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

  
65 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-002632-17-GB
(EUCTR)
25/07/201806/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Norway;Netherlands;Sweden;United Kingdom
2EUCTR2017-002632-17-PT
(EUCTR)
16/07/201819/04/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
3EUCTR2017-002631-42-IT
(EUCTR)
16/07/201817/06/2021A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis - . Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Mavenclad
Product Code: [-]
INN or Proposed INN: CLADRIBINA
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
MERCK KGAANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
265Phase 4Czechia;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
4EUCTR2017-002632-17-AT
(EUCTR)
11/07/201805/01/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden
5EUCTR2017-002631-42-FI
(EUCTR)
26/06/201828/02/2018A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
300Phase 4Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
6EUCTR2017-002632-17-SK
(EUCTR)
26/06/201817/04/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Czechia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden
7EUCTR2017-002632-17-GR
(EUCTR)
05/06/201829/05/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
8EUCTR2017-002632-17-BE
(EUCTR)
24/05/201801/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden
9EUCTR2017-002631-42-GB
(EUCTR)
21/05/201818/12/2017A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
265Phase 4Finland;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
10EUCTR2017-002632-17-NL
(EUCTR)
14/05/201827/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden
11EUCTR2017-002631-42-BE
(EUCTR)
09/05/201822/02/2018A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
300Phase 4Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
12EUCTR2017-002631-42-CZ
(EUCTR)
25/04/201830/01/2018A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
265Phase 4Czechia;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
13EUCTR2017-002632-17-CZ
(EUCTR)
25/04/201829/01/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Czechia;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden
14EUCTR2017-002632-17-SE
(EUCTR)
18/04/201817/01/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
15EUCTR2017-002631-42-SE
(EUCTR)
18/04/201805/12/2017A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
265Phase 4Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
16EUCTR2017-002632-17-FR
(EUCTR)
10/04/201807/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
17EUCTR2017-002631-42-FR
(EUCTR)
10/04/201814/02/2018A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
300Phase 4Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
18EUCTR2017-002632-17-DK
(EUCTR)
21/03/201801/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Denmark;Australia;Netherlands;Norway;Sweden
19EUCTR2017-002632-17-ES
(EUCTR)
16/03/201825/01/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
20EUCTR2017-002632-17-FI
(EUCTR)
05/03/201805/02/2018A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden
21EUCTR2017-002631-42-HU
(EUCTR)
26/02/201828/12/2017A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
300Phase 4Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Canada;Belgium;Australia;Denmark;Norway;Netherlands;Germany;Sweden
22EUCTR2017-002632-17-HU
(EUCTR)
26/02/201828/12/2017A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Ireland;Lithuania;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Sweden
23EUCTR2017-002631-42-AT
(EUCTR)
19/02/201811/01/2018A Clinical Research Study for People with Relapsing Multiple SclerosisA 2-year prospective study to evaluate the onset of action of Mavenclad® in subjects with highly active relapsing multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
265Phase 4Czechia;Finland;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Germany;Netherlands;Sweden
24EUCTR2017-002632-17-LT
(EUCTR)
30/01/201821/12/2017A Quality of Life Study for People with Relapsing Multiple SclerosisA 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad® Relapsing multiple sclerosis
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mavenclad®
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxyadenosine (2-CdA)
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
445Phase 4Portugal;Slovakia;Greece;Finland;Spain;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Sweden
25EUCTR2009-017978-21-PL
(EUCTR)
17/08/201206/03/2012Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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]
Product Name: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Belgium;Poland;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
26EUCTR2009-017978-21-PT
(EUCTR)
06/07/201211/08/2011Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Prospective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
27EUCTR2009-017978-21-GR
(EUCTR)
17/01/201208/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3Serbia;Portugal;United Arab Emirates;United States;Estonia;Saudi Arabia;Taiwan;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
28EUCTR2009-017978-21-DK
(EUCTR)
21/09/201112/09/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
29EUCTR2009-017978-21-LT
(EUCTR)
25/07/201130/03/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 16.0;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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
30EUCTR2009-017978-21-ES
(EUCTR)
13/07/201117/11/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials - PREMIERE Registry Pacientes con esclerosis múltiple que hayan participado en estudios con cladribina.
