13. Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238

  
71 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-003008-38-DE
(EUCTR)
10/03/202006/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Portugal;Serbia;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Germany;Kuwait;Tunisia
2EUCTR2018-004701-11-BG
(EUCTR)
10/01/202009/01/2020Evobrutinib compared to Avonex in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION MS1) Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib 10mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Product Name: Evobrutinib 25mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Avonex
Product Name: Interferon beta 1-a
INN or Proposed INN: INTERFERON BETA-1A
Merck Healthcare KGaANULLNot RecruitingFemale: yes
Male: yes
950Phase 3Serbia;United States;Taiwan;Estonia;Spain;Ukraine;Israel;Russian Federation;Italy;France;Bosnia and Herzegovina;Korea, Republic of;Austria;Montenegro;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Croatia;Bulgaria;Georgia;Germany
3EUCTR2018-004700-19-BG
(EUCTR)
10/01/202008/01/2020Evobrutinib compared to Avonex in participants with Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared with an Interferon Beta 1a (Avonex®), in Participants with Relapsing Multiple Sclerosis to Evaluate Efficacy and Safety. - Phase III Study of Evobrutinib in RMS (EVOLUTION MS2) Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Evobrutinib 10mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Product Name: Evobrutinib 25mg
Product Code: M2951
INN or Proposed INN: EVOBRUTINIB
Other descriptive name: MSC2364447C
Trade Name: Avonex
Product Name: Interferon beta 1-a
INN or Proposed INN: INTERFERON BETA-1A
Merck Healthcare KGaANULLNot RecruitingFemale: yes
Male: yes
950Phase 3Belarus;United States;Portugal;Slovakia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Switzerland;Italy;France;South Africa;Tunisia;Kuwait;Moldova, Republic of;Turkey;Lithuania;Mexico;Canada;Brazil;Poland;Romania;Bulgaria;Germany
4EUCTR2018-003008-38-HR
(EUCTR)
10/12/201917/01/2020A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
5NCT04032171
(ClinicalTrials.gov)
September 10, 201923/7/2019Study of Evobrutinib in Participants With Relapsing Multiple SclerosisA Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing-remitting Multiple SclerosisDrug: Evobrutinib;Drug: Avonex®;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years55 YearsAll1Phase 3United States;Germany
6EUCTR2018-003008-38-PT
(EUCTR)
02/09/201902/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Serbia;Portugal;United States;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Germany;Kuwait;Tunisia
7NCT04032158
(ClinicalTrials.gov)
August 26, 201923/7/2019Study of Evobrutinib in Participants With Relapsing Multiple Sclerosis (RMS)A Phase III, Multicenter, Randomized, Parallel Group, Double Blind, Double Dummy, Active Controlled Study of Evobrutinib Compared With an Interferon Beta 1a (Avonex®), in Participants With Relapsing Multiple Sclerosis to Evaluate Efficacy and SafetyRelapsing-remitting Multiple SclerosisDrug: Evobrutinib;Drug: Avonex®;Drug: PlaceboEMD Serono Research & Development Institute, Inc.Merck KGaA, Darmstadt, GermanyTerminated18 Years55 YearsAll3Phase 3United States;Germany;Argentina;Austria;Belgium;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;Mexico;Montenegro;Poland;Russian Federation;Serbia;Spain;Taiwan;Ukraine;United Kingdom
8EUCTR2018-003008-38-BE
(EUCTR)
17/07/201919/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
9EUCTR2018-003008-38-BG
(EUCTR)
10/07/201905/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a, 30 µg/0.5 ml
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a, 30 µg/0.5 ml
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Portugal;Serbia;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
10EUCTR2018-003008-38-IT
(EUCTR)
02/07/201915/06/2021A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension - na Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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
Product Name: PEGylated Interferon Beta-1a
