TYSABRI® ( DrugBank: - )


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28

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.TrialIDDate_
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registration
Public_titleScientific_titleConditionInterventionPrimary_
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Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1NCT04115488
(ClinicalTrials.gov)
October 1, 201910/9/2019Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS)Relapsing-Remitting Multiple Sclerosis (RRMS)Biological: Intravenous (IV) infusionsPolpharma Biologics S.A.NULLCompleted18 Years60 YearsAll265Phase 3Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine
2EUCTR2018-004751-20-HR
(EUCTR)
18/09/201902/12/2019A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple SclerosisAntelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope Relapsing-Remitting Multiple Sclerosis (RRMS)
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 Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Polpharma Biologics S.A.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
3EUCTR2018-004751-20-PL
(EUCTR)
22/07/201925/04/2019A study of biosimilar Natalizumab in comparision to Tysabri in Patients with Multiple SclerosisAntelope: Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri® in Patients with Relapsing-Remitting Multiple Sclerosis (RRMS) - Antelope Relapsing-Remitting Multiple Sclerosis (RRMS)
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 Code: PB006
INN or Proposed INN: NATALIZUMAB
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Polpharma Biologics S.A.NULLNot RecruitingFemale: yes
Male: yes
260Phase 3Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
4EUCTR2013-004622-29-DE
(EUCTR)
23/02/201511/11/2014Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) SubjectsA Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects Multiple Sclerosis (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]
Trade Name: Tysabri®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
540Phase 4France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
5EUCTR2013-005586-39-DE
(EUCTR)
29/01/201502/09/2014Natalizumab (BG00002) as an Efficacy Switch in Subjects with Relapsing Multiple Sclerosis (MS) after Failure on Other TherapiesA Phase 4 Multicenter, Open-Label, Single Arm Study toEvaluate Switching from BRACET/Gilenya® to Natalizumabin Subjects with Relapsing Forms of Multiple Sclerosis (MS) Multiple Sclerosis (MS)
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]
Trade Name: Tysabri®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
200Phase 4United States;Germany;Italy
6EUCTR2013-004622-29-DK
(EUCTR)
29/01/201504/12/2014Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) SubjectsA Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects Multiple Sclerosis (MS)
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: Tysabri®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
540Phase 4France;United States;Czech Republic;Spain;Australia;Denmark;Germany;Italy;United Kingdom;Sweden
7EUCTR2013-004622-29-SE
(EUCTR)
30/12/201429/09/2014Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) SubjectsA Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects Multiple Sclerosis (MS)
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: Tysabri®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
540Phase 4France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
8EUCTR2013-004622-29-ES
(EUCTR)
03/12/201403/10/2014Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) SubjectsA Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects Multiple Sclerosis (MS)
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: Tysabri®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
540Phase 4France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
9EUCTR2013-004622-29-GB
(EUCTR)
20/11/201428/08/2014Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) SubjectsA Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects Multiple Sclerosis (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]
Trade Name: Tysabri®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
540Phase 4France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
10EUCTR2013-004622-29-IT
(EUCTR)
10/11/201405/08/2014Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) SubjectsA Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects Multiple Sclerosis (MS)
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: Tysabri®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
540France;United States;Czech Republic;Canada;Spain;Denmark;Australia;Germany;United Kingdom;Italy;Sweden
11EUCTR2013-004622-29-CZ
(EUCTR)
31/10/201413/08/2014Impact of Natalizumab versus Fingolimod on Central Nervous System (CNS) Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis (RRMS) SubjectsA Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects Multiple Sclerosis (MS)
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: Tysabri®
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: Gilenya
Product Name: Fingolimod
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
540Phase 4France;United States;Czech Republic;Spain;Denmark;Australia;Germany;Italy;United Kingdom;Sweden
12NCT02159573
(ClinicalTrials.gov)
July 201419/5/2014Real-world Outcomes on Tecfidera (BG00012, Dimethyl Fumarate) Post-Tysabri (BG00002, Natalizumab)A Multicenter, Retrospective, Observational Study Evaluating Real-world Clinical Outcomes in Relapsing-remitting Multiple Sclerosis Patients Who Transition From Tysabri® (Natalizumab) to Tecfidera® (Dimethyl Fumarate)Relapsing-Remitting Multiple SclerosisBiological: natalizumab;Drug: dimethyl fumarateBiogenNULLCompleted18 YearsN/ABoth530N/AUnited States
13NCT03133403
(ClinicalTrials.gov)
