Teriflunomide (DrugBank: Teriflunomide)
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 | 227 |
| 25 | 進行性多巣性白質脳症 | 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 | NCT04586023 (ClinicalTrials.gov) | December 26, 2020 | 8/10/2020 | Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS) | A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 734 | Phase 3 | United States |
| 2 | 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 | ||
| 3 | NCT04586010 (ClinicalTrials.gov) | December 18, 2020 | 8/10/2020 | A Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Relapsing Multiple Sclerosis (RMS) | A Phase III Multicenter Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Fenebrutinib Compared With Teriflunomide In Adult Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: fenebrutinib;Drug: teriflunomide;Drug: placebo | Hoffmann-La Roche | NULL | Recruiting | 18 Years | 55 Years | All | 734 | Phase 3 | United States |
| 4 | EUCTR2019-004857-10-FI (EUCTR) | 20/11/2020 | 03/11/2020 | To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple Sclerosis | A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS | Relapsing multiple sclerosis (RMS) MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.0;Classification code 10080700;Term: Relapsing multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: fenebrutinib Product Code: RO7010939 INN or Proposed INN: FENEBRUTINIB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Genentech, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 734 | Phase 3 | United States;France;Finland;Netherlands | ||
| 5 | EUCTR2020-000637-41-FI (EUCTR) | 19/11/2020 | 07/09/2020 | 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: 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;Taiwan;Estonia;Hong Kong;Finland;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;China;Japan;Sweden;United States | ||
| 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 | EUCTR2020-000644-55-NL (EUCTR) | 09/11/2020 | 10/09/2020 | 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;Netherlands;Latvia;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Croatia;Germany;Norway | ||
| 7 | EUCTR2019-004972-20-FI (EUCTR) | 06/11/2020 | 04/09/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Serbia;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 8 | EUCTR2019-004972-20-DE (EUCTR) | 05/11/2020 | 11/05/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;United States;Serbia;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Denmark;Australia;Netherlands;Bosnia and Herzegovina | ||
| 9 | EUCTR2019-004980-36-LT (EUCTR) | 22/10/2020 | 25/05/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Latvia;Kuwait;Tunisia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 10 | EUCTR2020-000637-41-LT (EUCTR) | 22/10/2020 | 09/09/2020 | 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: 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 | ||
| 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 | EUCTR2020-000637-41-SE (EUCTR) | 16/10/2020 | 07/09/2020 | 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: 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;Estonia;Hong Kong;Finland;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;Japan;China;Sweden | ||
| 12 | EUCTR2019-004980-36-BG (EUCTR) | 12/10/2020 | 19/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Latvia;Kuwait;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 13 | EUCTR2020-000637-41-DK (EUCTR) | 08/10/2020 | 09/09/2020 | 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: 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;Estonia;Hong Kong;Finland;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Italy;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;China;Japan;Sweden | ||
| 14 | EUCTR2020-000644-55-CZ (EUCTR) | 07/10/2020 | 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;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 | ||
| 15 | EUCTR2019-004980-36-DE (EUCTR) | 29/09/2020 | 08/09/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Latvia;Kuwait;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden;United States;Belarus;Portugal | ||
| 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 | EUCTR2019-004972-20-BG (EUCTR) | 23/09/2020 | 19/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Hong Kong;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany;United States;Serbia;Taiwan;Estonia | ||
| 17 | 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 | ||
| 18 | EUCTR2020-000644-55-GR (EUCTR) | 18/09/2020 | 10/09/2020 | 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;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 | ||
| 19 | EUCTR2019-004980-36-LV (EUCTR) | 14/09/2020 | 01/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Kuwait;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 20 | 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 | ||
| 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 | EUCTR2019-004972-20-AT (EUCTR) | 26/08/2020 | 26/05/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Serbia;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;India;France;Peru;Denmark;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 22 | EUCTR2020-000637-41-BG (EUCTR) | 11/08/2020 | 15/07/2020 | 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: 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;Hong Kong;Estonia;Taiwan;Finland;Spain;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Italy;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;Japan;China;Sweden | ||
| 23 | EUCTR2019-004972-20-HU (EUCTR) | 05/08/2020 | 02/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Serbia;United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 24 | EUCTR2019-004980-36-GR (EUCTR) | 31/07/2020 | 02/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | United States;Belarus;Portugal;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Latvia;Kuwait;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Singapore;Romania;Bulgaria;Germany;Norway;Sweden | ||
| 25 | EUCTR2020-000637-41-DE (EUCTR) | 31/07/2020 | 17/06/2020 | 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: 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;Czechia;Taiwan;Estonia;Hong Kong;Finland;Spain;Ukraine;Turkey;Lithuania;Austria;Russian Federation;Italy;Mexico;Canada;Poland;Romania;Denmark;Bulgaria;Germany;China;Japan;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 |
| 26 | EUCTR2019-004980-36-SK (EUCTR) | 31/07/2020 | 27/05/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 2) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Tunisia;Kuwait;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden | ||
| 27 | EUCTR2019-004972-20-GB (EUCTR) | 29/07/2020 | 11/05/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Serbia;United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany | ||
| 28 | NCT04338061 (ClinicalTrials.gov) | July 2, 2020 | 6/4/2020 | Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS) | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety | Relapsing Multiple Sclerosis | Drug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib) | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | EMD Serono Research & Development Institute, Inc. | Recruiting | 18 Years | 55 Years | All | 930 | Phase 3 | United States;Bulgaria;Germany;Greece;Italy;Lithuania;Poland;Puerto Rico;Slovakia;Spain;Ukraine |
| 29 | NCT04410978 (ClinicalTrials.gov) | June 30, 2020 | 28/5/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168 | A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: SAR442168;Drug: Teriflunomide HMR1726;Drug: Placebo to match SAR442168;Drug: Placebo to match Teriflunomide | Sanofi | NULL | Recruiting | 18 Years | 55 Years | All | 900 | Phase 3 | United States;Bulgaria;Canada;Czechia;Estonia;Spain |
| 30 | NCT04338022 (ClinicalTrials.gov) | June 12, 2020 | 6/4/2020 | Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety | Relapsing Multiple Sclerosis | Drug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib) | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | EMD Serono Research & Development Institute, Inc. | Recruiting | 18 Years | 55 Years | All | 930 | Phase 3 | United States;Australia;Belgium;Bulgaria;Canada;Estonia;France;Italy;Korea, Republic of;Poland;Spain;Taiwan;Germany |
| 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 |
| 31 | NCT04410991 (ClinicalTrials.gov) | June 11, 2020 | 28/5/2020 | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168 | A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: SAR442168;Drug: Teriflunomide HMR1726;Drug: Placebo to match SAR442168;Drug: Placebo to match Teriflunomide | Sanofi | NULL | Recruiting | 18 Years | 55 Years | All | 900 | Phase 3 | United States;Belgium;Brazil;Canada;Chile;Czechia;Korea, Republic of;Latvia;Puerto Rico;Spain |
