46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 185 - 標的パスウェイ数 : 223

  
411 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04885829
(ClinicalTrials.gov)
May 31, 20213/5/2021Comparative Study of 3 Tocilizumab Products in Normal Healthy VolunteeersA Single Dose, Double-Blind, Two-Period, Crossover, Comparative Pharmacokinetic Study of Three Tocilizumab Products Administered by the Subcutaneous Route to Normal Healthy VolunteersRheumatoid Arthritis;Giant Cell ArteritisDrug: Tocilizumab Prefilled SyringeSyneos HealthDr. Reddy's Laboratories LimitedRecruiting18 Years50 YearsAll300Phase 1Australia;New Zealand
2NCT04842981
(ClinicalTrials.gov)
May 25, 202123/3/2021Interleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid ArthritisInterleukin-6 Inhibitors and Drug-drug Interactions in Patients With Rheumatoid ArthritisArthritis, Rheumatoid;InteractionDrug: Tocilizumab;Drug: SarilumabUniversity of Southern DenmarkOdense University Hospital;Hospital of South West Jutland;King Christian X´Hospital for Rheumatic Diseases;Sygehus Lillebaelt;Odense Patient Data Explorative NetworkRecruiting18 Years75 YearsAll12Phase 1/Phase 2Denmark
3JPRN-jRCTs071200107
25/05/202103/03/2021Efficacy 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 trialEfficacy 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 arthritisIn 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 AtsushiNULLRecruiting>= 20age oldNot applicableBoth400N/AJapan
4EUCTR2020-005998-27-DK
(EUCTR)
12/03/202125/01/2021Interleukin-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 DenmarkNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 1;Phase 2Denmark
5NCT05090410
(ClinicalTrials.gov)
March 3, 202130/9/2021Efficacy and Safety of Selective JAK 1 Inhibitor Filgotinib in Active Rheumatoid Arthritis Patients With Inadequate Response to MethotrexateEfficacy 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 AssessmentRheumatoid Arthritis;JAK Inhibitor;IL-6 Inhibitor;Musculoskeletal Ultrasound;BiomarkerDrug: filgotinib 200mg/day;Drug: subcutaneous tocilizumab 162mg/biweeklyAtsushi KawakamiGilead SciencesRecruiting20 YearsN/AAll400Phase 3Japan
6NCT05232396
(ClinicalTrials.gov)
March 2, 202125/11/2021Clinical Study of a IL-6R Injection in Patients With RAPhase 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 ArthritisRheumatoid ArthritisBiological: 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/kgBeijing VDJBio Co., LTD.NULLCompleted18 Years70 YearsAll40Phase 1/Phase 2China
7EUCTR2019-004369-42-DE
(EUCTR)
15/02/202127/11/2020A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
542Phase 3Serbia;United States;Czechia;Slovakia;Ukraine;Russian Federation;Hungary;Czech Republic;Poland;Bulgaria;Georgia;Germany;Moldova, Republic of
8EUCTR2019-004369-42-CZ
(EUCTR)
01/09/202005/08/2020A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
542Phase 3Serbia;Czechia;Hungary;Czech Republic;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of
9NCT04529863
(ClinicalTrials.gov)
August 17, 202025/8/2020Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM) - Tocilizumab vs AbataceptData Analysis for Drug Repurposing for Effective Alzheimer's Medicines- Tocilizumab vs AbataceptRheumatoid ArthritisDrug: Tocilizumab;Drug: AbataceptBrigham and Women's HospitalNational Institute on Aging (NIA);Rutgers University;Johns Hopkins UniversityCompleted18 YearsN/AAll30432United States
10EUCTR2019-004369-42-BG
(EUCTR)
28/05/202007/05/2020A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
542Phase 3Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Russian Federation;Georgia;Bulgaria;Germany;Moldova, Republic of
11EUCTR2019-004369-42-SK
(EUCTR)
12/05/202009/03/2020A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
542Phase 3Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of
12EUCTR2019-004369-42-PL
(EUCTR)
05/05/202023/03/2020A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
542Phase 3Serbia;Czechia;Czech Republic;Hungary;Slovakia;Poland;Bulgaria;Russian Federation;Georgia;Germany;Moldova, Republic of
13NCT04449224
(ClinicalTrials.gov)
April 27, 20207/6/2020Comparative Effectiveness of Targeted Therapy in RA PatientsComparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational StudyRheumatoid ArthritisDrug: Adalimuab, Etanercept, Tocilizumab, or Abatacept;Drug: Tofacitinib or BaricitinibHanyang UniversityMinistry of Health, Republic of KoreaRecruiting19 YearsN/AAll506Korea, Republic of
14EUCTR2019-004369-42-HU
(EUCTR)
27/04/202003/03/2020A 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 GmbHNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
542Phase 3United States;Serbia;Czech Republic;Hungary;Slovakia;Spain;Poland;Russian Federation;Georgia;Bulgaria;Moldova, Republic of
15NCT04115423
(ClinicalTrials.gov)
April 1, 20202/10/2019A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving TocilizumabA 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 DatabaseInfection;Rheumatoid ArthritisDrug: Tocilizumab;Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)Sungkyunkwan UniversityMinistry of Food and Drug Safety, KoreaActive, not recruiting18 YearsN/AAll9508Korea, Republic of
16NCT03895879
(ClinicalTrials.gov)
March 1, 202026/3/2019Use of Tocilizumab Drug Levels to Optimize Treatment in RAConcentration-guided Dose Reduction Versus Standard Dosing in Tocilizumab-treated Rheumatoid Arthritis Patients: a Randomised, Multicenter, Non-inferiority Trial (TODORA)Rheumatoid ArthritisDrug: TocilizumabReade Rheumatology Research InstituteZonMw: The Netherlands Organisation for Health Research and DevelopmentRecruiting18 YearsN/AAll98Phase 4Netherlands
17EUCTR2019-001754-25-NL
(EUCTR)
25/11/201925/11/2019Using adalimumab serum concentration to choose a subsequent biological treatment in rheumatoid arthritis patients failing adalimumab treatmentUsing 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
ReadeNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
84Phase 4Netherlands
18EUCTR2017-003037-28-NL
(EUCTR)
02/10/201922/07/2019Efficacy 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 UtrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 4Netherlands
19EUCTR2018-004605-57-NL
(EUCTR)
06/08/201924/07/2019Concentration-guided dose reduction versus standard dosing in tocilizumab-treated rheumatoid arthritis patientsConcentration-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
ReadeNULLAuthorised-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): yesNetherlands
20EUCTR2018-002202-31-BG
(EUCTR)
27/03/201930/11/2018A Phase 3 study to compare BAT1806 with RoActemra in patients with Rheumatoid ArthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
621Phase 3Poland;Ukraine;Georgia;Bulgaria;China
21ChiCTR1900021808
2019-03-082019-03-11A 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 SubjectsA 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 arthritis1:8 mg/kg QX003S ;2:Tocilizumab, 8 mg/kg;JiangSu Qyuns Therapeutics Co., LtdNULLRecruiting1850Male1:43;2:43;Phase 1China
22NCT03737708
(ClinicalTrials.gov)
February 13, 20198/11/2018A 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 TrialRheumatoid Arthritis (RA)Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abataceptAstellas Pharma Korea, Inc.NULLCompleted19 Years75 YearsAll21Phase 4Korea, Republic of
23NCT03781310
(ClinicalTrials.gov)
December 201817/12/2018Therapeutic Drug Monitoring of Tocilizumab in Rheumatoid ArthritisTherapeutic Drug Monitoring of Tocilizumab in Rheumatoid ArthritisRheumatoid Arthritis;TocilizumabDrug: TocilizumabTel-Aviv Sourasky Medical CenterAmsterdam Rheumatology and Immunology CenterUnknown status18 YearsN/AAll80Phase 4Israel
24EUCTR2017-004079-30-PT
(EUCTR)
09/08/201829/06/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
207Phase 3Portugal;Belgium;Spain;Italy
25EUCTR2017-004079-30-ES
(EUCTR)
10/07/201821/03/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
207Phase 3Portugal;Belgium;Spain;Italy
26EUCTR2017-004079-30-IT
(EUCTR)
06/07/201810/09/2021Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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 NOVARANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
207Phase 3Portugal;Spain;Belgium;Italy
27NCT03100253
(ClinicalTrials.gov)
March 1, 201817/3/2017Rheumatoid Arthritis Treatment After First Anti-TNF INvestiGationOpen-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-TNFRheumatoid ArthritisDrug: Tocilizumab;Drug: Etanercept;Drug: Infliximab;Drug: Adalimumab;Drug: Golimumab;Drug: Certolizumab PegolMario Negri Institute for Pharmacological ResearchNULLRecruiting18 YearsN/AAll208Phase 4Italy
28EUCTR2017-004079-30-BE
(EUCTR)
19/02/201819/02/2018Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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)NULLNot RecruitingFemale: yes
Male: yes
219Phase 3Portugal;Spain;Belgium;Italy
29NCT03227419
(ClinicalTrials.gov)
January 22, 201819/7/2017Abatacept vs Tocilizumab for the Treatment of RA in TNF Alpha Inhibitor Inadequate RespondersAbatacept Versus Tocilizumab by Subcutaneous Administration for the Treatment of Rheumatoid Arthritis in TNF Alpha Inhibitor Inadequate Responder Patients: A Randomized, Open-labeled, Superiority TrialArthritis, RheumatoidDrug: Tocilizumab Prefilled Syringe;Drug: Abatacept Prefilled SyringeLille Catholic UniversityNULLRecruiting18 YearsN/AAll224Phase 4France
30NCT03440892
(ClinicalTrials.gov)
November 1, 201714/2/2018Effects of Antirheumatic Treatment on Levels of Survivin in Rheumatoid Arthritis PatientsLongitudinal Observational Study on Rheumatoid Arthritis Patients: Effects of Antirheumatic Treatment on Serum Levels of SurvivinRheumatoid ArthritisDrug: methotrexate;Drug: sulfasalazine;Drug: abatacept;Drug: tocilizumab;Drug: tofacitinib/baricitinibVastra Gotaland RegionNULLRecruiting20 YearsN/AAll2500Sweden
31NCT03288584
(ClinicalTrials.gov)
October 27, 201716/9/2017Effects of Interleukin-6 Inhibition on Vascular, Endothelial and Left Ventricular Function in Rheumatoid ArthritisThe Effect of Inhibition of Interleukin-6 Activity on Vascular, Endothelial and Left Ventricular Function in Patients With Rheumatoid ArthritisRheumatoid Arthritis;InflammationDrug: Tocilizumab (Actemra®);Drug: Other biological agent;Drug: Corticosteroid and non-biological agents.University of AthensNULLRecruiting18 Years80 YearsAll60Greece
32EUCTR2016-001987-12-IT
(EUCTR)
18/08/201705/01/2021Clinical 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-TNFOpen-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 - SIRNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
208Phase 4Italy
33EUCTR2017-000947-41-FR
(EUCTR)
18/08/201721/06/2017ORENCIA 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 LilleNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4France
34NCT03155347
(ClinicalTrials.gov)
August 2, 201715/5/2017An 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) TherapyA 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 TherapyRheumatoid ArthritisDrug: Tocilizumab;Drug: MTX;Drug: Placebo Matched to MTX;Drug: Placebo Matched to TocilizumabHoffmann-La RocheNULLActive, not recruiting18 Years70 YearsAll340Phase 3China
35NCT03215407
(ClinicalTrials.gov)
August 1, 201722/6/2017The Comparative Study of Intra-articular Injection of Tocilizumab and Compound BetamethasoneThe Comparative Study of Safety and Effectiveness of Intra-articular Injection of Tocilizumab and Compound Betamethasone in Rheumatoid Arthritis of the KneeRheumatoid Arthritis of KneeDrug: Intra-articular Tocilizumab;Drug: Intra-articular Compound BetamethasoneChinese PLA General HospitalNULLNot yet recruiting18 Years65 YearsAll60Phase 4NULL
36NCT03291457
(ClinicalTrials.gov)
March 30, 201720/9/2017A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical PracticeA Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical PracticeRheumatoid ArthritisDrug: Tocilizumab;Drug: Glucocorticoid AgentHoffmann-La RocheNULLCompleted18 YearsN/AAll101Belgium
