13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| 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 | EUCTR2020-000644-55-DE (EUCTR) | 22/04/2021 | 17/06/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's TyrosineKinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 2 | EUCTR2020-000637-41-AT (EUCTR) | 16/02/2021 | 09/09/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's TyrosineKinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Belarus;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 3 | EUCTR2020-000644-55-FR (EUCTR) | 22/12/2020 | 15/06/2020 | RMS study of BTK inhibitor SAR442168 (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 4 | EUCTR2020-000644-55-HU (EUCTR) | 11/12/2020 | 12/10/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway | ||
| 5 | EUCTR2020-000644-55-PT (EUCTR) | 23/11/2020 | 17/09/2020 | RMS study of BTK inhibitor SAR442168 (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway | ||
| 6 | EUCTR2020-000637-41-FI (EUCTR) | 19/11/2020 | 07/09/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Belarus;Estonia;Taiwan;Hong Kong;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 7 | EUCTR2020-000644-55-NL (EUCTR) | 09/11/2020 | 10/09/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Netherlands;Latvia;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 8 | EUCTR2020-000637-41-CZ (EUCTR) | 05/11/2020 | 03/09/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib(SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Belarus;Taiwan;Hong Kong;Estonia;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 9 | EUCTR2020-000637-41-PL (EUCTR) | 23/10/2020 | 23/10/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Hong Kong;Estonia;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 10 | EUCTR2020-000637-41-LT (EUCTR) | 22/10/2020 | 09/09/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Estonia;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 11 | EUCTR2020-000637-41-SE (EUCTR) | 16/10/2020 | 07/09/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Estonia;Hong Kong;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 12 | EUCTR2020-000644-55-SK (EUCTR) | 09/10/2020 | 07/09/2020 | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 13 | EUCTR2020-000637-41-DK (EUCTR) | 08/10/2020 | 09/09/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Hong Kong;Estonia;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 14 | EUCTR2020-000644-55-CZ (EUCTR) | 07/10/2020 | 03/09/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Chile;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Croatia;Germany;Norway | ||
| 15 | EUCTR2020-000644-55-LV (EUCTR) | 21/09/2020 | 04/09/2020 | RMS study of BTK inhibitor SAR442168 (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway;United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine | ||
| 16 | EUCTR2020-000644-55-GR (EUCTR) | 18/09/2020 | 10/09/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's TyrosineKinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 17 | EUCTR2020-000637-41-IT (EUCTR) | 11/09/2020 | 15/06/2021 | RMS study of BTK inhibitor SAR442168 (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: . Product Code: [SAR442168] Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: [HMR1726] INN or Proposed INN: TERIFLUNOMIDE | GENZYME CORPORATION | NULL | Not Recruiting | Female: yes Male: yes | 1200 | Phase 3 | United States;Belarus;Taiwan;Hong Kong;Estonia;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 18 | EUCTR2020-000644-55-GB (EUCTR) | 04/09/2020 | 03/09/2020 | RMS study of BTK inhibitor SAR442168 (GEMINI 2) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 2 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Portugal;Serbia;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;Switzerland;India;France;Latvia;Netherlands;Korea, Republic of;Czechia;Turkey;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 19 | EUCTR2020-000637-41-BG (EUCTR) | 11/08/2020 | 15/07/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's Tyrosine Kinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | United States;Belarus;Taiwan;Hong Kong;Estonia;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Turkey;Lithuania;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 20 | EUCTR2020-000637-41-DE (EUCTR) | 31/07/2020 | 17/06/2020 | Relapsing Forms of multiple sclerosis (RMS) study of Bruton's TyrosineKinase (BTK) inhibitor Tolebrutinib (SAR442168) (GEMINI 1) | A Phase 3, randomized, double-blind efficacy and safety study comparing SAR442168 to teriflunomide (Aubagio®) in participants with relapsing forms of multiple sclerosis - GEMINI 1 | Relapsing Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Code: SAR442168 INN or Proposed INN: Not available Other descriptive name: PRN2246 Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1200 | Phase 3 | Belarus;United States;Hong Kong;Estonia;Taiwan;Spain;Ukraine;Russian Federation;Italy;Denmark;China;Czechia;Finland;Lithuania;Turkey;Austria;Czech Republic;Mexico;Canada;Poland;Romania;Bulgaria;Germany;Japan;Sweden | ||
| 21 | EUCTR2012-000540-10-PT (EUCTR) | 23/10/2015 | 21/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Hungary;United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 22 | EUCTR2012-000540-10-LT (EUCTR) | 21/10/2015 | 17/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 23 | EUCTR2012-000540-10-HU (EUCTR) | 15/10/2015 | 19/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 24 | EUCTR2012-000540-10-SE (EUCTR) | 07/10/2015 | 14/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 25 | EUCTR2012-000540-10-GR (EUCTR) | 02/10/2015 | 05/11/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 26 | EUCTR2012-000540-10-LV (EUCTR) | 25/09/2015 | 14/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 27 | EUCTR2012-000540-10-DE (EUCTR) | 23/09/2015 | 03/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 28 | EUCTR2012-000540-10-FI (EUCTR) | 23/09/2015 | 19/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 29 | EUCTR2012-000540-10-HR (EUCTR) | 23/09/2015 | 01/10/2015 | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | United States;Belarus;Portugal;Serbia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Sweden | ||
| 30 | EUCTR2012-000540-10-ES (EUCTR) | 21/09/2015 | 11/09/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 18.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Greece;Spain;Ukraine;Russian Federation;Israel;Italy;Serbia;Portugal;Belarus;United States;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 31 | EUCTR2012-000540-10-CZ (EUCTR) | 15/09/2015 | 17/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 32 | EUCTR2012-000540-10-PL (EUCTR) | 25/08/2015 | 12/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Phase 3 | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden | ||
| 33 | EUCTR2012-000540-10-FR (EUCTR) | 31/07/2015 | 03/08/2015 | International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosis | Multicenter, randomized, double-blind, parallel-group, active-controlled, superiority study to compare the efficacy and safety of ponesimod to teriflunomide in subjects with relapsing multiple sclerosis - OPTIMUM | relapsing multiple sclerosis MedDRA version: 20.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 20.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Trade Name: Aubagio® Product Name: Aubagio® INN or Proposed INN: TERIFLUNOMIDE Product Name: Ponesimod Product Code: ACT-128800 INN or Proposed INN: Ponesimod Other descriptive name: PONESIMOD Product Name: Ponesimod Product Code: ACT-1 | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | 1100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;Portugal;Belarus;United States;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;France;Latvia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;Sweden |