13. Multiple sclerosis/Neuromyelitis optica
3,050 clinical trials,   2,147 drugs   (DrugBank: 348 drugs),   244 drug target genes,   228 drug target pathways

Searched query = "Multiple sclerosis/Neuromyelitis optica", "Multiple sclerosis", "Neuromyelitis optica", "MS", "NMOSD", "Devic disease", "Balo concentric sclerosis", "Baló concentric sclerosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
95 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04565431
(ClinicalTrials.gov)
October 202025/8/2020Examining Effects of Tysabri on Cognitive Fatigue Using fMRIBiomarker for Cognitive Fatigue Using Functional Imaging in Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: TysabriKessler FoundationSt. Barnabas Medical CenterNot yet recruiting18 Years64 YearsAll25United States
2NCT04115488
(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.NULLActive, not recruiting18 Years60 YearsAll260Phase 3Belarus;Croatia;Georgia;Moldova, Republic of;Poland;Serbia;Ukraine
3EUCTR2018-004751-20-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
4EUCTR2018-004751-20-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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
260Phase 3Serbia;Belarus;Poland;Ukraine;Croatia;Georgia;Moldova, Republic of
5EUCTR2018-002145-11-GB
(EUCTR)
21/03/201911/10/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4- Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration - BIIB 101MS329 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]
Trade Name: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: TYSABRI
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-002145-11-NL
(EUCTR)
14/03/201905/11/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration 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]
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Germany;Netherlands;United Kingdom;New Zealand;Italy
7EUCTR2018-002145-11-DE
(EUCTR)
15/02/201917/10/2018A Study to Evaluate Efficacy, Safety, and Tolerability of EID of Natalizumab (BG00002) in Participants With RRMS Switching From Treatment With Natalizumab SID in Relation to Continued SID Treatment - Followed by Extension Study Comprising SC and IV Natalizumab AdministrationA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration 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]
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: BG00002
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
480Phase 3United States;France;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;New Zealand;Italy
8NCT03399981
(ClinicalTrials.gov)
January 24, 20189/1/2018Tysabri Observational Cohort Study - Multiple Sclerosis (MS) RegistriesAn Observational Study Utilising Data From the US Tysabri TOUCH Programme and Select EU MS Registries to Estimate the Risk of Progressive Multifocal Leukoencephalopathy (PML) and Other Serious Opportunistic Infections Among Patients Who Were Exposed to an MS Disease Modifying Treatment Prior to Treatment With TysabriProgressive Multifocal LeukoencephalopathyBiological: TysabriBiogenNULLActive, not recruitingN/AN/AAll72600United States
9EUCTR2017-002634-24-SE
(EUCTR)
29/09/201706/07/2017MultipleMS – a study with the aim to accelerate personalised medicine in multiple sclerosis.MultipleMS – Multiple-omics approach to accelerate personalised medicine in a prospective cohort of newly diagnosed MS and CIS patients. - MultipleMS Newly diagnosed patients with Clinically Isolated Syndrome (CIS) and multiple sclerosis (MS) -both relapsing remitting and primary progressive);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name:
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Sweden
10EUCTR2016-003587-39-SE
(EUCTR)
22/05/201723/03/2017This is a long-term study of the safety, efficacy and patient satisfaction of the drug rituximab in comparison with other immunomodulatory treatments for multiple sclerosis. The study will use a national registry for both retrospective and prospective data retrieval.COMBAT-MS (COMparison Between All immunoTherapies for Multiple Sclerosis)A prospective long-term cohort study of safety, efficacy and patient’s satisfaction of MS disease modulatory treatments in relapsing-remitting multiple sclerosis - COMparison Between All immunoTherapies for Multiple Sclerosis (COMBAT-MS) Relapsing-remitting multiple sclerosis (RRMS) that has started on their first or second immunomodulatory drug at the earliest 2011-01-01 and at the latest 2018-06-30. The clinical course and response to treatment is thereafter followed until 2021-06-30;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Tecfidera
INN or Proposed INN: DIMETHYL FUMARATE
Other descriptive name: DIMETHYL FUMARATE
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: FINGOLIMOD
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Betaferon
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Extavia
INN or Proposed INN: INTERFERON BETA-1B
Other descriptive name: INTERFERON BETA-1B
Trade Name: Avonex