November 201321/4/2016Hematopoietic Stem Cell Therapy for Inflammatory Multiple Sclerosis Failing Alternate Approved TherapyHematopoietic Stem Cell Therapy for Patients With Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyMultiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Tecfidera (BG12);Drug: Gilenya;Drug: Tysabri®;Drug: Avonex/Betaseron/Copaxone/Rebif;Procedure: Hematopoietic stem cell transplantation (HSCT)Sheffield Teaching Hospitals NHS Foundation TrustNULLRecruiting18 Years55 YearsAll5Phase 2/Phase 3United Kingdom
14NCT02142205
(ClinicalTrials.gov)
May 201216/5/2014Safety and Efficacy of Natalizumab (BG00002, Tysabri®) in Russian Participants With Relapsing Remitting Multiple Sclerosis (RRMS)A Prospective, Open-label, Non-randomized, Clinical Trial to Evaluate the Safety and Efficacy in RUSsian RRMS Patients on One Year Treatment With Natalizumab (TYSabri®).Relapsing-Remitting Multiple SclerosisBiological: BG00002Biogen IdecBiogen Idec International GmbHCompleted18 Years60 YearsBoth100Phase 4Russian Federation
15NCT01943526
(ClinicalTrials.gov)
November 30, 201112/9/2013Ireland Natalizumab (TYSABRI) Observational ProgramIreland Natalizumab (TYSABRI®) Observational Program (iTOP)Relapsing-Remitting Multiple SclerosisBiological: natalizumabBiogenNULLCompletedN/AN/AAll191Ireland
16NCT01070823
(ClinicalTrials.gov)
March 201017/2/2010JC-Virus (JCV) Antibody ProgramJCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1Multiple SclerosisDrug: Tysabri® (natalizumab)BiogenUnited BioSource Corporation;Elan Pharmaceuticals;United BioSource Corporation;Elan PharmaceuticalsCompletedN/AN/ABoth1096N/AUnited States
17NCT00871780
(ClinicalTrials.gov)
August 200926/3/2009A Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) PatientsA Prospective, Open-label, Non-randomized, Clinical Trial to Determine if Natalizumab (Tysabri®) Improves Ambulatory Measures in Relapsing-remitting Multiple Sclerosis (RRMS) Patients TIMER StudyRelapsing Remitting Multiple Sclerosis (RRMS)Drug: BG00002 (natalizumab)BiogenElan PharmaceuticalsCompleted18 Years60 YearsAll224Phase 4Belgium;Mexico;Poland;Romania;Saudi Arabia;Ukraine;Venezuela
18EUCTR2008-008065-35-SE
(EUCTR)
13/03/200917/12/2008A multi-centre and prospective trial to evaluate the effects on mul-tiple sclerosis related fatigue during treatment with Tysabri® in patients with relapsing remitting multiple sclerosis over the course of 12 months - TYNERGY Mutiple sclerosis related fatigue in subjects with relapsing remitting multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
MedDRA version: 9.1;Classification code 10016256;Term: Fatigue
Trade Name: TysabriBiogenIdec A/SNULLNot RecruitingFemale: yes
Male: yes
200Sweden
19NCT00937677
(ClinicalTrials.gov)
November 20079/7/2009Effect of Tysabri in Patients With Relapsing-Remitting Multiple Sclerosis: A Follow-up Magnetization Transfer Imaging (MTI) StudyEffect of Natalizumab (Tysabri®) on Remyelination in Patients With Relapsing-remitting Multiple Sclerosis. A Follow-up Voxel-wise Magnetization Transfer Imaging Study.Multiple SclerosisDrug: TysabriUniversity at BuffaloBiogen IdecCompleted18 Years65 YearsBoth85N/AUnited States
20EUCTR2005-004061-41-SE
(EUCTR)
29/06/200715/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
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]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
521Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
21EUCTR2005-004061-41-HU
(EUCTR)
22/11/200620/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
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]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
22EUCTR2005-004061-41-GR
(EUCTR)
31/10/200628/07/2006An Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATAAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
MedDRA version: 8.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
900Phase 3Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;Hungary;Czech Republic;Belgium;Denmark;Germany;Sweden
23EUCTR2005-004061-41-BE
(EUCTR)
17/07/200629/11/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
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]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
521Phase 3Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
24EUCTR2005-004061-41-DK
(EUCTR)
19/06/200609/01/2006TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
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]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Denmark;Australia;Netherlands;Germany;New Zealand;Sweden
25EUCTR2005-004061-41-DE
(EUCTR)
18/05/200614/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
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]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
521Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
26EUCTR2005-004061-41-FI
(EUCTR)
10/02/200601/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
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]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
27EUCTR2005-004061-41-CZ
(EUCTR)
26/01/200611/01/2006TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
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]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden
28EUCTR2005-004061-41-IE
(EUCTR)
20/01/200608/12/2005TYSABRI Long Term Re-Dosing StudyAn Open-label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801 or C-1802 and a Dosing Suspension Safety Evaluation - STRATA Multiple sclerosis (MS)
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]
Trade Name: TYSABRI®
Product Name: NATALIZUMAB
Product Code: BG00002
INN or Proposed INN: Natalizumab
Other descriptive name: Recombinant humanized anti-alpha 4 integrin antibody
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
458Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;New Zealand;Sweden