| 32 | NCT04410965 (ClinicalTrials.gov) | May 20, 2020 | 28/5/2020 | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese Relapsing Multiple Sclerosis Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks | Multiple Sclerosis | Drug: TERIFLUNOMIDE | Sanofi | NULL | Recruiting | 18 Years | 55 Years | All | 80 | Phase 4 | China |
| 33 | NCT04129736 (ClinicalTrials.gov) | October 10, 2019 | 15/10/2019 | Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis | Determination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily. | Multiple Sclerosis, Pharmacokinetics | Drug: Teriflunomide 14 MG | Jan Lycke | NULL | Recruiting | 18 Years | 65 Years | All | 20 | Phase 4 | Sweden |
| 34 | NCT04056897 (ClinicalTrials.gov) | June 7, 2019 | 12/8/2019 | Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis | International Multicenter, Randomized, Double-blind, Double-masked, Placebo-controlled Study of the Efficacy and Safety of BCD-132 Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis | Multiple Sclerosis | Biological: BCD-132, 125 mg;Drug: Teriflunomide;Drug: Placebo;Biological: BCD-132, 500 mg | Biocad | NULL | Recruiting | 18 Years | 60 Years | All | 270 | Phase 2 | Russian Federation |
| 35 | NCT03856619 (ClinicalTrials.gov) | March 27, 2019 | 25/2/2019 | To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis | A Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: TERIFLUNOMIDE HMR1726 | Sanofi | NULL | Recruiting | 18 Years | N/A | All | 193 | Phase 4 | India |
| 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 |
| 36 | NCT03526224 (ClinicalTrials.gov) | June 4, 2018 | 3/5/2018 | Teriflunomide Tecfidera LMCE | Effect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot Study | Tecfidera;Teriflunomide | Drug: Dimethyl Fumarate;Drug: Teriflunomide | University at Buffalo | NULL | Unknown status | 18 Years | 65 Years | All | 120 | United States | |
| 37 | NCT03464448 (ClinicalTrials.gov) | April 17, 2018 | 7/3/2018 | Mechanistic Studies of Teriflunomide in RRMS | Mechanistic Studies of Teriflunomide in Relapsing Remitting Multiple Sclerosis: Regulatory B Lymphocytes as Central Mediators of the Therapeutic Effects of Teriflunomide in MS | Relapsing Remitting Multiple Sclerosis | Drug: Teriflunomide | University of Michigan | NULL | Active, not recruiting | 18 Years | 65 Years | All | 30 | United States | |
| 38 | EUCTR2016-004414-10-SE (EUCTR) | 23/02/2018 | 02/01/2018 | Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily. | Determination of the concentration of Teriflunomide in serum and cerebrospinal fluid from patients with multiple sclerosis who are treated with Teriflunomide 14 mg daily. | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | MS Centrum, Department of Neurology, Sshlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 4 | Sweden | ||
| 39 | EUCTR2017-000639-15-HR (EUCTR) | 19/12/2017 | 13/04/2018 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDY | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Serbia;Belarus;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;Georgia;United Kingdom | ||
| 40 | EUCTR2017-000638-75-PL (EUCTR) | 13/12/2017 | 20/09/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Serbia;Belarus;United States;Spain;Poland;Ukraine;Russian Federation;Georgia;United Kingdom | ||
| 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 |
| 41 | EUCTR2017-000639-15-ES (EUCTR) | 05/12/2017 | 10/10/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - ULTIMATE II STUDY | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Belarus;United States;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom | ||
| 42 | EUCTR2017-000638-75-GB (EUCTR) | 05/12/2017 | 06/09/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | United States;Serbia;Belarus;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom | ||
| 43 | EUCTR2017-000638-75-ES (EUCTR) | 05/12/2017 | 10/10/2017 | UbLiTuximab In Multiple Sclerosis Treatment Effects | Phase III: UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) - ULTIMATE I STUDY | Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ublituximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | Serbia;Belarus;United States;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom | ||
| 44 | EUCTR2017-000639-15-GB (EUCTR) | 04/12/2017 | 06/09/2017 | Ublituximab In Multiple Sclerosis Treatment Effects | Phase III: UbliTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) - Ultimate II Study | Multiple Sclerosis MedDRA version: 21.0;Level: PT;Classification code 10029202;Term: Nervous system disorder;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: Ubltuximab Product Code: TG-1101 INN or Proposed INN: UBLITUXIMAB Other descriptive name: LFB-R603 Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | TG Therapeutics | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 440 | Phase 3 | United States;Belarus;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom | ||
| 45 | NCT03122652 (ClinicalTrials.gov) | September 25, 2017 | 12/4/2017 | Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated Syndrome | Multi-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS Study | Multiple Sclerosis | Drug: Teriflunomide 14 MG Oral Tablet [Aubagio];Drug: Placebo Oral Tablet | Centre Hospitalier Universitaire de Nice | Genzyme, a Sanofi Company | Active, not recruiting | 18 Years | N/A | All | 125 | Phase 3 | France;Switzerland;Turkey;Germany;Martinique;Sweden;United Kingdom |
| 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 |
| 46 | EUCTR2016-003622-16-FI (EUCTR) | 19/09/2017 | 27/02/2017 | The effect of teriflunomide on brain microglial cell activation in multiple sclerosis. | Targeting SPMS: Effect of teriflunomide treatment on microglial activation in an MS patient cohort at risk of progression. A [11C]PK11195 Brain PET study. | Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: AUBAGIO Product Name: Teriflunomide Product Code: L04AA31 | Turku University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Finland | |||
| 47 | NCT03277248 (ClinicalTrials.gov) | August 1, 2017 | 7/9/2017 | A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compares to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) (ULTIMATE 2) | ubLiTuximab in Multiple Sclerosis Treatment Effects (ULTIMATE II STUDY) | Relapsing Multiple Sclerosis (RMS) | Biological: Ublituximab;Drug: Teriflunomide | TG Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 500 | Phase 3 | United States |
| 48 | NCT03277261 (ClinicalTrials.gov) | August 1, 2017 | 7/9/2017 | A Phase 3, Randomized, Multi-center, Double-blinded, Active-controlled Study to Assess the Efficacy and Safety/Tolerability of Ublituximab (TG-1101; UTX) as Compared to Teriflunomide in Subjects With Relapsing Multiple Sclerosis (RMS) | UbLiTuximab In Multiple Sclerosis Treatment Effects (ULTIMATE I STUDY) | Relapsing Multiple Sclerosis (RMS) | Biological: Ublituximab;Drug: Teriflunomide | TG Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | 55 Years | All | 500 | Phase 3 | United States |
| 49 | EUCTR2011-005249-12-SI (EUCTR) | 15/05/2017 | 13/03/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Israel;Russian Federation;France;Macedonia, the former Yugoslav Republic of;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;Poland;Bulgaria | |||
| 50 | EUCTR2011-005249-12-PT (EUCTR) | 24/04/2017 | 01/02/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE 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 | 165 | Phase 3 | United States;Portugal;Serbia;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Israel;Russian Federation;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Bosnia and Herzegovina;Slovenia;Turkey;Lithuania;United Kingdom;Egypt;Canada;Belgium;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 |
| 51 | EUCTR2011-005249-12-NL (EUCTR) | 15/03/2017 | 08/11/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE 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 | 165 | Phase 3 | Portugal;Serbia;United States;Estonia;Morocco;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Netherlands;Tunisia;China;Bosnia and Herzegovina | ||
| 52 | EUCTR2015-005418-31-FR (EUCTR) | 07/03/2017 | 12/01/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;European Union;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 53 | EUCTR2015-005419-33-HR (EUCTR) | 10/02/2017 | 05/06/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 54 | EUCTR2015-005418-31-CZ (EUCTR) | 31/01/2017 | 14/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;Australia;Denmark;Netherlands;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 55 | EUCTR2015-005419-33-CZ (EUCTR) | 31/01/2017 | 20/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 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 |
| 56 | EUCTR2015-005419-33-BG (EUCTR) | 19/01/2017 | 25/11/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany;United States;Portugal | ||
| 57 | EUCTR2015-005418-31-NL (EUCTR) | 04/01/2017 | 08/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 58 | EUCTR2015-005418-31-HR (EUCTR) | 13/12/2016 | 15/12/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 59 | EUCTR2015-005418-31-BG (EUCTR) | 01/12/2016 | 12/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 60 | NCT03561402 (ClinicalTrials.gov) | December 1, 2016 | 7/6/2018 | Biomarkers and Disease Activity in Patients Treated With Teriflunomide (Aubagio) | Association of Possible Biomarkers With Disease Activity in Patients Treated With Teriflunomide (Aubagio) | Multiple Sclerosis, Relapsing-Remitting | Drug: Teriflunomide | McGill University | NULL | Unknown status | 18 Years | 55 Years | All | 75 | Canada | |
| 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 |
| 61 | EUCTR2015-005418-31-PL (EUCTR) | 11/11/2016 | 20/09/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 62 | EUCTR2015-005419-33-LV (EUCTR) | 03/11/2016 | 11/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United States;United Arab Emirates;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 63 | EUCTR2015-005419-33-DE (EUCTR) | 21/10/2016 | 07/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 64 | EUCTR2015-005418-31-GR (EUCTR) | 21/10/2016 | 05/09/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;France;Australia;Denmark;Netherlands;Kuwait;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 65 | EUCTR2016-001515-20-IT (EUCTR) | 20/10/2016 | 07/02/2018 | nd | EFFECT OF TERIFLUNOMIDE ON T CELL SUBPOPULATIONS INPERIPHERAL BLOOD FROM RRMS PATIENTS - nd | RELAPSING-REMITTING MULTIPLE SCLEROSIS MedDRA version: 20.0;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: AUBAGIO - 14 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - BLISTER (ALU/ALU) - 28 COMPRESSE Product Name: teriflunomide Product Code: nd | UNIVERSITÀ CATTOLICA DEL SACRO CUORE- POLICLINICO A. GEMELLI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 30 | Phase 4 | Italy | ||
| 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 |
| 66 | EUCTR2015-005418-31-BE (EUCTR) | 17/10/2016 | 07/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 67 | EUCTR2015-005419-33-FR (EUCTR) | 14/10/2016 | 12/01/2017 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Portugal;United Arab Emirates;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Czech Republic;Hungary;Mexico;European Union;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 68 | EUCTR2015-005418-31-GB (EUCTR) | 11/10/2016 | 11/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 69 | EUCTR2015-005419-33-GB (EUCTR) | 11/10/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 70 | EUCTR2015-005419-33-PT (EUCTR) | 06/10/2016 | 28/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1313 | Phase 3 | United States;United Arab Emirates;Portugal;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Bulgaria;Germany | ||
| 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 |
| 71 | EUCTR2015-005419-33-LT (EUCTR) | 03/10/2016 | 23/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | Bulgaria;United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Germany | ||
| 72 | EUCTR2015-005419-33-BE (EUCTR) | 26/09/2016 | 11/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;United States;Portugal;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;China;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 73 | EUCTR2015-005418-31-DK (EUCTR) | 23/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 74 | EUCTR2015-005418-31-HU (EUCTR) | 21/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Chile;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 75 | EUCTR2015-005419-33-HU (EUCTR) | 21/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 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 |
| 76 | EUCTR2015-005419-33-FI (EUCTR) | 20/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 77 | NCT02792218 (ClinicalTrials.gov) | September 20, 2016 | 2/6/2016 | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis | A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis | Relapsing Multiple Sclerosis | Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 930 | Phase 3 | United States;Argentina;Australia;Belgium;Bulgaria;Canada;Croatia;Czechia;Denmark;Estonia;France;Germany;Greece;Hungary;India;Israel;Italy;Mexico;Netherlands;Poland;Puerto Rico;Russian Federation;Slovakia;Spain;Sweden;Switzerland;Thailand;Turkey;United Kingdom |
| 78 | EUCTR2015-005419-33-SK (EUCTR) | 19/09/2016 | 03/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 79 | EUCTR2015-005418-31-SK (EUCTR) | 19/09/2016 | 29/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 80 | EUCTR2015-005418-31-DE (EUCTR) | 13/09/2016 | 08/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;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 |
| 81 | EUCTR2015-005418-31-EE (EUCTR) | 12/09/2016 | 10/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 82 | EUCTR2015-005418-31-SE (EUCTR) | 06/09/2016 | 13/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Slovakia;Greece;Thailand;Spain;Russian Federation;Israel;Switzerland;India;France;Australia;Denmark;Netherlands;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Germany;Sweden | ||
| 83 | EUCTR2015-005418-31-ES (EUCTR) | 03/09/2016 | 05/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 900 | Phase 3 | United States;Estonia;Saudi Arabia;Slovakia;Greece;Thailand;Spain;Israel;Chile;Russian Federation;Switzerland;India;France;Australia;Denmark;Kuwait;Netherlands;Korea, Republic of;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Germany;Sweden | ||
| 84 | EUCTR2015-005419-33-ES (EUCTR) | 03/09/2016 | 05/08/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157 INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Farmacéutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United Arab Emirates;Portugal;United States;Taiwan;Slovakia;Spain;Lebanon;Russian Federation;Switzerland;India;France;Australia;Peru;South Africa;Latvia;China;Finland;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Belgium;Croatia;Bulgaria;Germany | ||
| 85 | NCT02792231 (ClinicalTrials.gov) | August 26, 2016 | 2/6/2016 | Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. | A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis. | Relapsing Multiple Scelrosis | Drug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injections | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 957 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Bulgaria;Canada;Croatia;Czechia;Finland;France;Germany;Hungary;India;Italy;Latvia;Lithuania;Mexico;Norway;Peru;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;Taiwan;Turkey;United Kingdom |
| 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 |
| 86 | EUCTR2015-005419-33-AT (EUCTR) | 16/08/2016 | 15/07/2016 | Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosis | A randomized, double-blind, double-dummy, parallel-group study comparing the efficacy and safety of ofatumumab versus teriflunomide in patients with relapsing multiple sclerosis | 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] | Trade Name: Arzerra Product Name: ofatumumab Product Code: OMB157G INN or Proposed INN: OFATUMUMAB Trade Name: Aubagio Product Name: Teriflunomide INN or Proposed INN: TERIFLUNOMIDE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 1313 | Phase 3 | United States;Portugal;Taiwan;Slovakia;Spain;Russian Federation;Switzerland;India;France;Peru;Australia;South Africa;Latvia;Finland;Turkey;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Belgium;Croatia;Bulgaria;Germany | ||
| 87 | NCT02587195 (ClinicalTrials.gov) | December 18, 2015 | 22/9/2015 | A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period | A National, Multi-center Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period | Multiple Sclerosis | Drug: Teriflunomide | Centre Hospitalier Universitaire de Nice | NULL | Unknown status | 18 Years | 55 Years | All | 5 | Phase 3 | France |
| 88 | EUCTR2011-005249-12-LT (EUCTR) | 06/11/2015 | 02/10/2015 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | 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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE 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 | 165 | Phase 3 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| 89 | NCT02490982 (ClinicalTrials.gov) | November 2015 | 26/6/2015 | Teriflunomide Observational Effectiveness Study | Teriflunomide Observational Effectiveness Study | Relapsing Remitting Multiple Sclerosis | Drug: Teriflunomide | Centre hospitalier de l'Université de Montréal (CHUM) | Genzyme, a Sanofi Company;Montreal Neurological Institute and Hospital | Enrolling by invitation | 18 Years | N/A | All | 300 | N/A | Canada |
| 90 | 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 | ||
