Active Systemic Onset Juvenile Idiopathic Arthritis	Arthritis, Juvenile Rheumatoid;Still's Disease, Juvenile Onset	Biological: tocilizumab	Tufts Medical Center	Hoffmann-La Roche	Terminated	2 Years	16 Years	All	1	N/A	United States
54	NCT00862758 (ClinicalTrials.gov)	February 2009	16/3/2009	Request for Single Patient IND for Compassionate/Emergency Use of Tocilizumab	Emergency IND for Provision of Tocilizumab	Juvenile Idiopathic Arthritis	Drug: Tocilizumab	University of Oklahoma	Hoffmann-La Roche	No longer available	11 Years	12 Years	Male		N/A	United States
55	EUCTR2007-000872-18-NL (EUCTR)	01/12/2008	06/03/2008	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA, Actemra	F. Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	108		Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Italy;Sweden
56	EUCTR2007-000872-18-CZ (EUCTR)	16/10/2008	26/02/2008	The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 17.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	108		United States;Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Sweden
57	EUCTR2007-000872-18-GB (EUCTR)	03/10/2008	26/08/2009	The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	108	Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no	United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden
58	JPRN-UMIN000001457	2008/10/01	28/10/2008	The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial	The efficacy evaluation of tocilizumab to glucocorticoid-resistant patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial - Efficacy assessment of tocilizumab to steroid-resistant patients with adult Still's disease	Adult Still's disease and systemic juvenile idiopathic arthritis	Tocilizumab is to be infused every 2 to 4 weeks at 8 mg/kg of body weight	Division of Rheumatology & Clinical Immunology, Jichi Medical University	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	10	Not selected	Japan
59	EUCTR2007-000872-18-GR (EUCTR)	09/09/2008	21/03/2008	A 12- week randomized, double blind, placebo - controlled, parallel group, 2- arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92- week single arm open- label extension to examine the long term use of tocilizumab	A 12- week randomized, double blind, placebo - controlled, parallel group, 2- arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92- week single arm open- label extension to examine the long term use of tocilizumab	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab Other descriptive name: MRA (Actemra)	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	108	Phase 3	Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Norway;Germany;United Kingdom;Italy;Sweden
60	EUCTR2007-000872-18-DE (EUCTR)	11/07/2008	14/02/2008	The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 14.0;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	108		United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Norway;Sweden
61	JPRN-UMIN000001250	2008/07/01	16/07/2008	Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial	Study on the glucocorticoid-sparing effects of tocilizumab among glucocorticoid-dependent patients with adult Still's disease and systemic juvenile idiopathic arthritis: the open trial - Effects of tocilizumab-addition to steroid-dependent patients with adult Still's disease	Adult Still's disease or systemic juvenile idiopathic arthritis	Tocilizumab (8 mg/kg of body weight) is to be infused every 2 to 4 weeks.	Division of Rheumatology & Clinical Immunology, Jichi Medical University	NULL	Complete: follow-up complete	16years-old	Not applicable	Male and Female	10	Not selected	Japan
62	EUCTR2007-000872-18-DK (EUCTR)	27/06/2008	05/03/2008	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Product Name: Tocilizumab Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA Other descriptive name: Actemra	F. Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	108		Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
63	EUCTR2007-000872-18-SK (EUCTR)	09/06/2008	09/04/2008	A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab	A 12-week randomized, double blind, placebo-controlled, parallelgroup, 2-arm study to evaluate the efficacy and safety oftocilizumab in patients with active systemic juvenile idiopathicarthritis (sJIA); with a 92-week single arm open-label extensionto examine the long term use of tocilizumab	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Product Name: Actemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA	F. Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	108		Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
