13. 多発性硬化症/視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


臨床試験数 : 3,340 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238

  
26 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004980-36-RO
(EUCTR)
29/06/202127/04/2022Evobrutinib 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;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
2EUCTR2019-004980-36-SI
(EUCTR)
18/03/202106/10/2020Evobrutinib 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
3EUCTR2019-004980-36-NO
(EUCTR)
16/12/202003/07/2020Evobrutinib 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 KGaANULLNot RecruitingFemale: 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;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
4EUCTR2019-004972-20-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 3Serbia;United States;Hong Kong;Taiwan;Estonia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Georgia;Bulgaria;Germany
5EUCTR2019-004972-20-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 3Serbia;United States;Taiwan;Hong Kong;Estonia;Spain;Ukraine;Russian Federation;Israel;Chile;Colombia;Italy;India;France;Denmark;Peru;Australia;Netherlands;Bosnia and Herzegovina;Korea, Republic of;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Georgia;Bulgaria;Germany
6EUCTR2019-004980-36-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
7EUCTR2019-004980-36-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 3Portugal;Belarus;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Turkey;Lithuania;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
8EUCTR2019-004972-20-CZ
(EUCTR)
01/10/202005/06/2020Evobrutinib 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;Hong Kong;Taiwan;Estonia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Finland;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Georgia;Bulgaria;Germany
9EUCTR2019-004980-36-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 3Germany;Puerto Rico;Russian Federation;Singapore;United States;Malaysia;Thailand;Portugal;Saudi Arabia;Greece;Latvia;Sweden;Brazil;Poland;Slovakia;Slovenia;Kuwait;France;Lithuania;Bulgaria;Tunisia;Romania;Philippines;Ukraine;Belarus;Switzerland;India;Spain;Canada;Turkey;Norway;Moldova, Republic of;Mexico;South Africa;Italy
10EUCTR2019-004972-20-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 3Serbia;United States;Hong Kong;Taiwan;Estonia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Georgia;Bulgaria;Germany
11EUCTR2019-004980-36-PT
(EUCTR)
21/09/202022/05/2020Evobrutinib 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 3Belarus;Portugal;United States;Philippines;Saudi Arabia;Slovakia;Greece;Spain;Thailand;Ukraine;Russian Federation;Switzerland;Italy;India;France;Puerto Rico;Malaysia;South Africa;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
12EUCTR2019-004980-36-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
13EUCTR2019-004980-36-IT
(EUCTR)
31/08/202021/01/2021Evobrutinib 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;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
Product Code: [non applicabile]
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;Kuwait;Tunisia;Latvia;Moldova, Republic of;Slovenia;Lithuania;Turkey;Mexico;Canada;Poland;Brazil;Singapore;Romania;Bulgaria;Norway;Germany;Sweden
14EUCTR2019-004972-20-IT
(EUCTR)
31/08/202021/01/2021Evobrutinib 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;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
Product Code: [non applicabile]
INN or Proposed INN: TERIFLUNOMIDE
MERCK HEALTHCARE KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
930Phase 3Canada;Argentina;Poland;Belgium;Croatia;Georgia;Serbia;United States;Estonia;Hong Kong;Taiwan;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Australia;Peru;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Bulgaria;Germany
15EUCTR2019-004972-20-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;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Bulgaria;Georgia;Germany
16EUCTR2019-004972-20-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;Hong Kong;Taiwan;Estonia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;India;France;Peru;Australia;Denmark;Netherlands;Korea, Republic of;Bosnia and Herzegovina;Czechia;Finland;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Croatia;Georgia;Bulgaria;Germany
17EUCTR2019-004980-36-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 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
18EUCTR2019-004980-36-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
19EUCTR2019-004972-20-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
20NCT04338061
(ClinicalTrials.gov)
July 2, 20206/4/2020Study of Evobrutinib in Participants With RMS (evolutionRMS 2)A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 2)Relapsing 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.Active, not recruiting18 Years55 YearsAll1124Phase 3United States;Belarus;Brazil;Bulgaria;Canada;France;Germany;Greece;India;Italy;Latvia;Lithuania;Malaysia;Moldova, Republic of;Norway;Philippines;Poland;Portugal;Puerto Rico;Romania;Russian Federation;Saudi Arabia;Singapore;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Thailand;Turkey;Ukraine
21NCT04338022
(ClinicalTrials.gov)
June 12, 20206/4/2020Study of Evobrutinib in Participants With RMS (evolutionRMS 1)A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With Teriflunomide, in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety (evolutionRMS 1)Relapsing 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.Active, not recruiting18 Years55 YearsAll1124Phase 3France;Georgia;Germany;Hong Kong;Hungary;India;Israel;Italy;Korea, Republic of;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine;United Kingdom;Argentina;Australia;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Colombia;Croatia;Czechia;Estonia;Finland;United States
22EUCTR2018-004701-11-BG
(EUCTR)
10/01/202009/01/2020Evobrutinib compared to Avonex in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION MS1) 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 10mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Product Name: Evobrutinib 25mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Avonex
Product Name: Interferon beta 1-a
INN or Proposed INN: INTERFERON BETA-1A
Merck Healthcare KGaANULLNot RecruitingFemale: yes
Male: yes
950Phase 3Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
23EUCTR2018-004700-19-BG
(EUCTR)
10/01/202008/01/2020Evobrutinib compared to Avonex in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION MS2) 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 10mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Product Name: Evobrutinib 25mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Avonex
Product Name: Interferon beta 1-a
INN or Proposed INN: INTERFERON BETA-1A
Merck Healthcare KGaANULLNot RecruitingFemale: yes
Male: yes
950Phase 3Belarus;United States;Portugal;Slovakia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;South Africa;Tunisia;Kuwait;Moldova, Republic of;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Romania;Bulgaria;Germany
24NCT04032171
(ClinicalTrials.gov)
September 10, 201923/7/2019Study 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 an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing-remitting Multiple SclerosisDrug: Evobrutinib;Drug: Avonex®;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years55 YearsAll1Phase 3United States;Germany
25NCT04032158
(ClinicalTrials.gov)
August 26, 201923/7/2019Study 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 an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing-remitting Multiple SclerosisDrug: Evobrutinib;Drug: Avonex®;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years55 YearsAll3Phase 3United States;Germany;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;Mexico;Montenegro;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine;United Kingdom
26EUCTR2019-004972-20-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 3Croatia;Colombia;Argentina;Hungary;Ukraine;United Kingdom;India;Spain;Canada;Czech Republic;Belgium;Taiwan;Finland;Denmark;Mexico;Italy;Israel;Georgia;Australia;Peru;Germany;Estonia;Russian Federation;Hong Kong;United States;Czechia;Austria;Netherlands;Korea, Republic of;Poland;Chile;France;Bulgaria;Serbia;Bosnia and Herzegovina