37NCT03112213
(ClinicalTrials.gov)
January 12, 201710/4/2017Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) TreatmentCONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)Rheumatoid ArthritisDrug: Tocilizumab;Drug: NSAIDsHoffmann-La RocheNULLCompleted18 YearsN/AAll135Germany
38JPRN-jRCTs041180071
13/10/201607/03/2019T-ReX studyTocilizumab treatment with Reducing and stopping methotreXate in patients with rheumatoid arthritis in stable low disease activity-state - T-ReX study Rheumatoid arthritisAt 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 ToshihisaNULLComplete>= 20age oldNot applicableBoth51N/AJapan
39NCT02648035
(ClinicalTrials.gov)
September 22, 20165/1/2016EMBRACE-SC: Observational Study of Subcutaneous (SC) Tocilizumab Alone or in Combination With Conventional Disease-Modifying Antirheumatic Drugs (cDMARDs) in Rheumatoid ArthritisMulticenter, 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 ArthritisBiological: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll200Greece
40EUCTR2012-002535-28-NL
(EUCTR)
13/09/201601/09/2016A 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
41JPRN-UMIN000021247
2016/07/2222/07/2016Tocilizumab treatment with reducing and stopping methotrexate in patients with rheumatoid arthritis in stable low disease activity-stateTocilizumab 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 arthritisDouble 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 HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female51Not selectedJapan
42NCT02765074
(ClinicalTrials.gov)
June 30, 201619/4/2016Filling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of Subcutaneous Tocilizumab in Rheumatoid ArthritisFilling Bone Erosions: a Longitudinal Multicentric HR-pQCT Study of 12 Months Subcutaneous Tocilizumab in Rheumatoid Arthritis Phase IV Prospective Multicentrique StudyRheumatoid ArthritisDrug: subcutaneous tocilizumabCentre Hospitalier Régional d'OrléansRennes University HospitalRecruiting18 Years85 YearsAll60Phase 4France
43NCT02659150
(ClinicalTrials.gov)
May 18, 201621/12/2015Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid ArthritisA Multicenter, Open-Label, Proof-of-Activity Study of the Effect of Subcutaneous ACTEMRA on Inflamed Atherosclerotic Plaques in Patients With Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumabMassachusetts General HospitalBrigham and Women's HospitalUnknown status50 Years75 YearsFemale21Phase 4NULL
44NCT02573012
(ClinicalTrials.gov)
March 29, 20161/10/2015Study to Compare the Efficacy of Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis ParticipantsProspective, Multicentre, Placebo-controlled, Double-blind Interventional Study to Compare the Efficacy of Maintenance Treatment With Tocilizumab With or Without Glucocorticoid Discontinuation in Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: Placebo matched to prednisone;Drug: Prednisone;Biological: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll314Phase 4France;Germany;Italy;Russian Federation;Serbia;Tunisia;Egypt;Switzerland;Turkey
45NCT02679001
(ClinicalTrials.gov)
March 24, 20168/2/2016A 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 TREATMENTRheumatoid ArthritisDrug: TNF inhibitor/TCZHoffmann-La RocheNULLCompleted18 YearsN/AAll200Sweden
46NCT02682823
(ClinicalTrials.gov)
March 21, 201611/2/2016Tocilizumab Real-Life Human Factors (RLHFs) Validation StudyTocilizumab Real-Life Human Factors Validation StudyRheumatoid ArthritisDevice: AI-1000 G2;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll91Phase 4United States
47EUCTR2014-004673-16-DE
(EUCTR)
12/01/201615/07/2015Randomized, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
226Phase 4Serbia;France;Egypt;Lebanon;Turkey;Russian Federation;Germany;Italy;Switzerland
48NCT02608112
(ClinicalTrials.gov)
December 31, 201516/11/2015Study to Describe Real World Drug Retention Rate of the Tocilizumab at One YearSubcutaneous 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 YearRheumatoid ArthritisDrug: Methotrexate;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll291France
49NCT02837146
(ClinicalTrials.gov)
December 20157/7/2016Ultrasound as Imaging Biomarker of Early Response to Tocilizumab and Methotrexate in Very Early Rheumatoid ArthritisUltrasound Scores as Imaging Biomarkers of Early Response to Subcutaneous Tocilizumab in Association With Methotrexate in Very Early Rheumatoid Arthritis (TOVERA)Rheumatoid ArthritisBiological: Tocilizumab (TCZ);Drug: Methotrexate (MTX)Maria StoenoiuNULLRecruiting18 Years75 YearsBoth45Phase 3Belgium
50EUCTR2014-004673-16-FR
(EUCTR)
16/11/201505/08/2015Randomized, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
226Phase 4Serbia;Egypt;France;Slovenia;Lebanon;Turkey;Russian Federation;Germany;Tunisia;Italy;Switzerland
51NCT02552940
(ClinicalTrials.gov)
October 31, 201516/9/2015An 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 PracticeA 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 PRACTICERheumatoid ArthritisDrug: TocilizumabHoffmann-La Rochenv Roche saCompleted18 YearsN/AAll140Belgium;Luxembourg
52EUCTR2015-001246-28-BE
(EUCTR)
19/10/201523/07/2015Ultrasound 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 LouvainNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
53EUCTR2015-000581-58-CZ
(EUCTR)
14/10/201516/06/2015A Randomized,Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of ActionA 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 PrahaNULLNot RecruitingFemale: yes
Male: yes
40Phase 4Czech Republic
54NCT02534311
(ClinicalTrials.gov)
October 13, 201525/8/2015A 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 LevelRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll60Phase 4Slovakia
55NCT02778789
(ClinicalTrials.gov)
October 201516/5/2016Comparing the Efficacy of Periarticular Bone Structure in Patients Treated With Either Tocilizumab or Tumor Necrosis Factor BlockersNon 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 ArthritisDrug: Tocilizumab;Drug: TNF-alpha InhibitorUniversity of Erlangen-Nürnberg Medical SchoolNULLCompleted18 YearsN/AAll66Germany
56JPRN-UMIN000027241
2015/08/3103/05/2017the change of IMT of carotide artery in RA with treatment of tocilizumab rheumatoid arthritistofacitinibhiroshima clinicNULLComplete: follow-up complete18years-old80years-oldMale and Female50Not applicableJapan
57NCT02797769
(ClinicalTrials.gov)
August 20158/6/2016A 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 DatabasesRheumatoid ArthritisDrug: Other Biologics;Drug: TocilizumabHoffmann-La RocheNULLNot yet recruiting18 YearsN/ABoth75000N/ANULL
58EUCTR2012-002535-28-ES
(EUCTR)
22/07/201510/07/2015A 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)NULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Belgium;Spain;Netherlands;Italy;United Kingdom
59EUCTR2014-003012-36-BG
(EUCTR)
19/06/201512/03/2015A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA 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 NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
60EUCTR2014-003012-36-CZ
(EUCTR)
10/06/201505/01/2015A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA 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 NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
61EUCTR2014-003012-36-ES
(EUCTR)
27/05/201502/02/2015A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA 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 NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
62EUCTR2014-003012-36-DE
(EUCTR)
21/05/201529/12/2014A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA 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 NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
63NCT02402686
(ClinicalTrials.gov)
May 20, 201525/3/2015Non-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 ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll353Hungary
64EUCTR2011-004720-35-NO
(EUCTR)
04/05/201526/01/2015A 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 4Finland;Denmark;Norway;Sweden
65NCT02404558
(ClinicalTrials.gov)
May 201526/3/2015Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid ArthritisAn 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 ArthritisRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: tocilizumabSanofiRegeneron PharmaceuticalsCompleted20 YearsN/ABoth30Phase 1Japan
66JPRN-UMIN000016950
2015/03/2703/04/2015Clinical outcome in patients with rheumatoid arthritis switched to tumor nesrosis factor blockers after tocilizumab or abatacept rheumatoid arthritisInfliximab or adalimumab or golimumabOsaka Medical CollegeNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
67EUCTR2014-003012-36-BE
(EUCTR)
23/03/201518/12/2014A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA 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 NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Czech Republic;Hungary;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
68EUCTR2014-003012-36-HU
(EUCTR)
10/03/201530/12/2014A Phase IIb Study for ALX-0061 Monotherapy in Subjects with Rheumatoid ArthritisA 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 NVNULLNot RecruitingFemale: yes
Male: yes
228Phase 2Serbia;United States;Spain;Hungary;Czech Republic;Mexico;Macedonia, the former Yugoslav Republic of;Argentina;Belgium;Poland;Romania;Bulgaria;Georgia;Germany;Moldova, Republic of
69NCT02287922
(ClinicalTrials.gov)
March 20155/11/2014A Phase IIb Study for ALX-0061 Monotherapy in Subjects With Rheumatoid ArthritisA 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 InappropriateRheumatoid ArthritisBiological: ALX-0061;Biological: Placebo;Biological: TocilizumabAblynxNULLCompleted18 Years74 YearsAll251Phase 2United 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
70NCT02353780
(ClinicalTrials.gov)
March 201530/6/2013Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or AbataceptMechanistic Studies of B- and T-Cell Function in Rheumatoid Arthritis Patients Treated With TNF Antagonists, Tocilizumab, or AbataceptRheumatoid Arthritis (RA)Drug: TNF Antagonist (enbrel, humire, remicade, cimzia, symponi);Drug: Abatacept;Drug: TocilizumabDr. Larry W. MorelandGenentech, Inc.;Bristol-Myers SquibbTerminated18 Years64 YearsAll10Phase 4United States
71EUCTR2012-002535-28-IT
(EUCTR)
16/01/201504/11/2014A 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 LondonNULLNot RecruitingFemale: yes
Male: yes
180Phase 4Portugal;Spain;Belgium;Netherlands;United Kingdom;Italy
72EUCTR2014-003529-16-GB
(EUCTR)
16/12/201422/06/2015Stratification of biologic Therapies for Rheumatoid Arthritis by PathobiologyStratification 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)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
219Phase 3United Kingdom
73EUCTR2011-004720-35-FI
(EUCTR)
10/09/201409/09/2014A 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 InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Finland;Denmark;Sweden
74NCT01717859
(ClinicalTrials.gov)
September 201419/10/2012Musculoskeletal Ultrasound in Predicting Early Dose Titration With TocilizumabMusculoskeletal Ultrasound in Predicting Early Dose Titration With TocilizumabRheumatoid ArthritisDrug: TocilizumabUniversity of California, Los AngelesGenentech, Inc.Completed18 YearsN/AAll74Phase 4United States
75NCT02234960
(ClinicalTrials.gov)
August 20145/9/2014Local, 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 ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/ABoth102N/APoland
76JPRN-UMIN000015175
2014/07/0117/09/2014Head-to-head comparison of Subcutaneous Tocilizumab versus Abatacept for Rheumatoid arthritis : prospective, randomized trial. Rheumatoid ArthritisSubcutaneous Tocilizumab 162mg every other week.
Subcutaneous Abatacept 125mg every week.
