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


臨床試験数 : 3,342 薬物数 : 2,355 - (DrugBank : 406) / 標的遺伝子数 : 266 - 標的パスウェイ数 : 240

  
383 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1EUCTR2020-004505-32-DE
(EUCTR)
06/07/202125/05/2021Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patientsAn Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Product Name: Glatiramer acetate
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Product Name: Glatiramer acetate
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Product Name: Interferon ß-1b
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3France;Spain;Germany;Italy
2EUCTR2020-004505-32-FR
(EUCTR)
09/06/202126/04/2021Study of efficacy and tolerability of ofatumumab vs. First Line disease modifying treatment (DMT) - physician’s choice in the treatment of newly diagnosed relapsing multiple sclerosis (RMS) patientsAn Open-Label, Rater-Blind, Randomized, Multi-Center, Parallel-Arm, Active-Comparator Study to Assess the Efficacy and Tolerability of Ofatumumab 20mg SC monthly vs. First Line DMT-physician’s choice in the treatment of newly diagnosed RMS - STHENOS Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Kesimpta
Product Name: ofatumumab
Product Code: OMB157
INN or Proposed INN: OFATUMUMAB
Product Name: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Product Name: Glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Product Name: Interferon ß-1b
Other descriptive name: INTERFERON BETA-1B
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Product Name: Interferon ß-1a
INN or Proposed INN: Interferon beta-1a
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
236Phase 3France;Germany
3NCT04655222
(ClinicalTrials.gov)
May 1, 202130/11/2020Study to Investigate Pregnancy Outcomes in Female Participants Exposed to Subcutaneous (SC) Peginterferon Beta-1a and Intramuscular (IM) Interferon Beta-1a Reported in a German Participant Support ProgramNon-interventional Safety Study to Investigate Pregnancy Outcomes in Female Patients Exposed to SC Peginterferon Beta-1a and IM Interferon Beta-1a Reported in a German Patient Support ProgramMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Interferon Beta TherapyBiogenNULLCompleted18 YearsN/AFemale470Germany
4EUCTR2018-003008-38-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
5EUCTR2018-004700-19-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
6EUCTR2018-004701-11-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 3Georgia;Germany;Bulgaria;Croatia;Poland;Belgium;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Montenegro;Austria;Korea, Republic of;Bosnia and Herzegovina;France;Italy;Russian Federation;Israel;Ukraine;Spain;Estonia;Taiwan;United States;Serbia
7EUCTR2018-003008-38-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
8NCT04032171
(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
9EUCTR2018-003008-38-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 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;Kuwait;Germany
10NCT04032158
(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
11EUCTR2018-003008-38-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
12EUCTR2018-003008-38-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
13EUCTR2018-000516-22-PT
(EUCTR)
08/07/201927/11/2018Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric ParticipantsA Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacyand Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis 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: TECFIDERA
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
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
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
340Phase 3United States;Serbia;Portugal;Taiwan;Saudi Arabia;Estonia;Greece;Thailand;Turkey;Israel;Russian Federation;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
14EUCTR2018-003008-38-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
15EUCTR2018-003008-38-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
16EUCTR2018-003008-38-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
17EUCTR2018-003008-38-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
18EUCTR2018-003008-38-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
19EUCTR2018-003008-38-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
20NCT03283397
(ClinicalTrials.gov)
March 26, 201912/9/2017A Phase IIIb, Multicenter, International Study to Evaluate the Efficacy, Safety and Tolerability of EK-12 in Patients With RRMSA Phase IIIb, Multi-center, International, Randomized, Assessor-blind, Active-controlled Parallel Arm Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Neuropeptide Combination of Metenkefalin and Tridecactide (EK-12) in Comparison to Interferon Beta-1a (REBIF®) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)Multiple Sclerosis, Relapsing-RemittingDrug: EK-12;Drug: INF beta-1aBosnalijek D.DMonitorCRORecruiting18 Years55 YearsAll400Phase 3Turkey
21EUCTR2018-000516-22-HU
(EUCTR)
04/03/201902/01/2019Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric ParticipantsA Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3-Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis 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: TECFIDERA
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
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
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
340 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;Taiwan;Estonia;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
22EUCTR2018-000516-22-EE
(EUCTR)
14/01/201917/12/2018Study to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, 3- Arm, Parallel-Group Study in Pediatric Subjects Aged 10 Through 17 Years to Evaluate the Efficacy and Safety of BG00012 and BIIB017 for the Treatment of Relapsing-Remitting Multiple Sclerosis 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: TECFIDERA
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
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
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
340 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;Estonia;Taiwan;Greece;Thailand;Turkey;Russian Federation;Israel;Colombia;Italy;Hungary;Mexico;Jordan;Malaysia;Croatia;Bulgaria;Tunisia;Korea, Republic of
23EUCTR2017-005129-18-IT
(EUCTR)
08/01/201926/03/2018Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis.Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis. Relapsing-remitting multiple sclerosis with paediatric onset
MedDRA version: 20.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Copaxone 40 mg/ml solution for injection, pre-filled syringe
INN or Proposed INN: Glatiramer Acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: AVONEX 30 µg/0,5 ml solution for injection
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Università degli Studi Aldo MoroNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
142Phase 3Italy
24NCT03387046
(ClinicalTrials.gov)
March 26, 201822/12/2017A Pilot Study in Participants With Relapsing Remitting Multiple Sclerosis (RR-MS)Evaluation of clINical reCovery After a Relapse: a Pilot Study assEssing the Neuronal Effects of D-Aspartate in RR-MS Subjects Treated With IntErferon Beta 1a 44 mcg TIW (INCREASE)Multiple Sclerosis, Relapsing-RemittingDietary Supplement: D-aspartate;Drug: Placebo;Biological: IFN beta-1a;Drug: MethylprednisoloneMerck KGaA, Darmstadt, GermanyNULLTerminated18 Years55 YearsAll7Phase 2Italy;Germany
25EUCTR2016-004819-12-IT
(EUCTR)
10/01/201820/01/2022Discontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patientsDiscontinuation of first-line disease modifying treatment (DMT) in long-term full responders MS patients: a multicentre randomized clinical trial. - Full Responders Relapsing-Remitting multiple sclerosis (RR-MS),
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: BETAFERON - 15 FLACONCINI 0.25 MG + 15 FLACONCINI 2 ML
Product Name: Interferone Beta-1B
Product Code: [032166011]
INN or Proposed INN: INTERFERONE BETA 1B
Other descriptive name: Interferon Beta-1B
Trade Name: AVONEX - 30 MCG (6 MILIONI UI) POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 4 FLACONI CON DISPOSITIVO BIOSET + 4 SIRINGHE PRERIEMPITE USO INTRAMUSCOLARE
Product Name: Inteferone Beta-1A
Product Code: [033283045]
INN or Proposed INN: INTERFERON BETA - 1A
Other descriptive name: Interferon Beta 1-A
Trade Name: COPAXONE - 40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
Product Name: Glatiramer acetato
Product Code: [035418060]
INN or Proposed INN: GLATIRAMER ACETATO
Other descriptive name: Glatiramer acetate
Trade Name: REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML)12 PENNE PRERIEMPITE
Product Name: Interferon Beta-1a
Product Code: [034091165]
INN or Proposed INN: INTERFERON BETA - 1A
Other descriptive name: Interferon Beta-1a
OSPEDALE SAN RAFFAELENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Phase 4Italy
26NCT05242133
(ClinicalTrials.gov)
December 20, 201717/1/2022Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple SclerosisEfficacy and Safety of Peginterferon Beta-1a (CinnaGen) Versus CinnoVex® (CinnaGen) in Reducing the Annualized Relapse Rate in Participants With Relapsing Remitting Multiple Sclerosis: A Phase III, Randomized, Parallel, Noninferiority StudyRelapsing Remitting Multiple Sclerosis (RRMS)Drug: Pegylated interferon beta-1a;Drug: Interferon Beta-1A Prefilled SyringeCinnagenNULLActive, not recruiting18 Years50 YearsAll168Phase 3Iran, Islamic Republic of
27NCT03347370
(ClinicalTrials.gov)
November 27, 201716/11/2017A Post-Authorization Safety Study of Interferon Beta Therapy in Participants With Multiple SclerosisSubcutaneous (SC) Interferon Beta Therapy in Multiple Sclerosis Patients and Characterization of Injection Site Reactions and Flu-Like Symptoms Under Daily Practice SettingMultiple Sclerosis, Relapsing-RemittingDrug: SC Peginterferon beta-1a;Drug: SC interferon beta-1a;Drug: SC interferon beta-1bBiogenAMS Advanced Medical Services GmbHCompleted18 YearsN/AAll626Germany
28EUCTR2017-002634-24-SE
(EUCTR)
29/09/201706/07/2017MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name:
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Sweden
29NCT03424733
(ClinicalTrials.gov)
September 25, 201731/1/2018Evaluating the Use of Prednisone to Decrease Pegylated Interferon Beta-1a Side EffectsA Trial of Prednisone and Acetaminophen Versus Acetaminophen Alone in Minimizing Flu-like Symptoms From Pegylated Interferon Beta-1aMultiple SclerosisDrug: Plegridy;Drug: Prednisone;Drug: Tylenol PillHoly Name Medical Center, Inc.BiogenRecruiting18 YearsN/AAll50Phase 4United States
30EUCTR2016-003587-39-SE
(EUCTR)
22/05/201723/03/2017This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3700Phase 4Sweden
31EUCTR2013-002318-11-FR
(EUCTR)
21/03/201717/06/2015A study on the safety and effectiveness of BG00012 in children from 10 to less than 18 years old with a type of Multiple Sclerosis that is called Relapsing-Remitting Multiple Sclerosis.Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 18.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.0;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: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
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 3Italy;France;Czech Republic;Hungary;Belgium;Poland;Denmark;Germany;Sweden;United Kingdom;Ukraine;Spain;Serbia
32NCT03177083
(ClinicalTrials.gov)
January 30, 201726/1/2017Evaluate Safety/Tolerability in Portuguese Participants With RRMS Transitioning From Current TherapyOpen-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 SclerosisDrug: peginterferon beta-1a;Drug: interferon beta-1a;Drug: interferon beta-1bBiogenNULLCompleted18 Years65 YearsAll80Phase 4Portugal
33EUCTR2016-002180-33-PL
(EUCTR)
16/11/201614/07/2016Multiple sclerosis therapy with transdermal myelin peptide stimulation.Multiple sclerosis therapy with transdermal myelin peptide stimulation. relapsing-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: SMderpept
INN or Proposed INN: PLP peptide
INN or Proposed INN: MBP peptide
INN or Proposed INN: MOG peptide
Product Name: SMderpept
INN or Proposed INN: PLP peptide
INN or Proposed INN: MBP peptide
INN or Proposed INN: MOG peptide
Product Name: Avonex
INN or Proposed INN: Interferon beta 1-A
Other descriptive name: INTERFERON BETA-1A
Centrum Neurologii Krzysztof SelmajNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
220Phase 2Poland
34EUCTR2016-000434-21-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
35NCT02921035
(ClinicalTrials.gov)
June 30, 201629/9/2016Non-interventional Study to Assess Adherence to Treatment for Patients With RMS (MAIN-MS)A Multicenter, Prospective, Non-interventional Study to Assess Adherence to Treatment for patIeNts With RMS Who Are Prescribed Subcutaneous (sc) Interferon Beta-1a (MAIN-MS)Relapsing Multiple Sclerosis (RMS)Drug: Rebif (Interferon beta-1a)Merck KGaA, Darmstadt, GermanyMerck Serono Middle East FZ LLCCompleted18 Years60 YearsAll594Hungary;Iran, Islamic Republic of;Korea, Republic of;Kuwait;Lebanon;Morocco;Poland;Saudi Arabia;Germany;Tunisia;United Arab Emirates;Algeria;Argentina;Bahrain;Bulgaria;Egypt
36NCT02749396
(ClinicalTrials.gov)
May 2, 201620/4/2016EPID Multiple Sclerosis Pregnancy StudyPregnancy Outcomes in Multiple Sclerosis Populations Exposed and Unexposed to Interferon ß - a Register-based Study in the Nordic CountriesMultiple SclerosisDrug: Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG;Drug: Extavia (interferon beta-1b), Novartis Pharma AG;Drug: Rebif (interferon beta-1a), Merck Serono Europe Ltd;Drug: Plegridy (peginterferon beta-1a), Biogen Idec Ltd;Drug: Avonex (interferon beta-1a), Biogen Idec Ltd;Drug: MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046);Other: No MSDMDs therapy (control)BayerEPID Research;Biogen;Merck Serono Europe Ltd;Novartis PharmaceuticalsCompletedN/AN/AFemale2089Finland
37EUCTR2013-002318-11-DE
(EUCTR)
15/04/201603/09/2015Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
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]
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
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
132Phase 3Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Kuwait;Sweden
38EUCTR2013-002318-11-ES
(EUCTR)
02/03/201608/05/2015Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With relapsing-remitting multiple sclerosis (RRMS).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis - CONNECT Relapsing-Remitting Multiple Sclerosis
MedDRA version: 18.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 18.1;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: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
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;Spain;Turkey;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Poland;Belgium;Romania;Croatia;Denmark;Sweden
39EUCTR2011-005677-23-HR
(EUCTR)
25/11/201501/02/2016Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLNot RecruitingFemale: yes
Male: yes
190Phase 3Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
40EUCTR2012-003735-32-GR
(EUCTR)
19/11/201506/08/2015Study to compare the efficacy and/or safety of masitinib to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments.A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment Relapsing-remitting multiple sclerosis (RR MS)
MedDRA version: 18.0;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: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: masitinib mesylate
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinb mesylate