| 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 |
| 91 | 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] | 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 | |||
| 92 | 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 | ||
| 93 | 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 | ||
| 94 | 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] | 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 | |||
| 95 | 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] | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | 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 | |||
| 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 |
| 96 | EUCTR2012-000540-10-HR (EUCTR) | 23/09/2015 | 01/10/2015 | 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] | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | 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 | |||
| 97 | 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 | ||
| 98 | 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] | 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 | |||
| 99 | 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 | ||
| 100 | 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] | 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 | |||
| 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 |
| 101 | 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 | ||
| 102 | 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] | 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 | |||
| 103 | EUCTR2011-005249-12-PL (EUCTR) | 11/06/2015 | 07/07/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis with Relapsing Forms of Multiple Sclerosis Followed byan Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 18.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | United States;Estonia;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Poland;Belgium;Australia;China | |||
| 104 | NCT02425644 (ClinicalTrials.gov) | June 4, 2015 | 21/4/2015 | Oral Ponesimod Versus 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 | Multiple Sclerosis | Drug: ponesimod;Drug: teriflunomide | Actelion | NULL | Completed | 18 Years | 55 Years | All | 1133 | Phase 3 | United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Finland;France;Georgia;Germany;Greece;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Argentina;Czech Republic |
| 105 | EUCTR2011-005249-12-GB (EUCTR) | 29/09/2014 | 14/07/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | 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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE 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 | 165 | Phase 3 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| 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 |
| 106 | EUCTR2011-005249-12-EE (EUCTR) | 13/08/2014 | 27/02/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 17.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE 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 | 165 | United States;Estonia;Greece;Canada;Spain;Belgium;Lebanon;Turkey;Australia;Russian Federation;Israel;China | |||
| 107 | EUCTR2013-001439-34-GR (EUCTR) | 29/07/2014 | 23/04/2014 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Canada;Greece;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | ||
| 108 | NCT02201108 (ClinicalTrials.gov) | July 16, 2014 | 17/7/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients With Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo | Genzyme, a Sanofi Company | NULL | Active, not recruiting | 10 Years | 17 Years | All | 166 | Phase 3 | United States;Belgium;Bulgaria;Canada;China;Estonia;France;Greece;Israel;Lebanon;Lithuania;Morocco;Netherlands;North Macedonia;Portugal;Russian Federation;Serbia;Slovenia;Spain;Tunisia;Turkey;Ukraine;United Kingdom;Australia;Macedonia, The Former Yugoslav Republic of;Poland |
| 109 | EUCTR2011-005249-12-BE (EUCTR) | 11/07/2014 | 17/03/2014 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | 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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE 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 | 165 | Phase 3 | Serbia;United States;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;North Macedonia;Israel;France;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||
| 110 | EUCTR2011-005249-12-GR (EUCTR) | 07/07/2014 | 21/05/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 17.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE 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 | 165 | United States;Estonia;Greece;Spain;Lebanon;Turkey;Israel;Russian Federation;United Kingdom;Canada;Belgium;Australia;China | |||
| 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 |
| 111 | EUCTR2011-005249-12-ES (EUCTR) | 03/06/2014 | 01/04/2014 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China | |||
| 112 | NCT02046629 (ClinicalTrials.gov) | May 2014 | 23/1/2014 | A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers | An Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese Subjects | Multiple Sclerosis | Drug: Teriflunomide HMR1726;Drug: cholestyramine | Sanofi | NULL | Completed | 18 Years | 45 Years | Both | 12 | Phase 1 | China |
| 113 | EUCTR2013-001439-34-DE (EUCTR) | 15/04/2014 | 12/12/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | |||
| 114 | EUCTR2013-001439-34-AT (EUCTR) | 20/03/2014 | 09/01/2014 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | |||
| 115 | EUCTR2013-001439-34-BE (EUCTR) | 19/03/2014 | 03/12/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | United States;Greece;Canada;Finland;Spain;Belgium;Austria;Chile;Germany;United Kingdom;Switzerland;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 |
| 116 | EUCTR2013-001439-34-GB (EUCTR) | 17/02/2014 | 20/12/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;Switzerland;United Kingdom;Sweden | ||
| 117 | EUCTR2013-001439-34-IT (EUCTR) | 03/01/2014 | 16/10/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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 | 1000 | Phase 4 | United States;Greece;Finland;Spain;Austria;Chile;Italy;Switzerland;United Kingdom;Canada;Belgium;Germany;Sweden | ||
| 118 | EUCTR2013-001439-34-FI (EUCTR) | 18/11/2013 | 19/09/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 19.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | ||
| 119 | EUCTR2013-001439-34-SE (EUCTR) | 17/11/2013 | 20/09/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis MedDRA version: 17.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Trade Name: Aubagio Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 4 | United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden | ||
| 120 | EUCTR2013-001439-34-ES (EUCTR) | 15/11/2013 | 24/10/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients - TERI-PRO | Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | 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 | 1000 | United States;Canada;Spain;Chile;Switzerland;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 |
| 121 | NCT01863888 (ClinicalTrials.gov) | October 2013 | 23/5/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis | Multiple Sclerosis | Drug: teriflunomide HMR1726;Drug: cholestyramine;Drug: charcoal | Sanofi | NULL | Completed | 18 Years | 55 Years | Both | 70 | Phase 3 | Belgium;Germany;Netherlands |
| 122 | NCT01970410 (ClinicalTrials.gov) | October 2013 | 22/10/2013 | Sub-Study: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide - SWITCH-JCV | Switching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? (Sub-study: SWITCH-JCV) | Multiple Sclerosis | Drug: teriflunomide | Providence Health & Services | Multiple Sclerosis Center of Northeastern New York | Recruiting | 21 Years | 60 Years | All | 70 | Phase 4 | United States |
| 123 | EUCTR2012-005324-16-NL (EUCTR) | 26/09/2013 | 03/05/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | multiple sclerosis MedDRA version: 16.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Germany;Netherlands | |||
| 124 | EUCTR2012-005324-16-BE (EUCTR) | 27/08/2013 | 17/04/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | multiple sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Germany;Netherlands | |||
| 125 | EUCTR2012-005324-16-DE (EUCTR) | 05/08/2013 | 06/06/2013 | Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis | Exploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple Sclerosis - TERI-DYNAMIC | multiple sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 68 | Belgium;Netherlands;Germany | |||
| 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 |
| 126 | NCT01895335 (ClinicalTrials.gov) | June 2013 | 3/7/2013 | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients | A Prospective, Single-Arm, Clinical-Setting Study to Describe Efficacy, Tolerability and Convenience of Teriflunomide Treatment Using Patient Reported Outcomes (PROs) in Relapsing Multiple Sclerosis (RMS) Patients | Multiple Sclerosis | Drug: Teriflunomide | Sanofi | NULL | Completed | 18 Years | N/A | All | 1001 | Phase 4 | United States;Austria;Belgium;Canada;Chile;Finland;France;Germany;Greece;Italy;Norway;Spain;Sweden;United Kingdom |
| 127 | NCT03198351 (ClinicalTrials.gov) | April 25, 2013 | 22/6/2017 | An Observational Study on Teriflunomide-exposed Pregnancies | Teriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy Project | Multiple Sclerosis | Drug: Teriflunomide (HMR1726) | Sanofi | NULL | Recruiting | 16 Years | N/A | Female | 325 | United States;Canada | |
| 128 | EUCTR2010-023172-12-LT (EUCTR) | 12/06/2012 | 13/04/2012 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 15.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 129 | NCT01403376 (ClinicalTrials.gov) | September 2011 | 14/7/2011 | Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide | Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide Treatment and Using a Population of Patients With Multiple Sclerosis as a Reference | Multiple Sclerosis | Drug: teriflunomide;Drug: Interferon-ß-1;Biological: Influenza vaccine | Sanofi | NULL | Completed | 18 Years | 59 Years | All | 128 | Phase 2 | Austria;Canada;Germany;Russian Federation;Ukraine |
| 130 | EUCTR2011-001160-21-DE (EUCTR) | 18/07/2011 | 20/05/2011 | Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide | Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVA | Multiple sclerosis MedDRA version: 14.0;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Trade Name: Mutagrip Product Name: Mutagrip | sanofi-aventis recherche & developpement | NULL | Not Recruiting | Female: yes Male: yes | 120 | Canada;Ukraine;Austria;Russian Federation;Germany | |||
| 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 |
| 131 | EUCTR2011-001160-21-AT (EUCTR) | 06/07/2011 | 31/05/2011 | Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide | Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide treatment and using a population of patients with multiple sclerosis as a reference - TERIVA | Multiple sclerosis MedDRA version: 14.0;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Trade Name: Mutagrip Product Name: Mutagrip | sanofi-aventis recherche & developpement | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;Russian Federation;Ukraine;Canada;Austria | |||
| 132 | EUCTR2010-023172-12-AT (EUCTR) | 26/05/2011 | 06/04/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | 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] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 133 | EUCTR2010-023172-12-PT (EUCTR) | 30/03/2011 | 01/02/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 134 | EUCTR2010-023172-12-DK (EUCTR) | 23/03/2011 | 26/04/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 135 | EUCTR2010-023172-12-GR (EUCTR) | 15/03/2011 | 27/01/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Other descriptive name: NA Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis group | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;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 |
| 136 | EUCTR2010-023172-12-GB (EUCTR) | 14/03/2011 | 20/12/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 137 | EUCTR2010-023172-12-FI (EUCTR) | 02/03/2011 | 10/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | 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] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 138 | EUCTR2010-023172-12-DE (EUCTR) | 25/02/2011 | 05/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Sweden | |||
| 139 | EUCTR2010-023172-12-SE (EUCTR) | 18/02/2011 | 07/12/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | 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] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation;Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden | |||
| 140 | EUCTR2010-023172-12-NL (EUCTR) | 15/02/2011 | 17/11/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;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 |
| 141 | EUCTR2010-023172-12-ES (EUCTR) | 14/02/2011 | 23/12/2010 | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Estudio multicéntrico, doble ciego, controlado con placebo, de grupos paralelos para evaluar la eficacia y seguridad de la teriflunomida en pacientes con esclerosis múltiple recurrente que están en tratamiento con interferón-beta____________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Esclerosis múltiple_______Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 142 | EUCTR2010-023172-12-BE (EUCTR) | 08/02/2011 | 29/11/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 143 | EUCTR2010-023172-12-SK (EUCTR) | 26/01/2011 | 20/12/2010 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Phase 3 | Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden | ||
| 144 | EUCTR2010-023172-12-NO (EUCTR) | 25/01/2011 | 03/01/2011 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | Multiple sclerosis MedDRA version: 15.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | United States;Portugal;Estonia;Slovakia;Greece;Spain;Chile;Russian Federation;Colombia;Italy;France;Denmark;Australia;Tunisia;Netherlands;Korea, Republic of;Finland;Guatemala;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Norway;Germany;Sweden | |||
| 145 | EUCTR2010-023172-12-IT (EUCTR) | 13/01/2011 | 08/02/2011 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta - ND | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245 | Product Name: teriflunomide Product Code: HMR1726 INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726 INN or Proposed INN: teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;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 |
| 146 | EUCTR2010-023172-12-EE (EUCTR) | 12/01/2011 | 14/12/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | 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] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 1455 | Chile;Colombia;Italy;France;Australia;Denmark;Netherlands;Tunisia;Korea, Republic of;Finland;Guatemala;Lithuania;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Belgium;Brazil;Norway;Germany;Sweden;United States;Portugal;Estonia;Slovakia;Greece;Spain;Russian Federation | |||
| 147 | EUCTR2010-023172-12-HU (EUCTR) | 11/01/2011 | 23/11/2010 | Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-beta | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis who are treated with interferon-beta. - TERACLES | 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] | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis recherche et development | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1455 | Germany;France;Austria;Sweden;Brazil;Australia;Tunisia;Czech Republic;Canada;Belgium;Korea, Republic of;United States;Greece;Hungary;Portugal;Colombia;Turkey;Netherlands;Chile;Norway;Italy;Lithuania;Finland;United Kingdom;Russian Federation;Slovakia;Guatemala;Denmark;Argentina;Estonia;Spain | |||
| 148 | NCT01252355 (ClinicalTrials.gov) | January 2011 | 30/11/2010 | Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta | A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis Who Are Treated With Interferon-beta | Multiple Sclerosis Relapse | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-beta (IFN-beta) | Sanofi | NULL | Terminated | 18 Years | 55 Years | All | 534 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Colombia;Denmark;Estonia;Finland;France;Germany;Greece;Hungary;Italy;Korea, Republic of;Lithuania;Netherlands;Norway;Portugal;Russian Federation;Slovakia;Spain;Sweden;Tunisia;United Kingdom;Turkey |
| 149 | EUCTR2007-004452-36-SK (EUCTR) | 06/05/2010 | 11/04/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 150 | EUCTR2008-006226-34-GB (EUCTR) | 03/02/2010 | 01/11/2010 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE) | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Canada;Belgium;Spain;Germany;Tunisia;Italy;United Kingdom | |||
| 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 |
| 151 | EUCTR2008-006226-34-BE (EUCTR) | 23/12/2009 | 29/09/2009 | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif Product Code: L03 AB INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif Product Name: L03 AB INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy | |||
| 152 | EUCTR2006-003361-14-CZ (EUCTR) | 12/10/2009 | 05/05/2009 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 153 | EUCTR2006-003361-14-EE (EUCTR) | 25/09/2009 | 19/08/2009 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;Estonia;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 154 | EUCTR2006-001152-12-DE (EUCTR) | 14/09/2009 | 04/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 155 | EUCTR2007-004452-36-SE (EUCTR) | 20/08/2009 | 24/06/2009 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;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 |
| 156 | EUCTR2008-006226-34-GR (EUCTR) | 20/07/2009 | 19/03/2009 | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Czech Republic;Hungary;Greece;Belgium;Spain;Germany;United Kingdom;Italy | ||
| 157 | EUCTR2006-001152-12-LT (EUCTR) | 22/06/2009 | 31/03/2009 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 158 | EUCTR2008-006226-34-CZ (EUCTR) | 08/06/2009 | 02/03/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE) | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis MedDRA version: 13.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Hungary;Czech Republic;Canada;Belgium;Spain;Germany;Tunisia;United Kingdom;Italy | |||
| 159 | EUCTR2008-006226-34-DE (EUCTR) | 14/05/2009 | 03/02/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE) | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis MedDRA version: 16.1;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy | |||
| 160 | EUCTR2008-006226-34-FR (EUCTR) | 04/05/2009 | 25/03/2009 | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE | Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif | sanofi-aventis Recherche & Dévelopment | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Hungary;United Kingdom;Czech Republic;Germany;France;Spain;Italy | |||
| 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 |
| 161 | EUCTR2007-004452-36-AT (EUCTR) | 14/04/2009 | 14/04/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Chile;France;Australia;Tunisia;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| 162 | NCT00883337 (ClinicalTrials.gov) | April 2009 | 16/4/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis | A Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension Period | Multiple Sclerosis | Drug: Interferon ß-1a;Drug: Teriflunomide | Sanofi | NULL | Completed | 18 Years | N/A | All | 324 | Phase 3 | Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom |
| 163 | EUCTR2008-006226-34-ES (EUCTR) | 25/03/2009 | 23/01/2009 | Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE | Esclerosis Múltiple------------------------Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: REBIF 44 microgramos solución inyectable INN or Proposed INN: INTERFERON BETA1A Other descriptive name: INTERFERON BETA1A | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy | |||
| 164 | EUCTR2007-004452-36-GB (EUCTR) | 24/03/2009 | 01/02/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis using interferon-beta 1a (Rebif®) as an open-label rater-blind calibrator | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | Belarus;United States;Philippines;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Germany;Sweden | ||
| 165 | EUCTR2008-006226-34-IT (EUCTR) | 05/03/2009 | 09/03/2009 | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10063399 MedDRA version: 9.1;Classification code 10028245 | Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: REBIF INN or Proposed INN: interferone | sanofi-aventis recherche et development | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy | |||
| 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 |
| 166 | EUCTR2008-006226-34-HU (EUCTR) | 05/03/2009 | 09/02/2009 | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE) | A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE | Multiple sclerosis MedDRA version: 15.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A Trade Name: Rebif INN or Proposed INN: INTERFERON BETA-1A | sanofi-aventis recherche et developpement | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;Czech Republic;Hungary;Canada;Belgium;Spain;Germany;Tunisia;United Kingdom;Italy | |||
| 167 | EUCTR2007-004452-36-GR (EUCTR) | 17/02/2009 | 18/02/2009 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | ||
| 168 | EUCTR2007-004452-36-ES (EUCTR) | 04/12/2008 | 23/09/2008 | Estudio multicéntrico, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de teriflunomida en pacientes con esclerosis múltiple recurrente_________________________________________________________________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Estudio multicéntrico, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de teriflunomida en pacientes con esclerosis múltiple recurrente_________________________________________________________________A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Esclerosis múltiple_____________Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 169 | EUCTR2007-004452-36-FR (EUCTR) | 02/12/2008 | 21/10/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden | |||
| 170 | EUCTR2006-001152-12-SK (EUCTR) | 11/11/2008 | 16/04/2008 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 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 |
| 171 | EUCTR2007-004452-36-CZ (EUCTR) | 13/10/2008 | 07/04/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| 172 | EUCTR2007-004452-36-BE (EUCTR) | 30/09/2008 | 11/03/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | Phase 3 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Netherlands;Tunisia;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | ||
| 173 | EUCTR2006-001152-12-BG (EUCTR) | 17/09/2008 | 05/09/2008 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 174 | EUCTR2006-003361-14-DK (EUCTR) | 29/08/2008 | 22/07/2008 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Finland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
| 175 | NCT00751881 (ClinicalTrials.gov) | August 2008 | 7/5/2008 | An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis | A Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis | Multiple Sclerosis | Drug: Placebo;Drug: Teriflunomide | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 1169 | Phase 3 | United States;Australia;Austria;Belarus;Belgium;Canada;Chile;China;Czech Republic;Estonia;France;Germany;Greece;Mexico;Netherlands;Philippines;Poland;Romania;Slovakia;Spain;Sweden;Thailand;Tunisia;Turkey;Ukraine;United Kingdom;South Africa |
| 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 |
| 176 | EUCTR2007-004452-36-DE (EUCTR) | 23/07/2008 | 07/05/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden | |||
| 177 | EUCTR2007-003997-24-GB (EUCTR) | 08/07/2008 | 20/08/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis MedDRA version: 12.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 178 | EUCTR2007-004452-36-NL (EUCTR) | 09/06/2008 | 28/02/2008 | An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple Sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis - TOWER | Multiple sclerosis MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | United States;Belarus;Philippines;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Chile;France;Australia;Tunisia;Netherlands;China;Turkey;Austria;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Germany;Sweden | |||
| 179 | EUCTR2007-003997-24-IT (EUCTR) | 05/06/2008 | 13/06/2008 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses - ND | Multiple Sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-Aventis recherche & de'veloppement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 180 | EUCTR2007-004452-36-EE (EUCTR) | 22/05/2008 | 09/04/2008 | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1110 | France;Czech Republic;Estonia;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;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 |
| 181 | EUCTR2006-003361-14-PT (EUCTR) | 07/03/2008 | 07/01/2008 | Multiple Sclerosis study to document the safety of two doses of teriflunomide | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 18.1;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: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 182 | EUCTR2006-003361-14-NL (EUCTR) | 12/02/2008 | 07/01/2008 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 183 | EUCTR2006-001152-12-EE (EUCTR) | 08/02/2008 | 21/11/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 184 | EUCTR2004-000555-42-GB (EUCTR) | 05/02/2008 | 03/03/2005 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;Italy;United Kingdom;Sweden | |||
| 185 | NCT00622700 (ClinicalTrials.gov) | February 2008 | 14/2/2008 | Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis | An International, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Year Treatment With Teriflunomide 7 mg Once Daily and 14 mg Once Daily Versus Placebo in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis Plus a Long Term Extension Period | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 618 | Phase 3 | United States;Australia;Austria;Bulgaria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Hungary;Lithuania;Mexico;Poland;Romania;Russian Federation;Turkey;Ukraine;United Kingdom;Brazil;Italy;Slovakia |
| 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 |