St.Marianna University School of MedicineNULLRecruiting20years-oldNot applicableMale and Female120Not selectedJapan
77NCT02011334
(ClinicalTrials.gov)
July 20144/12/2013A 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 AMERICARheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth285Phase 3Argentina;Brazil;Colombia;Dominican Republic;Mexico;Venezuela;Ecuador;Uruguay
78EUCTR2012-002535-28-PT
(EUCTR)
06/06/201425/02/2014Not applicableA 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 LondonNULLNot RecruitingFemale: yes
Male: yes
160Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
79NCT02046616
(ClinicalTrials.gov)
May 28, 201424/1/2014A 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 ArthritisDrug: Tocilizumab;Drug: Methotrexate;Drug: Non-Biologic DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll133Phase 3Denmark;Finland;Norway;Sweden
80NCT02087696
(ClinicalTrials.gov)
May 20146/3/2014Uncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid ArthritisUncontrolled Study to Evaluate Efficacy of Tocilizumab in Patients With Moderate or Severe Rheumatoid Arthritis and Candidates With a Biological MonotherapyArthritis, RheumatoidDrug: TocilizumabSpanish Foundation of RheumatologyRoche Farma, S.ARecruiting18 YearsN/ABoth122Phase 4Spain
81EUCTR2012-002535-28-BE
(EUCTR)
28/04/201428/03/2014A 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-RAA 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)NULLNot 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): yesPortugal;Spain;Belgium;Netherlands;Italy;United Kingdom
82NCT02046603
(ClinicalTrials.gov)
March 4, 201424/1/2014A 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 AgentOpen-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 AgentRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDs;Drug: Oral Corticosteroids;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll162Phase 3United Kingdom
83NCT02097524
(ClinicalTrials.gov)
March 20143/3/2014Single-dose Study to Describe the Pharmacodynamics (PD) and Safety of Sarilumab (REGN88/SAR153191) and Tocilizumab in Adults With Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: Sarilumab;Drug: TocilizumabRegeneron PharmaceuticalsSanofiCompleted18 YearsN/ABoth105Phase 1United States
84EUCTR2013-004051-20-ES
(EUCTR)
26/02/201427/12/2013NOT 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 MONOTHERAPYNOT 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 REUMATOLOGIANULLNot RecruitingFemale: yes
Male: yes
122Phase 4Spain
85EUCTR2013-002007-34-SE
(EUCTR)
20/02/201423/01/2014Safety 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/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
86EUCTR2013-002007-34-FI
(EUCTR)
10/02/201414/11/2013Safety 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/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
87JPRN-JapicCTI-142505
01/2/2014Phase III study of MRA-SC 162 mg/weekA 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 arthritisIntervention 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.NULL20BOTH50Phase 3NULL
88NCT01987479
(ClinicalTrials.gov)
January 30, 20148/11/2013A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid ArthritisMulti-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 - OSCARRheumatoid ArthritisDrug: Non-Biologic DMARDs;Drug: Tocilizumab;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll150Phase 3Netherlands
89NCT02001987
(ClinicalTrials.gov)
January 201429/11/2013A 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 TherapyA 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 TherapyRheumatoid ArthritisDrug: Tocilizumab;Drug: Methotrexate;Drug: csDMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll139Phase 3France
90NCT02031471
(ClinicalTrials.gov)
January 201416/12/2013TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra TreatmentTOSCARA: An Open-label, Single Arm Study to Evaluate the Efficacy, Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid ArthritisRheumatoid ArthritisDrug: tocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll57Phase 3Belgium;Luxembourg
91NCT01988012
(ClinicalTrials.gov)
January 201431/10/2013A 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 ArthritisBiological: tocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll100Phase 3Israel
92JPRN-UMIN000012690
2013/12/2827/12/2013Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment Rheumatoid Arthritistocilizumab+tacrolimus+Bucillamine
tocilizumab
National hospital organization Chiba east national hospital Clinical Research CenterNULLComplete: follow-up complete20years-old99years-oldMale and Female60Not applicableJapan
93EUCTR2013-002150-79-BE
(EUCTR)
16/12/201324/10/2013A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patientsTOSCARA: 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.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3Belgium
94EUCTR2013-002007-34-DK
(EUCTR)
09/12/201309/12/2013Safety 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/sNULLNot RecruitingFemale: yes
Male: yes
137Phase 3Finland;Denmark;Sweden
95NCT01668966
(ClinicalTrials.gov)
December 9, 201316/8/2012A 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 ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 MonthsN/AAll23Phase 3Brazil
96JPRN-UMIN000012073
2013/12/0121/10/2013Effects of Subcutaneous Actemura and MTX Blending in RA rheumatoid arthritisAdults 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 SchoolNULLComplete: follow-up complete20years-old85years-oldMale and Female100Phase 4Japan
97NCT01941095
(ClinicalTrials.gov)
November 20, 201330/8/2013A Study of Subcutaneous Tocilizumab as Monotherapy and/or in Combination With Non-Biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) in Participants With Rheumatoid ArthritisMulticenter, 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 ArthritisRheumatoid ArthritisDrug: Azathioprine;Drug: Chloroquine;Drug: Hydroxychloroquine;Drug: Leflunomide;Drug: Methotrexate;Drug: Sulfasalazine;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll100Phase 3Greece
98NCT01951170
(ClinicalTrials.gov)
November 201323/9/2013An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid ArthritisAn 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 ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll52Phase 3Australia
99NCT01855789
(ClinicalTrials.gov)
November 201314/5/2013A Study of the Impact of Methotrexate (MTX) Discontinuation on the Efficacy of Subcutaneous Tocilizumab With Methotrexate in Participants With Moderate to Severe Active Rheumatoid ArthritisRheumatoid ArthritisDrug: Placebo;Drug: Tocilizumab;Drug: methotrexateHoffmann-La RocheNULLCompleted18 YearsN/ABoth718Phase 3United States
100NCT01980836
(ClinicalTrials.gov)
November 20134/11/2013Effect of Tocilizumab to the Cellular Immune Response to Influenza VaccineThe Effect of Tocilizumab on the Cellular Immune Response to Seasonal Influnza Vaccine in Patients With Rheumatoid ArthritisRheumatoid Arthritis;Cellular Immune ResponseBiological: Seasonal influenza vaccineTel-Aviv Sourasky Medical CenterNULLNot yet recruiting18 YearsN/ABoth40Phase 4Israel
101EUCTR2013-002341-11-GB
(EUCTR)
25/10/201326/07/2013This is a study in healthy subjects to look at the effect of tocilizumab (RoActemra) on a type of white blood cellA 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 LtdNULLNot RecruitingFemale: no
Male: yes
Phase 4United Kingdom
102EUCTR2013-000342-19-NL
(EUCTR)
24/10/201308/10/2013A 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.NULLNot RecruitingFemale: yes
Male: yes
Phase 3Netherlands
103EUCTR2013-002429-52-IE
(EUCTR)
23/10/201315/08/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA 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.ANULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
104EUCTR2013-002429-52-PT
(EUCTR)
21/10/201308/08/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA 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.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
105EUCTR2013-000054-22-GB
(EUCTR)
01/10/201307/08/2013OPEN-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 AGENTOPEN-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 LimitedNULLNot RecruitingFemale: yes
Male: yes
Phase 3United Kingdom
106EUCTR2013-000359-42-GR
(EUCTR)
12/09/201327/08/2013Not applicableMulticenter, 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.NULLNot RecruitingFemale: yes
Male: yes
Phase 3Greece
107NCT01941940
(ClinicalTrials.gov)
September 5, 20132/9/2013A 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) ParticipantsA 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) PatientsRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll227Phase 3Italy
108NCT01995201
(ClinicalTrials.gov)
September 20131/11/2013A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) as Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Patients With Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: DMARD;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLActive, not recruiting18 YearsN/ABoth401Phase 3Ireland;Portugal;Spain
109EUCTR2013-002429-52-ES
(EUCTR)
23/08/201312/07/2013STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITISA 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.ANULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Spain;Ireland
110EUCTR2013-001569-17-IT
(EUCTR)
02/08/201304/06/2013A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 3Italy
111EUCTR2012-004482-40-ES
(EUCTR)
18/06/201316/05/2013Evaluation of a protocol for the reduction of doses in patients with rheumatoid arthritis (RA) in clinical remission in treatment with biological therapiesEvaluation 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 GARCÍANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Spain
112EUCTR2012-003536-23-PL
(EUCTR)
05/06/201322/04/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden
113NCT01878318
(ClinicalTrials.gov)
June 20136/6/2013A 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 DMARDsOpen 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 DMARDsRheumatoid ArthritisDrug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLWithdrawn18 YearsN/ABoth0Phase 4Venezuela
114EUCTR2012-003536-23-GB
(EUCTR)
21/05/201315/03/2013To 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 & développementNULLNot 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): noUnited States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
115EUCTR2012-003536-23-NL
(EUCTR)
01/05/201322/02/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200Mexico;Argentina;Poland;Belgium;Brazil;Romania;Norway;Netherlands;Sweden;United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary
116NCT04157010
(ClinicalTrials.gov)
May 201315/4/2014Tocilizumab REMission in Early RAProspective, 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 ArthritisRheumatoid ArthritisDrug: Tocilizumab;Drug: MethotrexateUniversity of LeedsHoffmann-La RocheCompleted18 YearsN/AAll20Phase 4United Kingdom
117EUCTR2012-003536-23-NO
(EUCTR)
09/04/201312/02/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Germany;Sweden
118EUCTR2012-003536-23-SE
(EUCTR)
08/04/201307/02/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
119EUCTR2011-004017-17-GB
(EUCTR)
08/04/201311/01/2013Tocilizumab and Remission in early rheumatoid arthritisProspective, 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 LeedsNULLNot 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): yesUnited Kingdom
120EUCTR2012-003536-23-BE
(EUCTR)
04/04/201307/01/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Netherlands;Germany;Norway;Sweden
121EUCTR2012-003536-23-ES
(EUCTR)
01/04/201304/02/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
122EUCTR2012-003536-23-IT
(EUCTR)
29/03/201305/02/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Germany;Norway;Sweden
123EUCTR2012-003536-23-FI
(EUCTR)
13/03/201319/02/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Romania;Netherlands;Norway;Sweden
124EUCTR2012-003536-23-EE
(EUCTR)
13/03/201312/02/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Russian Federation;Israel;Colombia;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Brazil;Belgium;Poland;Romania;Netherlands;Norway;Sweden
125EUCTR2012-003536-23-HU
(EUCTR)
07/03/201316/01/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Sweden;Norway;Germany;Netherlands;Romania;Brazil;Belgium;Poland;Argentina
126NCT02843789
(ClinicalTrials.gov)
March 201319/7/2016Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab TherapyEvolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab TherapyArthritis, RheumatoidDrug: TocilizumabCentre Hospitalier Universitaire de BesanconNULLCompleted18 Years80 YearsAll109Phase 4France
127NCT01768572
(ClinicalTrials.gov)
March 201311/1/2013To 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 AntagonistsRheumatoid ArthritisDrug: sarilumab SAR153191 (REGN88);Drug: tocilizumab;Drug: hydroxychloroquine;Drug: methotrexate;Drug: sulfasalazine;Drug: leflunomide;Drug: subcutaneous placebo;Drug: intravenous placeboSanofiRegeneron PharmaceuticalsCompleted18 YearsN/AAll202Phase 3United States;Argentina;Belgium;Brazil;Czechia;Estonia;Finland;Hungary;Israel;Italy;Mexico;Netherlands;Norway;Poland;Romania;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic
128EUCTR2012-003536-23-CZ
(EUCTR)
20/02/201303/01/2013To 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 & développementNULLNot RecruitingFemale: yes
Male: yes
200United States;Estonia;Finland;Spain;Israel;Russian Federation;Colombia;Italy;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Poland;Brazil;Romania;Norway;Netherlands;Sweden
129JPRN-UMIN000010033
2013/02/1414/02/2013To investigate the efficacy of tocilizumab in RA patients with moderate disease activity under biologic therapy Rheumatoid ArthritisTocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks.Daihei KidaNULLComplete: follow-up complete20years-old75years-oldMale and Female20Not selectedJapan
130EUCTR2012-002535-28-GB
(EUCTR)
21/01/201314/12/2012A 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-RAA 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)NULLNot RecruitingFemale: yes
Male: yes
160Phase 4Portugal;Spain;Belgium;Netherlands;Italy;United Kingdom
131NCT01715831
(ClinicalTrials.gov)
January 15, 201325/10/2012A Long-term Safety Extension Study of Tocilizumab in Brazilian Participants With Rheumatoid Arthritis (RA) Who Completed the Studies ML21530 and MA21488A 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 TreatmentArthritis, RheumatoidDrug: DMARDs;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll26Phase 4Brazil