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Karolinska InstitutetNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
3700Phase 4Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-000345-31-NL
(EUCTR)
30/09/201611/04/2016Reduce the number of natalizumab infusions in patients with multiple sclerosisTowards personalized dosing of natalizumab in multiple sclerosis - Personalised Dosing of Natalizumab in Multiple Sclerosis (The PDNMS trial) multiple sclerosis
MedDRA version: 18.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: tysabri
Product Name: natalizumab
INN or Proposed INN: NATALIZUMAB
VU medical centerNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 4Netherlands
12EUCTR2013-004622-29-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
13EUCTR2013-004622-29-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
14EUCTR2013-005586-39-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
15EUCTR2013-004622-29-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2013-004622-29-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
17EUCTR2013-004622-29-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
18EUCTR2013-004622-29-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
19EUCTR2013-004622-29-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
20EUCTR2014-003669-97-BE
(EUCTR)
27/10/201402/09/2014A safety study for patients with Relapsing Forms of Multiple Sclerosis who participated STRATA.A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA. Relapsing Forms of Multiple Sclerosis
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Biogen IdecNULLNot RecruitingFemale: yes
Male: yes
10Phase 4Belgium
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-003209-14-FR
(EUCTR)
01/09/201418/06/2015ASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSISASSESSMENT OF EARLY CHANGES OBSERVABLE IN DIFFUSION MRI IN RESPONSE TO TYSABRI TREATMENT TO TWO YEARS IN PATIENTS WITH MULTIPLE SCLEROSIS - TYSADIFF MULTIPLE SCLEROSIS;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: TYSABRI 300 mg solution à diluer pour perfusion
INN or Proposed INN: NATALIZUMAB
Hôpitaux Universitaires de StrasbourgNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
22NCT02159573
(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
23EUCTR2013-004616-21-DE
(EUCTR)
13/03/201404/02/2014A study to assess immune function and typical disease characteristics in patients with multiple sclerosis, when switching from the medication Natalizumab to the medication Gilenya.A 32-week, monocentric, exploratory, single arm study to assess immune function and MRI disease activity in patients with relapsing remitting multiple sclerosis (RRMS) transferred from previous treatment with Natalizumab to Gilenya® (Fingolimod) - ToFingo Successor relapsing remitting multiple sclerosis
MedDRA version: 18.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Universitätsklinikum MünsterNULLNot RecruitingFemale: yes
Male: yes
Germany
24NCT02137109
(ClinicalTrials.gov)
March 20141/5/2014Safety and Efficacy in Pediatric MS Patients Prescribed TysabriMeta-Analysis of the Safety and Efficacy of Natalizumab in Pediatric Patients With Multiple SclerosisMultiple SclerosisDrug: natalizumabBiogenNULLCompletedN/A18 YearsBoth400N/ANULL
25EUCTR2013-004626-28-FI
(EUCTR)
20/12/201320/11/2013Does targeting of S1P receptors reduce microglial activation in multiple sclerosis?Does targeting of S1P receptors reduce microglial activation in multiple sclerosis? Multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: REBIF
Product Name: beetainterferoni -1a
Other descriptive name: INTERFERON BETA-1A
Trade Name: Gilenya
Product Name: Fingolimodi
Other descriptive name: FINGOLIMOD
Trade Name: Avonex
Trade Name: Betaferon
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Lemtrada
Other descriptive name: ALEMTUZUMAB
Turku University HospitalNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Finland
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2012-004165-41-GB
(EUCTR)
04/11/201319/09/2013Hematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized StudyHematopoietic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - Hematopoietic Stem Cell Therapy for Inflammatory MS Inflammatory Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: Tysabri
Product Name: Tysabri
INN or Proposed INN: natalizumab
Trade Name: Fingolimod
Product Name: Gilenya
INN or Proposed INN: Fingolimod
Trade Name: Tecfidera
Product Name: Tecfidera
Product Code: BG-12 120
INN or Proposed INN: dimethyl fumarate
Northwestern UniversityNULLNot RecruitingFemale: yes
Male: yes
110Phase 2United States;United Kingdom
27NCT03133403
(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
28EUCTR2012-005082-13-IT
(EUCTR)
02/04/201318/02/2013A Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple SclerosisA Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects with Relapsing Remitting Multiple Sclerosis Relapsing Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
12Phase 1Italy
29EUCTR2011-001437-16-DE
(EUCTR)
