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 | 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 | |||
| 2 | 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 | ||
| 3 | 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 | |||
| 4 | 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 | ||
| 5 | 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 | |||
| 6 | 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 | ||||
| 7 | 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 | |||
| 8 | 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 | ||
| 9 | 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 | ||||
| 10 | 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 | |||
| 11 | 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 |