Other descriptive name: masitinib mesylate
AB ScienceNULLNot RecruitingFemale: yes
Male: yes
450Phase 3Slovakia;Greece;Spain;United Kingdom;Italy;Czech Republic;Hungary;Mexico;Argentina;Belgium;Brazil;Bulgaria;Germany
41EUCTR2014-002320-27-NL
(EUCTR)
15/09/201508/01/2015A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Receptos, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
42EUCTR2014-002320-27-HR
(EUCTR)
27/07/201501/10/2015A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1346Phase 3Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
43EUCTR2014-002320-27-GB
(EUCTR)
22/07/201517/06/2015A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Poland;Brazil;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden;Argentina;Canada;Mexico;Hungary;Czech Republic;United Kingdom;Austria;Lithuania;Bosnia and Herzegovina;Moldova, Republic of;Latvia;Netherlands;South Africa;Peru;Switzerland;Colombia;Russian Federation;Ukraine;Spain;Estonia;United States;Belarus;Portugal;Serbia
44EUCTR2014-002320-27-HU
(EUCTR)
03/07/201511/05/2015A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1346Phase 3Belarus;Portugal;Serbia;United States;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
45EUCTR2013-002318-11-PL
(EUCTR)
03/07/201509/06/2014Phase 3 Efficacy and Safety Study of BG00012 in Subjects Withrelapsing-remitting multiple sclerosis (RRMS).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
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]
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
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
132Phase 3United States;Serbia;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Kuwait;Sweden
46EUCTR2014-002320-27-LT
(EUCTR)
09/06/201517/04/2015A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1346Phase 3Serbia;Belarus;United States;Portugal;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
47EUCTR2014-002320-27-ES
(EUCTR)
21/04/201509/02/2015A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. - Sunbeam Relapsing Multiple Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Receptos, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
48EUCTR2012-003735-32-SK
(EUCTR)
01/04/201509/04/2015Study to compare the efficacy and/or safety of masitinib at 3 mg/kg/day with switch to 4.5 then to 6 mg/kg/day to interferon beta-1a, interferon beta-1b, peginterferon beta-1a or glatiramer acetate in patients with relapsing remitting multiple sclerosis with unsatisfactory response to these first line treatments. A 96-weeks, prospective, multicentre, randomised, open label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to first line treatment, in patients with relapsing remitting multiple sclerosis with unsatisfactory response to first line treatment Prospective, multicentre, randomised, open-label, active-controlled, parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib at 3 mg/kg/day with switch to 4.5 then 6 mg/kg/day as single agent first line treatment.;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: masitinib mesylate
Product Name: mastinib
Product Code: AB1010
INN or Proposed INN: masitinib mesylate
Other descriptive name: masitinib mesylate
AB ScienceNULLNot Recruiting Female: yes
Male: yes
450 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSlovakia;Greece;Spain;Colombia;Switzerland;United Kingdom;Italy;Mexico;Canada;Argentina;Belgium;Brazil;Bulgaria;Germany
49EUCTR2014-002320-27-BG
(EUCTR)
19/03/201521/01/2015A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1346Phase 3Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Canada;Brazil;Poland;Romania;Croatia;Bulgaria;Georgia;Germany;New Zealand;Sweden
50EUCTR2014-002320-27-PL
(EUCTR)
01/03/201527/01/2015A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: SUB175614
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: SUB175614
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: SUB175614
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1346Phase 3Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
51EUCTR2014-002320-27-SE
(EUCTR)
12/02/201508/12/2014A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Receptos, Inc.NULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Serbia;Portugal;Belarus;United States;Estonia;Spain;Ukraine;Russian Federation;Colombia;Switzerland;Peru;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
52EUCTR2014-002320-27-LV
(EUCTR)
23/01/201530/10/2014A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1346Phase 3Belarus;United States;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
53EUCTR2012-005086-12-PL
(EUCTR)
07/01/201516/09/2014Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 19.0;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: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Serbia;Hungary;Poland;Ukraine;Austria;Russian Federation;Bulgaria;Germany
54EUCTR2014-001012-19-NL
(EUCTR)
17/12/201415/10/2014Effects of fingolimod on advanced brain measures and clinical measures in multiple sclerosisEffects of fingolimod on functional brain adaptation and clinical measures in multiple sclerosis - Effect of fingolimod on brain and cognition Relapsing-remitting (RR) multiple sclerosis (MS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Gilenya
INN or Proposed INN: fingolimod
Product Name: Interferon Beta
INN or Proposed INN: interferon beta-1b
Other descriptive name: INTERFERON BETA-1B
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
55NCT02294058
(ClinicalTrials.gov)
December 3, 20145/8/2014Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)A Phase 3, Multi-Center, Randomized, Double-Blind, Double-Dummy, Active Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of RPC1063 Administered Orally To Relapsing Multiple Sclerosis PatientsMultiple SclerosisDrug: Ozanimod;Drug: Interferon beta-1a;Drug: Placebo to ozanimod;Drug: Placebo to interferon beta-1aCelgeneNULLCompleted18 Years55 YearsAll1346Phase 3United States;Belarus;Bosnia and Herzegovina;Bulgaria;Canada;Croatia;Czechia;Estonia;Georgia;Germany;Hungary;Latvia;Lithuania;Moldova, Republic of;Netherlands;New Zealand;Poland;Portugal;Romania;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom;Argentina;Austria;Colombia;Czech Republic;Mexico;Peru
56EUCTR2014-002320-27-EE
(EUCTR)
21/11/201408/10/2014A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Other descriptive name: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1346Phase 3United States;Belarus;Portugal;Serbia;Estonia;Spain;Ukraine;Russian Federation;Switzerland;South Africa;Latvia;Netherlands;Moldova, Republic of;Bosnia and Herzegovina;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Brazil;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
57EUCTR2014-002320-27-PT
(EUCTR)
21/11/201408/10/2014A clinical study to evaluate in a blinded and scientific way, the efficacy and safety of the new medicinal product RPC1063 in patients with Relapsing Multiple Sclerosis.A Phase 3, multi-center, randomized, Double-Blind, double-dummy, active controlled, parallel group study to evaluate the efficacy and safety of RPC1063 administered orally to relapsing multiple sclerosis patients. Relapsing Multiple Sclerosis
MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1.0mg RPC1063
Product Code: RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1346Phase 3Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Poland;Croatia;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden;Estonia;Spain;Ukraine;Russian Federation;Switzerland;Peru;Netherlands;Latvia;Moldova, Republic of;Bosnia and Herzegovina;Serbia;Belarus;United States;Portugal
58EUCTR2011-005677-23-EE
(EUCTR)
21/11/201422/10/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLNot Recruiting Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
59EUCTR2014-001290-14-RO
(EUCTR)
24/10/201427/03/2017Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania using Electronic Device RebiSmart™Prospective Phase IV Clinical Trial on Effectiveness of Rebif Treatment of CIS and RMS Patients in Romania using Electronic Device RebiSmart™ - PROCEED Clinical isolated syndrome and relapse multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: REBIF
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
MERCK ROMANIA SRLNULLNot RecruitingFemale: yes
Male: yes
Phase 4Romania
60EUCTR2012-002714-40-HR
(EUCTR)
17/10/201405/11/2014A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Receptos, Inc.NULLNot RecruitingFemale: yes
Male: yes
1410Phase 2;Phase 3Serbia;United States;Belarus;Slovakia;Slovenia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
61EUCTR2011-005677-23-RO
(EUCTR)
08/10/201430/05/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Belarus;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Romania;Bulgaria;Germany;Sweden
62NCT02269930
(ClinicalTrials.gov)
October 201417/10/2014Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy VolunteersAn Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy VolunteersMultiple SclerosisDrug: peginterferon beta-1a;Drug: RebifBiogen IdecNULLCompleted18 Years45 YearsBoth30Phase 1United States
63EUCTR2011-005677-23-NL
(EUCTR)
19/08/201425/02/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Estonia;Slovakia;Spain;Lithuania;Austria;United Kingdom;Italy;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Netherlands;Latvia;Germany;Sweden
64EUCTR2011-005677-23-SE
(EUCTR)
07/08/201412/03/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Serbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
65EUCTR2011-005677-23-GB
(EUCTR)
15/07/201412/03/2014Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
66EUCTR2013-002318-11-DK
(EUCTR)
14/07/201425/04/2014Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects Withrelapsing-remitting multiple sclerosis (RRMS).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
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]
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
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
132Phase 3United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Kuwait;Sweden
67EUCTR2013-002318-11-CZ
(EUCTR)
10/07/201402/05/2014Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
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]
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
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
132Phase 3Serbia;United States;Spain;Turkey;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden
68EUCTR2013-002318-11-GB
(EUCTR)
08/07/201416/03/2015Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
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]
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
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
132Phase 3United States;Serbia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Kuwait;Sweden
69NCT02727907
(ClinicalTrials.gov)
July 201429/5/2015Study of Efficacy and Safety of Drugs BCD-033 and Rebif for Treatment of Patients With Multiple SclerosisInternational, Multicenter, Double-blinded, Placebo-controlled, Randomized Study of the Efficacy and Safety of Drugs BCD-033 and Rebif for the Treatment of Patients With Relapsing-remitting Multiple SclerosisMultiple SclerosisDrug: BCD-033 (interferon beta 1a);Drug: Rebif (interferon beta 1a);Drug: PlaceboBiocadNULLActive, not recruiting18 Years55 YearsBoth147Phase 2/Phase 3Russian Federation
70EUCTR2013-003126-83-DE
(EUCTR)
23/06/201417/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
71EUCTR2013-002318-11-BE
(EUCTR)
17/06/201417/03/2014Phase 3 Efficacy and Safety Study of BG00012 in Subjects With relapsing-remitting multiple sclerosis (RRMS).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, with Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
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]
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
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
132Phase 3Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden
72EUCTR2013-002318-11-SE
(EUCTR)
05/06/201414/03/2014Phase 3 Efficacy and Safety Study of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMs).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
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]
Product Name: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
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
132Phase 3Serbia;United States;Czechia;Spain;Turkey;Israel;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Kuwait;Germany;Sweden
73EUCTR2012-002714-40-SK
(EUCTR)
02/06/201412/03/2014A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1578Phase 2;Phase 3Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
74EUCTR2012-002714-40-GB
(EUCTR)
29/05/201428/02/2014A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot Recruiting Female: yes
Male: yes
1265 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;South Africa;Bulgaria;Georgia;Moldova, Republic of;Bosnia and Herzegovina
75EUCTR2013-002318-11-HU
(EUCTR)
27/05/201408/04/2014Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Subjects With relapsing-remitting multiple sclerosis (RRMS).Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension - CONNECT Relapsing-Remitting Multiple Sclerosis
MedDRA version: 19.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 19.1;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: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
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;Spain;Turkey;Israel;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Bulgaria;Germany;Sweden
76EUCTR2013-003126-83-GR
(EUCTR)
27/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Denmark;Peru;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden
77EUCTR2013-003126-83-ES
(EUCTR)
26/05/201405/03/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3Serbia;Belarus;United States;United Arab Emirates;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
78EUCTR2013-002351-15-ES
(EUCTR)
26/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-?-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-?-1a in patients with multiple sclerosis 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 Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3Serbia;Portugal;Belarus;United States;United Arab Emirates;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Peru;Denmark;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Lithuania;Turkey;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
79EUCTR2013-002351-15-HU
(EUCTR)
21/05/201421/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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 Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden;Belgium;Brazil;Poland;Argentina;Canada;Mexico;Czech Republic;Hungary;Egypt;United Kingdom;Austria;Lithuania;Turkey;Finland;Bosnia and Herzegovina;Tunisia;Latvia;Peru;Denmark;Jordan;France;Italy;Colombia;Russian Federation
80EUCTR2013-003126-83-HU
(EUCTR)
21/05/201421/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3Canada;Argentina;Poland;Brazil;Belgium;Romania;Georgia;Bulgaria;Germany;New Zealand;Sweden;Mexico;Czech Republic;Hungary;United Kingdom;Turkey;Finland;Netherlands;South Africa;Peru;Denmark;France;Italy;Colombia;Russian Federation;Chile;Israel;Ukraine;Spain;Greece;Slovakia;Serbia;Belarus;United Arab Emirates;United States
81EUCTR2013-002351-15-BG
(EUCTR)
21/05/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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 Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Interferon-ß-1a
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden
82EUCTR2013-002318-11-IT
(EUCTR)
13/05/201420/03/2014A study on the safety and effectiveness of BG00012 in children from 10 to less than 18 years old with a type of Multiple Sclerosis that is called Relapsing-Remitting Multiple Sclerosis.Open-Label, Randomized, Multicenter, Multiple-Dose, Active Controlled, Parallel-Group, Efficacy and Safety Study of BG00012 in Children From 10 to Less Than 18 Years of Age With Relapsing-Remitting Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis
MedDRA version: 16.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 16.1;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: BG00012
Product Code: BG00012
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: AVONEX
Product Name: Avonex
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
142France;Serbia;Hungary;Czech Republic;Belgium;Poland;Ukraine;Denmark;United Kingdom;Italy;Sweden
83EUCTR2013-002351-15-PT
(EUCTR)
09/05/201425/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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 Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Portugal;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
84EUCTR2013-003126-83-BG
(EUCTR)
16/04/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Interferon-ß-1a
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Merck KGaANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Belarus;Serbia;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Colombia;Italy;France;Peru;Denmark;South Africa;Netherlands;Finland;Turkey;United Kingdom;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Georgia;Germany;New Zealand;Sweden
85EUCTR2013-002351-15-AT
(EUCTR)
13/03/201428/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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 Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Russian Federation;Chile;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
86EUCTR2013-002351-15-EE
(EUCTR)
13/03/201418/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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 Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3United States;United Arab Emirates;Portugal;Belarus;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Lebanon;Chile;Russian Federation;Colombia;Italy;France;Jordan;Denmark;Peru;Latvia;Tunisia;Bosnia and Herzegovina;Finland;Turkey;Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Georgia;Bulgaria;Germany;Japan;Sweden
87EUCTR2013-002351-15-LV
(EUCTR)
03/03/201420/02/2014Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator.A Phase III, Randomized, Double-Blind, Double Dummy, Multicenter Trial Comparing the Efficacy and Safety of 2 Doses of Daily Oral ONO 4641 (0.05 mg and 0.1 mg) versus Interferon-ß-1a 30 µg IM Weekly in Subjects with Relapsing-Remitting Multiple Sclerosis - Efficacy and safety of ONO-4641 versus Interferon-ß-1a in patients with multiple sclerosis Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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 Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifimod
Other descriptive name: ONO-4641
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Product Code: MSC2430913A or ONO-4641 (to be used as synonyms)
INN or Proposed INN: Ceralifmod
Other descriptive name: ONO-4641
Merck KGaANULLNot RecruitingFemale: yes
Male: yes
1176Phase 3Lithuania;Austria;United Kingdom;Egypt;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Romania;Croatia;Bulgaria;Georgia;Germany;Japan;Sweden;Turkey;Finland;Bosnia and Herzegovina;Tunisia;Latvia;Peru;Denmark;Jordan;France;Italy;Colombia;Russian Federation;Chile;Lebanon;Ukraine;Spain;Slovakia;Morocco;Estonia;Serbia;Belarus;Portugal;United Arab Emirates;United States
88EUCTR2011-005677-23-AT
(EUCTR)
24/01/201419/12/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Sweden;Germany;Bulgaria;Romania;Croatia;Poland;Brazil;Canada;Mexico;United Kingdom;Austria;Turkey;Lithuania;Netherlands
89EUCTR2011-005677-23-PL
(EUCTR)
13/01/201420/11/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
90EUCTR2013-002082-19-NL
(EUCTR)
09/01/201417/10/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.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) - LIBRETTO 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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Ireland;Italy;Switzerland;United Kingdom;France;Belgium;Denmark;Netherlands;Germany;Norway;Sweden
91EUCTR2012-005450-30-AT
(EUCTR)
08/01/201411/11/2013Investigation of neutralising antibodies against interferon-beta in patients with multiple sclerosis, in order to find markers to predict the development of these antibodies and minimize the risk of ineffective therapyAnti-Biopharmaceutical Immunization: Prediction and analysis of clinical relevance to minimize the risk of immunization in multiple sclerosis patients on interferon-beta treatment - ABIRISK Development of neutralising antibodies against Interferon-beta in the treatment of multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Avonex
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Betaferon
INN or Proposed INN: Interferon-beta 1b
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: Interferon-beta 1b
Other descriptive name: INTERFERON BETA-1B
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: INTERFERON BETA-1A
Medizinische Universität InnsbruckNULLNot RecruitingFemale: yes
Male: yes
100Phase 4Austria;Sweden
92EUCTR2013-002082-19-ES
(EUCTR)
02/01/201431/10/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon beta-1a (Avonex, authorised drug) administered once weekly.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 beta-1a administered Intra Muscular Once Weekly in Subjects with Relapsing Remitting Multiple Sclerosis (RRMS) - LIBRETTO 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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
93EUCTR2013-004626-28-FI
(EUCTR)
20/12/201320/11/2013Does targeting of S1P receptors reduce microglial activation in multiple sclerosis?Does targeting of S1P receptors reduce microglial activation in multiple sclerosis? Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: REBIF
Product Name: beetainterferoni -1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Gilenya
Product Name: Fingolimodi
Other descriptive name: FINGOLIMOD
Trade Name: Avonex
Trade Name: Betaferon
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Lemtrada
Other descriptive name: ALEMTUZUMAB
Turku University HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Finland
94EUCTR2011-005677-23-DE
(EUCTR)
16/12/201309/04/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active-controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
95EUCTR2013-002082-19-FI
(EUCTR)
04/12/201315/10/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.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) - LIBRETTO Relapsing remitting multiple sclerosis
MedDRA version: 16.1;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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
96EUCTR2013-002082-19-DK
(EUCTR)
03/12/201303/12/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.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) - LIBRETTO 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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
97EUCTR2011-005677-23-BG
(EUCTR)
28/11/201315/11/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled Core Phase study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
190 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Belarus;United States;Venezuela, Bolivarian Republic of;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
98EUCTR2013-002082-19-BE
(EUCTR)
25/11/201313/09/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.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) - LIBRETTO 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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Ireland;Switzerland;United Kingdom;Italy;France;Belgium;Denmark;Norway;Germany;Netherlands;Sweden
99EUCTR2013-002082-19-SE
(EUCTR)
21/11/201313/09/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.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) - LIBRETTO 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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Finland;Spain;Denmark;Netherlands;United Kingdom;Switzerland;Sweden
100EUCTR2012-005086-12-BG
(EUCTR)
14/11/201319/08/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 18.1;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: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
234Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
101EUCTR2013-002082-19-GB
(EUCTR)
13/11/201306/11/2013A clinical study in subjects with relapsing-remitting multiple sclerosis (RRMS) to assess the efficacy, safety and tolerability of two oral doses of laquinimod either of 0.6 mg/day or 1.2mg/day (experimental drug) as compared to Interferon ß-1a (Avonex, authorised drug) administered once weekly.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) - LIBRETTO 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: Laquinimod capsules 0.6 mg
Product Code: TV-5600
INN or Proposed INN: LAQUINIMOD
Other descriptive name: Laquinimod Sodium (USAN)
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Teva Pharmaceutical Industries, Ltd.NULLNot RecruitingFemale: yes
Male: yes
600Phase 3Finland;Spain;Belgium;Denmark;Netherlands;Switzerland;United Kingdom;Sweden
102EUCTR2012-005086-12-DE
(EUCTR)
12/11/201301/07/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing 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]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
103EUCTR2011-006262-40-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
104EUCTR2012-002714-40-ES
(EUCTR)
02/08/201309/04/2013A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Receptos, Inc.NULLNot RecruitingFemale: yes
Male: yes
1280Phase 2;Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden
105EUCTR2012-005086-12-HU
(EUCTR)
31/07/201318/06/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing 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]
Trade Name: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
106NCT01892722
(ClinicalTrials.gov)
July 26, 20138/5/2013Safety and Efficacy of Fingolimod in Pediatric Patients With Multiple SclerosisA 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon ß-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension PhaseMultiple SclerosisDrug: Interferon beta-1a;Drug: Fingolimod;Drug: Placebo capsule;Drug: Placebo i.m. injectionNovartis PharmaceuticalsNULLRecruiting10 Years17 YearsAll220Phase 3United States;Australia;Austria;Belarus;Brazil;Bulgaria;Canada;Croatia;Estonia;France;Germany;Italy;Latvia;Lithuania;Mexico;Netherlands;Poland;Puerto Rico;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Czech Republic;South Africa
107EUCTR2012-002714-40-GR
(EUCTR)
10/07/201317/05/2013A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 16.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Receptos, Inc.NULLNot RecruitingFemale: yes
Male: yes
1280Phase 2;Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Croatia;Romania;Georgia;Bulgaria;Sweden
108EUCTR2012-005086-12-AT
(EUCTR)
05/07/201308/05/2013Study to investigate the ability of a blood-derived score to select patients with relapsing multiple sclerosis who benefit from treatment with human immune globulinActive-controlled phase IIIb study to investigate the ability of the HAP score to predict responders to Octagam 5% in patients with early relapsing multiple sclerosis. - PREDICT trial relapsing multiple sclerosis
MedDRA version: 18.0;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: Octagam 50 mg/ml
INN or Proposed INN: Human normal immunoglobulin
Other descriptive name: IMMUNOGLOBULIN G
Trade Name: Copaxone 20 mg/ml
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: INTERFERON BETA-1a
Trade Name: Betaferon 250 microgram/ml
Product Name: Betaferon 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1b
Trade Name: Extavia 250 microgram/ml
Product Name: Extavia 250 microgram/ml
INN or Proposed INN: INTERFERON BETA-1a
Octapharma AGNULLNot RecruitingFemale: yes
Male: yes
216Phase 3Hungary;Poland;Austria;Russian Federation;Bulgaria;Germany
109EUCTR2011-006262-40-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
110NCT02076841
(ClinicalTrials.gov)
July 201319/2/2014Tolerability and Quality of Life Study in Participants Who Switched to Avonex PenTolerability and Quality of Life in Patients With Multiple Sclerosis Switched to Intramuscular Interferon Beta 1a Autoinjector (Avonex® PenTM)Relapsing-Remitting Multiple Sclerosis;Clinical Isolated Syndrome (CIS);Multiple SclerosisDevice: interferon beta-1aBiogenNULLCompleted18 YearsN/AAll40N/ACzech Republic;Switzerland
111EUCTR2011-006262-40-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
112EUCTR2011-006262-40-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
113EUCTR2012-002714-40-HU
(EUCTR)
10/06/201302/05/2013A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 19.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5 mg RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1 mg RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1578Phase 2;Phase 3Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Bosnia and Herzegovina
114EUCTR2011-006262-40-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
115EUCTR2011-006262-40-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
116NCT01717664
(ClinicalTrials.gov)
June 201324/10/2012Proof of Concept Study of RHB-104 as Add-On Therapy to Interferon Beta-1a in Relapsing Remitting Multiple Sclerosis (RRMS)A Phase IIa Proof of Concept Study to Assess the Efficacy and Safety of Fixed Dose Combination RHB-104 as Add-On Therapy to Interferon Beta-1a in Patients Treated for Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: RHB-104RedHill Biopharma LimitedNULLCompleted18 YearsN/ABoth18Phase 2Israel
117EUCTR2012-002714-40-BG
(EUCTR)
17/05/201308/05/2013A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 19.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5 mg RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1 mg RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1578Phase 2;Phase 3Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;South Africa;Moldova, Republic of;Bosnia and Herzegovina
118EUCTR2011-005677-23-LT
(EUCTR)
10/05/201311/02/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Phase 3United States;Serbia;Belarus;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
119EUCTR2012-002714-40-IT
(EUCTR)
09/05/201308/03/2013A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 0.5 mg RPC1063
INN or Proposed INN: RPC1063
Product Name: 1 mg RPC1063
INN or Proposed INN: RPC1063
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Receptos, Inc.NULLNot RecruitingFemale: yes
Male: yes
1280Phase 2;Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;United Kingdom;Italy;Hungary;Canada;Belgium;Croatia;Georgia;Bulgaria
120EUCTR2012-002714-40-BE
(EUCTR)
29/04/201314/03/2013A CLINICAL STUDY TO EVALUATE IN A BLINDED AND SCIENTIFIC WAY THE EFFICACY AND SAFETY OF THE NEW MEDICINAL PRODUCT RPC1063 IN PATIENTS WITH RELAPSING MULTIPLE SCLEROSISA PHASE 2/3, MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED (PART A) AND DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED (PART B), PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RPC1063 ADMINISTERED ORALLY TO RELAPSING MULTIPLE SCLEROSIS PATIENTS - Radiance RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 18.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: 0.25 mg RPC1063
INN or Proposed INN: Ozanimod
Product Name: 0.5 mg RPC1063
INN or Proposed INN: Ozanimod
Product Name: 1 mg RPC1063
INN or Proposed INN: Ozanimod
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: Avonex
Other descriptive name: INTERFERON BETA-1A
Celgene International II Sàrl (CIS II)NULLNot RecruitingFemale: yes
Male: yes
1578Phase 2;Phase 3Serbia;United States;Belarus;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Croatia;Georgia;South Africa;Bulgaria;Moldova, Republic of;Sweden;Bosnia and Herzegovina
121EUCTR2011-005677-23-LV
(EUCTR)
29/04/201319/03/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase. Relapsing multiple sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Service AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190Belarus;United States;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;South Africa;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
122EUCTR2011-005677-23-ES
(EUCTR)
26/04/201309/04/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Farmaceutica S.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190United States;Venezuela, Bolivarian Republic of;Mexico;Canada;Brazil;Spain;Lithuania;Latvia
123EUCTR2011-005677-23-IT
(EUCTR)
02/04/201311/02/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlledstudy to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis Relapsing multiple sclerosis
MedDRA version: 15.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis FarmaNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
190United States;Venezuela, Bolivarian Republic of;Mexico;Canada;Spain;Brazil;Lithuania;Latvia;Italy
124EUCTR2011-005677-23-SK
(EUCTR)
27/03/201304/03/2013Safety and efficacy of fingolimod in pediatric patients with multiple sclerosisA two-year, double-blind, randomized, multicenter, active controlled study to evaluate the safety and efficacy of fingolimod administered orally once daily versus interferon ß-1a i.m. once weekly in pediatric patients with multiple sclerosis with five-year fingolimod Extension Phase - PARADIGMS Relapsing multiple sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Avonex
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Product Name: fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Belarus;Serbia;Estonia;Slovakia;Spain;Ukraine;Russian Federation;Italy;France;Australia;South Africa;Latvia;Netherlands;Lithuania;Turkey;Austria;United Kingdom;Mexico;Canada;Brazil;Poland;Croatia;Romania;Bulgaria;Germany;Sweden
125NCT01714089
(ClinicalTrials.gov)
March 201319/10/2012Proof of Concept Study Evaluating RNS60 in the Treatment of Relapsing Remitting Multiple SclerosisA Phase II Study Evaluating RNS60 Compared to Interferon Beta-1a (Avonex) for the Treatment of Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: RNS60 125 ml;Drug: RNS60 250 ml;Drug: Interferon beta 1aRevalesio CorporationNULLWithdrawn18 Years50 YearsBoth0Phase 2United States
126NCT01272128
(ClinicalTrials.gov)
December 20126/1/2011Avonex-evaluation of Quality of Life and Convenience in Belgian Participants - The AVAIL StudyA Multicenter, Prospective Non-interventional Study to Evaluate the Quality of Life in Belgian Patients With CIS or RRMS in Whom Interferon Beta-1a IM Treatment Has Been InitiatedMultiple SclerosisDrug: Interferon beta-1aBiogenNULLCompleted18 YearsN/ABoth100N/ABelgium;United States
127EUCTR2010-020315-36-CZ
(EUCTR)
18/10/201222/08/2012A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
128EUCTR2011-001437-16-DE
(EUCTR)
19/09/201209/02/2012A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosisA 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis - multiple sclerosis
MedDRA version: 15.0;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: Gilenya
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Extavia
INN or Proposed INN: Interferon beta-1b
Other descriptive name: INTERFERON BETA-1B
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Czech Republic;United Kingdom;Canada;Denmark;Spain;United States;Poland
129EUCTR2010-024477-39-CZ
(EUCTR)
29/08/201224/04/2012A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Intereron Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600United States;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
130EUCTR2010-024477-39-GB
(EUCTR)
07/08/201220/03/2012A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Intereron Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3United States;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
131EUCTR2011-005475-16-GB
(EUCTR)
25/07/201205/03/2012A Phase 1/2 study to test how effective different doses of MEDI-551 is for treating subjects with Relapsing-Remitting Multiple SclerosisA Phase 1/2 Randomized, Dose-finding Study of MEDI-551 in Subjects with Relapsing-Remitting Multiple Sclerosis 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: MEDI-551
Product Code: MEDI-551
Trade Name: Avonex
Product Name: Avonex
INN or Proposed INN: interferon beta-1a
MedImmune LLCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
512Phase 1/2Hungary;Germany;Turkey;Switzerland;Netherlands;France;Ireland;Italy;Austria;Sweden;Israel;Russian Federation;United Kingdom;Czech Republic;Ukraine;Canada;Denmark;Spain;United States;Poland
132EUCTR2010-024477-39-GR
(EUCTR)
14/05/201218/04/2012A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Intereron Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
133NCT01514370
(ClinicalTrials.gov)
April 30, 201217/1/2012Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1aProspeCtive Study to Evaluate Efficacy, Safety and tOlerability of Dietary supplemeNT of Curcumin (BCM95) in Subjects With Active Relapsing MultIple Sclerosis Treated With subcutaNeous Interferon Beta 1a 44 mcg Three Times a Week (TIW)Multiple SclerosisDrug: IFN beta 1a 44 mcg TIW;Drug: Curcumin;Drug: PlaceboMerck KGaA, Darmstadt, GermanyMerck Serono S.P.A., ItalyCompleted18 Years60 YearsAll80Phase 2Italy
134EUCTR2010-020337-99-NL
(EUCTR)
13/04/201219/10/2010 A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing Multiple Sclerosis
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]
Product Name: ocrelizumab 300mg /10ml
Product Code: RO4964913 F07
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Netherlands;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
135EUCTR2009-012500-11-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
136NCT01500408
(ClinicalTrials.gov)
January 201222/12/2011Demonstrate the Bioequivalence of Interferon Beta-1a (INFB) Manufactured by Two Different Processes in Healthy VolunteersA Randomized, Single-Blind, Crossover Study in Healthy Volunteers to Demonstrate the Bioequivalence of Interferon Beta-1a Manufactured by Two Different ProcessesMultiple SclerosisDrug: Interferon beta-1a (current approved manufacturing process invloving FBS);Drug: Interferon beta-1a (new process, manufactured without FBS)Biogen IdecNULLCompleted18 Years45 YearsBoth110Phase 1United States
137EUCTR2011-003570-89-NL
(EUCTR)
02/12/201107/11/2011The effect of interferon beta-1a treatment on adaptability of the brain in patients with MSThe effect of interferon beta-1a treatment on functional adaptation in Multiple Sclerosis (MS) - interferon beta-1a and functional adaptation Multiple sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10004504;Term: Beta interferon therapy;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Rebif
INN or Proposed INN: interferon beta-1a
VU University Medical CenterNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
138EUCTR2010-020315-36-BG
(EUCTR)
28/11/201119/08/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
139EUCTR2010-024477-39-BG
(EUCTR)
16/11/201120/09/2011A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Intereron Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3United States;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
140EUCTR2010-020315-36-BE
(EUCTR)
14/11/201130/06/2011 A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
800 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
141EUCTR2010-020315-36-IE
(EUCTR)
04/11/201108/09/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing 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]
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLNot RecruitingFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
142EUCTR2010-020337-99-PL
(EUCTR)
25/10/201113/09/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Brazil;Poland;Belgium;Bulgaria;Germany;New Zealand
143EUCTR2010-020315-36-GB
(EUCTR)
20/10/201116/08/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
144EUCTR2010-020337-99-GB
(EUCTR)
20/10/201105/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
145EUCTR2010-020315-36-SK
(EUCTR)
18/10/201128/06/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Belarus;United States;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
146EUCTR2010-020315-36-ES
(EUCTR)
18/10/201121/07/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 14.0;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: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Croatia;United States;Bosnia and Herzegovina;Spain;Argentina;Mexico;Belgium;Belarus;Peru;Canada;Ukraine;Russian Federation;United Kingdom;Brazil;Sweden;Italy;Ireland;Turkey;Colombia
147EUCTR2010-020315-36-FR
(EUCTR)
07/10/201102/09/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing Multiple Sclerosis
MedDRA version: 14.0;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: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
148EUCTR2010-020315-36-IT
(EUCTR)
05/10/201127/12/2011A study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis.A Randomized, Double-Blind, Double Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA II Relapsing 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: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: OCRELIZUMAB
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
ROCHENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
469Colombia;Turkey;Ireland;Italy;Sweden;Brazil;United Kingdom;Russian Federation;Canada;Ukraine;Belarus;Peru;Belgium;Argentina;Mexico;Spain;Bosnia and Herzegovina;United States;Croatia
149EUCTR2010-024477-39-EE
(EUCTR)
29/09/201126/09/2011A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Intereron Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
150EUCTR2010-024477-39-DE
(EUCTR)
22/09/201121/06/2011A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Intereron Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Phase 3United States;Serbia;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
151EUCTR2010-020315-36-DE
(EUCTR)
22/09/201108/07/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
152EUCTR2010-020337-99-ES
(EUCTR)
21/09/201120/07/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing Multiple Sclerosis
MedDRA version: 14.0;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: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;Serbia;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain
153NCT01412333
(ClinicalTrials.gov)
September 20, 20118/8/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif) in Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placeboHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll835Phase 3United States;Argentina;Belarus;Belgium;Bosnia and Herzegovina;Brazil;Bulgaria;Canada;Croatia;Czechia;France;Germany;Ireland;Italy;Mexico;Norway;Poland;Russian Federation;Slovakia;Spain;Sweden;Turkey;Ukraine;United Kingdom;Colombia;Czech Republic;Morocco
154EUCTR2010-024477-39-BE
(EUCTR)
19/09/201120/06/2011A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Intereron Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
155EUCTR2010-020337-99-IT
(EUCTR)
19/09/201129/03/2012A Study of Ocrelizumab in Comparison With Interferon Beta-1a inPatients With Relapsing Multiple Sclerosis.A Randomized, Double-Blind, Double-Dummy, Parallel-Group Study ToEvaluate The Efficacy And Safety Of Ocrelizumab In Comparison ToInterferon Beta-1a (Rebif) In Patients With Relapsing Multiple Sclerosis. - OPERA I Relapsing 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: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: OCRELIZUMAB
Other descriptive name: NA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: NA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: NA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: NA
ROCHENULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Germany;Bulgaria;Austria;South Africa;Brazil;Australia;Tunisia;Czech Republic;New Zealand;Peru;Belgium;United States;Poland;Portugal;Hungary;Switzerland;Chile;Italy;Morocco;Latvia;Lithuania;Israel;Finland;Russian Federation;United Kingdom;Ukraine;Mexico;Argentina;Estonia;Spain
156EUCTR2010-020337-99-DE
(EUCTR)
05/09/201111/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
157EUCTR2010-020315-36-SE
(EUCTR)
31/08/201105/07/2011A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA II Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3United States;Belarus;Slovakia;Spain;Ukraine;Ireland;Turkey;Russian Federation;Colombia;Italy;United Kingdom;France;Czech Republic;Mexico;Canada;Argentina;Belgium;Brazil;Croatia;Peru;Bulgaria;Germany;Sweden;Bosnia and Herzegovina
158NCT01247324
(ClinicalTrials.gov)
August 31, 201123/11/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a (Rebif) in Participants With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate the Efficacy and Safety of Ocrelizumab in Comparison to Interferon Beta-1a (Rebif®) in Patients With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: Interferon beta-1a;Drug: Ocrelizumab-matching placebo;Drug: Ocrelizumab;Drug: Interferon beta-1a-matching placeboHoffmann-La RocheNULLActive, not recruiting18 Years55 YearsAll821Phase 3Germany;Hungary;Israel;Italy;Latvia;Lithuania;Mexico;Netherlands;Peru;Poland;Portugal;Russian Federation;Serbia;Slovakia;South Africa;Spain;Switzerland;Tunisia;Ukraine;United Kingdom;United States;Czech Republic;Morocco;New Zealand;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Chile;Czechia;Estonia;Finland;France
159EUCTR2010-024477-39-ES
(EUCTR)
22/08/201128/06/2011A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Interferon Beta 1a pegilado
Product Code: BIIB017
INN or Proposed INN: Interferón beta 1a
Other descriptive name: Interferón beta 1a pegilado
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600United States;Serbia;Estonia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Romania;Croatia;Bulgaria;Germany;New Zealand
160EUCTR2010-020337-99-SK
(EUCTR)
23/06/201114/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
161EUCTR2010-024477-39-LV
(EUCTR)
06/05/201121/03/2011A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis - ATTAIN Relapsing Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Intereron Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1600Serbia;United States;Estonia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Peru;Latvia;Netherlands;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany;New Zealand
162NCT01332019
(ClinicalTrials.gov)
April 201124/3/2011Long-Term Safety and Efficacy Study of Peginterferon Beta-1aA Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: peginterferon beta-1aBiogenNULLCompleted18 Years65 YearsAll1077Phase 3United States;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Estonia;France;Georgia;Germany;Greece;India;Latvia;Mexico;Netherlands;New Zealand;Peru;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
163EUCTR2010-024017-31-IT
(EUCTR)
15/03/201108/02/2011A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDENA 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy - GOLDEN Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Product Name: FINGOLIMOD
Product Code: FTY720D