Product Code: [BIIB017]
INN or Proposed INN: PEGINTERFERONE LAMBDA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: [IFN ß-1a]
INN or Proposed INN: INTERFERON BETA - 1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: [BIIB017]
INN or Proposed INN: PEGINTERFERONE LAMBDA-1A
Other descriptive name: PEGINTERFERONE BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: [BIIB 017]
INN or Proposed INN: PEGINTERFERONE LAMBDA-1A
Trade Name: AVONEX
Product Name: interferon beta-1a
Product Code: [IFN ß-1a]
INN or Proposed INN: INTERFERON BETA - 1A
BIOGEN IDEC RESEARCH LIMITEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Russian Federation;Israel;Italy;France;Australia;Tunisia;Kuwait;Czechia;Turkey;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Poland;Croatia;Bulgaria;Germany
11EUCTR2018-003008-38-GR
(EUCTR)
27/06/201903/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3United States;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Tunisia;Germany;Kuwait
12EUCTR2018-003008-38-SK
(EUCTR)
24/06/201926/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
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
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Serbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany
13EUCTR2018-003008-38-CZ
(EUCTR)
17/06/201906/03/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled,Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 inPediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-RemittingMultiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Hungary;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Tunisia;Germany;Kuwait;Serbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic
14EUCTR2018-003008-38-HU
(EUCTR)
30/05/201908/04/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Germany;Tunisia
15EUCTR2018-003008-38-ES
(EUCTR)
02/04/201917/05/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple SclerosisAn Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Poland;Belgium;Brazil;Croatia;Bulgaria;Kuwait;Tunisia;Germany
16NCT02744222
(ClinicalTrials.gov)
August 10, 20173/4/2016Comparative Clinical Trial to Evaluate Efficacy, Safety and Tolerance of BCD-054 and Avonex® for Treatment of Patients With Remitting-relapsing Multiple SclerosisAn International Multicenter Double-blind Placebo-controlled Randomized Study to Compare the Efficacy, Safety and Tolerability of BCD-054 (JSC BIOCAD, Russia), 180 µg and 240 µg, Versus Avonex® (Biogen Idec Ltd., UK) in Patients With Relapsing-remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: BCD-054 180 mcg;Biological: Avonex®;Biological: BCD-054 240 mcg;Other: PlaceboBiocadNULLCompleted18 Years60 YearsAll399Phase 2/Phase 3Russian Federation
17NCT01975298
(ClinicalTrials.gov)
January 201428/10/2013A Study to Evaluate 2 Doses Of Oral Administration Of Laquinimod Compared to Interferon ß-1a Administered by Injection in Participants With Relapsing Remitting Multiple Sclerosis (RRMS)A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Active-Control (Rater Blinded) Study, to Evaluate The Efficacy, Safety And Tolerability Of 2 Doses Of Oral Administration Of Laquinimod (0.6 mg/Day Or 1.2 mg/Day) Compared to Interferon ß-1a Administered Intra Muscular Once Weekly in Subjects With Relapsing Remitting Multiple Sclerosis (RRMS).Relapsing Remitting Multiple SclerosisDrug: Laquinimod;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLWithdrawn18 Years55 YearsAll0Phase 3Belgium;Denmark;Finland;France;Germany;Ireland;Italy;Netherlands;Norway;Spain;Sweden;Switzerland;United Kingdom
18EUCTR2011-006262-40-GB
(EUCTR)
24/09/201303/07/2013A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex®A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® Relapsing forms of multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIIB033
Product Code: BIIB033
Other descriptive name: Human anti-LINGO-1 monoclonal antibody
Trade Name: Avonex
Product Name: AVONEX
INN or Proposed INN: Interferon beta-1a
Biogen Idec Research LimitedNULLNot Recruiting Female: yes
Male: yes
396 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom
19EUCTR2011-006262-40-NL
(EUCTR)
03/07/201310/04/2013A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex®A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® Relapsing forms of multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIIB033
Product Code: BIIB033
INN or Proposed INN: PRD806998
Other descriptive name: Human anti-LINGO-1 monoclonal antibody
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
396Phase 2Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom
20EUCTR2011-006262-40-ES
(EUCTR)
28/06/201313/06/2013A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex®A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® Relapsing forms of multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIIB033
Product Code: BIIB033
INN or Proposed INN: No disponible
Other descriptive name: Anticuerpo monoclonal anti-LINGO-1 humano
Trade Name: Avonex
Product Name: AVONEX
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
396Phase 2France;United States;Serbia;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom
21EUCTR2011-006262-40-CZ
(EUCTR)
18/06/201305/04/2013A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex®A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® Relapsing forms of multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.0;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIIB033
Product Code: BIIB033
Other descriptive name: Human anti-LINGO-1 monoclonal antibody
Trade Name: Avonex
Product Name: AVONEX
INN or Proposed INN: Interferon beta-1a
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
396Phase 2Serbia;France;United States;Hungary;Czech Republic;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom
22EUCTR2011-006262-40-HU
(EUCTR)
06/06/201325/04/2013A study to assess the safety and efficacy of BIIB033 in patients with relapsing forms of multiple sclerosis when used concurrently with Avonex®A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® Relapsing forms of multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIIB033
Product Code: BIIB033
INN or Proposed INN: Not available
Other descriptive name: Human anti-LINGO-1 monoclonal antibody
Trade Name: Avonex
Product Name: AVONEX
INN or Proposed INN: Interferon beta-1a
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
396Phase 2Serbia;France;United States;Czech Republic;Hungary;Canada;Poland;Spain;Russian Federation;Netherlands;Italy;United Kingdom
23EUCTR2011-006262-40-IT
(EUCTR)
01/06/201308/04/2013A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects with Relapsing Forms of Multiple Sclerosis When Used Concurrently with Avonex® Relapsing forms of multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: BIIB033
Product Code: BIIB033
Other descriptive name: Human anti-LINGO-1 monoclonal antibody
Trade Name: Avonex
Product Name: AVONEX
INN or Proposed INN: Interferon beta-1a
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
396Phase 2United States;Serbia;Hungary;Czech Republic;Canada;Spain;Russian Federation;Netherlands;United Kingdom;Italy
24EUCTR2009-012500-11-SI
(EUCTR)
27/01/201210/01/2012Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab wih Greek suffix
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Denmark;Australia;Slovenia;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Germany;Sweden
25EUCTR2011-001956-12-CZ
(EUCTR)
25/05/201104/05/2011Biological Efficacy of Interferon ß Therapy in Patients with Multiple SclerosisMonitoring of MxA mRNA Expression as a Marker of Rresponse to Interferon ß Therapy in Patients with Multiple Sclerosis. To correlate bioactivity of IFNß reflected by level of MxA expression and clinical course of MS To measure expression of MxA protein in patients treated with IFNß depending on NAbs statusNAbs positive cohorts will be correlated NAbs titer with level of MxA expression, respectively if the MxA decrease is not preceding NAbs positivity. The MxA induction test will be tested.Trade Name: Avonex®
Product Name: Avonex®
Product Code: EU/1/97/033/002
Trade Name: Betaferon®
Product Name: Betaferon®
Product Code: EU/1/95/003/005-010
Trade Name: Rebif 22®
Product Name: Rebif 22®
