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

13. 多発性硬化症/視神経脊髄炎 [臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228
Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
227 / 3,050 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04586023
(ClinicalTrials.gov)
December 26, 20208/10/2020Study 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 SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: teriflunomide;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years55 YearsAll734Phase 3United States
2EUCTR2020-000644-55-FR
(EUCTR)
22/12/202015/06/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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
3NCT04586010
(ClinicalTrials.gov)
December 18, 20208/10/2020A 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 SclerosisRelapsing Multiple SclerosisDrug: fenebrutinib;Drug: teriflunomide;Drug: placeboHoffmann-La RocheNULLRecruiting18 Years55 YearsAll734Phase 3United States
4EUCTR2019-004857-10-FI
(EUCTR)
20/11/202003/11/2020To Evaluate the Efficacy and Safety of Fenebrutinib Compared with Teriflunomide in Adult Patients with Relapsing Multiple SclerosisA 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, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
734Phase 3United States;France;Finland;Netherlands
5EUCTR2020-000637-41-FI
(EUCTR)
19/11/202007/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Belarus;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2020-000644-55-NL
(EUCTR)
09/11/202010/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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
7EUCTR2019-004972-20-FI
(EUCTR)
06/11/202004/09/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United 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
8EUCTR2019-004972-20-DE
(EUCTR)
05/11/202011/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Korea, 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
9EUCTR2019-004980-36-LT
(EUCTR)
22/10/202025/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Portugal;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
10EUCTR2020-000637-41-LT
(EUCTR)
22/10/202009/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2020-000637-41-SE
(EUCTR)
16/10/202007/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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
12EUCTR2019-004980-36-BG
(EUCTR)
12/10/202019/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United 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
13EUCTR2020-000637-41-DK
(EUCTR)
08/10/202009/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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
14EUCTR2020-000644-55-CZ
(EUCTR)
07/10/202003/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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
15EUCTR2019-004980-36-DE
(EUCTR)
29/09/202008/09/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Philippines;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2019-004972-20-BG
(EUCTR)
23/09/202019/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Hong 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
17EUCTR2020-000644-55-LV
(EUCTR)
21/09/202004/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3Chile;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
18EUCTR2020-000644-55-GR
(EUCTR)
18/09/202010/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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
19EUCTR2019-004980-36-LV
(EUCTR)
14/09/202001/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United 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
20EUCTR2020-000644-55-GB
(EUCTR)
04/09/202003/09/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2019-004972-20-AT
(EUCTR)
26/08/202026/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United 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
22EUCTR2020-000637-41-BG
(EUCTR)
11/08/202015/07/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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
23EUCTR2019-004972-20-HU
(EUCTR)
05/08/202002/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Serbia;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
24EUCTR2019-004980-36-GR
(EUCTR)
31/07/202002/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3United 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
25EUCTR2019-004980-36-SK
(EUCTR)
31/07/202027/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Portugal;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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2020-000637-41-DE
(EUCTR)
31/07/202017/06/2020RMS 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1200Phase 3United 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
27EUCTR2019-004972-20-GB
(EUCTR)
29/07/202011/05/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Serbia;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
28NCT04338061
(ClinicalTrials.gov)
July 2, 20206/4/2020Study 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 SafetyRelapsing Multiple SclerosisDrug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib)Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyEMD Serono Research & Development Institute, Inc.Recruiting18 Years55 YearsAll930Phase 3United States;Bulgaria;Germany;Greece;Italy;Lithuania;Poland;Puerto Rico;Slovakia;Spain;Ukraine
29NCT04410978
(ClinicalTrials.gov)
June 30, 202028/5/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: SAR442168;Drug: Teriflunomide HMR1726;Drug: Placebo to match SAR442168;Drug: Placebo to match TeriflunomideSanofiNULLRecruiting18 Years55 YearsAll900Phase 3United States;Bulgaria;Canada;Czechia;Estonia;Spain
30NCT04338022
(ClinicalTrials.gov)
June 12, 20206/4/2020Study of Evobrutinib in Participants With Relapsing Multiple SclerosisA 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 SafetyRelapsing Multiple SclerosisDrug: Evobrutinib;Drug: Placebo (match to Teriflunomide);Drug: Teriflunomide;Drug: Placebo (match to Evobrutinib)Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, GermanyEMD Serono Research & Development Institute, Inc.Recruiting18 Years55 YearsAll930Phase 3United States;Australia;Belgium;Bulgaria;Canada;Estonia;France;Italy;Korea, Republic of;Poland;Spain;Taiwan;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT04410991
(ClinicalTrials.gov)
June 11, 202028/5/2020Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor SAR442168A Phase 3, Randomized, Double-blind Efficacy and Safety Study Comparing SAR442168 to Teriflunomide (Aubagio®) in Participants With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: SAR442168;Drug: Teriflunomide HMR1726;Drug: Placebo to match SAR442168;Drug: Placebo to match TeriflunomideSanofiNULLRecruiting18 Years55 YearsAll900Phase 3United States;Belgium;Brazil;Canada;Chile;Czechia;Korea, Republic of;Latvia;Puerto Rico;Spain
32NCT04410965
(ClinicalTrials.gov)
May 20, 202028/5/2020Evaluation 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 WeeksEvaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 WeeksMultiple SclerosisDrug: TERIFLUNOMIDESanofiNULLRecruiting18 Years55 YearsAll80Phase 4China
33NCT04129736
(ClinicalTrials.gov)
October 10, 201915/10/2019Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple SclerosisDetermination of Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Patients With Multiple Sclerosis Treated With Teriflunomide 14 mg Daily.Multiple Sclerosis, PharmacokineticsDrug: Teriflunomide 14 MGJan LyckeNULLRecruiting18 Years65 YearsAll20Phase 4Sweden
34NCT04056897
(ClinicalTrials.gov)
June 7, 201912/8/2019Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple SclerosisInternational 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 SclerosisMultiple SclerosisBiological: BCD-132, 125 mg;Drug: Teriflunomide;Drug: Placebo;Biological: BCD-132, 500 mgBiocadNULLRecruiting18 Years60 YearsAll270Phase 2Russian Federation
35NCT03856619
(ClinicalTrials.gov)
March 27, 201925/2/2019To Evaluate the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple SclerosisA Single Arm Phase IV Clinical Trial to Describe the Safety and Efficacy of Teriflunomide in Patients With Relapsing Forms of Multiple SclerosisRelapsing Multiple SclerosisDrug: TERIFLUNOMIDE HMR1726SanofiNULLRecruiting18 YearsN/AAll193Phase 4India
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36NCT03526224
(ClinicalTrials.gov)
June 4, 20183/5/2018Teriflunomide Tecfidera LMCEEffect of Teriflunomide on Cortical Atrophy and Leptomeningeal Inflammation in Multiple Sclerosis: A Retrospective Observational Case-control Pilot StudyTecfidera;TeriflunomideDrug: Dimethyl Fumarate;Drug: TeriflunomideUniversity at BuffaloNULLUnknown status18 Years65 YearsAll120United States
37NCT03464448
(ClinicalTrials.gov)
April 17, 20187/3/2018Mechanistic Studies of Teriflunomide in RRMSMechanistic Studies of Teriflunomide in Relapsing Remitting Multiple Sclerosis: Regulatory B Lymphocytes as Central Mediators of the Therapeutic Effects of Teriflunomide in MSRelapsing Remitting Multiple SclerosisDrug: TeriflunomideUniversity of MichiganNULLActive, not recruiting18 Years65 YearsAll30United States
38EUCTR2016-004414-10-SE
(EUCTR)
23/02/201802/01/2018Determination 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
20Phase 4Sweden
39EUCTR2017-000639-15-HR
(EUCTR)
19/12/201713/04/2018UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase 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 TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Serbia;Belarus;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;Georgia;United Kingdom
40EUCTR2017-000638-75-PL
(EUCTR)
13/12/201720/09/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Serbia;Belarus;United States;Spain;Poland;Ukraine;Russian Federation;Georgia;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2017-000638-75-GB
(EUCTR)
05/12/201706/09/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase 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 TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3United States;Serbia;Belarus;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom
42EUCTR2017-000638-75-ES
(EUCTR)
05/12/201710/10/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase 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 TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Serbia;Belarus;United States;Poland;Spain;Ukraine;Russian Federation;Georgia;United Kingdom
43EUCTR2017-000639-15-ES
(EUCTR)
05/12/201710/10/2017UbLiTuximab In Multiple Sclerosis Treatment EffectsPhase 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 TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3Belarus;United States;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom
44EUCTR2017-000639-15-GB
(EUCTR)
04/12/201706/09/2017Ublituximab In Multiple Sclerosis Treatment EffectsPhase 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 TherapeuticsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
440Phase 3United States;Belarus;Poland;Spain;Ukraine;Romania;Croatia;Russian Federation;United Kingdom
45NCT03122652
(ClinicalTrials.gov)
September 25, 201712/4/2017Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiologically Isolated SyndromeMulti-center, Randomized, Double-blinded Study of Teriflunomide® in Radiologically Isolated Syndrome (RIS) The TERIS StudyMultiple SclerosisDrug: Teriflunomide 14 MG Oral Tablet [Aubagio];Drug: Placebo Oral TabletCentre Hospitalier Universitaire de NiceGenzyme, a Sanofi CompanyActive, not recruiting18 YearsN/AAll125Phase 3France;Switzerland;Turkey;Germany;Martinique;Sweden;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2016-003622-16-FI
(EUCTR)
19/09/201727/02/2017The 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 HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Finland
47NCT03277248
(ClinicalTrials.gov)
August 1, 20177/9/2017A 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: TeriflunomideTG Therapeutics, Inc.NULLActive, not recruiting18 Years55 YearsAll500Phase 3United States
48NCT03277261
(ClinicalTrials.gov)
August 1, 20177/9/2017A 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: TeriflunomideTG Therapeutics, Inc.NULLActive, not recruiting18 Years55 YearsAll500Phase 3United States
49EUCTR2011-005249-12-SI
(EUCTR)
15/05/201713/03/2017Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLNot Recruiting Female: yes
Male: yes
165Phase 3Portugal;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
50EUCTR2011-005249-12-PT
(EUCTR)
24/04/201701/02/2017Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51EUCTR2011-005249-12-NL
(EUCTR)
15/03/201708/11/2016Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Portugal;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
52EUCTR2015-005418-31-FR
(EUCTR)
07/03/201712/01/2017Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
53EUCTR2015-005419-33-HR
(EUCTR)
10/02/201705/06/2017Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
54EUCTR2015-005418-31-CZ
(EUCTR)
31/01/201714/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
55EUCTR2015-005419-33-CZ
(EUCTR)
31/01/201720/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2015-005419-33-BG
(EUCTR)
19/01/201725/11/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Taiwan;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
57EUCTR2015-005418-31-NL
(EUCTR)
04/01/201708/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
58EUCTR2015-005418-31-HR
(EUCTR)
13/12/201615/12/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
59NCT03561402
(ClinicalTrials.gov)
December 1, 20167/6/2018Biomarkers 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-RemittingDrug: TeriflunomideMcGill UniversityNULLUnknown status18 Years55 YearsAll75Canada
60EUCTR2015-005418-31-BG
(EUCTR)
01/12/201612/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2015-005418-31-PL