64	EUCTR2007-000872-18-ES (EUCTR)	23/05/2008	26/02/2008	Estudio randomizado de 12 semanas de duración, doble ciego, controlado con placebo, con grupos paralelos y de dos brazos de tratamiento para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis idiopatica juvenil sistémica activa (sJIA); con un estudio abierto de extensión de 92 semanas de duración con un solo brazo de tratamiento para evaluar el uso a largo plazo del Tocilizumab A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab - TENDER	Estudio randomizado de 12 semanas de duración, doble ciego, controlado con placebo, con grupos paralelos y de dos brazos de tratamiento para evaluar la eficacia y seguridad de Tocilizumab en pacientes con Artritis idiopatica juvenil sistémica activa (sJIA); con un estudio abierto de extensión de 92 semanas de duración con un solo brazo de tratamiento para evaluar el uso a largo plazo del Tocilizumab A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab - TENDER	Artritis idiopatica juvenil sistémica (sJIA)Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: Actemra	F. Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	108		Czech Republic;Slovakia;Greece;Belgium;Spain;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
65	EUCTR2007-000872-18-IT (EUCTR)	12/05/2008	23/03/2009	A 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - ND	A 12-WEEK RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, 2-ARM STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN PATIENTS WITH ACTIVE SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA); WITH A 92-WEEK SINGLE ARM OPEN-LABEL EXTENSION TO EXAMINE THE LONG TERM USE OF TOCILIZUMAB - ND	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059177;Term: Juvenile arthritis	Product Name: ACTEMRA Product Code: RO4877533 (TCZ) INN or Proposed INN: Tocilizumab	ROCHE	NULL	Not Recruiting			Female: yes Male: yes	108		Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
66	NCT00642460 (ClinicalTrials.gov)	May 2008	19/3/2008	A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)	A Randomized, Placebo-controlled Study to Evaluate the Effect of Tocilizumab on Disease Response in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA), With an Open-label Extension to Examine the Long Term Use of Tocilizumab	Juvenile Idiopathic Arthritis	Drug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: Non-steroidal anti-inflammatory drugs (NSAIDs);Drug: methotrexate;Drug: corticosteroids	Hoffmann-La Roche	NULL	Completed	2 Years	17 Years	All	112	Phase 3	United States;Argentina;Australia;Belgium;Brazil;Canada;Czech Republic;Denmark;Germany;Greece;Italy;Mexico;Netherlands;Norway;Poland;Slovakia;Spain;Sweden;United Kingdom;France
67	EUCTR2007-000872-18-BE (EUCTR)	15/04/2008	29/01/2008	The effect of tocilizumab in children who have arthritis which can include fever, rash, inflammation of the lungs or heart, or enlarged spleen, liver or lymph nodes.	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab, followed by a 3 year open label continuation of the study to examine the long term use of tocilizumab. - TENDER	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 13.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra Product Name: RoActemra Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	108		United States;Slovakia;Greece;Spain;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Denmark;Australia;Netherlands;Norway;Germany;Sweden
68	EUCTR2007-000872-18-SE (EUCTR)	07/04/2008	05/02/2008	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: MRA, Actemra	F. Hoffmann-La Roche Limited	NULL	Not Recruiting			Female: yes Male: yes	108		Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Italy;Sweden
69	NCT00144625 (ClinicalTrials.gov)	February 2005	2/9/2005	Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)	An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety, Efficacy and PK of MRA in Patients With pJIA Who Participated in Study MRA318JP	Polyarticular Juvenile Idiopathic Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	2 Years	19 Years	Both	19	Phase 3	NULL
70	NCT00144664 (ClinicalTrials.gov)	November 2004	2/9/2005	Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)	An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA	Systemic Juvenile Idiopathic Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	2 Years	19 Years	Both	19	Phase 3	NULL