19/09/201209/02/2012A 3 year study to determine if optical coherence tomography can be used to measure disease progression in patients with multiple sclerosisA 3-year, multi-center study to evaluate optical coherence tomography as an outcome measure in patients with multiple sclerosis - multiple sclerosis
MedDRA version: 15.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
INN or Proposed INN: Fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Trade Name: Extavia
INN or Proposed INN: Interferon beta-1b
Other descriptive name: INTERFERON BETA-1B
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
INN or Proposed INN: glatiramer acetate
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Avonex
INN or Proposed INN: Interferon beta-1a
Other descriptive name: INTERFERON BETA-1A
Novartis Pharma Services AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Germany;Switzerland;Netherlands;France;Italy;Austria;Australia;Czech Republic;United Kingdom;Canada;Denmark;Spain;United States;Poland
30EUCTR2010-021978-11-IE
(EUCTR)
06/07/201214/05/2012A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856Phase 3United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31NCT02142205
(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
32NCT01591551
(ClinicalTrials.gov)
March 201222/4/2012NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Multiple Sclerosis Experiencing Fatigue or SleepinessNAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or SleepinessMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab (Tysabri)Cornerstone Health Care, PABiogen IdecCompleted18 Years65 YearsBoth37Phase 4United States
33NCT01485003
(ClinicalTrials.gov)
February 7, 20121/12/2011Observational Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JC Virus Antibody Negative ParticipantsA Multicenter, Observational, Open-Label, Single-Arm Study of Tysabri in Early Relapsing-Remitting Multiple Sclerosis in Anti-JCV Antibody Negative PatientsRelapsing-Remitting Multiple SclerosisBiological: natalizumabBiogenNULLCompleted18 Years65 YearsAll231United States
34EUCTR2010-021978-11-BE
(EUCTR)
03/02/201220/09/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis
MedDRA version: 16.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Sweden
35EUCTR2010-021978-11-IT
(EUCTR)
14/12/201102/03/2012A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis - 101MS326 Multiple Sclerosis
MedDRA version: 14.1;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI*IV 1FL 300MG 15ML
INN or Proposed INN: NA
Other descriptive name: NA
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
856United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2010-021978-11-PL
(EUCTR)
07/12/201128/10/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension Secondary Progressive Multiple Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
37EUCTR2010-021978-11-CZ
(EUCTR)
02/12/201122/08/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension Secondary Progressive Multiple Sclerosis
MedDRA version: 19.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856Phase 3United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
38NCT01943526
(ClinicalTrials.gov)
November 30, 201112/9/2013Ireland Natalizumab (TYSABRI) Observational ProgramIreland Natalizumab (TYSABRI®) Observational Program (iTOP)Relapsing-Remitting Multiple SclerosisBiological: natalizumabBiogenNULLCompletedN/AN/AAll191Ireland
39EUCTR2010-021978-11-ES
(EUCTR)
21/11/201126/09/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856Phase 3United States;Finland;Spain;Ireland;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
40EUCTR2010-024000-10-IT
(EUCTR)
26/10/201127/12/2011A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple SclerosisA Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis Relapsing-Remitting Multiple Sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: TYSABRI*IV 1FL 300MG 15ML
Trade Name: TYSABRI*IV 1FL 300MG 15ML
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Spain;Belgium;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41EUCTR2010-021978-11-FI
(EUCTR)
28/09/201115/08/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension Secondary Progressive Multiple Sclerosis
MedDRA version: 17.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
42EUCTR2010-021978-11-DK
(EUCTR)
19/09/201123/08/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, With Optional Open-Label Extension Secondary Progressive Multiple Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856Phase 3United States;Finland;Spain;Ireland;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
43EUCTR2010-021978-11-DE
(EUCTR)
19/08/201104/04/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis, with Optional Open-LabelExtension Secondary Progressive Multiple Sclerosis
MedDRA version: 18.0;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856United States;Finland;Spain;Ireland;Russian Federation;Israel;United Kingdom;Iraq;Italy;France;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Sweden
44EUCTR2010-024000-10-ES
(EUCTR)