Trade Name: EXTAVIA
INN or Proposed INN: Interferon beta-1b
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
Italy
164EUCTR2010-020337-99-BG
(EUCTR)
07/03/201117/12/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
165EUCTR2010-020337-99-BE
(EUCTR)
23/02/201112/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing Multiple Sclerosis
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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
166EUCTR2010-020337-99-CZ
(EUCTR)
21/02/201111/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
167EUCTR2010-020337-99-PT
(EUCTR)
04/02/201129/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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]
Product Name: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Serbia;Portugal;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
168NCT01285401
(ClinicalTrials.gov)
February 201126/1/2011Supplementation of VigantOL® Oil Versus Placebo as Add-on in Patients With Relapsing Remitting Multiple Sclerosis Receiving Rebif® TreatmentA Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif®Relapsing-Remitting Multiple SclerosisDrug: VigantOL oil plus interferon beta-1a (Rebif);Drug: Placebo plus interferon beta-1a (Rebif);Biological: Interferon beta-1a (Rebif®) aloneMerck KGaANULLCompleted18 Years55 YearsAll260Phase 2Austria;Denmark;Estonia;Finland;Germany;Italy;Latvia;Lithuania;Netherlands;Norway;Portugal;Switzerland;Belgium;Hungary
169EUCTR2010-020337-99-AT
(EUCTR)
20/01/201118/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
170EUCTR2010-020337-99-LT
(EUCTR)
17/01/201127/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;Serbia;United States;Estonia;Morocco;Slovakia;Spain;Ukraine;Russian Federation;Israel;Chile;Italy;Switzerland;Peru;Australia;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
171EUCTR2010-020337-99-LV
(EUCTR)
29/12/201011/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing Multiple Sclerosis
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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
172EUCTR2010-020337-99-FI
(EUCTR)
15/12/201011/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing Multiple Sclerosis
MedDRA version: 19.0;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: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
F.Hoffmann-La RocheNULLNot RecruitingFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Netherlands;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
173EUCTR2010-020337-99-EE
(EUCTR)
26/11/201027/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing 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: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: ocrelizumab 300mg/10ml
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Phase 3Portugal;United States;Serbia;Estonia;Morocco;Slovakia;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Netherlands;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
174EUCTR2009-015556-15-AT
(EUCTR)
19/11/201007/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
175EUCTR2010-020337-99-HU
(EUCTR)
17/11/201011/10/2010A Study of Ocrelizumab in Comparison With Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Randomized, Double-Blind, Double-Dummy, Parallel-Group Study To Evaluate The Efficacy And Safety Of Ocrelizumab In Comparison To Interferon Beta-1a (Rebif®) In Patients With Relapsing Multiple Sclerosis - OPERA I Relapsing Multiple Sclerosis
MedDRA version: 17.1;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: ocrelizumab
Product Code: RO4964913
INN or Proposed INN: ocrelizumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
F.Hoffmann-La RocheNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
800Portugal;United States;Serbia;Estonia;Morocco;Spain;Ukraine;Israel;Chile;Russian Federation;Italy;Switzerland;Australia;Peru;South Africa;Tunisia;Latvia;Finland;Lithuania;Austria;United Kingdom;Hungary;Czech Republic;Mexico;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand
176NCT02937285
(ClinicalTrials.gov)
November 20109/9/2016National Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple SclerosisNational Multicenter, Controlled, Single-blind Study With Two Parallel Groups Evaluating the Safety and Efficacy of Sequential Treatment With Mitoxantrone and Interferon Beta-1a (REBIF 44mg 3 Times / Week) Versus Interferon Alone in Patients With Strong Risk of Progression in the Initial Phase of Multiple SclerosisMultiple SclerosisDrug: Interferon beta 1a;Drug: MitoxantroneRennes University HospitalNULLActive, not recruiting18 Years50 YearsAll266Phase 3France
177EUCTR2009-012500-11-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
178EUCTR2009-015556-15-GB
(EUCTR)
02/09/201017/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
179EUCTR2009-012500-11-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
180EUCTR2009-015556-15-DK
(EUCTR)
25/08/201017/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
181EUCTR2009-015556-15-DE
(EUCTR)
20/08/201019/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
182EUCTR2009-012500-11-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
183EUCTR2009-015556-15-NL
(EUCTR)
13/08/201008/04/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
184NCT01337427
(ClinicalTrials.gov)
August 20107/4/2011Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple SclerosisOptical Coherence Tomography (OCT) in a Multicenter, Randomized,Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BIIB017Johns Hopkins UniversityBiogen IdecWithdrawn18 Years55 YearsBoth0Phase 3United States
185EUCTR2008-006333-27-CZ
(EUCTR)
22/07/201003/07/2009A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple SclerosisA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE Relapsing Multiple Sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1500Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand;United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom
186EUCTR2009-015556-15-HU
(EUCTR)
14/07/201007/04/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Hungary;Portugal;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
187EUCTR2009-012500-11-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
188EUCTR2009-012500-11-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
189EUCTR2009-015556-15-GR
(EUCTR)
13/07/201014/12/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
190EUCTR2009-016087-37-IT
(EUCTR)
02/07/201021/07/2010A multinational, multicenter, single blood samplingexploratory pharmacogenetic study of the REGARD (theREbif vs Glatiramer Acetate in Relapsing MS Disease)trial - REGARD PGxA multinational, multicenter, single blood samplingexploratory pharmacogenetic study of the REGARD (theREbif vs Glatiramer Acetate in Relapsing MS Disease)trial - REGARD PGx Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
MERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
325United Kingdom;France;Ireland;Spain;Italy
191EUCTR2009-015556-15-PT
(EUCTR)
02/07/201030/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
192EUCTR2009-012500-11-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
193EUCTR2009-012500-11-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
194EUCTR2009-012500-11-IT
(EUCTR)
18/06/201021/05/2010Multicenter, 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 Sclerosis - NDMulticenter, 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 - ND 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
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1500Slovenia;Greece;Finland;Spain;Ireland;Italy;United Kingdom;France;Czech Republic;Hungary;Denmark;Germany;Sweden
195EUCTR2009-015556-15-LV
(EUCTR)
11/06/201013/04/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1;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: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Sweden
196EUCTR2009-015556-15-CZ
(EUCTR)
10/06/201029/03/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1;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: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;Sweden
197EUCTR2009-015556-15-SI
(EUCTR)
07/06/201012/04/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.0;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: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States
198EUCTR2009-012500-11-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
199EUCTR2009-015556-15-IT
(EUCTR)
07/06/201007/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - NDA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Trade Name: TYSABRI
INN or Proposed INN: Natalizumab
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
Trade Name: REBIF*SC 12SIR 6000000UI 22MCG
INN or Proposed INN: Interferon beta-1a
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
200EUCTR2009-012500-11-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
201EUCTR2009-015556-15-FI
(EUCTR)
07/05/201024/02/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
202EUCTR2009-015556-15-SE
(EUCTR)
06/05/201009/03/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1;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: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack.
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden
203EUCTR2009-017490-38-DE
(EUCTR)
03/05/201001/02/2010Randomized Treatment Interruption of Natalizumab - RESTORERandomized Treatment Interruption of Natalizumab - RESTORE Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months.
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: TYSABRI
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: COPAXONE
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: AVONEX
Trade Name: Urbason Forte
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: URBASON FORTE
Biogen IdecNULLNot RecruitingFemale: yes
Male: yes
200Germany;Spain
204NCT01064401
(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
205EUCTR2009-012500-11-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
206EUCTR2009-017003-28-IT
(EUCTR)
12/04/201008/04/2010Relationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like SymdromeRelationship between IL-6 and TNF-α polymorphism and flu-like syndrome development in multiple sclerosis patients treated with Interferon-beta 1a i.m. Open label multicentre study - Flu-like Symdrome multiple sclerosis
MedDRA version: 9.1;Level: SOC;Classification code 10029205
MedDRA version: 9.1;Level: HLGT;Classification code 10012303
MedDRA version: 9.1;Level: HLT;Classification code 10052785
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
BIOGEN-DOMPE` SRLNULLNot RecruitingFemale: yes
Male: yes
Italy
207EUCTR2009-016824-29-DK
(EUCTR)
06/04/201025/02/2010REsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIRREsPons på interferon-Alfa hos InterfeRon-ß-neutraliserende antistof-positive patienter med multipel sklerose - REPAIR Multiple Sclerosis
MedDRA version: 12.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Multiferon
INN or Proposed INN: HUMAN LEUCOCYTE INTERFERON-ALPHA
Other descriptive name: HUMAN LEUCOCYTE INTERFERON-ALPHA
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Dansk Multipel Sclerose CenterNULLNot RecruitingFemale: yes
Male: yes
10Denmark
208NCT01181115
(ClinicalTrials.gov)
April 20105/8/2010Avonex Safety and Tolerability in Chinese Subjects With Relapsing Multiple Sclerosis (MS)An Open-Label Study to Evaluate the Safety and Tolerability and to Explore the Efficacy of Avonex (Interferon Beta-1a) in Chinese Subjects With Relapsing Multiple SclerosisMultiple SclerosisDrug: AvonexBiogen IdecNULLCompleted18 Years55 YearsBoth60Phase 3China
209EUCTR2009-012500-11-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
210EUCTR2008-003706-33-GR
(EUCTR)
10/03/201012/03/2009A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) TrialA Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
211EUCTR2008-006333-27-GR
(EUCTR)
10/03/201023/10/2009A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCEA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE Relapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Other descriptive name: PEGylated Interferon Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Czech Republic;Estonia;Greece;Spain;Belgium;Bulgaria;Netherlands;Germany;Latvia;United Kingdom
212NCT01071083
(ClinicalTrials.gov)
March 201017/2/2010Treatment Interruption of NatalizumabRandomized Treatment Interruption of NatalizumabRelapsing Remitting Multiple SclerosisDrug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetateBiogenElan PharmaceuticalsCompleted18 Years60 YearsAll175Phase 2United States;Germany;Spain
213NCT01058005
(ClinicalTrials.gov)
March 201026/1/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BG00002 (natalizumab);Drug: interferon beta-1a;Drug: glatiramer acetateBiogenElan PharmaceuticalsTerminated18 Years60 YearsAll84Phase 3United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden
214EUCTR2009-015502-19-GB
(EUCTR)
08/02/201017/03/2010A multinational, multicenter, single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial - PRISMS-15A multinational, multicenter, single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial - PRISMS-15 Multiple Sclerosis
MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Rebif
Product Name: Rebif
Product Code: L03 AB07
Other descriptive name: INTERFERON BETA-1A
Merck Serono SA – GenevaNULLNot RecruitingFemale: yes
Male: yes
300Finland;Germany;United Kingdom;Belgium;Sweden
215EUCTR2009-016087-37-GB
(EUCTR)
05/02/201017/03/2010A multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGxA multinational, multicenter, single blood sampling exploratory pharmacogenetic study of the REGARD (the REbif vs Glatiramer Acetate in Relapsing MS Disease) trial - REGARD-PGx Multiple Sclerosis
MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Rebif
Product Name: Rebif
INN or Proposed INN: interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
325United Kingdom;France;Ireland;Spain;Italy
216EUCTR2008-006226-34-GB
(EUCTR)
03/02/201001/11/2010A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE)A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
sanofi-aventis recherche et developpementNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Canada;Belgium;Spain;Germany;Tunisia;Italy;United Kingdom
217EUCTR2009-015502-19-DE
(EUCTR)
25/01/201023/11/2009A multinational, multicenter, single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial - PRISMS-15A multinational, multicenter, single visit, exploratory pharmacogenetic trial and long-term follow-up of the PRISMS (Prevention of Relapses and Disability by Interferon beta-1a Subcutaneously in Multiple Sclerosis) trial - PRISMS-15 Multiple Sclerosis
MedDRA version: 12.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: RebifMerck Serono SA – GenevaNULLNot RecruitingFemale: yes
Male: yes
300Finland;Belgium;Germany;United Kingdom;Sweden
218NCT01101776
(ClinicalTrials.gov)
January 20108/4/2010Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical Setting.Post Marketing Surveillance Study to Evaluate the Tolerability of Rebif® New Formulation in Patients With Relapsing Multiple Sclerosis in an Australian Clinical SettingMultiple SclerosisDrug: Interferon beta-1a (Rebif)Merck KGaAMerck Serono Australia Pty LtdCompleted18 YearsN/ABoth49N/AAustralia
219EUCTR2008-008554-23-SE
(EUCTR)
29/12/200926/06/2009Neutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNFNeutralizing Antibodies to Interferon beta in patients treated with Rebif New Formulation - NAb development with RNF IFNß-naïve patients fulfilling Poser or McDonald criteria for CDMS or MS and in whom a decision has been made to initiate treatment with RNF (Rebif New Formulation).