Product Code: EU/1/98/063/001-003
Trade Name: Rebif 44®
Product Name: Rebif 44®
Product Code: EU/1/98/063/004-006
Trade Name: Extavia®
Product Name: Extavia®
Product Code: EU/1/08/454/001-002, EU/1/08/454/005-007
University Hospital MotolNULLNot RecruitingFemale: yes
Male: yes
Phase 4Czech Republic
26EUCTR2009-012500-11-DK
(EUCTR)
08/09/201004/06/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1800Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden
27EUCTR2009-012500-11-FR
(EUCTR)
25/08/201011/01/2010Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis Relapsing-remitting Multiple Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: DACLIZUMAB HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
28EUCTR2009-012500-11-CZ
(EUCTR)
19/08/201020/01/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1800United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden
29EUCTR2009-012500-11-GR
(EUCTR)
13/07/201017/05/2010Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis Relapsing-remitting Multiple Sclerosis
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: DACLIZUMAB HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1500Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
30EUCTR2009-012500-11-DE
(EUCTR)
13/07/201020/01/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1800Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden
31EUCTR2009-012500-11-FI
(EUCTR)
29/06/201022/03/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden
32EUCTR2009-012500-11-ES
(EUCTR)
24/06/201012/04/2010Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.)Estudio multicéntrico, doble ciego, aleatorizado, en grupos paralelos, en monoterapia, controlado con fármaco activo, para determinar la eficacia y la seguridad de daclizumab obtenido mediante un proceso de alto rendimiento (DAC HYP) frente a Avonex® (interferón beta 1a) en pacientes con esclerosis múltiple recidivante-remitente. (Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon beta 1a) in Patients with Relapsing-Remitting Multiple Sclerosis.) Esclerosis Múltiple recidivante-remitente
MedDRA version: 11;Level: PT;Classification code 10063399;Term: Esclerosis múltiple remitente-recurrente
Product Name: DACLIZUMAB HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX 30 microgramos/0,5 ml (Interferón Beta - 1a) Solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1500Phase 3Slovenia;Greece;Finland;Spain;Ireland;United Kingdom;Italy;France;Czech Republic;Hungary;Denmark;Germany;Sweden
33EUCTR2009-012500-11-SE
(EUCTR)
07/06/201009/04/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1800United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Switzerland;Italy;India;France;Denmark;Australia;Moldova, Republic of;Slovenia;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Romania;Georgia;Germany;Sweden
34EUCTR2009-012500-11-GB
(EUCTR)
03/06/201016/04/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab HYP
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1800Phase 3United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden
35NCT01064401
(ClinicalTrials.gov)
May 201026/1/2010Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ß 1a in Participants With Relapsing-Remitting Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon ß 1a) in Patients With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple SclerosisBiological: BIIB019 (Daclizumab High Yield Process);Drug: Interferon beta-1a Placebo;Biological: Interferon beta-1a;Drug: Daclizumab High Yield Process PlaceboBiogenAbbVieCompleted18 Years55 YearsAll1841Phase 3United States;Argentina;Australia;Brazil;Canada;Czech Republic;Denmark;Finland;France;Georgia;Germany;Greece;Hungary;India;Ireland;Israel;Italy;Mexico;Moldova, Republic of;Poland;Romania;Russian Federation;Serbia;Spain;Sweden;Switzerland;Ukraine;United Kingdom;Bulgaria;Egypt;Slovenia
36EUCTR2009-012500-11-IE
(EUCTR)
12/04/201007/01/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1800Serbia;United States;Greece;Spain;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden
37EUCTR2009-012500-11-HU
(EUCTR)