| 186 | EUCTR2006-001152-12-HU (EUCTR) | 09/01/2008 | 09/10/2007 | Not applicable | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. - TOPIC | Multiple Sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 187 | EUCTR2006-001152-12-FR (EUCTR) | 08/01/2008 | 11/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis (MS) - | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis recherche & développement | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 780 | Hungary;Finland;United Kingdom;Germany;Czech Republic;Denmark;Bulgaria;Estonia;France;Austria;Lithuania | ||||
| 188 | EUCTR2006-001152-12-DK (EUCTR) | 05/12/2007 | 30/10/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 189 | EUCTR2007-003997-24-ES (EUCTR) | 26/11/2007 | 15/10/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses.------------------------------------------------------------------ Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias | Multiple Sclerosis.-----------------------Esclerosis Múltiple. | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 190 | EUCTR2006-001152-12-GB (EUCTR) | 24/10/2007 | 14/10/2010 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Russian Federation;Chile;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | |||
| 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 |
| 191 | EUCTR2006-001152-12-FI (EUCTR) | 15/10/2007 | 11/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.0;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | Phase 3 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | ||
| 192 | EUCTR2006-001152-12-CZ (EUCTR) | 15/10/2007 | 07/08/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 14.1;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 600 | Phase 3 | United States;Belarus;Estonia;Slovakia;Finland;Ukraine;Lithuania;Turkey;Austria;Chile;Russian Federation;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Poland;Croatia;Romania;Denmark;Australia;Bulgaria;Germany | ||
| 193 | EUCTR2007-003997-24-AT (EUCTR) | 14/10/2007 | 21/09/2007 | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study PDY6045 and PDY6046 to document the safety of teriflunomide when added to treatment with interferon-beta or glatiramer acetate in patients with multiple sclerosis with relapses | Multiple Sclerosis | Product Name: Teriflunomide Product Code: HMR 1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-Aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 240 | United Kingdom;Spain;Italy;Austria | |||
| 194 | EUCTR2006-001152-12-AT (EUCTR) | 04/10/2007 | 20/09/2007 | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | An international, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of two year treatment with teriflunomide 7 mg once daily and 14 mg once daily versus placebo in patients with a first clinical episode suggestive of multiple sclerosis plus a long-term extension period. | Multiple Sclerosis MedDRA version: 16.1;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: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 780 | France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom | |||
| 195 | NCT00811395 (ClinicalTrials.gov) | October 2007 | 18/12/2008 | Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Studies PDY6045 and PDY6046 to Document the Safety of Teriflunomide When Added to Treatment With Interferon-Beta or Glatiramer Acetate in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA] | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 182 | Phase 2 | United States;Austria;Canada;Germany;Italy;Spain;United Kingdom |
| 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 |
| 196 | EUCTR2006-003134-14-IT (EUCTR) | 24/09/2007 | 24/07/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis - ND | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;Spain;Italy | |||
| 197 | EUCTR2006-004893-29-IT (EUCTR) | 24/09/2007 | 24/07/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis - ND | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis - ND | multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;United Kingdom;Italy;Austria | |||
| 198 | EUCTR2006-004893-29-GB (EUCTR) | 25/07/2007 | 17/12/2006 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | Multiple sclerosis | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | Austria;Germany;Italy;United Kingdom | |||
| 199 | EUCTR2006-003361-14-SE (EUCTR) | 24/07/2007 | 27/06/2007 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 200 | EUCTR2004-000555-42-EE (EUCTR) | 06/07/2007 | 18/04/2007 | A randomized, double-blind, placebo-controlled, parallel group design study toevaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing thefrequency of relapses and delaying the accumulation of physical disability insubjects with multiple sclerosis with relapses. | A randomized, double-blind, placebo-controlled, parallel group design study toevaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing thefrequency of relapses and delaying the accumulation of physical disability insubjects with multiple sclerosis with relapses. | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: | Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | Sanofi-aventis U.S. Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;United Kingdom;Denmark;Norway;Estonia;Italy;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 |
| 201 | EUCTR2006-003134-14-DE (EUCTR) | 04/06/2007 | 08/02/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;Spain;Italy | |||
| 202 | EUCTR2006-003361-14-IT (EUCTR) | 23/05/2007 | 07/03/2007 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 HMR1726D/3001 to document the safety of two doses of teriflunomide 7 and 14 mg in patients with multiple sclerosis with relapses - ND | Multiple sclerosis MedDRA version: 9.1;Level: LLT;Classification code 10048393;Term: Multiple sclerosis relapse | Product Name: teriflunomide Product Code: HMR1726D Product Name: teriflunomide Product Code: HMR1726D | sanofi-aventis recherche de veloppement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden | |||
| 203 | EUCTR2004-000555-42-CZ (EUCTR) | 14/05/2007 | 09/03/2007 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | sanofi-aventis U.S Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;United Kingdom;Czech Republic;Denmark;Estonia;Norway;Italy;Sweden | |||
| 204 | NCT00489489 (ClinicalTrials.gov) | May 2007 | 20/6/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-Blind, Placebo-Controlled, Parallel-Group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Interferon-beta in Subjects With Multiple Sclerosis. | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for Teriflunomide);Drug: Interferon-ß | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 118 | Phase 2 | United States;Canada;Germany;Italy;Spain;Poland |
| 205 | NCT00475865 (ClinicalTrials.gov) | April 2007 | 18/5/2007 | Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis | A Randomized, Multinational, Double-blind, Placebo-controlled, Parallel-group Design Pilot Study to Estimate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamic Effects of Teriflunomide for 24 Weeks When Added to Treatment With Glatiramer Acetate in Subjects With Multiple Sclerosis | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 123 | Phase 2 | United States;Austria;Canada;Germany;Italy;United Kingdom |
| 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 |
| 206 | EUCTR2006-004893-29-AT (EUCTR) | 19/03/2007 | 08/03/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Germany;United Kingdom;Italy;Austria | |||
| 207 | EUCTR2006-003361-14-DE (EUCTR) | 01/03/2007 | 28/12/2006 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United States;Portugal;Estonia;Finland;Ukraine;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Sweden | |||
| 208 | EUCTR2006-003134-14-ES (EUCTR) | 23/02/2007 | 26/10/2009 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with interferon-beta in subjects with multiple sclerosis.----------------------------------------------------------------------------------------------------------Extensión a largo plazo de los estudios multinacionales, doble ciego, controlados con placebo PDY6045 y PDY6046 para documentar la seguridad de la teriflunomida cuando se añade al tratamiento con interferón-ß o acetato de glatirámero en pacientes con esclerosis múltiple con recurrencias”. | Multiple sclerosis.Esclerosis Múltiple. | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Germany;Spain;Italy | |||
| 209 | EUCTR2006-003361-14-GB (EUCTR) | 23/01/2007 | 29/09/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden | |||
| 210 | EUCTR2006-003361-14-FI (EUCTR) | 19/12/2006 | 10/11/2006 | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Phase 3 | Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;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 |