08/08/201126/05/2011A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple SclerosisA Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Name: Natalizumab for IV Infusion
Product Code: AN100226; BG00002
INN or Proposed INN: NATALIZUMAB
Product Name: Natalizumab for Subcutaneous Injection
Product Code: AN100226; BG00002
INN or Proposed INN: NATALIZUMAB
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Belgium;Spain;Germany;Italy
45EUCTR2010-024000-10-DE
(EUCTR)
19/07/201121/04/2011A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple SclerosisA Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Name: Natalizumab for IV Infusion
Product Code: AN100226; BG00002
INN or Proposed INN: NATALIZUMAB
Product Name: Natalizumab for Subcutaneous Injection
Product Code: AN100226; BG00002
INN or Proposed INN: NATALIZUMAB
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Spain;Belgium;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2010-024000-10-BE
(EUCTR)
28/06/201108/04/2011A Study to Evaluate the Effect of Different Doses of TYSABRI on Safety and Efficacy in Relapsing Multiple SclerosisA Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis - REFINE Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: TYSABRI
Product Name: Natalizumab for IV Infusion
Product Code: AN100226; BG00002
INN or Proposed INN: NATALIZUMAB
Product Name: Natalizumab for Subcutaneous Injection
Product Code: AN100226; BG00002
INN or Proposed INN: NATALIZUMAB
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 2Spain;Belgium;Germany;Italy
47EUCTR2010-021978-11-SE
(EUCTR)
04/05/201130/03/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With SPMSA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Natalizumab on Reducing Disability Progression in Subjects With Secondary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10063400;Term: Secondary progressive multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
Product Code: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Other descriptive name: SUB22282
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
856United States;Finland;Spain;Ireland;Israel;Russian Federation;Italy;United Kingdom;France;Czech Republic;Canada;Poland;Belgium;Denmark;Netherlands;Germany;Sweden
48EUCTR2010-023560-40-SE
(EUCTR)
23/03/201121/12/2010Blood stem cell transplantation for patients with relapsiong-remitting multiple sclerosis, in whom standard treatment has failed.Haematopoetic Stem Cell Therapy for Patients with Inflammatory Multiple Sclerosis Failing Alternate Approved Therapy: A Randomized Study - MIST Relapsing-remitting multiple sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Sendoxan
Other descriptive name: CYCLOPHOSPHAMIDE MONOHYDRATE
Trade Name: Thymoglobuline
Other descriptive name: RABBIT HUMAN T LYMPHOCYTE IMMUNOGLOBULIN
Trade Name: Neupogen
Trade Name: Solu-Medrol
Uppsala l?ns landstingNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120United States;Canada;Brazil;Sweden
49NCT01455220
(ClinicalTrials.gov)
January 201110/10/2011The Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple SclerosisThe Effect of Natalizumab (Tysabri) on Sexual Dysfunction in Multiple SclerosisMultiple SclerosisDrug: Tysabri ® (Natalizumab)University of South FloridaNULLCompleted18 Years60 YearsAll45N/AUnited States
50EUCTR2009-015556-15-AT
(EUCTR)
19/11/201007/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT01440101
(ClinicalTrials.gov)
November 201014/4/2011Natalizumab (BG00002, Tysabri) Study in Japanese Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)Multicenter Study of BG00002 in Japanese Subjects With RRMS, Consisting of a Multiple-Dose, Open-Label Evaluation of Its Safety, Tolerability, Pharmacokinetics and Pharmacodynamics (Part A) and a Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Evaluation of Safety and Efficacy (Part B)Multiple SclerosisDrug: Natalizumab (BG00002);Drug: PlaceboBiogenNULLCompleted18 Years65 YearsAll106Phase 2;Phase 3Japan;China
52EUCTR2009-015556-15-GB
(EUCTR)
02/09/201017/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
53EUCTR2009-015556-15-DK
(EUCTR)
25/08/201017/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
54EUCTR2009-015556-15-DE
(EUCTR)
20/08/201019/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
55EUCTR2009-015556-15-NL
(EUCTR)
13/08/201008/04/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif 44 micrograms solution for injection in pre-filled syringe
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56EUCTR2009-009503-19-BE
(EUCTR)
20/07/201012/05/2009A prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMERA prospective, open label, non-randomised, clinical trial to determine if natalizumab (Tysabri) improves ambulatory measures in relapsing remitting multiple sclerosis (RRMS) patients. - TIMER Multiple sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: Natalizumab
Biogen Idec International GmbHNULLNot RecruitingFemale: yes
Male: yes
200Phase 4Belgium
57EUCTR2009-015556-15-HU
(EUCTR)
14/07/201007/04/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Hungary;Portugal;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
