Mabcampath (DrugBank: -)
2 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 24 |
| 60 | 再生不良性貧血 | 1 |
| 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 | NCT01307332 (ClinicalTrials.gov) | March 2011 | 26/1/2011 | Advanced MRI Measures of Repair in Alemtuzumab Treated Patients | Advanced Magnetic Resonance Imaging Measures of Repair in Alemtuzumab Treated Patients | Relapsing Remitting Multiple Sclerosis | Drug: MabCampath-1h | University of British Columbia | Genzyme, a Sanofi Company | Completed | 18 Years | 50 Years | All | 27 | Phase 3 | Canada |
| 2 | EUCTR2009-010788-18-IT (EUCTR) | 03/02/2011 | 31/05/2011 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - ND | Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Czech Republic;Spain;Poland;Belgium;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 3 | EUCTR2009-010788-18-AT (EUCTR) | 21/12/2010 | 17/08/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath Product Name: alemtuzumab INN or Proposed INN: alemtuzumab | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Serbia;United States;Spain;Ukraine;Austria;Russian Federation;Israel;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 4 | EUCTR2009-010788-18-ES (EUCTR) | 27/09/2010 | 08/01/2010 | Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab. | Protocolo de extensión para pacientes con esclerosis múltiple que participaron en los estudios de alemtuzumab patrocinados por Genzyme./An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab. | Esclerosis Multiple de Recaida-Remision/Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MABCAMPATH 10 mg/ml concentrado para solución para perfusión INN or Proposed INN: ALEMTUZUMAB Other descriptive name: ALEMTUZUMAB | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 5 | EUCTR2009-010788-18-NL (EUCTR) | 07/06/2010 | 18/09/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A. | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | Serbia;United States;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 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 |
| 6 | EUCTR2009-010788-18-DE (EUCTR) | 08/01/2010 | 11/08/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated inGenzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N/A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Croatia;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 7 | EUCTR2009-010788-18-CZ (EUCTR) | 02/11/2009 | 14/09/2009 | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab | An Extension Protocol For Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuzumab - CARE-MS Extension Study | Relapsing Remitting Multiple Sclerosis MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: alemtuzumab Other descriptive name: N.A. | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Phase 3 | United States;Serbia;Spain;Ukraine;Austria;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 8 | EUCTR2007-001162-32-AT (EUCTR) | 23/10/2008 | 14/07/2008 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | ||
| 9 | EUCTR2007-001162-32-PL (EUCTR) | 21/10/2008 | 24/10/2008 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis. | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland | ||
| 10 | EUCTR2007-001161-14-PL (EUCTR) | 21/10/2008 | 12/05/2008 | ?Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: MabCampath® INN or Proposed INN: Alemtuzumab Trade Name: Rebif Product Name: Rebif® INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland | ||
| 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 |
| 11 | EUCTR2007-001162-32-DK (EUCTR) | 20/08/2008 | 25/07/2008 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis. | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: alemtuzumab INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Belgium;Denmark;Argentina;Mexico;Spain;Croatia;United States;Poland | ||
| 12 | EUCTR2007-001162-32-IT (EUCTR) | 06/08/2008 | 14/07/2008 | A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II | A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab Trade Name: REBIF INN or Proposed INN: Interferon beta-1a | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Phase 3 | France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 13 | EUCTR2007-001162-32-CZ (EUCTR) | 30/07/2008 | 31/03/2008 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 573 | Phase 3 | Germany;United Kingdom;Czech Republic;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | ||
| 14 | EUCTR2007-001162-32-SE (EUCTR) | 28/07/2008 | 28/12/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis. | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland | ||
| 15 | EUCTR2007-001162-32-DE (EUCTR) | 02/06/2008 | 02/01/2008 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis. | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® INN or Proposed INN: Alemtuzumab Other descriptive name: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Other descriptive name: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 840 | Phase 3 | Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland | ||
| 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 |
| 16 | EUCTR2007-001162-32-BE (EUCTR) | 26/05/2008 | 22/01/2008 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 573 | Phase 3 | France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 17 | EUCTR2007-001161-14-SE (EUCTR) | 21/05/2008 | 18/12/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Germany;France;Sweden;Australia;Brazil;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland | ||
| 18 | EUCTR2007-001162-32-NL (EUCTR) | 06/05/2008 | 19/12/2007 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | ||
| 19 | EUCTR2007-001162-32-FR (EUCTR) | 11/04/2008 | 08/01/2008 | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | ||
| 20 | EUCTR2007-001161-14-FR (EUCTR) | 11/04/2008 | 08/01/2008 | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 525 | Phase 3 | Czech Republic;Germany;United Kingdom;France;Poland;Sweden | ||
| 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 |
| 21 | EUCTR2007-001161-14-CZ (EUCTR) | 09/04/2008 | 11/09/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Sclerosis. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif® INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Germany;France;Australia;Brazil;Sweden;Czech Republic;Russian Federation;United Kingdom;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland | ||
| 22 | EUCTR2007-001162-32-ES (EUCTR) | 22/02/2008 | 14/02/2008 | Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II | Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II | Esclerosis Múltiple de recaída-remisión MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden | |||
| 23 | EUCTR2007-001161-14-DE (EUCTR) | 06/02/2008 | 23/08/2007 | Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland | ||
| 24 | EUCTR2007-001161-14-GB (EUCTR) | 24/08/2007 | 01/08/2007 | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I | Relapsing Remitting Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis | Trade Name: MabCampath ® Product Name: Alemtuzumab INN or Proposed INN: Alemtuzumab Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 525 | Phase 3 | Czech Republic;Germany;United Kingdom;France;Poland;Sweden |
| 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 | EUCTR2008-001151-22-IT (EUCTR) | 06/06/2007 | 14/06/2011 | ALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - Alesaa | ALEMTUZUMAB AND LOW-DOSE CYCLOSPORINE-A AS ALTERNATIVE IMMUNOSUPPRESSIVE TREATMENT FOR SEVERE APLASTIC ANEMIA (SAA) AND SINGLE-LINEAGE APLASTIC PATIENTS. - Alesaa | Aplastic anemia and single-lineage bone marrow failure MedDRA version: 13.1;Level: PT;Classification code 10002965;Term: Aplasia pure red cell;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 13.1;Level: LLT;Classification code 10047350;Term: Very few granulocyte precursors;Classification code 10002967;Term: Aplastic anaemia;Classification code 10001507;Term: Agranulocytosis;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: MABCAMPATH INN or Proposed INN: Alemtuzumab | UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Italy |