BIIB017 (Peginterferon beta-1a) ( DrugBank: Peginterferon beta-1a )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 13 | 多発性硬化症／視神経脊髄炎 | 15 |
13. 多発性硬化症／視神経脊髄炎
臨床試験数 : 3,340 / 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 | EUCTR2018-003008-38-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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |