46. 悪性関節リウマチ Malignant rheumatoid arthritis Clinical trials / Disease details
臨床試験数 : 4,356 / 薬物数 : 2,567 - (DrugBank : 415) / 標的遺伝子数 : 192 - 標的パスウェイ数 : 228
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2013-002007-34-SE (EUCTR) | 20/02/2014 | 23/01/2014 | Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs. | Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | Roche a/s | NULL | Not Recruiting | Female: yes Male: yes | 137 | Phase 3 | Finland;Denmark;Sweden | ||
| 2 | EUCTR2013-002007-34-FI (EUCTR) | 10/02/2014 | 14/11/2013 | Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs. | Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound. - TOZULTRA | Rheumatoid Arthritis MedDRA version: 18.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | Roche a/s | NULL | Not Recruiting | Female: yes Male: yes | 137 | Phase 3 | Finland;Denmark;Sweden | ||
| 3 | EUCTR2013-002150-79-BE (EUCTR) | 16/12/2013 | 24/10/2013 | A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patients | TOSCARA: An open-label, single-arm study to evaluate the efficacy, safety and tolerability of tocilizumab (TCZ) subcutaneous in TCZ-naïve patients with active rheumatoid arthritis - TOSCARA | Rheumatoid Arthritis MedDRA version: 17.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-02 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | N.V. Roche S.A. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | Belgium | ||
| 4 | EUCTR2013-002007-34-DK (EUCTR) | 09/12/2013 | 09/12/2013 | Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs. | Tocilizumab SC in patients with active rheumatoid arthritis and inadequate response to DMARDs. A single-arm, open-label study to evaluate safety, tolerability and efficacy. In a sub-group of patients inflammation will be measured by ultasound - TOZULTRA | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: Tocilizumab Other descriptive name: Recombinant humanized anti-human monoclonal antibody directed against the IL-6R | Roche a/s | NULL | Not Recruiting | Female: yes Male: yes | 137 | Phase 3 | Finland;Denmark;Sweden | ||
| 5 | EUCTR2013-000342-19-NL (EUCTR) | 24/10/2013 | 08/10/2013 | A clinical trial where patients with Rheumatoid Arthritis are treated with the study drug tocilizumab, subcutaneous (injection in the skin), with or without other non-biological anti-rhematic drugs, to study the safety and efficacy of the drug. | MULTI-CENTER, OPEN LABEL, SINGLE ARM PHASE IIIB STUDY ON SAFETY AND EFFICACY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGIC DISEASE MODIFYING ANTIRHEUMATIC DRUGS (DMARDS) IN RHEUMATOID ARTHRITIS PATIENTS WITH AN INADEQUATE RESPONSE TO NON-BIOLOGIC DMARDS - OSCAR | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Nederland B.V. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Netherlands | |||
| 6 | EUCTR2013-002429-52-IE (EUCTR) | 23/10/2013 | 15/08/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis MedDRA version: 19.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab SC Other descriptive name: TOCILIZUMAB SC | Roche Farma S.A | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 7 | EUCTR2013-002429-52-PT (EUCTR) | 21/10/2013 | 08/08/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Farma S.A. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 8 | EUCTR2013-000054-22-GB (EUCTR) | 01/10/2013 | 07/08/2013 | OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT | OPEN-LABEL, PHASE IIIB STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS TOCILIZUMAB (MONOTHERAPY OR COMBINATION THERAPY WITH METHOTREXATE OR OTHER DMARDS) IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS WHO HAVE AN INADEQUATE RESPONSE TO CURRENT NON-BIOLOGIC DMARD THERAPY OR THE FIRST ANTI-TNF BIOLOGIC AGENT - ACT-MOVE | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanised anti-human monoclonal antibody directed against the IL-6R | Roche Products Limited | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | United Kingdom | |||
| 9 | EUCTR2013-000359-42-GR (EUCTR) | 12/09/2013 | 27/08/2013 | Not applicable | Multicenter, open label, phase IIIb study to evaluate the safety and tolerability of subcutaneous tocilizumab as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs in patients with Rheumatoid Arthritis | Rheumatoid Arthritis MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: Tocilizumab SC Product Code: Ro 487-7533/F10-04 | ROCHE HELLAS S.A. | NULL | Not Recruiting | Female: yes Male: yes | Phase 3 | Greece | |||
| 10 | EUCTR2013-002429-52-ES (EUCTR) | 23/08/2013 | 12/07/2013 | STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) IN SUBJECTS WITH RHEUMATOID ARTHRITIS | A PHASE IIIb STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF SUBCUTANEOUS (SC) TOCILIZUMAB (TCZ) GIVEN AS MONOTHERAPY OR IN COMBINATION WITH METHOTREXATE (MTX) OR OTHER NON-BIOLOGICS DMARDs IN SUBJECTS WITH RHEUMATOID ARTHRITIS | Rheumatoid Arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Trade Name: RoActemra Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: tocilizumab Other descriptive name: TOCILIZUMAB | Roche Farma S.A | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Spain;Ireland | ||
| 11 | EUCTR2013-001569-17-IT (EUCTR) | 02/08/2013 | 04/06/2013 | A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with other non-biological medicinal products in rheumatoid arthritis (RA) patients. | A national, open-label, single-arm, phase IIIB study to evaluate the efficacy of weekly tocilizumab subcutaneous, administered as monotherapy or in combination with methotrexate and/or other DMARDS in rheumatoid arthritis (RA) patients. | Rheumatoid Arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: tocilizumab SC Product Code: Ro 487-7533/F10-04 INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB | Roche S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 225 | Phase 3 | Italy | ||
| 12 | EUCTR2010-019912-18-BG (EUCTR) | 03/10/2011 | 25/08/2011 | A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa | Adult Rheumatoid Arthritis (RA) MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand | |||
