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 : 187 - 標的パスウェイ数 : 224
| 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 | EUCTR2008-005320-81-ES (EUCTR) | 18/02/2009 | 20/01/2009 | Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2 | Segundo estudio de extensión abierto de 2 años de duración para evaluar la seguridad tolerabilidad y eficacia de canakinumab (ACZ885), un anticuerpo monoclonal anti-interleuquina-1?, en pacientes con artritis reumatoide activa - A2201E2 | Artritis Reumatoide MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class | Novartis Farmacéutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2 | Belgium;Spain;Austria;Germany | ||
| 2 | EUCTR2008-005320-81-BE (EUCTR) | 16/02/2009 | 20/02/2009 | A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 | A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class | Novartis Pharma Services AG | Novartis Pharma Belgium | Not Recruiting | Female: yes Male: yes | Spain;Belgium;Austria;Germany | ||||
| 3 | EUCTR2008-005320-81-DE (EUCTR) | 06/02/2009 | 17/11/2008 | A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 | A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to interleukin-1beta of the IgG1-Kappa-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 213 | Germany;Spain;Austria | |||
| 4 | EUCTR2008-005320-81-AT (EUCTR) | 21/10/2008 | 22/09/2008 | A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 | A 2-year open-label second extension study to evaluate the safety, tolerability and efficacy of canakinumab (ACZ885) an anti-interleukin-1ß monoclonal antibody in patients with active rheumatoid arthritis - A2201E2 | Rheumatoid Arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab Other descriptive name: Recombinant human monoclonal antibody to inerleukin-1beta of the IgG1-K-class | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Spain;Austria | |||
| 5 | EUCTR2007-001665-15-IT (EUCTR) | 10/12/2007 | 05/10/2007 | A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND | A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 monoclonal antibody) in patients with rheumatoid arthritis - ND | rheumatoid arthritis MedDRA version: 6.1;Level: PT;Classification code 10039073 | Product Name: Canakinumab Product Code: ACZ885 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 179 | Phase 2 | Germany;Netherlands;Spain;Italy | ||
| 6 | EUCTR2007-000491-16-AT (EUCTR) | 06/12/2007 | 05/04/2007 | A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available | A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 260 | Germany;Spain;Austria | |||
| 7 | EUCTR2007-001665-15-NL (EUCTR) | 09/11/2007 | 17/10/2007 | A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis | A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 179 | Phase 2 | Germany;Netherlands;Spain;Italy | ||
| 8 | EUCTR2007-001665-15-DE (EUCTR) | 16/10/2007 | 30/07/2007 | A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis | A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 179 | Phase 2 | Germany;Netherlands;Spain;Italy | ||
| 9 | NCT00554606 (ClinicalTrials.gov) | October 2007 | 5/11/2007 | Long-term Efficacy, Safety and Tolerability of ACZ885 in Patients With Rheumatoid Arthritis | A 54-week, Phase II, Multi-center, Open-label Extension Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1B Monoclonal Antibody) in Patients With Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ACZ885 | Novartis | NULL | Completed | 18 Years | 75 Years | All | 115 | Phase 2 | United States;Belgium;Germany;Italy;Netherlands;Russian Federation;Spain;Switzerland;Turkey |
| 10 | EUCTR2007-001665-15-ES (EUCTR) | 14/09/2007 | 27/06/2007 | Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide. | Estudio de extensión abierto, multicéntrico, de fase II, de 54 semanas de duración, para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide. | Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Farmaceutica S.A. | NULL | Not Recruiting | Female: yes Male: yes | 179 | Belgium;Spain;Netherlands;Germany;Italy | |||
| 11 | EUCTR2007-001665-15-BE (EUCTR) | 05/09/2007 | 02/08/2007 | A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis | A 54-week, phase II, multi-center, open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1beta monoclonal antibody) in patients with rheumatoid arthritis | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 179 | Phase 2 | Spain;Belgium;Netherlands;Germany;Italy | ||
