0.25mg rpc1063 (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 | 22 |
| 97 | 潰瘍性大腸炎 | 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 | EUCTR2015-002500-91-SE (EUCTR) | 01/06/2017 | 27/06/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia | ||
| 2 | EUCTR2015-002500-91-HR (EUCTR) | 13/06/2016 | 06/07/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 3 | EUCTR2015-002500-91-PT (EUCTR) | 06/06/2016 | 13/04/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis. - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 4 | EUCTR2015-002500-91-LT (EUCTR) | 31/05/2016 | 17/03/2016 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2495 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 5 | EUCTR2015-002500-91-SK (EUCTR) | 22/01/2016 | 28/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;Ukraine;Russian Federation;Italy;Peru;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain | ||
| 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 | EUCTR2015-002500-91-PL (EUCTR) | 20/01/2016 | 01/12/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Serbia;Belarus;Portugal;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 7 | EUCTR2015-002500-91-BG (EUCTR) | 13/01/2016 | 20/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCl | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;Peru | ||
| 8 | EUCTR2015-002500-91-ES (EUCTR) | 24/11/2015 | 05/10/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Receptos, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2350 | Serbia;Portugal;Belarus;United States;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Colombia;Italy;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | |||
| 9 | EUCTR2015-002500-91-GR (EUCTR) | 18/11/2015 | 04/11/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod HCI | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden | ||
| 10 | EUCTR2015-002500-91-GB (EUCTR) | 10/11/2015 | 18/09/2015 | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis | A Multi-Site, Open-Label Extension Trial of Oral RPC1063 in Relapsing Multiple Sclerosis - Open Label Extension (OLE) study | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 2496 | Phase 3 | United States;Belarus;Portugal;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;South Africa;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;United Kingdom;Hungary;Mexico;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;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 |
| 11 | EUCTR2014-002320-27-NL (EUCTR) | 15/09/2015 | 08/01/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 12 | EUCTR2014-002320-27-HR (EUCTR) | 27/07/2015 | 01/10/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 13 | EUCTR2014-002320-27-GB (EUCTR) | 22/07/2015 | 17/06/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 14 | EUCTR2014-002320-27-HU (EUCTR) | 03/07/2015 | 11/05/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 15 | EUCTR2014-002320-27-LT (EUCTR) | 09/06/2015 | 17/04/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;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 |
| 16 | EUCTR2014-002320-27-ES (EUCTR) | 21/04/2015 | 09/02/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. - Sunbeam | Relapsing Multiple Sclerosis MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 17 | EUCTR2014-002320-27-BG (EUCTR) | 19/03/2015 | 21/01/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 18 | EUCTR2014-002320-27-PL (EUCTR) | 01/03/2015 | 27/01/2015 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: SUB175614 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 19 | EUCTR2014-002320-27-SE (EUCTR) | 12/02/2015 | 08/12/2014 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Receptos, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2014-002320-27-LV (EUCTR) | 23/01/2015 | 30/10/2014 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;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 | EUCTR2014-002320-27-PT (EUCTR) | 21/11/2014 | 08/10/2014 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Interferon beta-1a Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 1346 | Phase 3 | Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Peru;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Serbia;Belarus;United States;Portugal | ||
| 22 | EUCTR2014-002320-27-EE (EUCTR) | 21/11/2014 | 08/10/2014 | A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis. | A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. | Relapsing Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 0.5mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Product Name: 1.0mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: RPC1063 Trade Name: Avonex Product Name: Avonex INN or Proposed INN: Avonex Other descriptive name: INTERFERON BETA-1A | Celgene International II Sàrl (CIS II) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1346 | Phase 3 | Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;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 | EUCTR2015-000319-41-ES (EUCTR) | 12/07/2018 | 21/05/2018 | The purpose of this study is to determine whether RPC1063 is safe and effective in the treatment of ulcerative colitis (UC). | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Oral RPC1063 as Induction and Maintenance Therapy for Moderate to Severe Ulcerative Colitis - Efficacy and Safety Study of RPC1063 in Ulcerative Colitis | Ulcerative colitis MedDRA version: 20.1;Level: LLT;Classification code 10045365;Term: Ulcerative colitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 0.25mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride Product Name: 1.0 mg RPC1063 Product Code: RPC1063 INN or Proposed INN: Ozanimod Other descriptive name: (S)-5-(3-(1-((2-hydroxyethyl)amino)-2,3-dihydro-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-isopropoxybenzonitrile hydrochloride | Celgene International II Sàrl (CIS II) | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | France;Belarus;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Australia;South Africa;Latvia;Netherlands;Korea, Republic of;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;New Zealand |