| 13 | EUCTR2010-019912-18-HU (EUCTR) | 31/08/2011 | 08/06/2011 | A Study of RoActemra/Actemra (Tocilizumab) Given Subcutaneously in Combination With Traditional DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis - BrevActa | Adult Rheumatoid Arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab SC 162 mg/0.9 ml pre-filled syringe with safety device (PFS) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin-6 Receptor (IL-6R) monoclonal antibody Product Name: tocilizumab SC 162 mg/0.9 ml disposable auto-injector (AI) Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: Recombinant humanized anti-human Interleukin 6-Receptor (IL-6R) monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Philippines;Greece;Thailand;Costa Rica;Spain;Russian Federation;Chile;Israel;Colombia;Switzerland;Malaysia;Australia;Peru;South Africa;Panama;Guatemala;Hungary;Mexico;Canada;Argentina;Brazil;Dominican Republic;Bulgaria;New Zealand | |||
| 14 | EUCTR2010-019912-18-GR (EUCTR) | 18/04/2011 | 01/04/2011 | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis | Rheumatoid arthritis (RA) MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Product Name: tocilizumab 162mg/0.9ml SC PFS SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6; | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Hungary;Greece;Spain;Bulgaria | |||
| 15 | EUCTR2010-019912-18-ES (EUCTR) | 17/01/2011 | 19/01/2011 | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa. | A randomized, double-blind, parallel-group study of safety and the effect on clinical outcome of tocilizumab SC versus placebo SC in combination with traditional disease modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a placebo SC en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa. | Rheumatoid arthritis (RA)Artritis Reumatoide (AR) MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: tocilizumab 162mg/0.9ml SC PFS SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: MRA;Recombinant humanized anti-human Interleukin-6; | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | Hungary;Greece;Spain;Bulgaria | ||
| 16 | EUCTR2010-018375-22-BG (EUCTR) | 25/11/2010 | 23/09/2010 | A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. | A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand | |||
| 17 | EUCTR2010-018375-22-LT (EUCTR) | 11/10/2010 | 16/08/2010 | A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. | A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand | |||
| 18 | EUCTR2010-018375-22-DE (EUCTR) | 05/10/2010 | 14/07/2010 | A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. | A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA | Rheumatoid arthritis MedDRA version: 14.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | United States;Philippines;Hong Kong;Spain;Thailand;Russian Federation;Colombia;Italy;France;Australia;Peru;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;New Zealand | |||
| 19 | EUCTR2010-018375-22-GB (EUCTR) | 14/09/2010 | 29/06/2010 | A global study to investigate the safety and effect on clinical outcome of tocilizumab given subcutaneously versus tocilizumab given intravenously, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. | A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease-modifying anti-rheumatic drugs (DMARDs), in patients with moderate to severe active rheumatoid arthritis. - SUMMACTA | Rheumatoid arthritis MedDRA version: 14.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders ;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody Trade Name: RoActemra® Product Code: Ro 487-7533/F01 INN or Proposed INN: tocilizumab Other descriptive name: IL-6 receptor inhibitor, humanized monoclonal antibody | F. Hoffmann-La Roche Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Philippines;Hong Kong;Thailand;Spain;Russian Federation;Colombia;Italy;France;Peru;Australia;South Africa;Guatemala;Lithuania;United Kingdom;Mexico;Canada;Argentina;Poland;Brazil;Singapore;Romania;Bulgaria;Germany;New Zealand | ||
| 20 | EUCTR2010-018375-22-ES (EUCTR) | 03/08/2010 | 04/06/2010 | A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa. | A randomized, double-blind, parallel group study of the safety and effect on clinical outcome of tocilizumab SC versus tocilizumab IV, in combination with traditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), in patients with oderate to severe active rheumatoid arthritis.Estudio randomizado, doble ciego, con grupos de tratamiento paralelos, para evaluar la seguridad y el efecto sobre el resultado clínico de tocilizumab SC frente a tocilizumab IV en combinación con fármacos antirreumáticos modificadores de la enfermedad (FAMEs) tradicionales, en pacientes con artritis reumatoide activa moderada a severa. | Rheumatoid arthritisArtritis Reumatoide MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: tocilizumab 162mg/0.9ml jeringa SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Trade Name: ROACTEMRA 20 mg/ml, concentrado para solución para perfusión INN or Proposed INN: TOCILIZUMAB Other descriptive name: TOCILIZUMAB | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Spain;Lithuania;Bulgaria;Germany;Italy;United Kingdom | ||
| 21 | EUCTR2010-018375-22-IT (EUCTR) | 29/07/2010 | 05/07/2010 | A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND | A randomized, double-blind, parallel group study of the safety and effect onclinical outcome of tocilizumab SC versus tocilizumab IV, in combination withtraditional disease modifying anti-rheumatoid arthritis drugs (DMARDs), inpatients with moderate to severe active rheumatoid arthritis - ND | Rheumatoid arthritis MedDRA version: 12.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: tocilizumab 162mg/0.9ml syringe SC Product Code: Ro 487-7533/F10 INN or Proposed INN: tocilizumab Trade Name: RoActemra INN or Proposed INN: tocilizumab | F. Hoffmann-La Roche Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Spain;Lithuania;Bulgaria;Germany;United Kingdom;Italy |