13. 多発性硬化症／視神経脊髄炎 Multiple sclerosis/Neuromyelitis optica Clinical trials / Disease details
臨床試験数 : 3,340 / 薬物数 : 2,163 - (DrugBank : 383) / 標的遺伝子数 : 241 - 標的パスウェイ数 : 238
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2018-003008-38-DE (EUCTR) | 10/03/2020 | 06/05/2019 | A 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 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United 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 | ||
| 2 | EUCTR2018-003008-38-HR (EUCTR) | 10/12/2019 | 17/01/2020 | A 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 Limited | NULL | Authorised-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): no | Serbia;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 | ||
| 3 | EUCTR2018-003008-38-PT (EUCTR) | 02/09/2019 | 02/04/2019 | A 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 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Serbia;Portugal;United States;Czechia;Saudi Arabia;Slovakia;Greece;Spain;Turkey;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Argentina;Belgium;Croatia;Australia;Bulgaria;Germany;Kuwait;Tunisia | ||
| 4 | EUCTR2018-003008-38-BE (EUCTR) | 17/07/2019 | 19/04/2019 | A 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 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United 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 | ||
| 5 | EUCTR2018-003008-38-BG (EUCTR) | 10/07/2019 | 05/04/2019 | A 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 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United 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 | ||
| 6 | EUCTR2018-000516-22-PT (EUCTR) | 08/07/2019 | 27/11/2018 | Study 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 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 340 | Phase 3 | United 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 | ||
| 7 | EUCTR2018-003008-38-IT (EUCTR) | 02/07/2019 | 15/06/2021 | A 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 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 LIMITED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United 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 | ||
| 8 | EUCTR2018-003008-38-GR (EUCTR) | 27/06/2019 | 03/05/2019 | A 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 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | United 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 | ||
| 9 | EUCTR2018-003008-38-SK (EUCTR) | 24/06/2019 | 26/04/2019 | A 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 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Serbia;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 | ||
| 10 | EUCTR2018-003008-38-CZ (EUCTR) | 17/06/2019 | 06/03/2019 | A 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 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 Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 142 | Phase 3 | Hungary;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 | ||
| 11 | EUCTR2018-003008-38-HU (EUCTR) | 30/05/2019 | 08/04/2019 | A 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 Limited | NULL | Authorised-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): no | Serbia;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 | ||
| 12 | EUCTR2018-003008-38-ES (EUCTR) | 02/04/2019 | 17/05/2019 | A 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 Limited | NULL | Authorised-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): no | Serbia;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 | ||
| 13 | NCT03870763 (ClinicalTrials.gov) | March 19, 2019 | 7/3/2019 | Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) 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 | Multiple Sclerosis, Relapsing-Remitting | Drug: Dimethyl Fumarate;Drug: Peginterferon Beta-1a;Drug: Placebo | Biogen | NULL | Terminated | 10 Years | 17 Years | All | 11 | Phase 3 | United States;Colombia;Estonia;Hungary;Jordan;Korea, Republic of;Malaysia;Mexico;Saudi Arabia;Taiwan;Thailand;Tunisia;Turkey |
| 14 | EUCTR2018-000516-22-HU (EUCTR) | 04/03/2019 | 02/01/2019 | Study 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 Limited | NULL | Authorised-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): no | Serbia;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 | ||
| 15 | EUCTR2018-000516-22-EE (EUCTR) | 14/01/2019 | 17/12/2018 | Study 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 Limited | NULL | Authorised-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): no | Serbia;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 | ||
| 16 | NCT02269930 (ClinicalTrials.gov) | October 2014 | 17/10/2014 | Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers | An Open-label Crossover Phase 1 Study to Evaluate the Pharmacokinetic Profiles of BIIB017 (Peginterferon Beta-1a) and Rebif® (Interferon Beta-1a) in Healthy Volunteers | Multiple Sclerosis | Drug: peginterferon beta-1a;Drug: Rebif | Biogen Idec | NULL | Completed | 18 Years | 45 Years | Both | 30 | Phase 1 | United States |
| 17 | NCT02234869 (ClinicalTrials.gov) | October 2014 | 5/9/2014 | Transition to Peginterferon Beta-1a (BIIB017) From Subcutaneous Interferon Therapy | Open-label, Randomized, 2-arm, Active Comparator Study to Evaluate Safety and Tolerability in Patients With Relapsing Multiple Sclerosis Transitioning From Standard-of-care Subcutaneous Interferon Therapy to Peginterferon Beta-1a (BIIB017) | Relapsing Multiple Sclerosis | Drug: Interferon Beta;Drug: BIIB017 (Peginterferon beta-1a) | Biogen Idec | NULL | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 4 | NULL |
| 18 | NCT01939002 (ClinicalTrials.gov) | November 2013 | 23/8/2013 | Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-ß) Therapies to Peginterferon Beta-1a (BIIB017) | An Open-Label, Two-Arm Randomized Study to Characterize Flu-Like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Current Interferon Beta Therapies to BIIB017 | Relapsing Multiple Sclerosis | Drug: BIIB017;Drug: naproxen | Biogen | NULL | Completed | 18 Years | 65 Years | All | 251 | Phase 3 | United States |
| 19 | EUCTR2010-024477-39-CZ (EUCTR) | 29/08/2012 | 24/04/2012 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | United 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 | |||
| 20 | EUCTR2010-024477-39-GB (EUCTR) | 07/08/2012 | 20/03/2012 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | United 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 | ||