(EUCTR)
11/11/201620/09/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
62EUCTR2015-005419-33-LV
(EUCTR)
03/11/201611/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Portugal;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
63EUCTR2015-005418-31-GR
(EUCTR)
21/10/201605/09/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
64EUCTR2015-005419-33-DE
(EUCTR)
21/10/201607/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
65EUCTR2016-001515-20-IT
(EUCTR)
20/10/201607/02/2018ndEFFECT 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. GEMELLINULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 4Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2015-005418-31-BE
(EUCTR)
17/10/201607/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
67EUCTR2015-005419-33-FR
(EUCTR)
14/10/201612/01/2017Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Portugal;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
68EUCTR2015-005419-33-GB
(EUCTR)
11/10/201613/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
69EUCTR2015-005418-31-GB
(EUCTR)
11/10/201611/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
70EUCTR2015-005419-33-PT
(EUCTR)
06/10/201628/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1313Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2015-005419-33-LT
(EUCTR)
03/10/201623/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3Bulgaria;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
72EUCTR2015-005419-33-BE
(EUCTR)
26/09/201611/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
73EUCTR2015-005418-31-DK
(EUCTR)
23/09/201613/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
74EUCTR2015-005419-33-HU
(EUCTR)
21/09/201608/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
75EUCTR2015-005418-31-HU
(EUCTR)
21/09/201608/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT02792218
(ClinicalTrials.gov)
September 20, 20162/6/2016Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple SclerosisA Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injectionsNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll930Phase 3United 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
77EUCTR2015-005419-33-FI
(EUCTR)
20/09/201613/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
78EUCTR2015-005418-31-SK
(EUCTR)
19/09/201629/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
79EUCTR2015-005419-33-SK
(EUCTR)
19/09/201603/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
80EUCTR2015-005418-31-DE
(EUCTR)
13/09/201608/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81EUCTR2015-005418-31-EE
(EUCTR)
12/09/201610/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
82EUCTR2015-005418-31-SE
(EUCTR)
06/09/201613/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
83EUCTR2015-005419-33-ES
(EUCTR)
03/09/201605/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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.NULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
84EUCTR2015-005418-31-ES
(EUCTR)
03/09/201605/08/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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.NULLNot RecruitingFemale: yes
Male: yes
900Phase 3United 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
85NCT02792231
(ClinicalTrials.gov)
August 26, 20162/6/2016Efficacy 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 ScelrosisDrug: Ofatumumab subcutaneous injection;Drug: Teriflunomide-matching placebo capsules;Drug: Teriflunomide capsule;Drug: Matching placebo of ofatumumab subcutaneous injectionsNovartis PharmaceuticalsNULLCompleted18 Years55 YearsAll957Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2015-005419-33-AT
(EUCTR)
16/08/201615/07/2016Study of efficacy and safety of ofatumumab compared to teriflunomide in patients with relapsing forms of multiple sclerosisA 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 AGNULLNot RecruitingFemale: yes
Male: yes
1313Phase 3United 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
87NCT02587195
(ClinicalTrials.gov)
December 18, 201522/9/2015A 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 PeriodA 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 PeriodMultiple SclerosisDrug: TeriflunomideCentre Hospitalier Universitaire de NiceNULLUnknown status18 Years55 YearsAll5Phase 3France
88EUCTR2011-005249-12-LT
(EUCTR)
06/11/201502/10/2015Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United 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
89NCT02490982
(ClinicalTrials.gov)
November 201526/6/2015Teriflunomide Observational Effectiveness StudyTeriflunomide Observational Effectiveness StudyRelapsing Remitting Multiple SclerosisDrug: TeriflunomideCentre hospitalier de l'Université de Montréal (CHUM)Genzyme, a Sanofi Company;Montreal Neurological Institute and HospitalEnrolling by invitation18 YearsN/AAll300N/ACanada
90EUCTR2012-000540-10-PT
(EUCTR)
23/10/201521/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Hungary;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2012-000540-10-LT
(EUCTR)
21/10/201517/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot Recruiting Female: yes
Male: yes
1100Phase 3Serbia;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
92EUCTR2012-000540-10-HU
(EUCTR)
15/10/201519/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;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
93EUCTR2012-000540-10-SE
(EUCTR)
07/10/201514/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;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
94EUCTR2012-000540-10-GR
(EUCTR)
02/10/201505/11/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot Recruiting Female: yes
Male: yes
1100Phase 3Serbia;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
95EUCTR2012-000540-10-LV
(EUCTR)
25/09/201514/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100Phase 3Serbia;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2012-000540-10-DE
(EUCTR)
23/09/201503/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;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
97EUCTR2012-000540-10-HR
(EUCTR)
23/09/201501/10/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1100Phase 3Serbia;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
98EUCTR2012-000540-10-FI
(EUCTR)
23/09/201519/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot Recruiting Female: yes
Male: yes
1100Phase 3Serbia;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
99EUCTR2012-000540-10-ES
(EUCTR)
21/09/201511/09/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Greece;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
100EUCTR2012-000540-10-CZ
(EUCTR)
15/09/201517/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot Recruiting Female: yes
Male: yes
1100Phase 3Serbia;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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2012-000540-10-PL