132NCT01772316
(ClinicalTrials.gov)
December 201217/1/2013A Long-Term Extension Study of WA22763 and NA25220 of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: tocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll47Phase 3Spain
133EUCTR2012-001760-30-IT
(EUCTR)
05/11/201225/07/2012Evaluation 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 GISEANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
134NCT01741688
(ClinicalTrials.gov)
October 26, 201230/11/2012An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid ArthritisA Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With TocilizumabRheumatoid ArthritisBiological: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll16N/APeru
135JPRN-UMIN000008812
2012/10/0101/10/2012Efficacy and safety of tocilizumab mono-therapy in patients with large vessel vasculitis (LVV; giant cell arteritis or Takayasu arteritis) and polymyalgia rheumatica (PMR) Rheumatoid arthritistocilizumab monotherapyDepartment of Rheumatology & Clinical ImmunologySaitama Medical Center, Saitama Medical UniversitityNULLComplete: follow-up complete16years-old80years-oldMale and Female40Not selectedJapan
136NCT01734993
(ClinicalTrials.gov)
October 201219/11/2012A 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 ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll11Phase 3France
137NCT01730456
(ClinicalTrials.gov)
October 201215/11/2012A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926A 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 ARTHRITISRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth13Phase 3Macedonia, The Former Yugoslav Republic of
138NCT01661140
(ClinicalTrials.gov)
September 20127/8/2012A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Severe Active Rheumatoid Arthritis, Comparing Tapering Versus Maintaining the Methotrexate DosageRandomized, 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 MTXRheumatoid ArthritisDrug: Methotrexate (stable dose);Drug: Tocilizumab;Drug: Methotrexate (tapering dose)Hoffmann-La RocheNULLTerminated18 YearsN/AAll427Phase 4United Kingdom
139NCT01662063
(ClinicalTrials.gov)
August 201230/7/2012A 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 ArthritisRheumatoid ArthritisDrug: TocilizumabGenentech, Inc.NULLCompleted18 YearsN/AAll218Phase 3United States;Puerto Rico
140NCT01705730
(ClinicalTrials.gov)
July 31, 201210/10/2012A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in MonotherapyMon-ACT: A Multi-center, Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab in MonotherapyRheumatoid ArthritisDrug: tocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll71Belgium
141JPRN-UMIN000008404
2012/07/0112/07/2012Extension of Tocilizumab Dose Intervals in Patients with Low to Moderate Disease Activity Rheumatoid Arthritis using IL-6 Serum Level as Starting Criteria. rheumatoid arthritisExtension of Tocilizumab Dose IntervalsJapan Labour Health and Welfare Organization,Yokohama Rosai HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female50Not selectedJapan
142NCT01649804
(ClinicalTrials.gov)
July 201223/7/2012A Long-Term Safety Extension Study of WA19926 in Participants With Rheumatoid ArthritisA 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 ARTHRITISRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll12Phase 3Hungary
143NCT01665430
(ClinicalTrials.gov)
July 201213/8/2012A Long-Term Extension Study to WA19926 (NCT01007435) of Tocilizumab in Participants With Early, Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLTerminated18 YearsN/AAll38Phase 3Poland
144EUCTR2011-005260-20-GB
(EUCTR)
28/06/201210/05/2012RoActemra® (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 LimitedNULLNot 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): yesUnited Kingdom
145EUCTR2011-005204-15-AT
(EUCTR)
20/06/201215/05/2012Could 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 ImmunologieNULLNot RecruitingFemale: yes
Male: yes
110Phase 4Austria
146NCT01664104
(ClinicalTrials.gov)
June 20127/8/2012A Study to Evaluate Tocilizumab Treatment in a Real-Life SettingCRP and BMI Study: Evaluation in Real Life of Clinical Remission Rate and Correlation Between CRP and BMI in Patients Treated With TocilizumabRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll151N/AItaly
147EUCTR2011-006040-79-DK
(EUCTR)
25/05/201225/05/2012A clinical trial with the aim to explore the efficacy and safety of adding tocilizumab to standard of care in patients withearly rheumatoid arthThe 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 UNULLNot RecruitingFemale: yes
Male: yes
180Phase 4Denmark
148EUCTR2012-000139-21-AT
(EUCTR)
14/05/201223/04/2012Multi-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 IIINULLNot RecruitingFemale: yes
Male: yes
Phase 4Czech Republic;Slovakia;Austria;Russian Federation;Switzerland
149EUCTR2011-006125-14-HU
(EUCTR)
04/05/201208/03/2012A 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 LTEA 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.NULLNot RecruitingFemale: yes
Male: yes
241Hungary
150JPRN-UMIN000014484
2012/05/0101/12/2014Saitama Actemra study for QOL in patients with Rheumatoid arthritis rheumatoid arthritisTreatment with TocilizumabJuntendo University, Juntendo Koshigaya HospitalNULLComplete: follow-up complete20years-oldNot applicableMale and Female40Not selectedJapan
151NCT01664598
(ClinicalTrials.gov)
May 201210/8/2012An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth49Phase 3Russian Federation
152NCT01579006
(ClinicalTrials.gov)
May 201216/4/2012Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid ArthritisA Multi National, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab (Actemra)Rheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheClalit Health ServicesCompleted18 YearsN/AAll184N/AIsrael
153NCT01617005
(ClinicalTrials.gov)
May 20128/6/2012A 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 DMARDRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll50N/AMontenegro
154JPRN-UMIN000007380
2012/04/0101/05/2012Comparison of the effects of single high-dose methotrexate and methotrexate-tocilizumab therapy on rheumatoid arthritis rheumatoid arthritistocilizumab + methotrexate (10mg/week)
high-dose methotrexate (stepwisely increased to 16mg/week)
Kinki University Faculty of Medicine, Division of Hematology and RheumatologyNULLComplete: follow-up complete20years-old80years-oldMale and Female40Not selectedJapan
155NCT01655381
(ClinicalTrials.gov)
April 201230/7/2012A Long-Term Extension Study of WA19926 on the Safety of Tocilizumab (RoActemra/Actemra) in Participants With Early Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll15Phase 3France
156NCT01557374
(ClinicalTrials.gov)
April 201216/3/2012TOward the Lowest Effective DOse of Abatacept or TocilizumabTapering Abatacept or Tocilizumab in Rheumatoid Arthritis in Remission. An Evaluation of Disease Activity, Relapse Risk, Structural Progression and the Economic Impact of a Tapering StrategyRheumatoid ArthritisDrug: Tocilizumab, Abatacept;Drug: Decrease Tocilizumab, AbataceptAssistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompleted18 YearsN/AAll232Phase 4France
157JPRN-UMIN000017230
2012/03/0122/04/2015Correlation 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 arthritisBiologic treatment (tocilizumab)Kyushu UniversityNULLRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
158NCT01670045
(ClinicalTrials.gov)
March 201217/8/2012A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid ArthritisA Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With TocilizumabRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll43N/AIndonesia;Greece
159JPRN-UMIN000007019
2012/02/0101/02/2012Efficacy and safety of tocilizumab mono-therapy in patients with adult-onset Still's disease Rheumatoid arthritistocilizumab monotherapyDepartment of Rheumatology & Clinical Immunology,Saitama Medical Center, Saitama Medical UniversitityNULLComplete: follow-up complete16years-old70years-oldMale and Female40Not selectedJapan
160NCT01562327
(ClinicalTrials.gov)
February 201221/3/2012A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid ArthritisA Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab ActemraRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll50N/AArgentina
161NCT01587989
(ClinicalTrials.gov)
February 201212/3/2012A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to MethotrexateA 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 ArthritisDrug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll77Phase 3Austria
162NCT01474291
(ClinicalTrials.gov)
January 201215/11/2011An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical PracticeEvaluation of Factors Influencing Use of RoActemra® as Monotherapy in Rheumatoid Arthritis Patients in a Real Life Setting - ACT SOLORheumatoid ArthritisBiological: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll608N/AFrance;Monaco
163EUCTR2010-020065-24-GR
(EUCTR)
05/12/201104/11/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
2800Phase 4United 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
164NCT01326962
(ClinicalTrials.gov)
November 30, 20117/3/2011A Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to DMARDs or Anti-TNFTocilizumab Efficacy and Safety in RA Patients After Inadequate Response to DMARDs or Anti-TNFRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll28Phase 3Saudi Arabia
165NCT01251120
(ClinicalTrials.gov)
November 201130/11/2010A Study of RoActemra/Actemra (Tocilizumab) in Combination With DMARDs Versus Current Best Practice DMARD Therapy in Patients With Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: DMARDHoffmann-La RocheNULLTerminated18 YearsN/AAll2Phase 4Finland
166NCT01468077
(ClinicalTrials.gov)
November 20117/11/2011A Study in Patients With Moderate to Severe Active Rheumatoid Arthritis Comparing Different Infusion Durations of RoActemra/Actemra (Tocilizumab) TreatmentMulticenter, 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 HourRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll47Phase 2Denmark;Iceland
167EUCTR2010-019912-18-BG
(EUCTR)
03/10/201125/08/2011A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
600United 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
168EUCTR2010-020065-24-BE
(EUCTR)
26/09/201116/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080United States;Serbia;Philippines;Ecuador;Greece;Spain;Russian Federation;Israel;Chile;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
169EUCTR2010-023587-40-NL
(EUCTR)
06/09/201111/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
700Germany;Netherlands;Italy;Sweden;Greece;Finland;Spain
170EUCTR2010-020065-24-DE
(EUCTR)
06/09/201130/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
2800Phase 4United 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
171NCT01245439
(ClinicalTrials.gov)
September 201117/11/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid ArthritisLocal 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 DMARDRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll65Phase 3Turkey
172NCT01462162
(ClinicalTrials.gov)
September 201127/10/2011A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid ArthritisA 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 PracticeRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll122N/ASpain
173NCT01399697
(ClinicalTrials.gov)
September 201120/7/2011A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to MethotrexateA 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 ArthritisDrug: methotrexate;Drug: placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll261Phase 4Spain
174EUCTR2010-020065-24-NL
(EUCTR)
31/08/201106/07/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
175EUCTR2010-019912-18-HU
(EUCTR)
31/08/201108/06/2011A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
600United 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
176EUCTR2010-020065-24-ES
(EUCTR)
25/08/201101/07/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
2800Phase 4United 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
177EUCTR2011-002363-15-IS
(EUCTR)
17/08/201122/06/2011A 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/sNULLNot RecruitingFemale: yes
Male: yes
56Denmark;Iceland
178EUCTR2011-002363-15-DK
(EUCTR)
16/08/201127/07/2011A 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/sNULLNot RecruitingFemale: yes
Male: yes
56Denmark;Iceland
179EUCTR2010-020065-24-GB
(EUCTR)
15/08/201108/04/2011A 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.NULLNot 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): yesSerbia;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
180NCT01331837
(ClinicalTrials.gov)
August 2, 20117/4/2011A Study of Tocilizumab in Comparison to Etanercept in Participants With Rheumatoid Arthritis and Cardiovascular Disease Risk FactorsA 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 ArthritisDrug: Etanercept;Drug: TocilizumabHoffmann-La RocheNULLCompleted50 YearsN/AAll3080Phase 4United 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
181EUCTR2010-020065-24-AT
(EUCTR)
28/07/201117/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
182EUCTR2011-001863-39-AT
(EUCTR)
28/07/201115/06/2011A 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 GmbHNULLNot RecruitingFemale: yes
Male: yes
Austria
183EUCTR2010-020065-24-CZ
(EUCTR)
26/07/201127/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
184EUCTR2010-020065-24-LT
(EUCTR)
25/07/201125/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Serbia;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
185EUCTR2010-020065-24-HU
(EUCTR)
15/06/201102/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
186EUCTR2010-023587-40-DE
(EUCTR)
14/06/201102/03/2011A 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-InhibitorA 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.NULLNot RecruitingFemale: yes
Male: yes
700United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
187EUCTR2010-020065-24-LV
(EUCTR)
08/06/201111/05/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
3080Phase 4Serbia;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
188EUCTR2011-000215-79-FR
(EUCTR)
07/06/201124/02/2011Tociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRATociluzimab effect on Endothelial function in patients with Rheumatoid Arthritis - TEFRA Polyarthrite rhumatoïdeTrade Name: Roactemra
Other descriptive name: TOCILIZUMAB