| 211 | EUCTR2006-003361-14-AT (EUCTR) | 21/11/2006 | 10/10/2006 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term extension of the multinational, double-blind, placebo controlled study EFC6049 (HMR1726D/3001) to document the safety of two doses of teriflunomide (7 and 14 mg) in patients with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide Product Name: Teriflunomide Product Code: HMR1726D INN or Proposed INN: Teriflunomide | sanofi-aventis recherche & développement | NULL | Not Recruiting | Female: yes Male: yes | 1080 | United States;Portugal;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Norway;Germany;Sweden | |||
| 212 | NCT00803049 (ClinicalTrials.gov) | October 2006 | 1/12/2008 | Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple Sclerosis | Long-term Extension of the Multinational, Double-blind, Placebo Controlled Study EFC6049 (HMR1726D/3001) to Document the Safety of Two Doses of Teriflunomide (7 and 14 mg) in Patients With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide (HMR1726) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 742 | Phase 3 | United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 213 | EUCTR2004-000555-42-PT (EUCTR) | 26/01/2006 | 04/11/2005 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Aventis Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 870 | Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden | |||
| 214 | EUCTR2004-000555-42-DK (EUCTR) | 12/12/2005 | 23/01/2008 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden | |||
| 215 | EUCTR2004-000555-42-IT (EUCTR) | 30/12/2004 | 23/11/2004 | A randomized, double-blind, placebo-controlled, parallel-group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO | A randomized, double-blind, placebo-controlled, parallel-group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO | Multiple sclerosis with relapses 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] | Product Name: TERIFLUNOMIDE Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | sanofi-aventis Recherche & De`veloppement | NULL | Not Recruiting | Female: yes Male: yes | 870 | Portugal;Estonia;Czech Republic;Denmark;Norway;United Kingdom;Italy;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 |
| 216 | EUCTR2004-000555-42-AT (EUCTR) | 02/12/2004 | 28/10/2004 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-Aventis US, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;United Kingdom;Italy;Sweden | |||
| 217 | EUCTR2004-000555-42-NO (EUCTR) | 22/11/2004 | 27/09/2004 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses - TEMSO | Multiple sclerosis | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden | |||
| 218 | EUCTR2004-000555-42-SE (EUCTR) | 17/11/2004 | 29/09/2004 | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | A randomized, double-blind, placebo-controlled, parallel group design study to evaluate the efficacy and safety of teriflunomide (HMR1726D) in reducing the frequency of relapses and delaying the accumulation of physical disability in subjects with multiple sclerosis with relapses | Multiple sclerosis MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: | Product Code: HMR1726 INN or Proposed INN: Teriflunomide Product Code: HMR1726 INN or Proposed INN: Teriflunomide | Sanofi-aventis US, Inc | NULL | Not Recruiting | Female: yes Male: yes | 1080 | Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden | |||
| 219 | NCT00134563 (ClinicalTrials.gov) | September 2004 | 23/8/2005 | Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis | A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Design Study to Evaluate the Efficacy and Safety of Teriflunomide in Reducing the Frequency of Relapses and Delaying the Accumulation of Physical Disability in Subjects With Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (for teriflunomide) | Sanofi | NULL | Completed | 18 Years | 55 Years | All | 1088 | Phase 3 | United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom |
| 220 | NCT00228163 (ClinicalTrials.gov) | January 2002 | 26/9/2005 | Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Extension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: teriflunomide (HMR1726) | Sanofi | NULL | Completed | 18 Years | 65 Years | Both | 147 | Phase 2 | Canada;France |
| 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 |
| 221 | NCT01487096 (ClinicalTrials.gov) | April 2001 | 5/12/2011 | Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With Relapses | Multiple Sclerosis | Drug: Teriflunomide;Drug: Placebo (placebo for teriflunomide) | Sanofi | NULL | Completed | 18 Years | 65 Years | Both | 179 | Phase 2 | Canada;France |
| 222 | EUCTR2011-005249-12-Outside-EU/EEA (EUCTR) | 10/05/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 165 | Phase 3 | Tunisia;Turkey;United States;Australia;Bosnia and Herzegovina;Canada;China;Israel;Lebanon;Morocco;Russian Federation | |||
| 223 | EUCTR2011-005249-12-BG (EUCTR) | 13/01/2017 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | 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] | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 165 | Phase 3 | United States;Serbia;Portugal;Estonia;Morocco;Greece;Spain;Ukraine;Lebanon;Ireland;Russian Federation;Israel;France;Macedonia, the former Yugoslav Republic of;Australia;Tunisia;Netherlands;China;Slovenia;Turkey;Lithuania;United Kingdom;Canada;Belgium;Poland;Bulgaria | ||||
| 224 | EUCTR2006-004893-29-DE (EUCTR) | 06/02/2007 | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | A randomized, multinational, double-blind, placebo-controlled, parallel-group design pilot study to estimate the tolerability, safety, pharmacokinetics, and pharmacodynamic effects of teriflunomide for 24 weeks when added to treatment with glatiramer acetate in subjects with multiple sclerosis | Multiple sclerosis | Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide Product Name: teriflunomide Product Code: HMR1726D INN or Proposed INN: teriflunomide | Sanofi-aventis U.S. Inc. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Austria;Germany;Italy;United Kingdom | ||||
| 225 | EUCTR2011-005249-12-IE (EUCTR) | 21/06/2016 | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple Sclerosis | A Two Year, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Teriflunomide Administered Orally Once Daily in Pediatric Patients with Relapsing Forms of Multiple Sclerosis Followed by an Open-Label Extension - TERIKIDS | Multiple Sclerosis MedDRA version: 19.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | Not Recruiting | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Estonia;Slovenia;Morocco;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;Tunisia;China;Bosnia and Herzegovina | |||
| 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 |
| 226 | EUCTR2011-005249-12-FR (EUCTR) | 17/06/2015 | A two year, randomized, placebo-controlled study to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide once daily in pediatric patients with relapsing forms of multiple sclerosis | A two year, multicenter, randomized, double-blind, placebo-controlled, parallel group trial to evaluate efficacy, safety, tolerability, and pharmacokinetics of teriflunomide administered orally once daily in pediatric patients with relapsing forms of multiple sclerosis - TERIKIDS | Multiple Sclerosis MedDRA version: 18.0;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: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE Product Name: Teriflunomide Product Code: HMR1726 INN or Proposed INN: TERIFLUNOMIDE | Genzyme Corporation | NULL | NA | Female: yes Male: yes | 165 | Phase 3 | Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;China | |||
| 227 | EUCTR2019-004972-20-BE (EUCTR) | 04/06/2020 | Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple Sclerosis | A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with Teriflunomide, in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION RMS 1) | Relapsing Multiple Sclerosis MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1;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: Evobrutinib Product Code: M2951 INN or Proposed INN: EVOBRUTINIB Other descriptive name: MSC2364447C Trade Name: Aubagio Product Name: Aubagio INN or Proposed INN: TERIFLUNOMIDE | Merck Healthcare KGaA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 930 | Phase 3 | Serbia;United States;Taiwan;Estonia;Hong Kong;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany |
| 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 | NCT01970410 (ClinicalTrials.gov) | October 2013 | 22/10/2013 | Sub-Study: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide - SWITCH-JCV | Switching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? (Sub-study: SWITCH-JCV) | Multiple Sclerosis | Drug: teriflunomide | Providence Health & Services | Multiple Sclerosis Center of Northeastern New York | Recruiting | 21 Years | 60 Years | All | 70 | Phase 4 | United States |