(EUCTR)
25/08/201512/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Serbia;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
102EUCTR2012-000540-10-FR
(EUCTR)
31/07/201503/08/2015International clinical trial to compare ponesimod and teriflunomide in relapsing multiple sclerosisMulticenter, 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 LtdNULLNot Recruiting Female: yes
Male: yes
1100Phase 3Serbia;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
103EUCTR2011-005249-12-PL
(EUCTR)
11/06/201507/07/2014A 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 sclerosisA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
165United States;Estonia;Greece;Spain;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;Canada;Poland;Belgium;Australia;China
104NCT02425644
(ClinicalTrials.gov)
June 4, 201521/4/2015Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple SclerosisMulticenter, Randomized, Double-blind, Parallel-group, Active-controlled, Superiority Study to Compare the Efficacy and Safety of Ponesimod to Teriflunomide in Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: ponesimod;Drug: teriflunomideActelionNULLCompleted18 Years55 YearsAll1133Phase 3United 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
105EUCTR2011-005249-12-GB
(EUCTR)
29/09/201414/07/2014Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2011-005249-12-EE
(EUCTR)
13/08/201427/02/2014Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165United States;Estonia;Greece;Canada;Spain;Belgium;Lebanon;Turkey;Australia;Russian Federation;Israel;China
107EUCTR2013-001439-34-GR
(EUCTR)
29/07/201423/04/2014Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Canada;Greece;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden
108NCT02201108
(ClinicalTrials.gov)
July 16, 201417/7/2014Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple SclerosisA 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 ExtensionMultiple SclerosisDrug: Teriflunomide;Drug: PlaceboGenzyme, a Sanofi CompanyNULLActive, not recruiting10 Years17 YearsAll166Phase 3United 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
109EUCTR2011-005249-12-BE
(EUCTR)
11/07/201417/03/2014Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165Phase 3Serbia;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
110EUCTR2011-005249-12-GR
(EUCTR)
07/07/201421/05/2014A 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 sclerosisA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
165United States;Estonia;Greece;Spain;Lebanon;Turkey;Israel;Russian Federation;United Kingdom;Canada;Belgium;Australia;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
111EUCTR2011-005249-12-ES
(EUCTR)
03/06/201401/04/2014A 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 sclerosisA 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 CorporationNULLNot Recruiting Female: yes
Male: yes
165Phase 3Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Belgium;Poland;Australia;Bulgaria;Netherlands;China
112NCT02046629
(ClinicalTrials.gov)
May 201423/1/2014A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese VolunteersAn Open-label, Single-dose Study to Evaluate the Pharmacokinetic Profiles of 14 mg Teriflunomide Tablet in Healthy Chinese SubjectsMultiple SclerosisDrug: Teriflunomide HMR1726;Drug: cholestyramineSanofiNULLCompleted18 Years45 YearsBoth12Phase 1China
113EUCTR2013-001439-34-DE
(EUCTR)
15/04/201412/12/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden
114EUCTR2013-001439-34-AT
(EUCTR)
20/03/201409/01/2014Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden
115EUCTR2013-001439-34-BE
(EUCTR)
19/03/201403/12/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000United States;Greece;Canada;Finland;Spain;Belgium;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116EUCTR2013-001439-34-GB
(EUCTR)
17/02/201420/12/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;Switzerland;United Kingdom;Sweden
117EUCTR2013-001439-34-IT
(EUCTR)
03/01/201416/10/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000Phase 4United States;Greece;Finland;Spain;Austria;Chile;Italy;Switzerland;United Kingdom;Canada;Belgium;Germany;Sweden
118EUCTR2013-001439-34-FI
(EUCTR)
18/11/201319/09/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden
119EUCTR2013-001439-34-SE
(EUCTR)
17/11/201320/09/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
1000Phase 4United States;Greece;Canada;Finland;Belgium;Spain;Austria;Chile;Germany;United Kingdom;Switzerland;Sweden
120EUCTR2013-001439-34-ES
(EUCTR)
15/11/201324/10/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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 CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1000United States;Canada;Spain;Chile;Switzerland;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT01970410
(ClinicalTrials.gov)
October 201322/10/2013Sub-Study: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide - SWITCH-JCVSwitching 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 SclerosisDrug: teriflunomideProvidence Health & ServicesMultiple Sclerosis Center of Northeastern New YorkRecruiting21 Years60 YearsAll70Phase 4United States
122NCT01863888
(ClinicalTrials.gov)
October 201323/5/2013Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple SclerosisExploratory Open Label Study to Investigate the Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Relapsing Forms of Multiple SclerosisMultiple SclerosisDrug: teriflunomide HMR1726;Drug: cholestyramine;Drug: charcoalSanofiNULLCompleted18 Years55 YearsBoth70Phase 3Belgium;Germany;Netherlands
123EUCTR2012-005324-16-NL
(EUCTR)
26/09/201303/05/2013Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple SclerosisExploratory 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
68Belgium;Germany;Netherlands
124EUCTR2012-005324-16-BE
(EUCTR)
27/08/201317/04/2013Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple SclerosisExploratory 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
68Belgium;Germany;Netherlands
125EUCTR2012-005324-16-DE
(EUCTR)
05/08/201306/06/2013Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple SclerosisExploratory 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
68Belgium;Netherlands;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT01895335
(ClinicalTrials.gov)
June 20133/7/2013Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) PatientsA 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) PatientsMultiple SclerosisDrug: TeriflunomideSanofiNULLCompleted18 YearsN/AAll1001Phase 4United States;Austria;Belgium;Canada;Chile;Finland;France;Germany;Greece;Italy;Norway;Spain;Sweden;United Kingdom
127NCT03198351
(ClinicalTrials.gov)
April 25, 201322/6/2017An Observational Study on Teriflunomide-exposed PregnanciesTeriflunomide Pregnancy Outcome Exposure Registry: An OTIS Autoimmune Diseases in Pregnancy ProjectMultiple SclerosisDrug: Teriflunomide (HMR1726)SanofiNULLRecruiting16 YearsN/AFemale325United States;Canada