CHU de Clermont FerrandNULLNot 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): noFrance
189JPRN-UMIN000005590
2011/06/0112/05/2011Maintenance of remission by tocilizumab mono-therapy after remission obtained by combination with methotrexate in patients with rheumatoid arthritis Rheumatoid arthritisCessation of MTX (tocilizumab monotherapy)
Continue MTX with tocilizumab
Department of Rheumatology and Clinical Immunology, Saitama Medical Center, Saitama Medical UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female40Not selectedJapan
190EUCTR2010-020839-39-BE
(EUCTR)
10/05/201125/11/2010Efficacy and safety of CDP6038 in patients with rheumatoid arthritis withan unsuccessful response to anti-TNF therapyA 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 CompaniesNULLNot RecruitingFemale: yes
Male: yes
220Phase 2United States;Belgium;United Kingdom
191EUCTR2010-023587-40-GR
(EUCTR)
10/05/201116/05/2011A 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-InhibitorA 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.NULLNot RecruitingFemale: yes
Male: yes
700United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
192EUCTR2010-023587-40-SE
(EUCTR)
04/05/201114/03/2011A 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-InhibitorA 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.NULLNot RecruitingFemale: yes
Male: yes
96United States;European Union;Greece;Finland;Spain;Russian Federation;Netherlands;Germany;Italy;Sweden
193NCT01283971
(ClinicalTrials.gov)
May 201125/1/2011A 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)-InhibitorA 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 InhibitorRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: adalimumab;Drug: placebo to tocilizumab;Drug: placebo to adalimumab;Drug: methotrexate;Drug: folateHoffmann-La RocheNULLTerminated18 YearsN/AAll96Phase 4United States;Denmark;Finland;France;Germany;Greece;Italy;Netherlands;Puerto Rico;Russian Federation;Spain;Sweden;United Kingdom
194NCT01347983
(ClinicalTrials.gov)
May 20113/5/2011Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis PatientsExtension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis PatientsRheumatoid ArthritisDrug: Tocilizumab+Methotrexate(MTX)Chugai Pharma TaiwanNULLCompleted20 Years75 YearsBoth72Phase 3Taiwan
195EUCTR2010-020065-24-IT
(EUCTR)
29/04/201120/03/2012A 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
ROCHENULLNot RecruitingFemale: yes
Male: yes
2800Phase 4United 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
196EUCTR2010-023587-40-DK
(EUCTR)
28/04/201112/04/2011A 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-InhibitorA 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.NULLNot RecruitingFemale: yes
Male: yes
700Phase 4United States;European Union;Greece;Finland;Spain;Denmark;Russian Federation;Netherlands;Germany;Italy;Sweden
197EUCTR2010-019912-18-GR
(EUCTR)
18/04/201101/04/2011A 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 arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
600Hungary;Greece;Spain;Bulgaria
198EUCTR2010-023587-40-FI
(EUCTR)
15/04/201124/02/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
96Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
199EUCTR2010-023587-40-ES
(EUCTR)
13/04/201117/02/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
700Phase 4Greece;Finland;Spain;Denmark;Netherlands;Germany;Italy;Sweden
200EUCTR2010-023587-40-IT
(EUCTR)
10/03/201127/04/2011A 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. - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
700Greece;Finland;Spain;Netherlands;Germany;Italy;Sweden
201NCT01332994
(ClinicalTrials.gov)
March 201118/3/2011A Study of RoActemra/Actemra and, if Initially Inadequately Responded to RoActemra/Actemra, Followed by MabThera/Rituxan in Patients With Rheumatoid ArthritisEfficacy 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 ArthritisDrug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll519Phase 3Germany
202NCT01232569
(ClinicalTrials.gov)
March 20111/11/2010A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: Tocilizumab 162 mg;Drug: PlaceboHoffmann-La RocheNULLCompleted18 YearsN/AAll656Phase 3United 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
203NCT01353859
(ClinicalTrials.gov)
March 201113/5/2011A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Non-biologic DMARDsAn 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 DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: methotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll39Phase 3Indonesia;Greece
204EUCTR2010-020839-39-GB
(EUCTR)
25/02/201112/10/2010Efficacy and safety of CDP6038 in patients with rheumatoid arthritis with an unsuccessful response to anti-TNF therapyA 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, IncNULLNot RecruitingFemale: yes
Male: yes
220United Kingdom;United States
205NCT01235507
(ClinicalTrials.gov)
February 201115/10/2010A 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 DMARDsRheumatoid ArthritisDrug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll71Phase 3Bosnia and Herzegovina
206NCT01254331
(ClinicalTrials.gov)
February 20113/12/2010An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local EnvironmentOpen 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 DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll51Phase 3Tunisia
207EUCTR2010-019912-18-ES
(EUCTR)
17/01/201119/01/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Hungary;Greece;Spain;Bulgaria
208EUCTR2010-022049-88-DE
(EUCTR)
05/01/201111/11/2010Efficacy 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) - MIRAIEfficacy 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 AGNULLNot RecruitingFemale: yes
Male: yes
Germany
209NCT01219933
(ClinicalTrials.gov)
January 201111/10/2010A 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 ArthritisDrug: methylprednisolone;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll68Phase 4Belgium
210NCT01258712
(ClinicalTrials.gov)
December 20108/12/2010Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis PatientsRandomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis PatientsRheumatoid Arthritis (RA)Drug: Tocilizumab + methotrexate(MTX);Drug: Tocilizumab placebo + methotrexate(MTX)Chugai Pharma TaiwanNULLCompleted20 Years75 YearsBoth86Phase 3Taiwan
211EUCTR2010-018375-22-BG
(EUCTR)
25/11/201023/09/2010A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200United 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
212JPRN-UMIN000004412
2010/11/0120/10/2010Corticosteroid-sparing effect of Actemra in patients with Rheumatoid Arthritis refractory to anti-TNF agents, methotrexate and corticosteroid rheumatoid arthritistocilizumabGeneral Internal Medicine, Tenri HospitalNULLRecruiting16years-old80years-oldMale and Female25Not applicableJapan
213NCT01242488
(ClinicalTrials.gov)
November 201015/11/2010Efficacy and Safety of CDP6038 in Patients With Rheumatoid Arthritis With an Unsuccessful Response to Anti-Tumor Necrosis Factor (Anti-TNF) TherapyRandomized, 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 TherapyRheumatoid ArthritisBiological: CDP6038;Biological: Tocilizumab (Actemra or RoActemra);Other: Placebo sc;Other: Placebo ivUCB PharmaNULLCompleted18 YearsN/ABoth221Phase 2United States;Belgium;United Kingdom
214EUCTR2008-006924-68-AT
(EUCTR)
28/10/201012/01/2009Extension 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 MA21573Extension 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Portugal;Hungary;Czech Republic;Spain;Austria;Netherlands;United Kingdom;Italy
215NCT01362062
(ClinicalTrials.gov)
October 26, 201026/5/2011Study 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) TherapyA 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 ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll110N/AIndia
216EUCTR2010-018375-22-LT
(EUCTR)
11/10/201016/08/2010A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200United 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
217EUCTR2010-018375-22-DE
(EUCTR)
05/10/201014/07/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
1200United 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
218EUCTR2009-015845-21-GR
(EUCTR)
04/10/201004/10/2010A 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 arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
219EUCTR2009-015845-21-PT
(EUCTR)
01/10/201022/07/2010A 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 arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
300Finland;Portugal;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
220NCT01214733
(ClinicalTrials.gov)
October 20104/10/2010A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid ArthritisAn 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth30Phase 3South Africa
221NCT01149057
(ClinicalTrials.gov)
October 201022/6/2010A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic and/or Biologic DMARDSAn 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 DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheClalit Health ServicesCompleted18 YearsN/AAll145Phase 4Israel
222EUCTR2010-019694-15-BE
(EUCTR)
28/09/201028/07/2010Act-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-AloneAct-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.NULLNot RecruitingFemale: yes
Male: yes
Phase 4Belgium
223EUCTR2010-019935-37-FI
(EUCTR)
15/09/201002/07/2010A 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 ArthritisA 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 OyNULLNot RecruitingFemale: yes
Male: yes
160Finland
224EUCTR2010-018375-22-GB
(EUCTR)
14/09/201029/06/2010A 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 LtdNULLNot 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): noUnited 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
225NCT01194414
(ClinicalTrials.gov)
September 20101/9/2010A Study to Compare Subcutaneous Versus Intravenous Administration of RoActemra/Actemra (Tocilizumab) in Participants With Moderate to Severe Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: tocilizumab SC;Drug: tocilizumab IV;Drug: placebo to tocilizumab SC;Drug: placebo to tocilizumab IV;Drug: Disease-modifying antirheumatic drugs (DMARDs)Hoffmann-La RocheNULLCompleted18 YearsN/AAll1262Phase 3United 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
226NCT01163747
(ClinicalTrials.gov)
September 201014/7/2010A 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 MethotrexateRheumatoid ArthritisBiological: tocilizumab;Drug: methotrexate;Biological: 23-Valent Pneumococcal Polysaccharide Vaccine;Biological: Tetanus Toxoid Adsorbed VaccineGenentech, Inc.NULLCompleted18 Years64 YearsAll91Phase 4United States
227EUCTR2010-018375-22-ES
(EUCTR)
03/08/201004/06/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom
228NCT01195272
(ClinicalTrials.gov)
August 20102/9/2010A 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 TherapyRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll21Phase 4United Kingdom
229EUCTR2010-018375-22-IT
(EUCTR)
29/07/201005/07/2010A 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 - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
1200Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy
230EUCTR2009-015845-21-DE
(EUCTR)
22/07/201018/03/2010A 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 arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;United Kingdom;Germany;Belgium;Spain;Greece;Sweden
231EUCTR2009-012759-12-CZ
(EUCTR)
16/07/201022/02/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Czech Republic;Denmark;Germany;Sweden
232EUCTR2009-015845-21-CZ
(EUCTR)
16/07/201026/03/2010A 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 arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
233EUCTR2009-015845-21-SE
(EUCTR)
06/07/201010/05/2010A 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 arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
234EUCTR2009-015845-21-FI
(EUCTR)
16/06/201030/04/2010A 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 arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
300Portugal;Finland;Czech Republic;Germany;United Kingdom;Belgium;Spain;Greece;Sweden
235EUCTR2009-012759-12-GR
(EUCTR)
15/06/201013/11/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
236EUCTR2009-015845-21-BE
(EUCTR)
08/06/201004/05/2010A 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 arthritisA 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
237EUCTR2010-019873-13-BE
(EUCTR)
07/06/201014/04/2010Comparative 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 - TOMERAComparative 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 LucNULLNot RecruitingFemale: yes
Male: yes
Phase 2Belgium
238EUCTR2009-015845-21-GB
(EUCTR)
13/05/201017/03/2010A 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 arthritisA 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.NULLNot 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): yesPortugal;Czech Republic;Greece;Finland;Spain;Belgium;Germany;United Kingdom;Sweden
239EUCTR2010-018331-18-GB
(EUCTR)
12/05/201018/03/2010A 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 TherapyA 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.NULLNot RecruitingFemale: yes
Male: yes
United Kingdom
240EUCTR2009-015845-21-ES
(EUCTR)
12/05/201012/01/2012A 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.NULLNot RecruitingFemale: yes
Male: yes
300Phase 4United States;Portugal;Greece;Finland;Spain;Turkey;United Kingdom;Switzerland;Czech Republic;Mexico;Belgium;Brazil;Australia;Germany;Sweden
241NCT01245452
(ClinicalTrials.gov)
May 201019/11/2010Study of the Response and Cardiorespiratory Endurance in Early RA Patients Treated With Tocilizumab or MethotrexateComparative 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 BiopsiesRheumatoid ArthritisDrug: Tocilizumab;Drug: MethotrexatePatrick DurezNULLCompleted18 Years70 YearsBoth30N/ABelgium
242NCT01119859
(ClinicalTrials.gov)
May 20101/4/2010A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: Tocilizumab;Drug: Adalimumab;Drug: Placebo to tocilizumab;Drug: Placebo to adalimumabHoffmann-La RocheNULLCompleted18 YearsN/AAll326Phase 4United States;Australia;Belgium;Brazil;Czech Republic;Finland;Germany;Greece;Mexico;Portugal;Spain;Sweden;Switzerland;Turkey;United Kingdom;Norway
243EUCTR2010-018696-21-FR
(EUCTR)
14/04/201015/02/2010Etude 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 17Etude 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 DIJONNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
244EUCTR2009-012759-12-HU
(EUCTR)
