Rebif 44 micrograms solution for injection ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
13多発性硬化症/視神経脊髄炎15

13. 多発性硬化症/視神経脊髄炎


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 269 - 標的パスウェイ数 : 241
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2009-015556-15-NL
(EUCTR)
13/08/201008/04/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
2EUCTR2008-003706-33-GR
(EUCTR)
10/03/201012/03/2009A 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: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
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 InternationalNULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
3EUCTR2008-003706-33-FR
(EUCTR)
02/07/200912/03/2009A 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: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
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 InternationalNULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden
4EUCTR2008-003706-33-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
5EUCTR2008-003706-33-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
6EUCTR2008-003706-33-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
7EUCTR2008-003706-33-AT
(EUCTR)
02/04/200924/11/2008A 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: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
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 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
8EUCTR2008-003706-33-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
9EUCTR2008-003706-33-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
10EUCTR2008-003706-33-NO
(EUCTR)
18/03/200909/12/2008A 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: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
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 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
11EUCTR2008-003706-33-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
12EUCTR2008-003706-33-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
13EUCTR2008-003706-33-ES
(EUCTR)
29/01/200909/12/2008A 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.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - 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.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - 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).Sujetos con un primer episodio de desmielinización clínica (Síndrome aislado desde el punto de vista clínico (CIS)) de alto riesgo de conversión a Esclerosis Múltiple (EM).
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2?-deoxy-ß-D-adenosine
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 InternationalNULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
14EUCTR2008-003706-33-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
15EUCTR2008-003706-33-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