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 | EUCTR2008-001523-57-NO (EUCTR) | 10/06/2011 | 23/09/2008 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Denmark;Germany;Norway;France;Hungary;Spain;Italy;United Kingdom | ||
| 2 | EUCTR2008-001523-57-DE (EUCTR) | 14/10/2010 | 10/06/2010 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - IM101179 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - IM101179 | Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;United Kingdom;Germany;Denmark;France;Norway;Spain;Italy | |||
| 3 | EUCTR2008-001523-57-HU (EUCTR) | 14/06/2010 | 27/04/2010 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Hungary;Germany;United Kingdom;Denmark;France;Norway;Spain;Italy | |||
| 4 | EUCTR2008-001523-57-ES (EUCTR) | 09/02/2009 | 22/10/2008 | Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Estudio abierto y multicéntrico de evaluación de la respuesta temprana a abatacept con metotrexato de fondo mediante ecografía Power-Doppler en pacientes con artritis reumatoide activa y respuesta insuficiente a metotrexato Multicenter, Open-Label Study to Assess Early Reponse to Abatacept with Background Methotrexate Using Power Doppler Ultrasound in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Sujetos adultos con artritis reumatoide activa, de acuerdo con los criterios de la asociación de reumatismo Americana para la clasificación de la AR y con respuesta al metotrexate inadecuada.Adult subjects with Active Rheumatoid Arthritis, in accordance with the American Rheumatology Association criteria for the classification of AR with inadequate response to Metotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom | ||
| 5 | EUCTR2008-001523-57-DK (EUCTR) | 07/01/2009 | 14/10/2008 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 13.1;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom | |||
| 6 | EUCTR2008-001523-57-GB (EUCTR) | 06/01/2009 | 22/10/2008 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom | ||
| 7 | EUCTR2007-005434-37-GB (EUCTR) | 07/11/2008 | 28/05/2008 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study) Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008), Amendment 08-Site Specific (v1.0, date 11-May-2009) & Amendment 15-Site Specific - UK sites only (v1.0, date 07-OCt-2010). And Pharmacogenetics Blood Sample Protocol Amendment 01 - Site-specific (v1.0, Date 07-Sep-2007). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS 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: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 8 | EUCTR2008-001523-57-FR (EUCTR) | 04/11/2008 | 21/10/2008 | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Multicenter, Open-Label Study to Assess Early Response to Abatacept with Background Methotrexate Using Power Doppler Ultrasonography in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate | Adult subjects with active rheumatoid arthritis (RA) according to the American Rheumatism Association criteria for the classification of RA and with inadequate response to methotrexate MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;Hungary;Spain;Denmark;Germany;Norway;Italy;United Kingdom | ||
| 9 | EUCTR2007-005434-37-GR (EUCTR) | 04/11/2008 | 06/02/2009 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 3 | France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 10 | EUCTR2007-005434-37-BE (EUCTR) | 08/08/2008 | 28/05/2008 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010), and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008) & Amendment 08-Site Specific (v1.0, date 11-May-2009). - MTX-IR Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010), and Administrative Letter 01. And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008) & Amendment 08-Site Specific (v1.0, date 11-May-2009). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 3 | France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 11 | EUCTR2007-005434-37-IE (EUCTR) | 08/08/2008 | 22/05/2008 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 3 | France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 12 | EUCTR2007-005434-37-DE (EUCTR) | 05/08/2008 | 29/05/2008 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study).Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects with Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study).Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 3 | France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 13 | EUCTR2007-005434-37-AT (EUCTR) | 30/07/2008 | 20/06/2008 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 02 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007), Protocol amendment 03 (v1.0, date 25-Apr-2008), and Protocol Amendment 06 (v1.0, date 25-Sep-2008). And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008). - MTX-IR Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 02 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007), Protocol amendment 03 (v1.0, date 25-Apr-2008), and Protocol Amendment 06 (v1.0, date 25-Sep-2008). And Anti-TNF failure Substudy Protocol Amendment 05-Site Specific (v2.0, date 02-Oct-2008). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 3 | France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 14 | EUCTR2007-005434-37-FR (EUCTR) | 24/07/2008 | 19/05/2008 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 3 | France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 15 | EUCTR2007-005434-37-NL (EUCTR) | 16/07/2008 | 30/05/2008 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 01 incorporating Protocol amendment 02 (v2.0 date 19-dec-2007) and Protocol amendment 03 (v1.0, date 25-Apr-2008). And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 3 | France;Hungary;Greece;Belgium;Ireland;Austria;Germany;Netherlands;Italy;United Kingdom | ||
| 16 | EUCTR2007-005434-37-HU (EUCTR) | 09/07/2008 | 26/05/2008 | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study | A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study toCompare the Efficacy and Safety of Abatacept Administered Subcutaneously andIntravenously in Subjects with Rheumatoid Arthritis, Receiving BackgroundMethotrexate, and Experiencing an Inadequate Response to Methotrexate. (Short title: MTX-IR Study)Revised Protocol 04 incorporating Protocol amendment 11 (v1.0 date 15-Jun-2010) and Administrative Letter 01. And Pharmacogenetics Blood sample Amendment - Site Specific (v1.0, date 07-Sep-2007). - MTX-IR Study | RHEUMATOID ARTHRITIS, NOS MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis | Trade Name: Orencia Product Name: Abatacept (IV) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig Product Name: Abatacept (SC) Product Code: BMS-188667 INN or Proposed INN: Abatacept Other descriptive name: CTLA4Ig | Bristol Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 2400 | Phase 3 | France;Hungary;Greece;Belgium;Ireland;Austria;Netherlands;Germany;Italy;United Kingdom |