31/03/201024/02/2010Comparison of Daclizumab HYP and Avonex® in Multiple SclerosisMulticenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) versus Avonex® (Interferon ß 1a) in Patients with Relapsing-Remitting Multiple Sclerosis - DECIDE Relapsing-remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: DACLIZUMAB HYP
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: Daclizumab HYP (DAC HYP)
Trade Name: AVONEX
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
1800United States;Serbia;Greece;Spain;Ukraine;Ireland;Israel;Russian Federation;Italy;Switzerland;India;France;Australia;Denmark;Moldova, Republic of;Slovenia;Finland;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Romania;Georgia;Germany;Sweden
38EUCTR2008-000256-26-GB
(EUCTR)
16/02/200908/12/2010An exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1aAn exploratory phase IIa study to evaluate the safety and immunological effects of intravenous interferonß-1a (IFNß-1a, Rebif®) therapy in the induction of tolerance to IFNß in MS patients with neutralising antibodies (NAbs) to subcutaneous IFNß-1a (Rebif® or Avonex®) - Tolerance induction with intravenous IFNß-1a Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Mitoxantrone
Product Name: Mitoxantrone
Product Code: PL 04515/0127
Trade Name: Rebif®
INN or Proposed INN: Mitoxantrone
Queen Mary, University of LondonNULLNot RecruitingFemale: yes
Male: yes
15Phase 2United Kingdom
39EUCTR2008-003098-42-CZ
(EUCTR)
06/01/200927/10/2008A Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple SclerosisA Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple Sclerosis To evaluate the immunogenicity of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: AVONEX
INN or Proposed INN: interferon beta 1a
Biogen Idec LtdNULLNot RecruitingFemale: yes
Male: yes
150Phase 3Czech Republic
40EUCTR2007-005450-23-DE
(EUCTR)
29/12/200828/10/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
INN or Proposed INN: INTERFERON BETA-1A
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy
41NCT00784836
(ClinicalTrials.gov)
October 200829/10/2008Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) PatientsA Multicenter, Open-Label, Immunogenicity and Safety Study of Avonex® (Interferon Beta-1a) 30 mcg Administered Subcutaneously to Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: BG9418 (interferon beta 1-a)BiogenNULLTerminated18 Years60 YearsAll3Phase 3United States
42EUCTR2007-005450-23-LT
(EUCTR)
27/08/200807/05/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A (Avonex®)
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
43EUCTR2007-006338-32-ES
(EUCTR)
16/07/200828/03/2008Estudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosisEstudio en fase II de búsqueda de dosis, multicéntrico, aleatorio, de grupos paralelos, parcialmente enmascarado, con placebo y Avonex® como fármacos control, para evaluar la eficacia, determinada por las lesiones cerebrales que aparecen en la RMN y la seguridad de dos pautas terapéuticas de ocrelizumab en pacientes con EMRR.Phase II, multicenter, randomized, parallel-group, partially blinded, placebo and Avonex controlled dose finding study to evaluate the efficacy, as measured by brain MRI lesions, and safety of 2 dose regimens of ocrelizumab in patients with relapsing-remitting multiple sclerosis Esclerosis Múltiple Recurrente-remitente Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Other descriptive name: RhuMab 2H7
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2France;Czech Republic;Slovakia;Finland;Belgium;Spain;Denmark;Bulgaria;Netherlands;Germany;Italy;United Kingdom
44EUCTR2007-005450-23-BG
(EUCTR)
29/05/200827/05/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Estonia;Bulgaria;Spain;Italy;Lithuania
45NCT00605215
(ClinicalTrials.gov)