128EUCTR2010-023172-12-LT
(EUCTR)
12/06/201213/04/2012Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455United 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
129NCT01403376
(ClinicalTrials.gov)
September 201114/7/2011Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on TeriflunomideStudy 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 ReferenceMultiple SclerosisDrug: teriflunomide;Drug: Interferon-ß-1;Biological: Influenza vaccineSanofiNULLCompleted18 Years59 YearsAll128Phase 2Austria;Canada;Germany;Russian Federation;Ukraine
130EUCTR2011-001160-21-DE
(EUCTR)
18/07/201120/05/2011Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomideStudy 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 & developpementNULLNot RecruitingFemale: yes
Male: yes
120Canada;Ukraine;Austria;Russian Federation;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2011-001160-21-AT
(EUCTR)
06/07/201131/05/2011Study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomideStudy 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 & developpementNULLNot RecruitingFemale: yes
Male: yes
120Germany;Russian Federation;Ukraine;Canada;Austria
132EUCTR2010-023172-12-AT
(EUCTR)
26/05/201106/04/2011Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455United 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
133EUCTR2010-023172-12-PT
(EUCTR)
30/03/201101/02/2011A 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. - TERACLESA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
134EUCTR2010-023172-12-DK
(EUCTR)
23/03/201126/04/2011A 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. - TERACLESA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
135EUCTR2010-023172-12-GR
(EUCTR)
15/03/201127/01/2011A 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. - TERACLESA 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 groupNULLNot RecruitingFemale: yes
Male: yes
1455Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136EUCTR2010-023172-12-GB
(EUCTR)
14/03/201120/12/2010A 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. - TERACLESA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
137EUCTR2010-023172-12-FI
(EUCTR)
02/03/201110/01/2011Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455United 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
138EUCTR2010-023172-12-DE
(EUCTR)
25/02/201105/01/2011Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455United 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
139EUCTR2010-023172-12-SE
(EUCTR)
18/02/201107/12/2010Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455United 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
140EUCTR2010-023172-12-NL
(EUCTR)
15/02/201117/11/2010Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
141EUCTR2010-023172-12-ES
(EUCTR)
14/02/201123/12/2010Estudio 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. - TERACLESEstudio 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
142EUCTR2010-023172-12-BE
(EUCTR)
08/02/201129/11/2010A 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. - TERACLESA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
143EUCTR2010-023172-12-SK
(EUCTR)
26/01/201120/12/2010A 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. - TERACLESA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455Phase 3Portugal;Estonia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
144EUCTR2010-023172-12-NO
(EUCTR)
25/01/201103/01/2011Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455United 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
145EUCTR2010-023172-12-IT
(EUCTR)
13/01/201108/02/2011A 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 - NDA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455Portugal;Estonia;Greece;Finland;Spain;Lithuania;Austria;Italy;United Kingdom;Hungary;Belgium;Denmark;Netherlands;Norway;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2010-023172-12-EE
(EUCTR)
12/01/201114/12/2010Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
1455Chile;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
147EUCTR2010-023172-12-HU
(EUCTR)
11/01/201123/11/2010Efficacy and safety of teriflunomide in patients with relapsing multiple sclerosis and treated with interferon-betaA 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 developmentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1455Germany;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
148NCT01252355
(ClinicalTrials.gov)
January 201130/11/2010Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-betaA 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-betaMultiple Sclerosis RelapseDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-beta (IFN-beta)SanofiNULLTerminated18 Years55 YearsAll534Phase 3United 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
149EUCTR2007-004452-36-SK
(EUCTR)
06/05/201011/04/2008A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden
150EUCTR2008-006226-34-GB
(EUCTR)
03/02/201001/11/2010A 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 developpementNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Canada;Belgium;Spain;Germany;Tunisia;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151EUCTR2008-006226-34-BE
(EUCTR)
23/12/200929/09/2009A 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. - TENEREA 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 sclerosisProduct 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 developmentNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy
152EUCTR2006-003361-14-CZ
(EUCTR)
12/10/200905/05/2009Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple SclerosisLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden
153EUCTR2006-003361-14-EE
(EUCTR)
25/09/200919/08/2009Long-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 relapsesLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Czech Republic;Estonia;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
154EUCTR2006-001152-12-DE
(EUCTR)
14/09/200904/09/2007An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
780France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom
155EUCTR2007-004452-36-SE
(EUCTR)
20/08/200924/06/2009A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110Phase 3France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
156EUCTR2008-006226-34-GR
(EUCTR)
20/07/200919/03/2009A 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. - TENEREA 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 sclerosisProduct 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 developmentNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;Czech Republic;Hungary;Greece;Belgium;Spain;Germany;United Kingdom;Italy
157EUCTR2006-001152-12-LT
(EUCTR)
22/06/200931/03/2009An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
600United 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