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2?-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
31EUCTR2009-017978-21-BE
(EUCTR)
12/07/201129/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;United Arab Emirates;Portugal;Serbia;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Netherlands;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
32EUCTR2009-017978-21-SE
(EUCTR)
08/06/201103/05/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
33EUCTR2009-017978-21-FI
(EUCTR)
07/06/201128/03/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
34EUCTR2009-017978-21-CZ
(EUCTR)
06/06/201111/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 15.1;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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
2175Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
35EUCTR2009-017978-21-GB
(EUCTR)
03/06/201111/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
2175Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Tunisia;Netherlands;Latvia;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Brazil;Belgium;Singapore;Romania;Croatia;Bulgaria;Georgia;Norway;Germany;Sweden
36EUCTR2009-017978-21-IT
(EUCTR)
16/05/201105/01/2012Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE). - PREMIERE Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine Tablet
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-CdA, 2-chloro-2'-deoxy-ß-D-adenosine
MERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
2175Phase 3Portugal;United Arab Emirates;Estonia;Saudi Arabia;Taiwan;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;India;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Korea, Democratic People's Republic of;Turkey;Lithuania;Austria;United States Minor Outlying Islands;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Bulgaria;Georgia;Germany;Sweden
37EUCTR2009-017978-21-LV
(EUCTR)
06/05/201118/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
MedDRA version: 15.1;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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
38EUCTR2009-017978-21-AT
(EUCTR)
05/05/201131/03/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
39EUCTR2009-017978-21-EE
(EUCTR)
21/04/201113/04/2011Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Taiwan;Saudi Arabia;Estonia;Morocco;Greece;Spain;Thailand;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Denmark;Australia;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Brazil;Poland;Belgium;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
40EUCTR2009-017978-21-BG
(EUCTR)
08/02/201111/09/2015Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
41EUCTR2009-017978-21-DE
(EUCTR)
20/12/201022/11/2010Long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trialsProspective observational long-term safety registry of Multiple Sclerosis patients who have participated in cladribine clinical trials (PREMIERE) - PREMIERE Registry Multiple Sclerosis patients who have participated in cladribine tablets clinical trials
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: Cladribine tablets
Product Code: Not applicable
INN or Proposed INN: Cladribine
Other descriptive name: 2-CdA, 2-chloro-2’-deoxy-ß-D-adenosine
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
2175 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;United Arab Emirates;Saudi Arabia;Taiwan;Estonia;Morocco;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;India;France;Macedonia, the former Yugoslav Republic of;Australia;Denmark;Netherlands;Latvia;Tunisia;Korea, Republic of;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Brazil;Singapore;Romania;Croatia;Georgia;Bulgaria;Norway;Germany;Sweden
42EUCTR2008-003706-33-GB
(EUCTR)
09/06/200927/11/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
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: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden
43EUCTR2008-003706-33-SE
(EUCTR)
04/06/200909/04/2009Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
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: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
44EUCTR2008-003706-33-BG
(EUCTR)
28/05/200909/07/2009Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
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: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway
45EUCTR2008-003706-33-DE
(EUCTR)
31/03/200909/12/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
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: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain
46EUCTR2008-003706-33-CZ
(EUCTR)
24/03/200922/10/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
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: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon
47EUCTR2008-003706-33-BE
(EUCTR)
16/03/200909/12/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
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: Cladribine
Product Code: L01BB04
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden
48EUCTR2008-003706-33-PT
(EUCTR)
06/03/200917/12/2008A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) TrialA Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden
49EUCTR2008-003706-33-EE
(EUCTR)
31/12/200820/11/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
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: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Romania;Estonia;Thailand;Spain;Bosnia and Herzegovina;Lebanon
50EUCTR2008-003706-33-FI
(EUCTR)
18/12/200810/11/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
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: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon
51EUCTR2007-000381-20-BG
(EUCTR)
28/10/200820/10/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
52EUCTR2007-000381-20-GR
(EUCTR)
09/09/200801/04/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Czech Republic;Denmark;Estonia;Greece;Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom
53EUCTR2007-000381-20-NL
(EUCTR)
29/08/200801/02/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
54EUCTR2007-000381-20-LT
(EUCTR)
15/07/200806/06/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
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: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
55EUCTR2007-000381-20-LV
(EUCTR)
29/05/200812/05/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany
56EUCTR2007-000381-20-EE
(EUCTR)
19/05/200828/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
57EUCTR2007-000381-20-PT
(EUCTR)
28/04/200815/01/2008A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Germany;Netherlands;Bulgaria;France;Italy;Austria;Lithuania;Finland;United Kingdom;Czech Republic;Denmark;Estonia;Greece
58EUCTR2007-000381-20-CZ
(EUCTR)
23/04/200814/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
59EUCTR2007-000381-20-DK
(EUCTR)
15/04/200805/03/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
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: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Australia;United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
60EUCTR2007-000381-20-DE
(EUCTR)
17/03/200828/02/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Portugal;Serbia;Estonia;Saudi Arabia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Denmark;Australia;Latvia;Netherlands;Finland;Turkey;Lithuania;Austria;United Kingdom;Czech Republic;Canada;Brazil;Belgium;Poland;Croatia;Bulgaria;Germany
61EUCTR2007-000381-20-GB
(EUCTR)
04/03/200826/11/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
1100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Italy;Switzerland;France;Australia;Denmark;Latvia;Netherlands;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
62EUCTR2007-000381-20-BE
(EUCTR)
21/01/200820/12/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3United States;Serbia;Portugal;Saudi Arabia;Estonia;Morocco;Greece;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;Australia;Denmark;Netherlands;Latvia;Finland;Lithuania;Turkey;Austria;United Kingdom;Czech Republic;Canada;Poland;Belgium;Brazil;Croatia;Bulgaria;Germany
63EUCTR2007-000381-20-AT
(EUCTR)
30/12/200703/01/2008CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;France;Bulgaria;Austria;Brazil;Australia;Czech Republic;Canada;Serbia;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Latvia;Morocco;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon
64EUCTR2007-000381-20-FR
(EUCTR)
14/12/200717/10/2007A Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MSA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - Extension trial to Trial 25643: Oral Cladribine in MS Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Portugal;Estonia;Greece;Finland;Lithuania;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Denmark;Bulgaria;Latvia;Netherlands;Germany
65EUCTR2007-000381-20-FI
(EUCTR)
16/11/200715/10/2007CLARITY Extension StudyA Phase IIIb, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have Completed Trial 25643 (CLARITY). - CLARITY EXTENSION Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: cladribine
Product Code: Not Applicable
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxyadenosine (2-CdA)
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
1100Phase 3Germany;Bulgaria;France;Austria;Australia;Brazil;Czech Republic;Serbia;Canada;Belgium;United States;Croatia;Greece;Poland;Portugal;Turkey;Switzerland;Netherlands;Italy;Morocco;Latvia;Lithuania;Finland;United Kingdom;Russian Federation;Ukraine;Saudi Arabia;Denmark;Estonia;Lebanon