April 24, 20088/1/2008BRAVO Study: Laquinimod Double-blind Placebo-controlled Study in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) With a Rater Blinded Reference Arm of Interferon ß-1a (Avonex®)A Multinational, Multicenter, Randomized, Parallel-Group Study Performed in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) to Assess the Efficacy, Safety and Tolerability of Laquinimod Over Placebo in a Double-blind Design and of a Reference Arm of Interferon ß-1a (Avonex®) in a Rater-blinded DesignMultiple SclerosisDrug: Laquinimod;Drug: Placebo;Drug: Avonex®Teva Branded Pharmaceutical Products R&D, Inc.NULLCompleted18 Years55 YearsAll1331Phase 3United States;Bulgaria;Croatia;Czechia;Estonia;Georgia;Germany;Israel;Italy;Lithuania;North Macedonia;Poland;Puerto Rico;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;Latvia;Macedonia, The Former Yugoslav Republic of;Montenegro;Turkey
46EUCTR2007-005450-23-CZ
(EUCTR)
14/04/200812/02/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
47EUCTR2007-005450-23-SK
(EUCTR)
10/04/200830/04/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Czech Republic;Estonia;Slovakia;Spain;Lithuania;Bulgaria;Germany;Italy
48EUCTR2007-005450-23-EE
(EUCTR)
28/03/200811/02/2008A Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVOA Multinational, Multicenter, Randomized, Parallel-Group study performed in subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) to assess the efficacy, safety and tolerability of laquinimod over placebo in a double-blind design and of a reference arm of Interferon ß-1a (Avonex®) in a rater-blinded design - BRAVO Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Laquinimod Capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgram/0.5 ml Solution for Injection
Product Name: -
Product Code: -
INN or Proposed INN: interferon beta-1a
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Czech Republic;Estonia;Spain;Lithuania;Bulgaria;Germany;Italy
49EUCTR2007-005450-23-ES
(EUCTR)
17/03/200829/01/2008Estudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVOEstudio multinacional, multicéntrico, randomizado, de grupos paralelos realizado en pacientes con Esclerosis Múltiple Remitente Recurrente (RRMS) para evaluar la eficacia, seguridad y tolerabilidad de laquinimod frente a placebo con un diseño doble ciego y con una rama con Interferón ß-1a (Avonex®) como tratamiento de referencia con evaluador ciego - BRAVO Esclerosis Múltiple Remitente Recurrente (RRMS)
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Cápsulas de Laquinimod 0.6 mg
Product Code: TV-5600
INN or Proposed INN: Laquinimod
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex 30 microgramos/0.5 ml Solución para inyección
Teva Pharmaceutical Industries LtdNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
50EUCTR2006-000704-17-BE
(EUCTR)
25/04/200706/07/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Greece;Spain;Belgium;Austria;Germany;Italy;United Kingdom
51EUCTR2006-000704-17-HU
(EUCTR)
16/04/200727/07/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
52EUCTR2006-000704-17-GR
(EUCTR)
19/12/200611/08/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Product Name: Interferon beta-1a
INN or Proposed INN: interferon beta-1a
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Phase 3Portugal;Hungary;Greece;Belgium;Spain;Austria;Germany;Italy;United Kingdom
53EUCTR2006-000704-17-PT
(EUCTR)
09/11/200602/08/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional extension phase - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional extension phase - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: Fingolimod
Trade Name: Avonex
Product Name: Interferon beta-1a
INN or Proposed INN: interferon beta-1a
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Hungary;Portugal;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
54EUCTR2006-000704-17-GB
(EUCTR)
19/10/200610/05/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 & E1 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Product Name: Interferon beta-1a
INN or Proposed INN: interferon beta-1a
Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
55EUCTR2006-000704-17-AT
(EUCTR)
08/09/200612/07/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase. - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;Germany;United Kingdom;Belgium;Spain;Italy;Greece;Austria
56NCT00398528
(ClinicalTrials.gov)
