RECOMBINANT INTERFERON BETA-1B ( DrugBank: Interferon beta-1b, Recombinant interferon beta-1b, Interferon beta )


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16

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 : 266 - 標的パスウェイ数 : 240
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-001176-31-PT
(EUCTR)
12/03/201801/03/2018A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany;Norway;Sweden
2EUCTR2017-001176-31-CZ
(EUCTR)
07/12/201703/08/2017A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
3EUCTR2017-001176-31-FR
(EUCTR)
07/12/201716/01/2018 A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
4EUCTR2017-001176-31-GB
(EUCTR)
06/11/201721/07/2017 A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
5EUCTR2017-001176-31-DK
(EUCTR)
25/10/201714/08/2017A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
6EUCTR2017-001176-31-ES
(EUCTR)
20/09/201712/07/2017A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 4Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden;Portugal;Slovenia
7EUCTR2017-001176-31-FI
(EUCTR)
14/09/201710/08/2017A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
8EUCTR2017-001176-31-AT
(EUCTR)
07/09/201726/07/2017A long term follow up study to look at the progress of patients withsymptoms suggestive of MS who took part in previous studies withBetaferon®/Betaseron®BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: RECOMBINANT INTERFERON BETA-1B
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Bayer AG,NULLNot RecruitingFemale: yes
Male: yes
300Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Norway;Germany;Sweden
9EUCTR2016-000434-21-PT
(EUCTR)
14/11/201614/09/2016PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™)PLENO – Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Portuguese Patients with Relapsing Remitting Multiple Sclerosis (MS) Transitioning from Current Subcutaneous Interferon Therapy to Peginterferon Beta 1a (PLEGRIDY™) Relapsing-remitting multiple sclerosis
MedDRA version: 21.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy 125 micrograms
INN or Proposed INN: Peginterferon beta-1a
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Rebif 22 micrograms
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 44 micrograms
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Betaferon 250 microgram/ml
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Trade Name: Extavia 250 micrograms/ml
INN or Proposed INN: Recombinant Interferon Beta-1b
Other descriptive name: RECOMBINANT INTERFERON BETA-1B
Trade Name: Plegridy 63 micrograms
INN or Proposed INN: Peginterferon beta-1a
Other descriptive name: PEGINTERFERON BETA-1A
Biogen PortugalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 4Portugal
10EUCTR2012-005262-35-GB
(EUCTR)
14/08/201311/06/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
468 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;Slovenia;Finland;Spain;Austria;Israel;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
11EUCTR2012-005262-35-IT
(EUCTR)
14/08/201325/06/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
Product Name: Betaferon
Product Code: BAY86-5046
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
468Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
12EUCTR2012-005262-35-AT
(EUCTR)
19/07/201302/04/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
468Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
13EUCTR2012-005262-35-SI
(EUCTR)
10/07/201310/07/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
468Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
14EUCTR2012-005262-35-ES
(EUCTR)
28/06/201313/06/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/mL, powder and solvent for solution for injection.
Product Name: Betaferon
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
468 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesPortugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
15EUCTR2012-005262-35-FI
(EUCTR)
18/06/201325/04/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
468Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden
16EUCTR2012-005262-35-CZ
(EUCTR)
13/06/201326/03/2013A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon®/Betaseron®BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis - BENEFIT 11 Clinically isolated syndrome (CIS) and multiple sclerosis (MS)
MedDRA version: 17.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 17.0;Classification code 10071068;Term: Clinically isolated syndrome;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Betaferon 250 microgram/ml, powder and solvent for solution for injection
INN or Proposed INN: Recombinant interferon beta-1b
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
468Phase 4Portugal;Slovenia;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Norway;Netherlands;Germany;Sweden