71	NCT00144612 (ClinicalTrials.gov)	July 2004	2/9/2005	Long-term Treatment Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)	An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP	Systemic Juvenile Idiopathic Arthritis	Drug: MRA(Tocilizumab)	Chugai Pharmaceutical	NULL	Completed	2 Years	19 Years	Both	60	Phase 3	NULL
72	NCT00144599 (ClinicalTrials.gov)	May 2004	2/9/2005	Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)	A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA	Systemic Juvenile Idiopathic Arthritis	Drug: MRA(Tocilizumab);Drug: placebo	Chugai Pharmaceutical	NULL	Completed	2 Years	19 Years	Both	56	Phase 3	NULL
73	EUCTR2012-003490-26-Outside-EU/EEA (EUCTR)		22/08/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd	NULL	NA			Female: yes Male: yes	48	Phase 1	Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy;Mexico
74	EUCTR2012-000444-10-NO (EUCTR)		27/09/2012	A study to look at less frequent dosing in patients with systemic juvenile idiopathic arthritis (sJIA) who have experienced a laboratory abnormality during treatment with tocilizumab	A PHASE IV STUDY TO EVALUATE DECREASED DOSE FREQUENCY IN PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WHO EXPERIENCE LABORATORY ABNORMALITIES DURING TREATMENT WITH TOCILIZUMAB	Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: RoActemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd.	NULL	Not Recruiting			Female: yes Male: yes	20	Phase 4	Mexico;Canada;Spain;Australia;Germany;Norway;United Kingdom;Italy;Sweden
75	JPRN-JapicCTI-050017		02/09/2005	Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA)	Phase 3 clinical study of MRA in patients with systemic juvenile idiopathic arthritis (sJIA)	sJIA	Intervention name : MRA (tocilizumab) Dosage And administration of the intervention : Intravenous infusion	Chugai Pharmaceutical Co., Ltd.	NULL		2	19			Phase 3	NULL
76	EUCTR2012-003486-18-Outside-EU/EEA (EUCTR)		22/08/2013	A study of a new sub-cutaneous formulation of Actemra/RoActemra in chldren with polyarticular-course juvenile idiopathic arthritis	A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH POLYARTICULAR-COURSE JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA) MedDRA version: 14.1;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R	F. Hoffmann-La Roche Ltd.	NULL	NA			Female: yes Male: yes	48	Phase 1	Peru;Poland;Russian Federation;Spain;United Kingdom;United States;Argentina;Australia;Brazil;Canada;France;Germany;Italy
77	EUCTR2015-000435-33-FR (EUCTR)		24/07/2015	A study to assess the pharmacokinetics and safety of tocilizumab in patients with Active Systemic Juvenile Idiopathic Arthritis.	A phase I pharmacokinetic and safety study of tocilizumab (TCZ) in patients less than 2 years old with active systemic juvenile idiopathic arthritis (sJIA)	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Trade Name: Roactemra INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, recombinant humanized monoclonal antibody	F. Hoffmann-La Roche Ltd	NULL	NA			Female: yes Male: yes	10	Phase 1	United States;France;Hungary;Canada;Argentina;Poland;Belgium;Spain;Russian Federation;Germany;Italy;United Kingdom
78	EUCTR2013-005212-98-FR (EUCTR)		17/06/2015	Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.	LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS	Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA) MedDRA version: 18.0;Level: PT;Classification code 10059176;Term: Juvenile idiopathic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]	Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB SC	F. Hoffmann-La Roche Ltd	NULL	Not Recruiting			Female: yes Male: yes	96	Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no	United States;Spain;Russian Federation;United Kingdom;Italy;France;Mexico;Canada;Argentina;Brazil;Australia;Peru;Germany
79	EUCTR2007-000872-18-NO (EUCTR)		20/02/2008	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab.	A 12-week randomized, double blind, placebo-controlled, parallel group, 2-arm study to evaluate the efficacy and safety of tocilizumab in patients with active systemic juvenile idiopathic arthritis (sJIA); with a 92-week single arm open-label extension to examine the long term use of tocilizumab.	Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 9.1;Level: LLT;Classification code 10059176;Term: Juvenile idiopathic arthritis	Product Name: Tocilizumab Roche Product Code: RO4877533 (TCZ) INN or Proposed INN: tocilizumab Other descriptive name: Actemra, MRA	F. Hoffmann-La Roche Limited	NULL	NA			Female: yes Male: yes	108	Phase 3	Czech Republic;Slovakia;Greece;Spain;Belgium;Denmark;Netherlands;Germany;Norway;United Kingdom;Italy;Sweden