September 20069/11/2006An fMRI Study of Treatment Optimization Comparing Two Disease Modifying Therapies Used to Treat Relapsing Remitting Multiple SclerosisAn fMRI Study of Treatment Optimization Recommendations Comparing Patients Changing Treatment From Glatiramer Acetate 20 mg qd SC (Copaxone®) to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Those Changing From to IFN-ß-1a 30 Mcg qw IM (Avonex®) to Glatiramer Acetate 20 mg qd SC (Copaxone®) in a Multicenter Study of Patients With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying Therapy.Relapsing-Remitting Multiple SclerosisDrug: Glatiramer acetate, (Copaxone®);Drug: IFN-ß-1a, (Avonex®)NeurognosticsNULLTerminated18 Years65 YearsBoth48United States
57EUCTR2006-000704-17-DE
(EUCTR)
21/08/200612/06/2006A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302A 12-month double-blind, randomized, multicenter, active controlled, parallel-group study comparing the efficacy and safety of 0.5 mg and 1.25 mg fingolimod (FTY720) administered orally once daily versus interferon ß-1a (Avonex®) administered i.m. once weekly in patients with relapsing-remitting multiple sclerosis with optional Extension Phase - D2302 Relapsing-remitting multiple sclerosis (RRMS)Product Code: FTY720
INN or Proposed INN: Fingolimod
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
1275Portugal;Hungary;United Kingdom;Germany;Belgium;Spain;Italy;Greece;Austria
58NCT00915577
(ClinicalTrials.gov)
August 20055/6/2009Patient Satisfaction Study of Single-Use Autoinjector for the Delivery of Pre-Filled Avonex SyringeAn Open-Label, Multicenter Study to Determine Subject Satisfaction in Using the Single-Use Autoinjector With a Pre-Filled Liquid AVONEX® Syringe in Multiple Sclerosis SubjectsMultiple SclerosisDrug: Interferon beta-1a;Device: Single-use autoinjectorBiogen IdecNULLCompleted18 Years65 YearsBoth74Phase 3NULL
59NCT00463710
(ClinicalTrials.gov)
June 200519/4/2007Effect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With MSEffect of Interferon Beta-1a (Avonex®) on Changes of Non-Conventional MRI Measures in Patients With Relapsing-Remitting and Secondary-Progressive Multiple SclerosisMultiple SclerosisDrug: Avonex® monotherapy (6.0 MIU administered i.m. each week)State University of New York at BuffaloBiogen IdecCompleted18 Years65 YearsBoth150United States
60NCT00101959
(ClinicalTrials.gov)
November 200418/1/2005Implementation Study of Treatment Optimization Recommendations on Relapsing-Remitting Multiple Sclerosis (RR MS) SubjectsAn Implementation Study of Treatment Optimization Recommendations Comparing Subjects Continuing Treatment With IFN-ß-1a 30 Mcg qw IM (Avonex®) or Glatiramer Acetate 20 mg qd SC (Copaxone®) to Those Randomized to IFN-ß-1a 44 Mcg Tiw SC (Rebif®), in a Multicenter Study of Subjects With Relapsing Remitting Multiple Sclerosis Currently on Disease-Modifying TherapyRelapsing-Remitting Multiple SclerosisDrug: RebifEMD SeronoNULLWithdrawn18 Years60 YearsBoth0Phase 4United States
61NCT00913250
(ClinicalTrials.gov)
August 20032/6/2009A Bioequivalence Study of Serum Free Avonex and Serum Containing Avonex in Healthy VolunteersA Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of AVONEX® (Interferon Beta-1a) Solutions for Injection Produced by a Serum-Containing Manufacturing Process and by a Serum-Free Manufacturing ProcessMultiple SclerosisDrug: Serum containing Avonex;Drug: Serum Free AvonexBiogen IdecNULLCompleted18 Years45 YearsBoth96Phase 1NULL
62NCT00112034
(ClinicalTrials.gov)
June 200327/5/2005AVONEX® Combination Trial - ACTA Multi-Center, Randomized, Blinded, Parallel-Group Study of AVONEX Compared With AVONEX in Combination With Oral Methotrexate, Intravenous Methylprednisolone, or Both in Subjects With Relapsing Remitting MS Who Have Breakthrough Disease on AVONEX Monotherapy.Multiple Sclerosis, Relapsing-RemittingDrug: Methotrexate;Drug: IV methylprednisoloneBiogen IdecNULLCompleted18 Years55 YearsBoth350Phase 4United States
63NCT00913666
(ClinicalTrials.gov)