158EUCTR2008-006226-34-CZ
(EUCTR)
08/06/200902/03/2009A 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 developpementNULLNot RecruitingFemale: yes
Male: yes
300France;Hungary;Czech Republic;Canada;Belgium;Spain;Germany;Tunisia;United Kingdom;Italy
159EUCTR2008-006226-34-DE
(EUCTR)
14/05/200903/02/2009A 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 developpementNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy
160EUCTR2008-006226-34-FR
(EUCTR)
04/05/200925/03/2009A 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 - TENEREA 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 sclerosisProduct 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 & DévelopmentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;United Kingdom;Czech Republic;Germany;France;Spain;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
161EUCTR2007-004452-36-AT
(EUCTR)
14/04/200914/04/2008An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple SclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110United 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
162NCT00883337
(ClinicalTrials.gov)
April 200916/4/2009A 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 Plus a Long Term Extension PeriodMultiple SclerosisDrug: Interferon ß-1a;Drug: TeriflunomideSanofiNULLCompleted18 YearsN/AAll324Phase 3Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom
163EUCTR2008-006226-34-ES
(EUCTR)
25/03/200923/01/2009Estudio 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. - TENEREEstudio 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 sclerosisProduct 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 developmentNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy
164EUCTR2007-004452-36-GB
(EUCTR)
24/03/200901/02/2008A 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 calibratorA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110Phase 3Belarus;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
165EUCTR2008-006226-34-HU
(EUCTR)
05/03/200909/02/2009A 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 developpementNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Canada;Belgium;Spain;Germany;Tunisia;United Kingdom;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
166EUCTR2008-006226-34-IT
(EUCTR)
05/03/200909/03/2009A 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 - TENEREA 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 developmentNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy
167EUCTR2007-004452-36-GR
(EUCTR)
17/02/200918/02/2009A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110Phase 3France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden
168EUCTR2007-004452-36-ES
(EUCTR)
04/12/200823/09/2008Estudio 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 - TOWEREstudio 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110France;Estonia;Czech Republic;Slovakia;Greece;Belgium;Spain;Austria;Germany;Netherlands;United Kingdom;Sweden
169EUCTR2007-004452-36-FR
(EUCTR)
02/12/200821/10/2008A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden
170EUCTR2006-001152-12-SK
(EUCTR)
11/11/200816/04/2008An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
780France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
171EUCTR2007-004452-36-CZ
(EUCTR)
13/10/200807/04/2008An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple SclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110United 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
172EUCTR2007-004452-36-BE
(EUCTR)
30/09/200811/03/2008An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple SclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110Phase 3United 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
173EUCTR2006-001152-12-BG
(EUCTR)
17/09/200805/09/2008An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
600Phase 3France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom
174EUCTR2006-003361-14-DK
(EUCTR)
29/08/200822/07/2008Long-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 relapsesLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Estonia;Czech Republic;Finland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
175NCT00751881
(ClinicalTrials.gov)
August 20087/5/2008An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple SclerosisA Multi-center Double-blind Parallel-group Placebo-controlled Study of the Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple SclerosisMultiple SclerosisDrug: Placebo;Drug: TeriflunomideSanofiNULLCompleted18 Years55 YearsAll1169Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
176EUCTR2007-004452-36-DE
(EUCTR)
23/07/200807/05/2008A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110France;Estonia;Czech Republic;Slovakia;Greece;Spain;Belgium;Austria;Netherlands;Germany;United Kingdom;Sweden
177EUCTR2007-003997-24-GB
(EUCTR)
08/07/200820/08/2007Long-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 relapsesLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
178EUCTR2007-004452-36-NL
(EUCTR)
09/06/200828/02/2008An Efficacy Study of Teriflunomide in Patients With Relapsing Multiple SclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110United 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
179EUCTR2007-003997-24-IT
(EUCTR)
05/06/200813/06/2008Long-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 - NDLong-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'veloppementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
180EUCTR2007-004452-36-EE
(EUCTR)
22/05/200809/04/2008A multi-center double-blind parallel-group placebo-controlled study of the efficacy and safety of teriflunomide in patients with relapsing multiple sclerosisA 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 & développementNULLNot RecruitingFemale: yes
Male: yes
1110France;Czech Republic;Estonia;Slovakia;Greece;Spain;Belgium;Austria;Germany;Netherlands;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
181EUCTR2006-003361-14-PT
(EUCTR)
07/03/200807/01/2008Multiple Sclerosis study to document the safety of two doses of teriflunomideLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080Phase 3Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
182EUCTR2006-003361-14-NL
(EUCTR)
12/02/200807/01/2008Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple SclerosisLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Norway;Sweden
183EUCTR2006-001152-12-EE
(EUCTR)
08/02/200821/11/2007An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
600United 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
184EUCTR2004-000555-42-GB
(EUCTR)
05/02/200803/03/2005A 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 relapsesA 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 sclerosisSanofi-aventis US, IncNULLNot Recruiting Female: yes
Male: yes
1080Phase 3Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;Italy;United Kingdom;Sweden