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Rebif
Product Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
The Multiple Sclerosis Research Group, Department of Clinical NeuroscienceNULLNot RecruitingFemale: yes
Male: yes
100Sweden
220EUCTR2008-006226-34-BE
(EUCTR)
23/12/200929/09/2009A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENEREA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE Multiple sclerosisProduct Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
Product Code: L03 AB
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
Product Name: L03 AB
INN or Proposed INN: INTERFERON BETA-1A
sanofi-aventis recherche et developmentNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Spain;Belgium;Germany;United Kingdom;Italy
221EUCTR2008-006333-27-GB
(EUCTR)
03/12/200918/10/2010 A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple SclerosisA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE Relapsing Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Biogen Idec LimitedNULLNot Recruiting Female: yes
Male: yes
1500 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelarus;United States;Serbia;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand
222EUCTR2008-006333-27-BE
(EUCTR)
09/11/200927/05/2009A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple SclerosisA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE Relapsing Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1500Serbia;United States;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Latvia;Netherlands;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand
223NCT01198132
(ClinicalTrials.gov)
November 20098/9/2010A Multicentre Study of the Efficacy and Safety of Supplementary Treatment With Cholecalciferol in Patients With Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times WeeklyA Multicentre, Randomised, Double-blind, Placebo-controlled Study of the Efficacy of Supplementary Treatment With Cholecalciferol (Vitamin D3) in Patients With Relapsing- Multiple Sclerosis (RMS) Treated With Subcutaneous Interferon Beta-1a 44 µg 3 Times WeeklyMultiple SclerosisDietary Supplement: Cholecalciferol (Vitamin D3);Dietary Supplement: Placebo;Drug: RebifMerck KGaAMerck Serono S.A.S, FranceCompleted18 Years65 YearsAll129Phase 2France
224EUCTR2009-013695-46-FR
(EUCTR)
22/10/200907/09/2009ETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - cholineETUDE MULTICENTRIQUE, RANDOMISEE EN DOUBLE AVEUGLE VERSUS PLACEBO EVALUANT L’EFFICACITE D’UN TRAITEMENT ADDITIONNEL PAR CHOLECALCIFEROL (VITAMINE D3) CHEZ DES PATIENTS ATTEINTS DE SCLEROSE EN PLAQUES RECURRENTE (SEP-R) TRAITES PAR INTERFERON BETA 1A 44 µG 3 FOIS PAR SEMAINE PAR VOIE SOUS-CUTANEE - choline Sclérose en plaques récurrente (SEP-R)
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: UVEDOSE 100 000 UI, solution buvable en ampoule
Product Name: UVEDOSE 100 000 UI
INN or Proposed INN: COLECALCIFEROL
MERCK SERONO s.a.sNULLNot RecruitingFemale: yes
Male: yes
France
225EUCTR2008-006333-27-NL
(EUCTR)
22/10/200929/05/2009A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple SclerosisA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE Relapsing Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1500United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand
226EUCTR2008-006333-27-BG
(EUCTR)
26/09/200916/09/2009A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple SclerosisA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE Relapsing Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1500United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Netherlands;Latvia;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand
227EUCTR2008-006333-27-ES
(EUCTR)
11/09/200902/07/2009Estudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis. - ADVANCEEstudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis. - ADVANCE Esclerosis múltiple recidivanteRelapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado
Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado
Product Name: Interferón Beta-1a pegilado
Product Code: BIIB017
Other descriptive name: Interferón Beta-1a pegilado
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1260Phase 3Czech Republic;Estonia;Greece;Belgium;Spain;Bulgaria;Netherlands;Germany;Latvia;United Kingdom
228EUCTR2009-013333-24-IT
(EUCTR)
03/08/200928/07/2009Multicenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE) - BRIDGEMulticenter, open-label, 12 weeks Phase IV study to assess adherence to treatment in relapsing multiple sclerosis (RMS) subjects switching from other injectable DMDs using ReBiSmart to self-inject Rebif New Formulation (RNF) In a multi-dose cartriDGE (BRIDGE) - BRIDGE RELAPSING MULTIPLE SCLEROSIS
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
MERCK SERONO SPANULLNot RecruitingFemale: yes
Male: yes
Phase 4Italy
229EUCTR2008-006226-34-GR
(EUCTR)
20/07/200919/03/2009A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENEREA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE Multiple sclerosisProduct Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: Rebif
sanofi-aventis recherche et developmentNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;Czech Republic;Hungary;Greece;Belgium;Spain;Germany;United Kingdom;Italy
230EUCTR2008-003706-33-FR
(EUCTR)
02/07/200912/03/2009A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) TrialA Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden
231EUCTR2008-006333-27-LV
(EUCTR)
19/06/200914/04/2009A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCEA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE Relapsing Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
Other descriptive name: PEGylated Interferon Beta-1a
Biogen Idec LTDNULLNot RecruitingFemale: yes
Male: yes
1260Czech Republic;Estonia;Greece;Spain;Belgium;Bulgaria;Netherlands;Germany;Latvia;United Kingdom
232EUCTR2008-006333-27-EE
(EUCTR)
16/06/200911/05/2009A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple SclerosisA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis - ADVANCE Relapsing Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Product Name: PEGylated Interferon Beta-1a
Product Code: BIIB017
INN or Proposed INN: Interferon beta 1a
Other descriptive name: PEGylated Interferon Beta-1a
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1500United States;Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Chile;Russian Federation;Colombia;India;France;Macedonia, the former Yugoslav Republic of;Peru;Latvia;Netherlands;Moldova, Republic of;Turkey;United Kingdom;Czech Republic;Mexico;Canada;Belgium;Poland;Croatia;Romania;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand
233EUCTR2008-003706-33-GB
(EUCTR)
09/06/200927/11/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2'-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot Recruiting Female: yes
Male: yes
600 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Korea, Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden
234EUCTR2008-006226-34-CZ
(EUCTR)
08/06/200902/03/2009A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE)A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE Multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
sanofi-aventis recherche et developpementNULLNot RecruitingFemale: yes
Male: yes
300France;Hungary;Czech Republic;Canada;Belgium;Spain;Germany;Tunisia;United Kingdom;Italy
235EUCTR2008-003706-33-SE
(EUCTR)
04/06/200909/04/2009Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3United States;United Arab Emirates;Serbia;Portugal;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden
236NCT00906399
(ClinicalTrials.gov)
June 200920/5/2009Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple SclerosisA Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: BIIB017 (peginterferon beta-1a);Drug: PlaceboBiogenNULLCompleted18 Years65 YearsAll1516Phase 3United States;Belgium;Bulgaria;Canada;Chile;Colombia;Croatia;Czech Republic;Estonia;France;Georgia;Germany;Greece;India;Latvia;Mexico;Netherlands;New Zealand;Peru;Poland;Romania;Russian Federation;Serbia;Spain;Ukraine;United Kingdom
237NCT00917839
(ClinicalTrials.gov)
June 20099/6/2009The Neuroprotective Effect of Lamotrigine and Interferon Beta 1a in Patients With Relapsing-Remitting Multiple SclerosisRandomized, Placebo-Controlled Phase II Monocentric Trial for the Neuroprotective Effect of Lamotrigine Plus Interferon Beta 1a 30mcg Once Weekly Intramuscular in Patients With Relapsing-Remitting Multiple Sclerosis.Relapsing-Remitting Multiple SclerosisDrug: lamotrigineCantonal Hospital of St. GallenNULLRecruiting18 Years50 YearsBoth88Phase 2Switzerland
238EUCTR2008-003706-33-BG
(EUCTR)
28/05/200909/07/2009Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway
239EUCTR2008-006226-34-DE
(EUCTR)
14/05/200903/02/2009A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE)A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE Multiple sclerosis
MedDRA version: 16.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
sanofi-aventis recherche et developpementNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy
240EUCTR2008-006226-34-FR
(EUCTR)
04/05/200925/03/2009A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENEREA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE Multiple sclerosisProduct Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: Rebif
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: Rebif
sanofi-aventis Recherche & DévelopmentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300Hungary;United Kingdom;Czech Republic;Germany;France;Spain;Italy
241NCT01075880
(ClinicalTrials.gov)
May 200924/2/2010Post-Authorization Observational Study to Evaluate Cognition and Fatigue in Relapsing-remitting Multiple Sclerosis (RRMS) Patients Treated With Rebif®Post-Authorization Observational Study to Evaluate Cognition and Fatigue in RRMS Patients Treated With RebifMultiple Sclerosis, Relapsing-RemittingDrug: Rebif (Interferon beta-1a)Merck KGaAMerck spol.s.r.o., Czech RepublicCompleted18 Years65 YearsBoth300N/ACzech Republic
242EUCTR2008-004954-34-IT
(EUCTR)
08/04/200912/03/2009Double-Blind Extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with rebif New Formulation (REFLEXION) - REFLEXIONDouble-Blind Extension of the study 27025 (REFLEX) to obtain long-term follow-up data in patients with clinically definite MS and patients with a first demyelinating event at high risk of converting to MS, treated with rebif New Formulation (REFLEXION) - REFLEXION Subjects at high risk of converting to Multiple Sclerosis or subjects already converted to Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: REBIF*SC 12SIR 12000000UI44MCG
INN or Proposed INN: Interferon beta-1a
MERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
492Portugal;Estonia;Greece;Finland;Spain;Austria;Italy;France;Czech Republic;Poland;Belgium;Bulgaria;Germany;Latvia
243EUCTR2008-003706-33-AT
(EUCTR)
02/04/200924/11/2008A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) TrialA Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
244NCT00883337
(ClinicalTrials.gov)
April 200916/4/2009A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple SclerosisA Multi-center, Randomized, Parallel-group, Rater-blinded Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis Plus a Long Term Extension PeriodMultiple SclerosisDrug: Interferon ß-1a;Drug: TeriflunomideSanofiNULLCompleted18 YearsN/AAll324Phase 3Belgium;Canada;Czech Republic;France;Germany;Greece;Hungary;Italy;Poland;Spain;Switzerland;Tunisia;United Kingdom
245EUCTR2008-003706-33-DE
(EUCTR)
31/03/200909/12/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Korea, Republic of;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Belgium;Poland;Singapore;Croatia;Romania;Georgia;Bulgaria;Germany;Norway;Sweden;United States;United Arab Emirates;Portugal;Serbia;Taiwan;Estonia;Saudi Arabia;Greece;Thailand;Spain
246EUCTR2008-006226-34-ES
(EUCTR)
25/03/200923/01/2009Estudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENEREEstudio multicéntrico, aleatorizado, de grupos paralelos, ciego para el evaluador, que compara la efectividad y seguridad de teriflunomida e interferón beta-1a en pacientes con esclerosis múltiple recidivante------------------------------------------------------------A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis. - TENERE Esclerosis Múltiple------------------------Multiple sclerosisProduct Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: REBIF 44 microgramos solución inyectable
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
sanofi-aventis recherche et developmentNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy
247EUCTR2008-003706-33-CZ
(EUCTR)
24/03/200922/10/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon
248EUCTR2008-003706-33-NO
(EUCTR)
18/03/200909/12/2008A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) TrialA Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
249EUCTR2008-003706-33-BE
(EUCTR)
16/03/200909/12/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine
Product Code: L01BB04
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Serbia;Portugal;United Arab Emirates;United States;Estonia;Taiwan;Saudi Arabia;Greece;Thailand;Spain;Ukraine;Lebanon;Russian Federation;Italy;India;France;Macedonia, the former Yugoslav Republic of;Bosnia and Herzegovina;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Argentina;Poland;Belgium;Singapore;Romania;Croatia;Georgia;Bulgaria;Germany;Norway;Sweden
250EUCTR2008-003706-33-PT
(EUCTR)
06/03/200917/12/2008A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) TrialA Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono SA - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Portugal;Estonia;Greece;Finland;Spain;Austria;United Kingdom;Italy;France;Czech Republic;Belgium;Bulgaria;Germany;Norway;Sweden
251EUCTR2008-006226-34-HU
(EUCTR)
05/03/200909/02/2009A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis (TENERE)A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis plus a long-term extension period. - TENERE Multiple sclerosis
MedDRA version: 15.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
sanofi-aventis recherche et developpementNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Canada;Belgium;Spain;Germany;Tunisia;United Kingdom;Italy
252EUCTR2008-006226-34-IT
(EUCTR)
05/03/200909/03/2009A multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENEREA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosisA multi-center, randomized, parallel-group, rater-blinded study comparing the effectiveness and safety of teriflunomide and interferon beta-1a in patients with relapsing multiple sclerosis - TENERE multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
MedDRA version: 9.1;Classification code 10028245
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Product Name: Teriflunomide
Product Code: HMR1726
INN or Proposed INN: Teriflunomide
Trade Name: REBIF
INN or Proposed INN: interferone
sanofi-aventis recherche et developmentNULLNot RecruitingFemale: yes
Male: yes
300France;Czech Republic;Hungary;Belgium;Spain;Germany;United Kingdom;Italy
253EUCTR2008-003706-33-IT
(EUCTR)
02/03/200923/02/2009A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORACLE Cladribine in Early MS (ORACLE MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORACLE Cladribine in Early MS (ORACLE MS) Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: CLADRIBINE
INN or Proposed INN: Cladribine
Trade Name: REBIF*SC 12SIR 12000000UI44MCG
INN or Proposed INN: Interferon beta-1a
MERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
254EUCTR2008-003706-33-ES
(EUCTR)
29/01/200909/12/2008A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) TrialA Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS.Ensayo clínico de fase III, aleatorizado, en doble ciego, controlado con placebo y multicéntrico, de cladribina oral en sujetos con un primer episodio clínico de alto riesgo de conversiòn a EM. - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS).Sujetos con un primer episodio de desmielinización clínica (Síndrome aislado desde el punto de vista clínico (CIS)) de alto riesgo de conversión a Esclerosis Múltiple (EM).