17/03/201025/01/2010A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
245NCT01610791
(ClinicalTrials.gov)
March 201031/5/2012A 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 ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll121Phase 3Morocco
246NCT01034397
(ClinicalTrials.gov)
March 201016/12/2009A Study of Tocilizumab Plus Non-biological DMARD in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Non-biological DMARDsA 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 DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: placebo;Drug: non-biological DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll54Phase 4Portugal
247NCT02010216
(ClinicalTrials.gov)
March 20104/12/2013A 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll23Phase 4Kazakhstan
248NCT01256736
(ClinicalTrials.gov)
March 201028/10/2010To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid ArthritisProspective, 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 StudyRheumatoid ArthritisDrug: Tocilizumab;Drug: DMARDsJW PharmaceuticalNULLCompleted18 YearsN/ABoth89Phase 3Korea, Republic of
249NCT01063062
(ClinicalTrials.gov)
February 28, 20103/2/2010A 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 ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll107Phase 3Egypt
250EUCTR2009-012759-12-IE
(EUCTR)
26/01/201005/11/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
251EUCTR2009-012759-12-PT
(EUCTR)
12/01/201021/10/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;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
252EUCTR2009-012759-12-SE
(EUCTR)
12/01/201017/11/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;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
253NCT01034137
(ClinicalTrials.gov)
January 201016/12/2009A Study of Tocilizumab and Methotrexate in Combination or as Monotherapy in Treatment-Naïve Patients With Early Rheumatoid ArthritisU-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 MonotherapyRheumatoid ArthritisDrug: methotrexate;Drug: placebo MTX;Drug: placebo TCZ;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll317Phase 3Netherlands
254NCT01089023
(ClinicalTrials.gov)
January 20108/3/2010A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisMulticenter, 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 ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll95Phase 4Bahrain;Iran, Islamic Republic of;Kuwait;Qatar;United Arab Emirates
255NCT01000441
(ClinicalTrials.gov)
December 23, 200922/10/2009Rotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid ArthritisRotation or Change of Biotherapy After First Anti-TNF Treatment Failure for Rheumatoid ArthritisRheumatoid ArthritisDrug: infliximab, etanercept, adalimumab;Drug: abatacept, rituximab or tocilizumabUniversity Hospital, Strasbourg, FranceNULLCompleted18 YearsN/AAll300Phase 4France;Monaco
256EUCTR2009-012759-12-FI
(EUCTR)
21/12/200928/09/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3United 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
257EUCTR2009-012759-12-DK
(EUCTR)
07/12/200903/11/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;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
258EUCTR2009-012759-12-ES
(EUCTR)
01/12/200923/09/2009Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
259NCT01044498
(ClinicalTrials.gov)
December 20097/1/2010A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid ArthritisAn 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 ArthritisDrug: Tocilizumab;Drug: Ortho-Novum® 1/35Hoffmann-La RocheNULLCompleted18 Years44 YearsFemale46Phase 3United States
260EUCTR2009-012185-32-IT
(EUCTR)
23/11/200925/06/2009Open 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) - NDOpen 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
ROCHENULLNot RecruitingFemale: yes
Male: yes
Phase 3Italy
261EUCTR2009-012759-12-FR
(EUCTR)
13/11/200909/10/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
262EUCTR2009-012759-12-DE
(EUCTR)
13/11/200925/08/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Portugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Denmark;Germany;Sweden
263EUCTR2009-012759-12-IT
(EUCTR)
12/11/200917/11/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden
264EUCTR2008-006924-68-HU
(EUCTR)
11/11/200902/09/2009Extension 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 MA21573Extension 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Portugal;Hungary;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
265EUCTR2009-013316-12-NL
(EUCTR)
10/11/200921/10/2009A 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-EarlyA 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.NULLNot RecruitingFemale: yes
Male: yes
Netherlands
266JPRN-UMIN000002744
2009/11/0110/11/2009Success of tocilizumab in RA patients with remission induction and sustained efficacy after discontinuation rheumatoid arthritistocilizumab plus methotrexate
tocilizumab
Keio UniversityNULLComplete: follow-up complete20years-old75years-oldMale and Female300Not selectedJapan
267NCT00951275
(ClinicalTrials.gov)
October 31, 200930/7/2009A Study of Tocilizumab + DMARDs in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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 ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Standard DMARDs (Disease Modifying Anti Rheumatic Drugs)Hoffmann-La RocheNULLCompleted18 YearsN/AAll105Phase 3Italy
268NCT00996203
(ClinicalTrials.gov)
October 31, 200915/10/2009A 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 ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: DMARDs (disease-modifying antirheumatic drugs)Hoffmann-La RocheNULLCompleted18 YearsN/AAll201Phase 4Russian Federation
269NCT01007435
(ClinicalTrials.gov)
October 31, 20093/11/2009A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: Tocilizumab;Drug: Placebo to tocilizumab;Drug: Methotrexate;Drug: Placebo to methotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll1162Phase 3United 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
270EUCTR2009-012759-12-GB
(EUCTR)
14/10/200917/08/2009A 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.NULLNot 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): noPortugal;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
271EUCTR2009-012218-30-PT
(EUCTR)
06/10/200912/08/2009A 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 - PORTRAITA 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: RoActemraRoche Farmacêutica Química, Lda.NULLNot RecruitingFemale: yes
Male: yes
Portugal
272NCT01120366
(ClinicalTrials.gov)
October 20096/5/2010Success of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After DiscontinuationSuccess of Tocilizumab in RA Patients With Remission Induction and Sustained Efficacy After DiscontinuationRheumatoid ArthritisDrug: Tocilizumab plus methotrexate;Drug: TocilizumabSURPRISE Study GroupNULLCompleted20 Years75 YearsBoth233Phase 4Japan
273NCT00996606
(ClinicalTrials.gov)
October 200915/10/2009A 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 DMARDsOpen 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 ArthritisDrug: DMARDs;Drug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll58Phase 3Italy
274NCT01211834
(ClinicalTrials.gov)
October 200929/9/2010Efficacy and Safety of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid ArthritisA 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 TherapyRheumatoid ArthritisDrug: tocilizumab;Drug: DMARDs;Drug: PlaceboJW PharmaceuticalNULLCompleted18 YearsN/ABoth90Phase 3Korea, Republic of
275EUCTR2009-012759-12-AT
(EUCTR)
14/09/200921/08/2009A 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.NULLNot RecruitingFemale: yes
Male: yes
1128Phase 3United 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
276EUCTR2008-001847-20-DE
(EUCTR)
08/09/200903/06/2009Safety 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 methotrexateRandomized 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.NULLNot RecruitingFemale: yes
Male: yes
470United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Germany;Latvia;Netherlands;Norway;Sweden
277JPRN-UMIN000002340
2009/08/0120/08/2009Comparison of effects between higher dosages of infliximab and switching to other biologics for rheumatoid arthritis patients with less responsiveness to infliximab therapy (cHAMLET) Rheumatoid ArthritisTreatment 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 SchoolNULLComplete: follow-up complete20years-oldNot applicableMale and Female60Phase 4Japan
278NCT00965653
(ClinicalTrials.gov)
August 200918/8/2009A Study of Subcutaneously Administered Tocilizumab in Patients With Rheumatoid ArthritisOpen-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 ArthritisRheumatoid ArthritisDrug: folic acid;Drug: methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 Years75 YearsBoth29Phase 1Canada;New Zealand;Spain;United Kingdom
279EUCTR2008-005525-11-GR
(EUCTR)
20/07/200917/11/2009A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Greece;Spain;Netherlands;Germany;United Kingdom
280EUCTR2008-006924-68-GR
(EUCTR)
03/06/200919/11/2009Extension 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 MA21573Extension 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
281NCT00947492
(ClinicalTrials.gov)
June 200927/7/2009Monitoring Epstein-Barr Virus (EBV) Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive DrugsMonitoring EBV Load in Rheumatoid Arthritis Patients Treated With New Immunosuppressive Drugs ; Orencia* (Abatacept) and RoActemra* (Tocilizumab).Rheumatoid ArthritisBiological: Venous blood sampleAssistance Publique Hopitaux De MarseilleNULLActive, not recruiting18 YearsN/ABoth60N/AFrance
282NCT01010503
(ClinicalTrials.gov)
June 20099/11/2009A 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 ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll32Phase 4Slovakia
283NCT00977106
(ClinicalTrials.gov)
June 200918/8/2009TORPEDO 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-TNFComparative 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 :TORPEDORheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: placeboHoffmann-La RocheNULLCompleted18 YearsN/AAll103Phase 3France
284EUCTR2008-006924-68-PT
(EUCTR)
18/05/200917/03/2009Extension 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 MA21573Extension 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200France;Portugal;Hungary;Czech Republic;Spain;Netherlands;United Kingdom;Italy
285EUCTR2009-011105-17-IT
(EUCTR)
17/05/200927/03/2009A 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 FatigueA 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
ROCHENULLNot RecruitingFemale: yes
Male: yes
Italy
286EUCTR2009-011520-53-SK
(EUCTR)
04/05/200917/03/2009Evaluation of Adherence and Persistence to Tocilizumab in combination with Methotrexate or Tocilizumab Monotherapy in patients with moderate to severe active rheumatoid arthritis in local environmentEvaluation 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 arthritisTrade Name: RoActemra®
INN or Proposed INN: tocilizumab
Other descriptive name: RoActemra
Roche Slovensko s.r.o.NULLNot RecruitingFemale: yes
Male: yes
Slovakia
287NCT00891020
(ClinicalTrials.gov)
May 200929/4/2009A 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 DMARDsRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Nonbiologic DMARDs of investigator's choiceHoffmann-La RocheNULLCompleted18 YearsN/AAll886Phase 3United States;Puerto Rico;United Kingdom
288NCT00887341
(ClinicalTrials.gov)
May 200922/4/2009A Study Comparing Infusion Rates of Tocilizumab in Patients With Moderate to Severe Rheumatoid ArthritisPhase 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 MinutesRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll76Phase 2Spain
289EUCTR2008-006924-68-CZ
(EUCTR)
28/04/200912/02/2009Extension 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 MA21573Extension 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
290EUCTR2008-008309-23-FR
(EUCTR)
24/04/200931/03/2009Etude 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. - TORPEDOEtude 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
ROCHENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
291EUCTR2008-005525-11-DE
(EUCTR)
24/04/200909/12/2008A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81United Kingdom;Germany;Netherlands;France;Spain
292EUCTR2008-006924-68-FR
(EUCTR)
06/04/200919/03/2009Extension 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Portugal;France;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;United Kingdom;Italy
293EUCTR2008-006924-68-IT
(EUCTR)
03/04/200923/03/2009Extension 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 MA21573Extension 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 RocheNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
294EUCTR2008-006924-68-NL
(EUCTR)
02/04/200909/02/2009Extension 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 MA21573Extension 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
295EUCTR2008-005525-11-NL
(EUCTR)
31/03/200912/12/2008A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81France;Spain;Germany;Netherlands;United Kingdom
296EUCTR2008-003011-12-GB
(EUCTR)
30/03/200927/04/2009Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRAProspective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis - TOCRA Rheumatoid ArthritisTrade Name: RoActemra®EV Product Code: PRD82321
Product Name: Tocilizumab
Product Code: RO4877533
University of LeedsNULLNot 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): noUnited Kingdom
297EUCTR2008-000587-17-DE
(EUCTR)
26/03/200917/12/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
298EUCTR2008-000587-17-IT
(EUCTR)
12/03/200920/03/2009Multi-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 - NDMulti-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
ROCHENULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
299EUCTR2008-006924-68-GB
(EUCTR)
06/03/200929/04/2009Extension 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 MA21573Extension 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 LtdNULLNot 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): noFrance;Portugal;Hungary;Czech Republic;Greece;Spain;Austria;Netherlands;Italy;United Kingdom
300NCT00845832
(ClinicalTrials.gov)
March 200917/2/2009A Study of Combination Treatment With MabThera (Rituximab) and RoActemra (Tocilizumab) Versus RoActemra in Patients With Rheumatoid Arthritis With an Incomplete Response to MethotrexateA 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 MethotrexateRheumatoid ArthritisDrug: Placebo;Drug: rituximab [MabThera/Rituxan];Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLTerminated18 Years65 YearsAll24Phase 2France;Germany;Greece;Netherlands;Poland;Spain;Switzerland;United Kingdom;Belgium;Sweden