185NCT00622700
(ClinicalTrials.gov)
February 200814/2/2008Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple SclerosisAn 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 PeriodMultiple SclerosisDrug: Teriflunomide;Drug: PlaceboSanofiNULLCompleted18 Years55 YearsAll618Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
186EUCTR2006-001152-12-HU
(EUCTR)
09/01/200809/10/2007Not applicableAn 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 & développementNULLNot RecruitingFemale: yes
Male: yes
600United 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
187EUCTR2006-001152-12-FR
(EUCTR)
08/01/200811/09/2007An 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 & développementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
780Hungary;Finland;United Kingdom;Germany;Czech Republic;Denmark;Bulgaria;Estonia;France;Austria;Lithuania
188EUCTR2006-001152-12-DK
(EUCTR)
05/12/200730/10/2007An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
600United 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
189EUCTR2007-003997-24-ES
(EUCTR)
26/11/200715/10/2007Long-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 recurrenciasLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
190EUCTR2006-001152-12-GB
(EUCTR)
24/10/200714/10/2010An 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 & développementNULLNot Recruiting Female: yes
Male: yes
600Phase 3United 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.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
191EUCTR2006-001152-12-CZ
(EUCTR)
15/10/200707/08/2007An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United 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
192EUCTR2006-001152-12-FI
(EUCTR)
15/10/200711/09/2007An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
780Phase 3France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom
193EUCTR2007-003997-24-AT
(EUCTR)
14/10/200721/09/2007Long-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 relapsesLong-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 SclerosisProduct 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 & développementNULLNot RecruitingFemale: yes
Male: yes
240United Kingdom;Spain;Italy;Austria
194EUCTR2006-001152-12-AT
(EUCTR)
04/10/200720/09/2007An 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 & développementNULLNot RecruitingFemale: yes
Male: yes
780France;Estonia;Hungary;Czech Republic;Slovakia;Finland;Lithuania;Denmark;Austria;Bulgaria;Germany;United Kingdom
195NCT00811395
(ClinicalTrials.gov)
October 200718/12/2008Long Term Safety of Teriflunomide When Added to Interferon-Beta or Glatiramer Acetate in Patients With Multiple SclerosisLong-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 RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Interferon-ß [IFN-ß];Drug: Glatiramer Acetate [GA]SanofiNULLCompleted18 Years55 YearsAll182Phase 2United States;Austria;Canada;Germany;Italy;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
196EUCTR2006-003134-14-IT
(EUCTR)
24/09/200724/07/2007A 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 - NDA 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. IncNULLNot RecruitingFemale: yes
Male: yes
120Germany;Spain;Italy
197EUCTR2006-004893-29-IT
(EUCTR)
24/09/200724/07/2007A 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 - NDA 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.NULLNot RecruitingFemale: yes
Male: yes
120Germany;United Kingdom;Italy;Austria
198EUCTR2006-004893-29-GB
(EUCTR)
25/07/200717/12/2006A 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 sclerosisA 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 sclerosisSanofi-aventis U.S. Inc.NULLNot Recruiting Female: yes
Male: yes
120Phase 2Austria;Germany;Italy;United Kingdom
199EUCTR2006-003361-14-SE
(EUCTR)
24/07/200727/06/2007Long-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 relapsesLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080Phase 3Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
200EUCTR2004-000555-42-EE
(EUCTR)
06/07/200718/04/2007A 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. IncNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Czech Republic;United Kingdom;Denmark;Norway;Estonia;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
201EUCTR2006-003134-14-DE
(EUCTR)
04/06/200708/02/2007A 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 sclerosisA 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 sclerosisProduct 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.NULLNot RecruitingFemale: yes
Male: yes
120Germany;Spain;Italy
202EUCTR2006-003361-14-IT
(EUCTR)
23/05/200707/03/2007Long-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 - NDLong-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 veloppementNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;United Kingdom;Italy;Sweden
203EUCTR2004-000555-42-CZ
(EUCTR)
14/05/200709/03/2007A 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 relapsesA 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 IncNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;United Kingdom;Czech Republic;Denmark;Estonia;Norway;Italy;Sweden
204NCT00489489
(ClinicalTrials.gov)
May 200720/6/2007Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple SclerosisA 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 SclerosisDrug: Teriflunomide;Drug: Placebo (for Teriflunomide);Drug: Interferon-ßSanofiNULLCompleted18 Years55 YearsAll118Phase 2United States;Canada;Germany;Italy;Spain;Poland
205NCT00475865
(ClinicalTrials.gov)
April 200718/5/2007Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple SclerosisA 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 SclerosisMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide);Drug: Glatiramer Acetate (GA)SanofiNULLCompleted18 Years55 YearsAll123Phase 2United States;Austria;Canada;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
206EUCTR2006-004893-29-AT
(EUCTR)
19/03/200708/03/2007A 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 sclerosisA 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 sclerosisProduct 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.NULLNot RecruitingFemale: yes
Male: yes
120Germany;United Kingdom;Italy;Austria
207EUCTR2006-003361-14-DE
(EUCTR)
01/03/200728/12/2006Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple SclerosisLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080United States;Portugal;Estonia;Finland;Ukraine;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Germany;Netherlands;Sweden
208EUCTR2006-003134-14-ES
(EUCTR)
23/02/200726/10/2009A 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Germany;Spain;Italy
209EUCTR2006-003361-14-GB
(EUCTR)
23/01/200729/09/2006Long-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 relapsesLong-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 & développementNULLNot Recruiting Female: yes