| 21 | EUCTR2010-024477-39-GR (EUCTR) | 14/05/2012 | 18/04/2012 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | Serbia;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 | ||
| 22 | EUCTR2010-024477-39-BG (EUCTR) | 16/11/2011 | 20/09/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | United 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 | ||
| 23 | EUCTR2010-024477-39-EE (EUCTR) | 29/09/2011 | 26/09/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Serbia;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 | |||
| 24 | EUCTR2010-024477-39-DE (EUCTR) | 22/09/2011 | 21/06/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Phase 3 | United 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 | ||
| 25 | EUCTR2010-024477-39-BE (EUCTR) | 19/09/2011 | 20/06/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Serbia;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 | |||
| 26 | EUCTR2010-024477-39-ES (EUCTR) | 22/08/2011 | 28/06/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | United 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 | |||
| 27 | EUCTR2010-024477-39-LV (EUCTR) | 06/05/2011 | 21/03/2011 | A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis | A 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1600 | Serbia;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 | |||
| 28 | NCT01332019 (ClinicalTrials.gov) | April 2011 | 24/3/2011 | Long-Term Safety and Efficacy Study of Peginterferon Beta-1a | A 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 | Relapsing Multiple Sclerosis | Drug: peginterferon beta-1a | Biogen | NULL | Completed | 18 Years | 65 Years | All | 1077 | Phase 3 | United 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 |
| 29 | NCT01337427 (ClinicalTrials.gov) | August 2010 | 7/4/2011 | Using Optical Coherence Tomography (OCT) to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Patients With Relapsing Multiple Sclerosis | Optical 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 Sclerosis | Relapsing Remitting Multiple Sclerosis | Drug: BIIB017 | Johns Hopkins University | Biogen Idec | Withdrawn | 18 Years | 55 Years | Both | 0 | Phase 3 | United States |
| 30 | EUCTR2008-006333-27-CZ (EUCTR) | 22/07/2010 | 03/07/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | 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 | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Czech 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 | |||
| 31 | EUCTR2008-006333-27-GR (EUCTR) | 10/03/2010 | 23/10/2009 | 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 | 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 | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Czech Republic;Estonia;Greece;Spain;Belgium;Bulgaria;Netherlands;Germany;Latvia;United Kingdom | |||
| 32 | EUCTR2008-006333-27-GB (EUCTR) | 03/12/2009 | 18/10/2010 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | 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 | 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 Limited | NULL | Not 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): no | Belarus;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 | ||
| 33 | EUCTR2008-006333-27-BE (EUCTR) | 09/11/2009 | 27/05/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | 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 | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | Serbia;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 | |||
| 34 | EUCTR2008-006333-27-NL (EUCTR) | 22/10/2009 | 29/05/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | 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 | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | United 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 | |||
| 35 | EUCTR2008-006333-27-BG (EUCTR) | 26/09/2009 | 16/09/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | 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 | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | 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;Czech Republic;Mexico;Canada;Poland;Belgium;Romania;Croatia;Kazakhstan;Bulgaria;Georgia;Germany;New Zealand | |||
| 36 | EUCTR2008-006333-27-ES (EUCTR) | 11/09/2009 | 02/07/2009 | Estudio 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 | Estudio 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Phase 3 | Czech Republic;Estonia;Greece;Belgium;Spain;Bulgaria;Netherlands;Germany;Latvia;United Kingdom | ||
| 37 | EUCTR2008-006333-27-LV (EUCTR) | 19/06/2009 | 14/04/2009 | 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 | 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 | 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 LTD | NULL | Not Recruiting | Female: yes Male: yes | 1260 | Czech Republic;Estonia;Greece;Spain;Belgium;Bulgaria;Netherlands;Germany;Latvia;United Kingdom | |||
| 38 | EUCTR2008-006333-27-EE (EUCTR) | 16/06/2009 | 11/05/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | 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 | 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | United 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 | |||
| 39 | NCT00906399 (ClinicalTrials.gov) | June 2009 | 20/5/2009 | Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis | 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 | Relapsing Multiple Sclerosis | Drug: BIIB017 (peginterferon beta-1a);Drug: Placebo | Biogen | NULL | Completed | 18 Years | 65 Years | All | 1516 | Phase 3 | United 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 |
| 40 | EUCTR2008-006333-27-DE (EUCTR) | 18/05/2009 | A Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis | 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 | Relapsing 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: 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 Limited | NULL | Not Recruiting | Female: yes Male: yes | 1500 | United States;Belarus;Serbia;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;Poland;Belgium;Romania;Croatia;Kazakhstan;Georgia;Bulgaria;Germany;New Zealand | ||||
| 41 | EUCTR2018-003008-38-FR (EUCTR) | 29/03/2019 | A 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 Limited | NULL | NA | Female: yes Male: yes | 142 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;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 |