301NCT02721004
(ClinicalTrials.gov)
March 20092/3/2016Efficacy and Safety Study of RoActemra (Tocilizumab) in Participants With Rheumatoid ArthritisDocumentation of the Efficacy and Safety of RoActemra in the Treatment of Rheumatoid ArthritisRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompletedN/AN/ABoth592N/AAustria
302NCT00810199
(ClinicalTrials.gov)
March 200916/12/2008A 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 TreatmentRandomized 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 ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: methotrexate;Drug: placeboHoffmann-La RocheNULLCompleted18 YearsN/AAll556Phase 3United States;Brazil;Croatia;Denmark;Estonia;France;Germany;Greece;Israel;Italy;Latvia;Netherlands;Norway;Romania;Russian Federation;Serbia;Spain;Sweden;Thailand;United Kingdom;Monaco
303NCT00883753
(ClinicalTrials.gov)
March 200917/4/2009An 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) TherapyAn 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 ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll934Phase 3Australia;Canada;Czech Republic;France;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Saudi Arabia;Spain;United Kingdom;Austria;Turkey
304EUCTR2008-000587-17-HU
(EUCTR)
27/02/200928/11/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
305EUCTR2008-006443-39-ES
(EUCTR)
23/02/200909/12/2008Estudio 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.NULLNot RecruitingFemale: yes
Male: yes
Spain
306EUCTR2008-001847-20-GR
(EUCTR)
17/02/200906/03/2009Randomized 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 ArthritisTrade 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.NULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
307EUCTR2008-006924-68-ES
(EUCTR)
13/02/200919/01/2009Fase 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 MA21573Fase 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1200Hungary;Portugal;United Kingdom;Czech Republic;Netherlands;France;Spain;Italy
308EUCTR2008-005525-11-FR
(EUCTR)
06/02/200913/03/2009A 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Greece;Spain;Netherlands;Germany;United Kingdom
309EUCTR2008-001847-20-SE
(EUCTR)
02/02/200923/10/2008Safety 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 methotrexateRandomized 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.NULLNot RecruitingFemale: yes
Male: yes
470Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
310NCT00754572
(ClinicalTrials.gov)
February 200917/9/2008A Study to Assess the Effect of Tocilizumab Plus Methotrexate on Safety and Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: methotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll418Phase 3Argentina;Brazil;Chile;Colombia;Costa Rica;Ecuador;Mexico;Peru;Uruguay;Venezuela
311EUCTR2008-005525-11-ES
(EUCTR)
29/01/200909/12/2008Estudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
81Phase 2France;Greece;Spain;Netherlands;Germany;United Kingdom
312EUCTR2008-001847-20-IT
(EUCTR)
18/01/200918/12/2008Randomized 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. - NDRandomized 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
ROCHENULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;United Kingdom;Italy;Sweden
313EUCTR2008-000587-17-GR
(EUCTR)
13/01/200930/01/2009Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Hungary;Portugal;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
314NCT02809833
(ClinicalTrials.gov)
January 200920/6/2016Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily RoutineTocilizumab for the Treatment of Rheumatoid Arthritis: Findings on The Use of Tocilizumab in Daily Clinical RoutineRheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll850N/AGermany
315NCT00848120
(ClinicalTrials.gov)
December 31, 200819/2/2009A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid ArthritisAn 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll29Phase 3Philippines
316EUCTR2008-005525-11-GB
(EUCTR)
29/12/200816/12/2008A 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 LtdNULLNot 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): noFrance;Greece;Spain;Netherlands;Germany;United Kingdom
317EUCTR2008-001847-20-LV
(EUCTR)
19/12/200829/12/2008Safety 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 methotrexateRandomized 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.NULLNot RecruitingFemale: yes
Male: yes
470United States;Serbia;Estonia;Greece;Thailand;Spain;Russian Federation;Israel;United Kingdom;Italy;France;Brazil;Croatia;Romania;Denmark;Latvia;Germany;Netherlands;Norway;Sweden
318EUCTR2008-001847-20-GB
(EUCTR)
19/12/200809/09/2008Safety 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.NULLNot 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): noSerbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
319EUCTR2008-001847-20-NL
(EUCTR)
10/12/200823/10/2008Randomized 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-RAYRandomized 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 ArthritisProduct Name: Tocilizumab
Product Code: RO04877533
Trade Name: Methotrexate 'Lederle' 2.5mg Tablets
Product Name: Methotrexate 'Lederle' 2.5mg Tablets
F Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
320EUCTR2008-001847-20-DK
(EUCTR)
10/12/200821/10/2008Safety 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 methotrexateRandomized 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.NULLNot RecruitingFemale: yes
Male: yes
470Serbia;United States;Estonia;Greece;Spain;Thailand;Israel;Russian Federation;Italy;United Kingdom;France;Brazil;Romania;Croatia;Denmark;Netherlands;Latvia;Germany;Norway;Sweden
321NCT00810277
(ClinicalTrials.gov)
November 30, 200816/12/2008A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDsAn 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 ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll14Phase 3Finland
322EUCTR2008-001847-20-EE
(EUCTR)
28/11/200813/10/2008Randomized 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 ArthritisTrade 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.NULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
323EUCTR2008-001847-20-FR
(EUCTR)
17/11/200821/10/2008Randomized 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 LtdNULLNot RecruitingFemale: yes
Male: yes
470Phase 3France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
324NCT00773461
(ClinicalTrials.gov)
October 31, 200815/10/2008A 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 TherapyRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: PlaceboHoffmann-La RocheNULLCompleted18 Years70 YearsAll209Phase 3China
325EUCTR2008-001847-20-ES
(EUCTR)
17/10/200811/08/2008Estudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
470France;Estonia;Greece;Spain;Denmark;Germany;Latvia;Netherlands;Italy;United Kingdom;Sweden
326EUCTR2008-000587-17-BE
(EUCTR)
13/10/200819/08/2008Multi-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-SureMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Belgium;Denmark;Spain;Greece
327EUCTR2008-000587-17-DK
(EUCTR)
22/09/200804/07/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
328EUCTR2008-000587-17-CZ
(EUCTR)
15/09/200820/06/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Denmark;Belgium;Spain;Greece
329EUCTR2008-000587-17-IE
(EUCTR)
11/09/200805/06/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
330EUCTR2008-004126-16-FI
(EUCTR)
05/09/200815/07/2008Local 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 DMARDsLocal 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 OyNULLNot RecruitingFemale: yes
Male: yes
Finland
331NCT00750880
(ClinicalTrials.gov)
September 200810/9/2008An 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 ArthritisDrug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/AAll1681Phase 3Australia;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
332EUCTR2008-000587-17-FI
(EUCTR)
20/08/200805/06/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
333EUCTR2008-000105-11-DE
(EUCTR)
19/08/200816/05/2008Effectiveness after 4 and 24 weeks and safety of tocilizumab in patients with active RA - TAMARA - Tocilizumab And DMARDs: Achievements in Rheumatoid ArthritisEffectiveness 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 AGNULLNot RecruitingFemale: yes
Male: yes
Germany
334EUCTR2008-000587-17-NL
(EUCTR)
12/08/200810/09/2008Multi-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 TherapyMulti-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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
335EUCTR2008-000587-17-FR
(EUCTR)
12/08/200816/07/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
336EUCTR2008-000587-17-PT
(EUCTR)
08/08/200806/06/2008Multi-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-SUREMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
337NCT00754559
(ClinicalTrials.gov)
August 200817/9/2008A 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 RARheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll286Phase 3Germany
338EUCTR2008-000587-17-ES
(EUCTR)
22/07/200826/05/2008Estudio 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 TherapyEstudio 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Portugal;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Denmark;Germany;Netherlands;Sweden
339EUCTR2008-000587-17-SE
(EUCTR)
03/07/200821/05/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
340JPRN-UMIN000001240
2008/07/0110/07/2008The efficacy of tocilizumab to patients with rheumatoid arthritis refractory to anti-TNF agents: the open trial rheumatoid arthritisTocilizumab (8 mg/kg of body weight) is to be infused every 4 weeks for 3 yearsDivision of Rheumatology & Clinical Immunology, Jichi Medical UniversityNULLComplete: follow-up complete20years-oldNot applicableMale and Female20Not selectedJapan
341JPRN-UMIN000002421
2008/07/0104/09/2009Multicenter, open-label parallel-groups study comparing tocilizumab versus conventional treatment in rheumatoid arthritis with the complication of AA amyloidosis rheumatoid arthritistocilizumab
Conventional DMARDs and immune suppressive drugs and biologics except for tocilizumab
AA amyloidosis clinical research conferenceNULLRecruiting20years-oldNot applicableMale and Female40Not selectedJapan
342EUCTR2008-000587-17-AT
(EUCTR)
19/06/200809/05/2008Multi-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-SUREMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Denmark;Belgium;Spain;Greece
343EUCTR2008-000587-17-GB
(EUCTR)
18/06/200818/04/2008Multi-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 TherapyMulti-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 LtdNULLNot RecruitingFemale: yes
Male: yes
1500Portugal;Hungary;Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;Greece;Spain;Belgium;Denmark;Czech Republic;United Kingdom
344EUCTR2007-001114-17-GB
(EUCTR)
12/12/200713/02/2008A 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 LimitedNULLNot RecruitingFemale: yes
Male: yes
120United Kingdom
345NCT00535782
(ClinicalTrials.gov)
October 31, 200724/9/2007A Study of the Effect of Tocilizumab on Markers of Atherogenic Risk in Patients With Moderate to Severe Rheumatoid ArthritisA 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 ArthritisDrug: Tocilizumab;Drug: Placebo;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 Years75 YearsAll132Phase 3United States;Canada;Puerto Rico;United Kingdom
346NCT00531817
(ClinicalTrials.gov)
October 200718/9/2007A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid ArthritisA 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 ArthritisDrug: Tocilizumab;Drug: Placebo;Drug: Permitted DMARDsHoffmann-La RocheNULLCompleted18 YearsN/AAll619Phase 3United States;Puerto Rico
347EUCTR2005-002909-23-PT
(EUCTR)
08/03/200703/01/2007Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NALong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden
348EUCTR2005-002909-23-IS
(EUCTR)
08/05/200625/04/2006Long-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 arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Germany;Iceland;Italy;United Kingdom;Sweden
349NCT00380601
(ClinicalTrials.gov)
May 200625/9/2006Phase?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 RARheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted20 YearsN/ABoth20Phase 3Japan
350EUCTR2005-002909-23-FI
(EUCTR)
19/04/200623/01/2006Long-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 arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
351EUCTR2005-002909-23-IT
(EUCTR)
11/04/200614/03/2006Long-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 LtdNULLNot RecruitingFemale: yes
Male: yes
2420Sweden;Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;United Kingdom;Italy
352EUCTR2005-002909-23-NO
(EUCTR)
30/03/200611/01/2006Long-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 arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Norway;Germany;Iceland;Sweden
353EUCTR2005-002909-23-GB
(EUCTR)
27/03/200613/01/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NALong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot 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): noPortugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
354EUCTR2005-002909-23-SI
(EUCTR)
16/03/200620/02/2006A 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 studiesLong-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 AGNULLNot RecruitingFemale: yes
Male: yes
2420United 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
355EUCTR2005-002909-23-CZ
(EUCTR)
13/03/200613/01/2006A 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 studiesLong-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.NULLNot RecruitingFemale: yes
Male: yes
2420France;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
356EUCTR2005-002909-23-LT
(EUCTR)
07/03/200611/01/2006Long-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 arthritisTrade Name: RoActemra
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Czech Republic;Slovenia;Finland;Spain;Lithuania;Denmark;Iceland;Germany;Italy;United Kingdom;Sweden
357EUCTR2005-002909-23-DK
(EUCTR)
21/02/200623/01/2006Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NALong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies. - NA Rheumatoid arthritisTrade Name: RoActemra
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Slovenia;Finland;Spain;Lithuania;United Kingdom;Italy;Czech Republic;Denmark;Germany;Norway;Iceland;Sweden