| 12 | NCT00505089 (ClinicalTrials.gov) | August 2007 | 19/7/2007 | Efficacy and Safety of Subcutaneous Versus Intravenous ACZ885 in Adult Patients With Established Rheumatoid Arthritis | An Exploratory, Open Label Pharmacokinetic - Pharmacodynamic Study to Compare Subcutaneous Versus Intravenous Administration of ACZ885 in Adult Patients With Established Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: ACZ885 | Novartis | NULL | Terminated | 18 Years | 75 Years | Both | 11 | Phase 1/Phase 2 | Belgium;Germany;Netherlands;Poland |
| 13 | EUCTR2006-004666-14-DE (EUCTR) | 17/07/2007 | 02/04/2007 | An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available | An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 32 | Germany | |||
| 14 | EUCTR2007-000491-16-BE (EUCTR) | 22/06/2007 | 04/05/2007 | A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available | A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | Spain;Belgium;Austria;Germany | ||||
| 15 | EUCTR2006-001553-10-DE (EUCTR) | 19/06/2007 | 21/02/2007 | A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 | A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 | Early Rheumatoid Arthritis in adults MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 Trade Name: Methotrexat 2,5 mg Tabletten medac Product Name: Methotrexate (MTX) INN or Proposed INN: Methotrexate Other descriptive name: MTX | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 2 | Germany;Netherlands;Italy | ||
| 16 | EUCTR2007-000491-16-DE (EUCTR) | 08/06/2007 | 22/03/2007 | A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available | A 76-week open-label extension study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1ß monoclonal antibody) in patients with active rheumatoid arthritis - not available | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Spain;Austria | |||
| 17 | EUCTR2006-004666-14-BE (EUCTR) | 04/06/2007 | 29/03/2007 | An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available | An exploratory, open label pharmacokinetic – pharmacodynamic study to compare subcutaneous versus intravenous administration of ACZ885 in adult patients with established rheumatoid arthritis. - not available | Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 32 | Belgium;Germany | |||
| 18 | EUCTR2006-001553-10-NL (EUCTR) | 23/05/2007 | 02/04/2007 | A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 | A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 | Early Rheumatoid Arthritis in adults MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: ACZ885 Drug Substance Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 92 | Phase 2 | Germany;Netherlands;Italy | ||
| 19 | NCT00504595 (ClinicalTrials.gov) | May 2007 | 19/7/2007 | Safety and Efficacy of ACZ885 in Adult Patients With Established Rheumatoid Arthritis | A 12-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR20) and to Determine a Biomarker Profile in Adult Patients With Established Rheumatoid Arthritis Responding to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) as Compared to Healthy Subjects Exposed to ACZ885 | Rheumatoid Arthritis | Drug: ACZ885 (investigational);Drug: Placebo | Novartis | NULL | Completed | 18 Years | 75 Years | All | 80 | Phase 2 | Russian Federation;Spain;Switzerland;Turkey |
| 20 | EUCTR2007-000491-16-ES (EUCTR) | 30/04/2007 | 05/03/2007 | Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available | Estudio de extensión abierto de 76 semanas de duración para evaluar la eficacia, seguridad y tolerabilidad de ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) en pacientes con artritis reumatoide activa - not available | Artritis Reumatoide MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | Belgium;Spain;Austria;Germany | ||||
| 21 | EUCTR2006-004669-32-ES (EUCTR) | 09/04/2007 | 06/02/2007 | Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available | Estudio multicéntrico, de fase II, aleatorizado, doble ciego, controlado con placebo, de 12 semanas de duración, para evaluar la respuesta al tratamiento (ACR20) y para determinar un perfil de biomarcadores en pacientes adultos con artritis reumatoide establecida respondedores a ACZ885 (anticuerpo monoclonal anti-interleuquina-1ß) comparado con sujetos sanos expuestos a ACZ885 - not available | Artritis reumatoide establecida MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: Canakinumab (proposed) Other descriptive name: ACZ885 Drug Substance | Novartis Farmacéutica S.A | NULL | Not Recruiting | Female: yes Male: yes | 80 | Spain | |||
| 22 | EUCTR2006-001553-10-BE (EUCTR) | 20/03/2007 | 21/02/2007 | A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 | A 26-week, phase II, multi-center, randomized, double-blind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - 2204 | Early Rheumatoid Arthritis in adults MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Code: ACZ885 INN or Proposed INN: ACZ885 Drug Substance Other descriptive name: ACZ885 Drug Substance | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 92 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Belgium;Netherlands;Germany;Italy | ||