MedDRA version: 9.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2?-deoxy-ß-D-adenosine
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono InternationalNULLNot RecruitingFemale: yes
Male: yes
642Phase 3Portugal;Germany;Bulgaria;Norway;France;Italy;Austria;Sweden;Finland;Czech Republic;United Kingdom;Belgium;Estonia;Spain;Greece
255EUCTR2008-003098-42-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 LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Czech Republic
256NCT00828204
(ClinicalTrials.gov)
January 200920/1/2009Evaluate the Safe and Effective Use of the Avonex® Single-Use Autoinjector in Multiple Sclerosis SubjectsAn Open-Label, Multicenter Study to Evaluate the Safe and Effective Use of the Single-Use Autoinjector With an Avonex® Prefilled Syringe in Multiple Sclerosis SubjectsMultiple SclerosisDevice: single-use autoinjector with a prefilled liquid Avonex syringe;Device: Avonex prefilled syringe via manual IM injection;Drug: BG9418 (interferon beta-1a)BiogenNULLCompleted18 Years65 YearsAll95Phase 3United States
257EUCTR2008-003706-33-EE
(EUCTR)
31/12/200820/11/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Romania;Estonia;Thailand;Spain;Bosnia and Herzegovina;Lebanon
258EUCTR2007-005450-23-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
259EUCTR2008-003706-33-FI
(EUCTR)
18/12/200810/11/2008Clinical trial with oral cladribine in early Multiple Sclerosis (MS)A Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial of oral cladribine in subjects with a first clinical event at high risk of converting to MS - ORAl CLadribine in Early MS (ORACLE MS) Trial Subjects with a first clinical demyelinating event (Clinically Isolated Syndrome (CIS)) at high risk of converting to Multiple Sclerosis (MS)
MedDRA version: 14.0;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Cladribine
INN or Proposed INN: CLADRIBINE
Other descriptive name: 2-chloro-2’-deoxy-ß-D-adenosine (2-CdA)
Trade Name: Rebif 44 micrograms solution for injection
Product Name: Interferon beta-1a FBS-free/HSA-free
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono S.A. - GenevaNULLNot RecruitingFemale: yes
Male: yes
600Phase 3Germany;United Arab Emirates;France;Bulgaria;Singapore;Austria;Sweden;Czech Republic;Serbia;Canada;Georgia;Belgium;Korea, Republic of;Greece;United States;Croatia;Macedonia, the former Yugoslav Republic of;Poland;Portugal;Turkey;Norway;Italy;India;Finland;Russian Federation;United Kingdom;Ukraine;Saudi Arabia;Taiwan;Argentina;Estonia;Romania;Thailand;Spain;Bosnia and Herzegovina;Lebanon
260NCT00771043
(ClinicalTrials.gov)
November 20087/10/2008A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-aOptical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1aRelapsing-Remitting Multiple SclerosisDrug: TYSABRI and AVONEXBiogen IdecNULLWithdrawn18 Years55 YearsBoth50Phase 4United States
261EUCTR2007-001162-32-AT
(EUCTR)
23/10/200814/07/2008A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
573Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
262EUCTR2007-001162-32-PL
(EUCTR)
21/10/200824/10/2008Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.0;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: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
840Phase 3Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
263EUCTR2007-001161-14-PL
(EUCTR)
21/10/200812/05/2008?Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.0;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: MabCampath ®
Product Name: MabCampath®
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
Product Name: Rebif®
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
264EUCTR2007-006338-32-FI
(EUCTR)
08/10/200830/06/2008Phase 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 sclerosisPhase 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 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 2Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy
265EUCTR2007-006338-32-BG
(EUCTR)
07/10/200831/07/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase 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 Multiple sclerosis is a disabling disease of brain and spinal cord thatdisrupts flow of information within brain, characterized by flare-ups withperiods of remission in between (relapsing remitting)
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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: oclelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
266EUCTR2008-000499-25-SE
(EUCTR)
02/10/200816/05/2008International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMSInternational, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmartTM in RMS Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Rebif New Formulation 44mcg multidose cartridge
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3Germany;Spain;Italy;Sweden
267NCT01080027
(ClinicalTrials.gov)
October 20082/3/2010Safety, Tolerability and Adherence With Rebif® New Formulation in Real Life Settings (STAR)An International, Multi Centre, Prospective, Observational Study of Safety, Tolerability and Adherence of Patients With Relapsing Remitting Multiple Sclerosis Administered Interferon Beta-1a (Rebif® New Formulation) in Real Life SettingsMultiple Sclerosis, Relapsing RemittingDrug: Rebif® New FormulationMerck KGaAMerck A.E., Greece;Merck OY, Finland;Merck B.V., Netherlands;Merck A.B., Sweden;Merck, S.A., PortugalCompleted18 Years60 YearsBoth254N/AGreece
268NCT00784836
(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
269EUCTR2007-006338-32-BE
(EUCTR)
15/09/200817/04/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase 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 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
270EUCTR2007-006338-32-IT
(EUCTR)
11/09/200802/10/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRI.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 RRMS. Relapsing-Remitting Multiple Sclerosis (RRMS).
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: Ocrelizumab
Product Code: RO4964913
INN or Proposed INN: Ocrelizumab
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
F.Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Finland;Spain;Ukraine;Russian Federation;Italy;Switzerland;United Kingdom;France;Czech Republic;Mexico;Canada;Belgium;Denmark;Bulgaria;Netherlands;Germany
271EUCTR2007-005450-23-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
272EUCTR2007-001162-32-DK
(EUCTR)
20/08/200825/07/2008Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 13.1;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: MabCampath ®
Product Name: alemtuzumab
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
840Phase 3Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Belgium;Denmark;Argentina;Mexico;Spain;Croatia;United States;Poland
273EUCTR2007-001162-32-IT
(EUCTR)
06/08/200814/07/2008A Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-IIA Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High- Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif) in Patients with Relapsing-Remitting Multiple Sclerosis Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: MABCAMPATH
INN or Proposed INN: Alemtuzumab
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
573Phase 3France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;United Kingdom;Italy;Sweden
274EUCTR2008-000499-25-ES
(EUCTR)
31/07/200810/06/2008International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS)Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMSInternational, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmartTM suitability for self-injection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS)Estudio de fase IIIb, de un solo brazo, abierto, 12 semanas de duración, multicéntrico e internacional, dirigido a evaluar la adecuación de RebiSmartTM para la autoinyección de Rebif® Nueva Formulación (RNF) en cartucho multidosis en pacientes con esclerosis múltiple recidivante (EMR) - RebiSmartTM in RMS Relapsing forms of Multiple Sclerosis (RMS) Esclerosis múltiple recidivante (EMR)
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Rebif New Formulation 44mcg multidose cartridge
INN or Proposed INN: INTERFERON BETA-1A
Merck Serono International S.A.NULLNot RecruitingFemale: yes
Male: yes
100Phase 3Germany;Spain;Italy;Sweden
275EUCTR2007-001162-32-CZ
(EUCTR)
30/07/200831/03/2008A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
573Phase 3France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
276EUCTR2007-006338-32-GB
(EUCTR)
28/07/200807/03/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase 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 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Slovakia;Finland;Spain;Ukraine;Russian Federation;Switzerland;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
277EUCTR2007-001162-32-SE
(EUCTR)
28/07/200828/12/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 13.1;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: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
840Phase 3Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
278EUCTR2008-000499-25-IT
(EUCTR)
24/07/200815/02/2010International, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMSInternational, multicenter, single-arm, open-label, 12-week phase IIIb study to evaluate RebiSmart suitability for selfinjection of Rebif New Formulation (RNF) in multidose cartridges in patients with relapsing form of multiple sclerosis (RMS) - RebiSmart in RMS Relapsing forms of Multiple Sclerosis (RMS)
MedDRA version: 9.1;Level: PT;Classification code 10063399
INN or Proposed INN: Interferon beta-1aMERCK SERONO SANULLNot RecruitingFemale: yes
Male: yes
100Phase 3Spain;Germany;Italy;Sweden
279EUCTR2007-006338-32-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
280EUCTR2007-006338-32-NL
(EUCTR)
09/07/200829/05/2008Phase 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 sclerosisPhase 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 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 2Finland;Czech Republic;Germany;United Kingdom;Netherlands;Belgium;Denmark;Bulgaria;France;Spain;Italy
281EUCTR2007-006338-32-DK
(EUCTR)
09/07/200809/04/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase 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 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
282EUCTR2007-006338-32-DE
(EUCTR)
09/07/200817/03/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase 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 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrrelizumab 300 mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrrelizumab 300 mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
F. Hoffman-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
283EUCTR2007-006338-32-SK
(EUCTR)
16/06/200809/04/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase 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 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Other descriptive name: OCRELIZUMAB
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
284EUCTR2007-001162-32-DE
(EUCTR)
02/06/200802/01/2008Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis.A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.0;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: MabCampath ®
INN or Proposed INN: Alemtuzumab
Other descriptive name: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
840Phase 3Germany;Netherlands;France;Italy;Austria;Sweden;Australia;Brazil;Israel;Czech Republic;Russian Federation;United Kingdom;Canada;Serbia;Ukraine;Denmark;Belgium;Argentina;Mexico;Spain;Croatia;United States;Poland
285EUCTR2007-006338-32-CZ
(EUCTR)
28/05/200801/04/2008A global clinical study in patients with relapsing-remitting multiple sclerosis to investigate the effect of two different dose regimens of ocrelizumab compared to a placebo or Avonex by measuring the effect on brain lesions seen on MRIPhase 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 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: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Trade Name: Ocrevus
Product Name: Ocrelizumab 300mg
Product Code: RO4964913/F07
INN or Proposed INN: ocrelizumab
Hoffman La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
200Phase 2United States;Serbia;Czechia;Slovakia;Finland;Spain;Ukraine;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Mexico;Canada;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany
286EUCTR2007-001162-32-BE
(EUCTR)
26/05/200822/01/2008A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
573Phase 3France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
287EUCTR2007-001161-14-SE