先頭へ

266. 家族性地中海熱

臨床試験数 : 28 / 薬物数 : 22 - (DrugBank : 5) / 標的遺伝子数 : 14 - 標的パスウェイ数 : 59

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	JPRN-UMIN000032557	2018/09/01	30/05/2018	An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance	An open-label continuation trial of tocilizumab for familial Mediterranean fever with colchicine ineffective or intolerance - An open-label continuation trial of tocilizumab for familial Mediterranean fever	familial Mediterranean fever	Tocilizumab	Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences	NULL	Complete: follow-up complete	12years-old	Not applicable	Male and Female	24	Not selected	Japan
2	NCT03446209 (ClinicalTrials.gov)	April 23, 2018	11/12/2017	Tocilizumab for the Treatment of Familial Mediterranean Fever	Tocilizumab for the Treatment of Familial Mediterranean Fever - A Randomized, Doubleblind, Phase II Proof of Concept Study	Familial Mediterranean Fever	Drug: Tocilizumab Infusion RoAcemtra (EU);Drug: 0.9% physiological saline	University Hospital Tuebingen	NULL	Completed	18 Years	64 Years	All	30	Phase 2	Germany
3	JPRN-UMIN000028010	2018/03/01	07/07/2017	Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever	Randomized, double-blind, parallel group comparison trial of Tocilizumab for colchicine-resistant familial Mediterranean fever - Clinical trial of Tocilizumab for colchicine-resistant familial Mediterranean fever	familial Mediterranean fever	Tocilizumab Placebo	Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences	NULL	Complete: follow-up complete	12years-old	Not applicable	Male and Female	24	Not selected	Japan
4	EUCTR2016-004505-13-DE (EUCTR)	27/11/2017	21/08/2017	Tocilizumab for the Treatment of Familial Mediterranean Fever	Tocilizumab for the Treatment of Familial Mediterranean Fever – A randomized, doubleblind, phase II proof of concept study-TOFFIFE - Tocilizumab for the Treatment of Familial Mediterranean Fever	Adult patients with Familial Mediterranean Fever, who have active disease MedDRA version: 20.0;Level: PT;Classification code 10016207;Term: Familial mediterranean fever;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]	Trade Name: RoActemra® 20mg/ml Konzentrat INN or Proposed INN: INN-Tocilizumab Other descriptive name: TOCILIZUMAB	University Hospital Tuebingen	NULL	Not Recruiting			Female: yes Male: yes	30	Phase 2	Germany

271. 強直性脊椎炎

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	EUCTR2009-017443-34-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	EUCTR2009-017443-34-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
6	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	Phase 3	Czech Republic;Slovakia;Belgium;Spain;Lithuania;Denmark;Bulgaria;Germany;Italy;United Kingdom
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

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331. 特発性多中心性キャッスルマン病

臨床試験数 : 33 / 薬物数 : 41 - (DrugBank : 21) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 123

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	JPRN-jRCT2071190029	25/05/2020	09/10/2019	Randomized, double-blind, placebo-controlled, parallel-group trial of sirolimus for tocilizumab-resistant idiopathic multicentric Castleman disease: Study protocol for clinical trial (SPIRIT Compliant)	Randomized, double-blind, placebo-controlled, parallel-group trial of sirolimus for tocilizumab-resistant idiopathic multicentric Castleman disease: Study protocol for clinical trial (SPIRIT Compliant)	idiopathic multicentric Castleman's disease Castleman's disease	Treatment: Sirolimus 2 mg po once/day. Control: Placebo given orally once daily	Kawakami Atsushi	NULL	Complete	>= 18age old	Not applicable	Both	20	Phase 2	Japan
2	NCT01441063 (ClinicalTrials.gov)	September 13, 2011	24/9/2011	Tocilizumab for KSHV-Associated Multicentric Castleman Disease	Pilot Study of Tocilizumab in Patients With Symptomatic Kaposi Sarcoma Herpesvirus (KSHV) - Associated Multicentric Castleman Disease	Castleman Disease;Multicentric Castleman Disease;Giant Lymph Node Hyperplasia	Drug: Zidovudine;Drug: Tocilizumab;Drug: Valganciclovir (VGC)	National Cancer Institute (NCI)	NULL	Completed	18 Years	N/A	All	8	Phase 2	United States
3	NCT01183598 (ClinicalTrials.gov)	August 2006	13/8/2010	A Study to Provide RoActemra/Actemra (Tocilzumab) to Patients With Multicentric Castleman's Disease Who Demonstrated Benefit From Previous RoActemra/Actemra Treatment	Provision of Tocilizumab for Patients With Multicentric Castleman's Disease Who Have Demonstrated Benefit From Previous Tocilizumab Treatment	Castleman's Disease	Drug: tocilizumab [RoActemra/Actemra]	Hoffmann-La Roche	NULL	Completed	18 Years	N/A	Both	3	Phase 1	United States

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