358EUCTR2005-002909-23-SE
(EUCTR)
09/02/200623/12/2005A 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 studiesLong-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.NULLNot RecruitingFemale: yes
Male: yes
2420Portugal;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
359EUCTR2005-002909-23-DE
(EUCTR)
10/01/200607/10/2005Long-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 arthritisTrade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann-La Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
360EUCTR2005-002423-13-HU
(EUCTR)
19/12/200505/11/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NALong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 - NA Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Germany;Bulgaria;Italy
361EUCTR2004-005210-37-FI
(EUCTR)
17/11/200514/03/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
362EUCTR2005-002423-13-SK
(EUCTR)
18/10/200520/09/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 Rheumatoid arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Austria;Bulgaria;Germany;Italy
363EUCTR2005-001138-33-PT
(EUCTR)
29/09/200521/09/2005A 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 ArthritisProduct 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 AGNULLNot RecruitingFemale: yes
Male: yes
650Portugal;Denmark;Slovenia;Norway;Spain;Italy
364EUCTR2005-001138-33-IT
(EUCTR)
28/09/200501/02/2007A 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
ROCHENULLNot RecruitingFemale: yes
Male: yes
650Portugal;Denmark;Slovenia;Norway;Spain;Italy
365EUCTR2005-002423-13-IT
(EUCTR)
28/09/200504/11/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA 17822Long-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 LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Bulgaria;Germany;Italy
366EUCTR2005-002909-23-ES
(EUCTR)
21/09/200508/09/2005Long-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 MRALong-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 arthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
F Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
2420Portugal;Finland;United Kingdom;Czech Republic;Germany;Iceland;Slovenia;Denmark;Spain;Italy;Sweden
367EUCTR2005-002423-13-DE
(EUCTR)
06/09/200505/07/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 Rheumatoid arthritisTrade Name: RoActemra
Product Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Germany;Bulgaria;Italy
368NCT00720798
(ClinicalTrials.gov)
September 200522/7/2008An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core StudiesLong-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core StudiesRheumatoid ArthritisDrug: Tocilizumab;Drug: Disease-modifying anti-rheumatic drugs;Drug: Non-steroidal anti-inflammatory drugs;Drug: Oral corticosteroidsHoffmann-La RocheNULLCompleted18 YearsN/AAll2067Phase 3United 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
369EUCTR2005-001138-33-DK
(EUCTR)
23/08/200520/06/2005A 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 ArthritisProduct 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 AGNULLNot RecruitingFemale: yes
Male: yes
650Portugal;Slovenia;Denmark;Norway;Spain;Italy
370EUCTR2005-002423-13-AT
(EUCTR)
22/08/200518/07/2005Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822Long-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822 Rheumatoid arthritisTrade Name: RoActemra
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Slovakia;Austria;Bulgaria;Germany;Italy
371EUCTR2005-000884-25-SE
(EUCTR)
11/08/200507/06/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche AGNULLNot RecruitingFemale: yes
Male: yes
450United Kingdom;Germany;Iceland;Italy;Sweden
372NCT00721123
(ClinicalTrials.gov)
August 200522/7/2008A Long-term Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients With Rheumatoid ArthritisLong-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in WA17822Rheumatoid ArthritisDrug: TocilizumabHoffmann-La RocheNULLCompleted18 YearsN/AAll538Phase 3Argentina;Australia;Austria;Brazil;Bulgaria;Canada;France;Germany;Hong Kong;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;China
373EUCTR2005-001138-33-LT
(EUCTR)
14/07/200530/05/2005A 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 AGNULLNot RecruitingFemale: yes
Male: yes
650Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
374EUCTR2005-000884-25-GB
(EUCTR)
11/07/200519/04/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche AGNULLNot 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): noIceland;Germany;Italy;United Kingdom;Sweden
375EUCTR2005-001138-33-NO
(EUCTR)
06/07/200506/06/2005A 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 ArthritisProduct 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 AGNULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
376EUCTR2005-001138-33-ES
(EUCTR)
05/07/200516/05/2006A 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 ArthritisProduct 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 AGNULLNot RecruitingFemale: yes
Male: yes
650Phase 3Portugal;Slovenia;Spain;Lithuania;Denmark;Norway;Italy
377EUCTR2004-005210-37-CZ
(EUCTR)
01/07/200530/06/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Germany;Czech Republic;Spain;Sweden
378NCT00109408
(ClinicalTrials.gov)
July 200527/4/2005A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: Methotrexate;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth673Phase 3United States;Argentina;Australia;Canada;China;Denmark;France;Israel;Italy;Lithuania;Mexico;Norway;Peru;Portugal;Serbia;Slovenia;South Africa;Spain;Croatia;Former Serbia and Montenegro
379EUCTR2005-000884-25-IS
(EUCTR)
27/06/200527/04/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche AGNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Germany;Iceland;Italy;United Kingdom;Sweden
380EUCTR2004-003741-40-SK
(EUCTR)
16/06/200507/12/2004A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
630Phase 3Hungary;Slovakia;Austria;Germany;Italy
381EUCTR2005-000884-25-DE
(EUCTR)
14/06/200513/04/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann-La Roche AGNULLNot RecruitingFemale: yes
Male: yes
450United Kingdom;Germany;Iceland;Italy;Sweden
382EUCTR2004-005210-37-DE
(EUCTR)
04/05/200510/03/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
383EUCTR2005-000884-25-IT
(EUCTR)
02/05/200522/06/2005A 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: METHOTREXATE*2,5MG 25CPR
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*7,5MG/ML 4SIR.
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*10MG/1,33ML 4S
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*20MG/2,66ML 4S
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*15MG/2ML 4SIR
INN or Proposed INN: Methotrexate
ROCHENULLNot RecruitingFemale: yes
Male: yes
570United Kingdom;Germany;Iceland;Italy;Sweden
384NCT00106522
(ClinicalTrials.gov)
May 200525/3/2005A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate TherapyA 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 TherapyRheumatoid ArthritisDrug: Methotrexate;Drug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth499Phase 3United States;Australia;Belgium;Canada;France;Germany;Iceland;Italy;Mexico;Netherlands;Puerto Rico;Sweden;Switzerland;United Kingdom
385EUCTR2004-005210-37-SE
(EUCTR)
26/04/200510/03/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Finland;Czech Republic;Germany;Spain;Sweden
386EUCTR2004-003741-40-HU
(EUCTR)
15/04/200507/02/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Germany;Italy
387NCT00106574
(ClinicalTrials.gov)
April 200525/3/2005A Study to Assess the Effect of Tocilizumab + DMARD Therapy on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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 TherapyRheumatoid ArthritisDrug: Placebo;Drug: tocilizumab [RoActemra/Actemra]Hoffmann-La RocheNULLCompleted18 YearsN/ABoth1220Phase 3United States;Argentina;Australia;Brazil;Canada;China;Costa Rica;Czech Republic;Finland;France;Germany;Hong Kong;Mexico;Panama;Russian Federation;South Africa;Spain;Sweden;Thailand
388EUCTR2004-005210-37-ES
(EUCTR)
29/03/200504/11/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Czech Republic;Finland;Spain;Germany;Sweden
389EUCTR2004-003733-14-FI
(EUCTR)
23/03/200517/11/2004A 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.NULLNot RecruitingFemale: yes
Male: yes
1170Phase 3United States;Greece;Finland;Spain;Italy;France;Mexico;Brazil;Poland;Australia;Denmark;South Africa;Norway;China
390NCT00144586
(ClinicalTrials.gov)
March 20052/9/2005Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA220JP or MRA221JPAn 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 MRA221JPRheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted20 Years75 YearsBoth42Phase 3NULL
391EUCTR2004-003741-40-DE
(EUCTR)
28/02/200501/12/2004A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Germany;Italy
392NCT00144560
(ClinicalTrials.gov)
February 20052/9/2005Drug-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 RARheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted20 Years75 YearsBoth31N/ANULL
393EUCTR2004-003733-14-ES
(EUCTR)
28/01/200507/12/2005A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
1170Finland;Denmark;Spain;Italy
394EUCTR2004-003733-14-DK
(EUCTR)
26/01/200507/12/2004A 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 arthritisTrade 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.NULLNot RecruitingFemale: yes
Male: yes
1170Finland;Spain;Denmark;Italy
395NCT00106548
(ClinicalTrials.gov)
January 200525/3/2005A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid ArthritisA 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/ABoth623Phase 3Argentina;Australia;Austria;Brazil;Bulgaria;Canada;China;France;Germany;Hungary;Israel;Italy;Mexico;Singapore;Slovakia;Switzerland;Thailand;Spain
396NCT00144573
(ClinicalTrials.gov)
January 20052/9/2005Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal ImpairmentAn Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal ImpairmentRheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted20 Years75 YearsBoth14N/ANULL
397NCT00106535
(ClinicalTrials.gov)
January 200525/3/2005A 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 ArthritisRheumatoid ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Placebo;Drug: MethotrexateHoffmann-La RocheNULLCompleted18 YearsN/AAll1196Phase 3United States;Australia;Brazil;China;Denmark;Finland;France;Greece;Italy;Mexico;Norway;Poland;Puerto Rico;South Africa;Spain;Switzerland
398NCT00365001
(ClinicalTrials.gov)
January 200515/8/2006A 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 ArthritisDrug: tocilizumab [RoActemra/Actemra];Drug: Methotrexate;Drug: SimvastatinHoffmann-La RocheNULLCompleted18 Years75 YearsBoth23Phase 1United States;New Zealand
399EUCTR2004-003741-40-AT
(EUCTR)
26/11/200422/10/2004A 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 ArthritisProduct Name: MRA
Product Code: RO4877533
INN or Proposed INN: Tocilizumab
Other descriptive name: MRA
F. Hoffmann La-Roche AGNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Austria;Germany;Italy
400EUCTR2004-003733-14-IT
(EUCTR)
09/11/200418/05/2005A 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: METHOTREXATE*2,5MG 25CPR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*10MG/1,33ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*15MG/2ML 4SIR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*20MG/2,66ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
ROCHENULLNot RecruitingFemale: yes
Male: yes
1170Finland;Denmark;Spain;Italy
401EUCTR2004-003741-40-IT
(EUCTR)
28/10/200421/09/2005A 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: METHOTREXATE*2,5MG 25CPR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*10MG/1,33ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*15MG/2ML 4SIR
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
Trade Name: METHOTREXATE*20MG/2,66ML 4S
Product Name: NA
Product Code: NA
INN or Proposed INN: Methotrexate
ROCHENULLNot RecruitingFemale: yes
Male: yes
Hungary;Germany;Italy
402NCT00144534
(ClinicalTrials.gov)
June 20042/9/2005Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JPAn Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA213JPRheumatoid ArthritisDrug: MRA (Tocilizumab)Chugai PharmaceuticalNULLCompleted20 Years75 YearsBoth115Phase 3NULL
403NCT00144547
(ClinicalTrials.gov)
April 20042/9/2005Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA012JPAn Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JPRheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted20 YearsN/ABoth241Phase 3NULL
404NCT00144521
(ClinicalTrials.gov)
February 20042/9/2005Comparative 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 RARheumatoid ArthritisDrug: MRA(Tocilizumab);Drug: MRA placebo;Drug: MTX;Drug: MTX placeboChugai PharmaceuticalNULLCompleted20 Years75 YearsBoth127Phase 3NULL
405NCT00144508
(ClinicalTrials.gov)
March 20032/9/2005Phase 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 RARheumatoid ArthritisDrug: MRA (Tocilizumab);Other: current treatmentChugai PharmaceuticalNULLCompleted20 YearsN/ABoth306Phase 3NULL
406NCT00144651
(ClinicalTrials.gov)
August 20012/9/2005Study 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 MRA009JPRheumatoid ArthritisDrug: MRA(Tocilizumab)Chugai PharmaceuticalNULLCompleted20 YearsN/ABoth135Phase 2NULL
407EUCTR2005-001138-33-SI
(EUCTR)
13/06/2005A 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 ArthritisProduct 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 AGNULLNot RecruitingFemale: yes
Male: yes
650Portugal;Denmark;Slovenia;Norway;Spain;Italy
408EUCTR2005-002423-13-BG
(EUCTR)
03/08/2010Study 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 LtdNULLNot RecruitingFemale: yes
Male: yes
630Hungary;Germany;Switzerland;Bulgaria;France;Italy;Singapore;Hong Kong;Austria;Australia;Brazil;Israel;Slovakia;Canada;Mexico;Argentina;Thailand
409JPRN-JapicCTI-050018
02/09/2005Double-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) RAIntervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion
Chugai Pharmaceutical Co., Ltd.NULL2074Phase 3NULL
410EUCTR2011-001626-15-ES
(EUCTR)
20/10/2011A 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.NULLNot RecruitingFemale: yes
Male: yes
Spain
411JPRN-JapicCTI-050016
02/09/2005A 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) RAIntervention name : MRA (tocilizumab)
Dosage And administration of the intervention : Intravenous infusion
Chugai Pharmaceutical Co., Ltd.NULL20Phase 3NULL