(EUCTR)
21/05/200818/12/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple SclerosisA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.0;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: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Germany;France;Sweden;Australia;Brazil;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
288EUCTR2007-001162-32-NL
(EUCTR)
06/05/200819/12/2007A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3Czech Republic;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Italy;Poland;Austria;Sweden
289EUCTR2007-006338-32-FR
(EUCTR)
06/05/200826/02/2008Phase 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 sclerosisPhase 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 Relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Product Name: Ocrelizumab
Product Code: RO4964913/F03
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
290EUCTR2007-001161-14-FR
(EUCTR)
11/04/200808/01/2008A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-IA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3France;Czech Republic;Poland;Germany;United Kingdom;Sweden
291EUCTR2007-001162-32-FR
(EUCTR)
11/04/200808/01/2008A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
292EUCTR2007-001161-14-CZ
(EUCTR)
09/04/200811/09/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple SclerosisA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Sclerosis. - CARE MS-I Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.0;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: MabCampath®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif®
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Germany;France;Australia;Brazil;Sweden;Czech Republic;Russian Federation;United Kingdom;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
293EUCTR2007-005450-23-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
294EUCTR2007-005450-23-IT
(EUCTR)
04/03/200813/03/2008A 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 β-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 β-1a (Avonex) in a rater-blinded design - Bravo Multiple sclerosis with relapse
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Product Name: laquinimod
Product Code: TV-5600
INN or Proposed INN: laquinimod
Trade Name: AVONEX*IM 4SIR 30MCG/0,5ML+4AG
INN or Proposed INN: Interferon beta-1a
TEVA ITALIA srlNULLNot RecruitingFemale: yes
Male: yes
1200Germany;Czech Republic;Bulgaria;Estonia;Spain;Italy;Lithuania
295EUCTR2007-001162-32-ES
(EUCTR)
22/02/200814/02/2008Estudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-IIEstudio aleatorio ciego para el evaluador y de dosis ciega de fase 3 que compara dos ciclos anuales intravenosos de dosis baja y alta de alemtuzumab con interferón beta-1a (Rebif®) subcutáneo tres veces a la semana en pacientes con esclerosis múltiple de recaída-remisión que han recaído durante el tratamiento - CARE MS-II Esclerosis Múltiple de recaída-remisión
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
1200Phase 3France;Czech Republic;Poland;Belgium;Spain;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
296EUCTR2007-001161-14-DE
(EUCTR)
06/02/200823/08/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple SclerosisA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.0;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: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Germany;France;Australia;Brazil;Sweden;Russian Federation;United Kingdom;Czech Republic;Serbia;Ukraine;Argentina;Mexico;Croatia;Poland
297EUCTR2007-001162-32-GB
(EUCTR)
24/12/200704/10/2007A Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-IIA Phase 3 Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Patients with Relapsing-Remitting Multiple Scleroris Who Have Relapsed On Therapy - CARE MS-II Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot Recruiting Female: yes
Male: yes
573 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Czech Republic;Poland;Spain;Belgium;Denmark;Austria;Germany;Netherlands;Italy;United Kingdom;Sweden
298EUCTR2008-007162-32-IT
(EUCTR)
30/10/200706/11/2008ADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSMADVANCED MRI STUDY ON INFLAMMATORY AND DEGENRATIVE DAMAGE IN MULTIPLE SCLEROSIS - RMaIDSM Multiple Sclerosis
MedDRA version: 9.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
Trade Name: AVONEX
INN or Proposed INN: Interferon beta-1a
ISTITUTO C. MONDINONULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Italy
299NCT00548405
(ClinicalTrials.gov)
October 200722/10/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study TwoA Phase 3, Randomized, Rater- and Dose-Blinded Study Comparing Two Annual Cycles of Intravenous Low- and High-Dose Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta 1a (Rebif®) in Patients With Relapsing Remitting Multiple Sclerosis Who Have Relapsed On TherapyMultiple Sclerosis, Relapsing-RemittingBiological: Alemtuzumab 12 mg;Biological: Alemtuzumab 24 mg;Biological: Interferon beta-1aGenzyme, a Sanofi CompanyBayerCompleted18 Years55 YearsAll840Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Canada;Croatia;Czech Republic;Denmark;France;Germany;Israel;Italy;Mexico;Netherlands;Poland;Russian Federation;Serbia;Spain;Sweden;Ukraine;United Kingdom
300EUCTR2006-003037-32-LT
(EUCTR)
11/09/200727/11/2006A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
301EUCTR2007-001161-14-GB
(EUCTR)
24/08/200701/08/2007A Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-IA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in treatment Naïve Patients with Relapsing-Remitting Multiple Scleroris. - CARE MS-I Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: MabCampath ®
Product Name: Alemtuzumab
INN or Proposed INN: Alemtuzumab
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Genzyme CorporationNULLNot RecruitingFemale: yes
Male: yes
525Phase 3Czech Republic;Germany;United Kingdom;France;Poland;Sweden
302NCT00530348
(ClinicalTrials.gov)
August 200713/9/2007Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study OneA Phase 3 Randomized, Rater-Blinded Study Comparing Two Annual Cycles of Intravenous Alemtuzumab to Three-Times Weekly Subcutaneous Interferon Beta-1a (Rebif®) in Treatment-Naïve Patients With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingBiological: Alemtuzumab;Biological: Interferon beta-1aGenzyme, a Sanofi CompanyBayerCompleted18 Years50 YearsAll581Phase 3United States;Argentina;Australia;Brazil;Canada;Croatia;Czech Republic;France;Germany;Mexico;Poland;Russian Federation;Serbia;Sweden;Ukraine;United Kingdom;Former Serbia and Montenegro
303NCT00619307
(ClinicalTrials.gov)
July 20078/2/2008Transition to Rebif New FormulationA Randomized, Multicenter, Two-arm, Open-label, Phase IIIb Study to Evaluate the Satisfaction in Relapsing Multiple Sclerosis Subjects Transitioning to Rebif® New Formulation From Rebif® (Interferon Beta-1a) With Ibuprofen When Necessary (PRN) or as ProphylaxisRelapsing Multiple SclerosisDrug: Rebif New Formulation + prophylactic Ibuprofen;Drug: Rebif New Formulation + ibuprofen PRNMerck KGaANULLCompleted18 Years60 YearsAll117Phase 3France;Germany
304EUCTR2006-005972-42-DE
(EUCTR)
20/06/200715/08/2007A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNFA randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: NA
Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF
Product Code: NA
INN or Proposed INN: Interferon beta-1a
Other descriptive name: recombinant human IFN beta
Trade Name: Ibuprofen Sandoz 400 mg Filmtabletten
Product Name: Ibuprofen
INN or Proposed INN: Ibuprofen
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
120Phase 3Germany;France
305EUCTR2006-005972-42-FR
(EUCTR)
12/06/200705/04/2007A randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNFA randomized, multicenter, two-arm, open-label, phase IIIb study to evaluate the satisfaction in relapsing Multiple Sclerosis subjects transitioning to Rebif® New Formulation (RNF) from Rebif® (Interferon beta-1a) with ibuprofen pro re nata (PRN) or as prophylaxis. - Transition to RNF Relapsing multiple sclerosis
MedDRA version: 9.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: NA
Product Name: Interferon-beta 1a FBS-free/HSA-free, RNF
Product Code: NA
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;Germany
306NCT00574041
(ClinicalTrials.gov)
June 200712/12/2007How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full DoseAn Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)Relapsing Remitting Multiple SclerosisDrug: Interferon beta-1aBiogen IdecNULLTerminated18 YearsN/ABoth19Phase 4Australia
307EUCTR2006-003037-32-DE
(EUCTR)
13/04/200701/12/2006A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
308NCT00472797
(ClinicalTrials.gov)
April 200710/5/2007Rebif New Formulation (RNF) Quality of Life (QOL) StudyA Randomized, Multicenter, Two-arm, 12 Week Phase IIIb Study to Evaluate Quality of Life (QOL) Measures in Subjects With Relapsing Forms of Multiple Sclerosis (MS) Who Are Transitioning From Rebif® (Interferon Beta-1a) to Rebif New Formulation (RNF)Relapsing Multiple SclerosisDrug: Rebif New Formulation Non Titrated;Drug: Rebif New Formulation TitratedEMD SeronoNULLCompleted18 Years60 YearsAll232Phase 3United States
309EUCTR2006-003037-32-IT
(EUCTR)
19/03/200715/10/2007A TWO-ARM, RANDOMISED, DOUBLE-BLIND, CONTROL GROUP-COMPARED, MULTICENTRE, PHASE IIIB STUDY WITH MONTHLY MRI AND BIOMARKER ASSESSMENT TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF REBIF NEW FORMULATION (IFN-BETA-1A) IN SUBJECTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS - IMPROVE (INVESTIGATING MRI PARAMETERS WITH REBIF IMPROVED FORMULATION)A TWO-ARM, RANDOMISED, DOUBLE-BLIND, CONTROL GROUP-COMPARED, MULTICENTRE, PHASE IIIB STUDY WITH MONTHLY MRI AND BIOMARKER ASSESSMENT TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF REBIF NEW FORMULATION (IFN-BETA-1A) IN SUBJECTS WITH RELAPSING REMITTING MULTIPLE SCLEROSIS - IMPROVE (INVESTIGATING MRI PARAMETERS WITH REBIF IMPROVED FORMULATION) RELAPSING REMITTING MULTIPLE SCLEROSIS
MedDRA version: 6.1;Level: PT;Classification code 10028245
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
INN or Proposed INN: Interferon beta-1a
MERCK SERONO INTERNATIONAL SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
310EUCTR2006-003037-32-EE
(EUCTR)
06/03/200726/01/2007A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta 1a
Other descriptive name: Not applicable
Merck Serono International SANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Germany;Estonia;Spain;Italy;Lithuania
311EUCTR2006-003366-33-ES
(EUCTR)
13/02/200703/03/2010Estudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple ActivaEstudio multicéntrico en fase II, aleatorizado, doble ciego y controlado frente a placebo, de seguridad, tolerabilidad y eficacia del tratamiento con Cladribina en comprimidos añadido a Rebif New Formulation, en pacientes con Esclerosis Múltiple Activa.A phase II, multi-center, randomized, double-blind, placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine tablet therapy with Rebif new formulation in multiple sclerosis subjects with active disease. - Estudio en fase II de Rebif NF más Cladribina en pacientes con Esclerosis Múltiple Activa Pacientes con esclerosis múltiple activa
MedDRA version: 9.0;Level: PT;Classification code 10028245
Trade Name: not applicable
Product Name: Interferon beta-1a FBS-free/HSA free, RNF
Product Code: Not applicable
Trade Name: not applicable
Product Name: cladribina oral
Product Code: not applicable
INN or Proposed INN: cladribine
Serono International, S.A.NULLNot RecruitingFemale: yes
Male: yes
290Phase 2Spain;Italy
312EUCTR2006-003037-32-ES
(EUCTR)
09/02/200710/03/2010Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation)Estudio en fase IIIb, multicéntrico, comparado con grupo de control, doble ciego, aleatorizado y de dos brazos, con evaluaciones mensuales por resonancia magnética y biomarcadores para evaluar la eficacia, la seguridad y la tolerabilidad de Rebif New Formulation (IFN beta-1a) en pacientes con esclerosis múltiple remitente-recurrente.A two-arm, randomized, double-blind, control group-compared, multicenter, phase IIIb study with monthly MRI and biomarker assessments to evaluate the efficacy, safety, and tolerability of Rebif® New Formulation (IFN-beta-1a) in subjects with relapsing remitting multiple sclerosis. - IMPROVE (Investigating MRI Parameters with Rebif® imprOVEd formulation) Relapsing remitting Multiple Sclerosis
MedDRA version: 9.0;Level: PT;Classification code 10063399
Trade Name: Rebif
Product Name: Interferon beta-1a FBS-free/HSA-free, RNF
Product Code: Not applicable
INN or Proposed INN: Interferon-beta<