November 20022/6/2009Pharmacodynamic Study to Better Understand the Therapeutic Response and Immunomodulatory Effects of Avonex in Multiple Sclerosis (MS) Patients and Healthy VolunteersA Pilot Multi-Center, Open-Label, Assessor Blinded, Prospective Profiling Study in MS Subjects Treated With AVONEX®, MS Subjects Naïve to Treatment, and Healthy Control SubjectsMultiple SclerosisDrug: Interferon beta-1a (Avonex)Biogen IdecNULLCompleted18 Years65 YearsBoth121Phase 4NULL
64NCT00599274
(ClinicalTrials.gov)
August 200211/1/2008Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple SclerosisA Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX® and Rebif® to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS)Multiple SclerosisDrug: Interferon beta-1aBiogen IdecNULLCompleted18 Years50 YearsBoth136N/AUnited States;Australia;Austria;Canada
65NCT00037115
(ClinicalTrials.gov)
May 200215/5/2002Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event.An Open Label Pilot Study of Induction Therapy With a Single High Dose Bolus of Intravenous Methotrexate With Leucovorin Rescue, Prior to Initiation of AVONEX® Treatment, in Patients Presenting With a First Acute Demyelinating Event: Comparison With CHAMPS Results.Demyelinating Disorders;Multiple Sclerosis;Optic Neuritis;Myelitis;NeuritisDrug: interferon beta 1a;Drug: methotrexate;Drug: methylprednisoloneMidAmerica Neuroscience Research Foundation at Rowe Neurology InstituteConsultants in NeurologyWithdrawn18 Years50 YearsAll0Phase 4United States
66NCT00030966
(ClinicalTrials.gov)
January 200215/2/2002Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogen IdecElan PharmaceuticalsCompleted18 Years55 YearsBoth1200Phase 3United States;Austria;Belgium;France;Germany;Israel;Italy
67NCT01863069
(ClinicalTrials.gov)
January 200120/5/2013Avonex®: Safety, Blood Levels and EffectsA Single-centre Study to Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of a New Inhaled Formulation of AVONEX® (Interferon Beta-1a) in Healthy VolunteersMultiple Sclerosis (MS)Drug: Interferon beta 1a;Drug: (IM) AVONEX®Trio Medicines Ltd.Biogen IdecCompleted18 Years45 YearsBoth77Phase 1United Kingdom
68NCT00292266
(ClinicalTrials.gov)
November 199913/2/2006A Study of Rebif® Compared With Avonex® in the Treatment of Relapsing-remitting Multiple Sclerosis (MS)An Open Label, Randomized, Multicenter, Comparative, Parallel Group Study of Rebif® 44 Mcg Administered Three Times Per Week by Subcutaneous Injection, Compared With Avonex® 30 Mcg Administered Once Per Week by Intramuscular Injection in the Treatment of Relapsing-remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Rebif®;Drug: Avonex®EMD SeronoMerck Serono International SACompleted18 Years55 YearsBoth677Phase 3NULL
69NCT00534261
(ClinicalTrials.gov)
November 199921/9/2007Does Quality of Life Improve in Multiple Sclerosis Patients Treated With Interferon Beta-1a?Evaluation of the Correlation Between the MS Functional Composite Index and Two Quality of Life Scales (MS54 and AMS Quality of Life) in Relapsing MS Patients Treated With Interferon Beta-1a (AVONEX®)Relapsing Remitting Multiple SclerosisDrug: Interferon beta-1aBiogen IdecNULLCompleted18 Years70 YearsBoth284Phase 4Belgium;Luxembourg;United Kingdom
70NCT00915460
(ClinicalTrials.gov)
September 19995/6/2009Open-Label Safety Extension Study of AvonexAn Open-Label Safety Extension Study of AVONEX® (Interferon Beta-1a) Treatment in Subjects Who Completed Biogen Studies C95-812, C96-823, or C97-830Multiple SclerosisDrug: Interferon beta-1a (Avonex)Biogen IdecNULLCompletedN/AN/ABoth408Phase 4NULL
71EUCTR2018-003008-38-FR
(EUCTR)
29/03/2019A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension Relapsing Remitting Multiple Sclerosis (RRMS)
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Plegridy
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: PEGINTERFERON BETA-1A
Other descriptive name: PEGINTERFERON BETA-1A
Trade Name: AVONEX®
Product Name: interferon beta-1a
Product Code: IFN ß-1a
INN or Proposed INN: Interferon Beta-1a
Other descriptive name: Interferon Beta-1a
Biogen Idec Research LimitedNULLNA Female: yes
Male: yes
142 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United States;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Kuwait;Tunisia;Germany