| 23 | NCT00487825 (ClinicalTrials.gov) | March 2007 | 18/6/2007 | Safety and Efficacy of Intravenous ACZ885 and Oral Methotrexate Therapy in Patients With Early Rheumatoid Arthritis | A 26-week, Phase II, Multi-center, Randomized, Double-blind, Placebo-controlled Study to Assess the Response to Treatment (ACR50) and to Determine a Biomarker Profile in Responders to ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) Plus MTX as Compared to MTX Alone in Early Rheumatoid Arthritis Patients | Rheumatoid Arthritis | Drug: Canakinumab (investigational);Drug: Placebo;Drug: Methotrexate (MTX) | Novartis | NULL | Completed | 18 Years | 75 Years | All | 78 | Phase 2 | United States;Belgium;Germany;Italy;Netherlands;Spain |
| 24 | EUCTR2006-001550-27-FI (EUCTR) | 13/02/2007 | 10/10/2006 | A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available | A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available | Active Rheumatoid Arthritis MedDRA version: 8.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: N/A Other descriptive name: N/A | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 260 | Finland;Germany;Spain;Austria | |||
| 25 | EUCTR2006-001550-27-DE (EUCTR) | 13/02/2007 | 19/10/2006 | A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate | A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate | Active Rheumatoid Arthritis | Product Name: ACZ885 Product Code: ACZ885 | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 293 | Finland;Spain;Austria;Germany | |||
| 26 | EUCTR2006-001553-10-IT (EUCTR) | 26/01/2007 | 15/05/2007 | A 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - ND | A 26-week, phase II, multi-center, randomized, doubleblind, placebo-controlled study to assess the response to treatment (ACR50) and to determine a biomarker profile in responders to ACZ885 (anti-interleukin-1beta monoclonal antibody) plus MTX as compared to MTX alone in early rheumatoid arthritis patients - ND | Early rheumatoid arthritis MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Product Name: ACZ885 Product Code: ACZ885 | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 87 | Phase 2 | Germany;Netherlands;Italy | ||
| 27 | NCT00424346 (ClinicalTrials.gov) | November 2006 | 17/1/2007 | Efficacy, Safety and Tolerability of ACZ885 in Patients With Active Rheumatoid Arthritis | A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of ACZ885 (Anti-interleukin-1beta Monoclonal Antibody) With Three Different Dose Regimens in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate Including 76-week and 96-week Extensions | Rheumatoid Arthritis | Drug: Canakinumab;Drug: Placebo | Novartis | NULL | Completed | 18 Years | N/A | All | 274 | Phase 2 | United States;Austria;Belgium;Canada;Germany;Spain;Finland |
| 28 | EUCTR2006-001550-27-BE (EUCTR) | 23/10/2006 | 17/08/2006 | A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available | A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available | Active Rheumatoid Arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: N/A Other descriptive name: N/A | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 260 | Finland;Spain;Belgium;Austria;Germany | |||
| 29 | EUCTR2006-001550-27-AT (EUCTR) | 18/09/2006 | 25/07/2006 | A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available | A 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-finding study to evaluate the efficacy, safety, and tolerability of ACZ885 (anti-interleukin-1 beta monoclonal antibody) with three different dose regimens in patients with active rheumatoid arthritis despite stable treatment with methotrexate - Not available | Active Rheumatoid Arthritis | Product Name: ACZ885 Product Code: ACZ885 INN or Proposed INN: N/A Other descriptive name: N/A | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 260 | Finland;Germany;Spain;Austria | |||
| 30 | NCT00619905 (ClinicalTrials.gov) | December 2003 | 8/2/2008 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Rheumatoid Arthritis With Ongoing Treatment With Methotrexate | A Randomized, Double-Blind, Placebo-Controlled, Cohort Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 (Anti-Interleukin-1Beta Monoclonal Antibody) in Patients With Active Rheumatoid Arthritis (RA) Despite Ongoing Treatment With Methotrexate (MTX) 15 mg or More Weekly for at Least 3 Months. | Rheumatoid Arthritis | Drug: ACZ885 | Novartis | NULL | Completed | 18 Years | 75 Years | Both | 53 | Phase 1/Phase 2 | Germany;Netherlands;Switzerland |