Male: yes
1080Phase 3Portugal;United States;Estonia;Finland;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Germany;Norway;Sweden
210EUCTR2006-003361-14-FI
(EUCTR)
19/12/200610/11/2006Long-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 relapsesLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080Phase 3Portugal;Estonia;Czech Republic;Finland;Denmark;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
211EUCTR2006-003361-14-AT
(EUCTR)
21/11/200610/10/2006Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple SclerosisLong-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 & développementNULLNot RecruitingFemale: yes
Male: yes
1080United States;Portugal;Estonia;Finland;Ukraine;Turkey;Austria;Chile;Russian Federation;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Poland;Denmark;Netherlands;Norway;Germany;Sweden
212NCT00803049
(ClinicalTrials.gov)
October 20061/12/2008Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in Patients With Relapsing-Remitting Multiple SclerosisLong-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 RelapsesMultiple SclerosisDrug: Teriflunomide (HMR1726)SanofiNULLCompleted18 Years55 YearsAll742Phase 3United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
213EUCTR2004-000555-42-PT
(EUCTR)
26/01/200604/11/2005A 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 relapsesA 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 sclerosisProduct Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Aventis Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
870Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden
214EUCTR2004-000555-42-DK
(EUCTR)
12/12/200523/01/2008A 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 relapsesA 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, IncNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden
215EUCTR2004-000555-42-IT
(EUCTR)
30/12/200423/11/2004A 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 - TEMSOA 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`veloppementNULLNot RecruitingFemale: yes
Male: yes
870Portugal;Estonia;Czech Republic;Denmark;Norway;United Kingdom;Italy;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
216EUCTR2004-000555-42-AT
(EUCTR)
02/12/200428/10/2004A 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 relapsesA 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.NULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Estonia;Czech Republic;Denmark;Austria;Norway;United Kingdom;Italy;Sweden
217EUCTR2004-000555-42-NO
(EUCTR)
22/11/200427/09/2004A 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 - TEMSOA 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 sclerosisProduct Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Sanofi-aventis US, IncNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden
218EUCTR2004-000555-42-SE
(EUCTR)
17/11/200429/09/2004A 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 relapsesA 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, IncNULLNot RecruitingFemale: yes
Male: yes
1080Portugal;Czech Republic;United Kingdom;Denmark;Estonia;Norway;Italy;Sweden
219NCT00134563
(ClinicalTrials.gov)
September 200423/8/2005Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple SclerosisA 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 RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (for teriflunomide)SanofiNULLCompleted18 Years55 YearsAll1088Phase 3United States;Austria;Canada;Chile;Czech Republic;Denmark;Estonia;Finland;France;Germany;Italy;Netherlands;Norway;Poland;Portugal;Russian Federation;Sweden;Switzerland;Turkey;Ukraine;United Kingdom
220NCT00228163
(ClinicalTrials.gov)
January 200226/9/2005Long Term Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesExtension of Protocol HMR1726D/2001, A Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesMultiple SclerosisDrug: teriflunomide (HMR1726)SanofiNULLCompleted18 Years65 YearsBoth147Phase 2Canada;France
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
221NCT01487096
(ClinicalTrials.gov)
April 20015/12/2011Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesA Phase II Study of the Safety and Efficacy of Teriflunomide (HMR1726) in Multiple Sclerosis With RelapsesMultiple SclerosisDrug: Teriflunomide;Drug: Placebo (placebo for teriflunomide)SanofiNULLCompleted18 Years65 YearsBoth179Phase 2Canada;France
222EUCTR2019-004972-20-BE
(EUCTR)
04/06/2020Evobrutinib compared to Teriflunomide in participants with Relapsing Multiple SclerosisA 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 KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Serbia;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
223EUCTR2006-004893-29-DE
(EUCTR)
06/02/2007A 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 sclerosisA 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 sclerosisProduct 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.NULLNot RecruitingFemale: yes
Male: yes
120Austria;Germany;Italy;United Kingdom
224EUCTR2011-005249-12-Outside-EU/EEA
(EUCTR)
10/05/2016Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLNAFemale: yes
Male: yes
165Phase 3Tunisia;Turkey;United States;Australia;Bosnia and Herzegovina;Canada;China;Israel;Lebanon;Morocco;Russian Federation
225EUCTR2011-005249-12-FR
(EUCTR)
17/06/2015A 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 sclerosisA 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 CorporationNULLNAFemale: yes
Male: yes
165Phase 3Portugal;United States;Estonia;Slovenia;Greece;Spain;Ireland;Lebanon;Lithuania;Turkey;Israel;Russian Federation;United Kingdom;France;Canada;Poland;Belgium;Australia;Bulgaria;Netherlands;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
226EUCTR2011-005249-12-BG
(EUCTR)
13/01/2017Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLNA Female: yes
Male: yes
165Phase 3United 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
227EUCTR2011-005249-12-IE
(EUCTR)
21/06/2016Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients with Relapsing Forms of Multiple SclerosisA 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 CorporationNULLNot RecruitingFemale: yes
Male: yes
165Phase 3Portugal;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

25. 進行性多巣性白質脳症 [臨床試験数:23,薬物数:33(DrugBank:20),標的遺伝子数:7,標的パスウェイ数:36
Searched query = "Progressive multifocal leukoencephalopathy", "PML", "Leukoencephalopathy, progressive multifocal"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.
1 / 23 trial found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT01970410
(ClinicalTrials.gov)
October 201322/10/2013Sub-Study: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide - SWITCH-JCVSwitching 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 SclerosisDrug: teriflunomideProvidence Health & ServicesMultiple Sclerosis Center of Northeastern New YorkRecruiting21 Years60 YearsAll70Phase 4United States