58EUCTR2009-015556-15-GR
(EUCTR)
13/07/201014/12/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
59EUCTR2009-015556-15-PT
(EUCTR)
02/07/201030/03/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Denmark;Germany;Netherlands;Sweden
60EUCTR2009-015556-15-LV
(EUCTR)
11/06/201013/04/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Latvia;Germany;Netherlands;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61EUCTR2009-015556-15-CZ
(EUCTR)
10/06/201029/03/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;Italy;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Germany;Netherlands;Latvia;Sweden
62EUCTR2009-015556-15-SI
(EUCTR)
07/06/201012/04/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Canada;Denmark;Slovenia;Spain;Greece;United States
63EUCTR2009-015556-15-IT
(EUCTR)
07/06/201007/06/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - NDA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon β 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - ND Relapsing Remitting Multiple Sclerosis
MedDRA version: 9.1;Level: LLT;Classification code 10063399
Trade Name: TYSABRI
INN or Proposed INN: Natalizumab
Trade Name: COPAXONE
INN or Proposed INN: Glatiramer acetate
Trade Name: REBIF
INN or Proposed INN: Interferon beta-1a
Trade Name: REBIF*SC 12SIR 6000000UI 22MCG
INN or Proposed INN: Interferon beta-1a
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
64EUCTR2009-015556-15-ES
(EUCTR)
24/05/201024/03/2010Estudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSEstudio multicéntrico, aleatorizado, con evaluador ciego, en grupos paralelos, controlado por grupo activo, para evaluar los beneficios del cambio de tratamiento de Glatiramer Acetato o Interferón Beta 1a a Natalizumab en pacientes con esclerosis múltiple recidivante-remitente A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon B- 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Esclerosis Múltiple Recidivante-RemitenteRelapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: TYSABRI 300 mg concentrado para solución para perfusión
INN or Proposed INN: NATALIZUMAB
Other descriptive name: NATALIZUMAB
Trade Name: COPAXONE 20 mg/ml solución inyectable en jeringa precargada
INN or Proposed INN: GLATIRAMERO ACETATO
Other descriptive name: GLATIRAMER ACETATE
Trade Name: REBIF 44 microgramos solución inyectable en jeringa precargada
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
INN or Proposed INN: INTERFERON BETA1A
Other descriptive name: INTERFERON BETA1A
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
65EUCTR2009-015556-15-FI
(EUCTR)
07/05/201024/02/2010A Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASSA Multicenter, Randomized, Rater-Blind, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Trade Name: Rebif
Other descriptive name: INTERFERON BETA-1A
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack
Other descriptive name: INTERFERON BETA-1A
Trade Name: Copaxone
Other descriptive name: GLATIRAMER ACETATE
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
1800Portugal;Hungary;Germany;Netherlands;Italy;Austria;Sweden;Finland;United Kingdom;Slovenia;Denmark;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
66EUCTR2009-015556-15-SE
(EUCTR)
06/05/201009/03/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon ß 1a) to Natalizumab in Subjects with Relapsing Remitting Multiple Sclerosis - SURPASS Relapsing-Remitting Multiple Sclerosis
MedDRA version: 13.1;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Trade Name: Rebif
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Rebif 8.8 micrograms and 22 micrograms solution for injection in pre-filled syringe initiation pack.
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: Not available
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: Not available
Biogen Idec LimitedNULLNot RecruitingFemale: yes
Male: yes
76United States;Portugal;Slovenia;Greece;Finland;Spain;Austria;United Kingdom;Italy;Hungary;Canada;Denmark;Germany;Netherlands;Sweden
67EUCTR2009-017490-38-DE
(EUCTR)
03/05/201001/02/2010Randomized Treatment Interruption of Natalizumab - RESTORERandomized Treatment Interruption of Natalizumab - RESTORE Natalizumab is a highly efficacious therapy used in the treatment of patients with relapsing multiple sclerosis (MS).This is a prospective randomized study in subjects with relapsing forms of MS who have been receiving natalizumab treatment for at least 12 months with no MS relapses during these 12 months.
MedDRA version: 12.1;Level: LLT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis
Trade Name: Tysabri
INN or Proposed INN: NATALIZUMAB
Other descriptive name: TYSABRI
Trade Name: Copaxone
INN or Proposed INN: GLATIRAMER ACETATE
Other descriptive name: COPAXONE
Trade Name: AVONEX
INN or Proposed INN: INTERFERON BETA-1A
Other descriptive name: AVONEX
Trade Name: Urbason Forte
INN or Proposed INN: METHYLPREDNISOLONE
Other descriptive name: URBASON FORTE
Biogen IdecNULLNot RecruitingFemale: yes
Male: yes
200Germany;Spain
68NCT01071512
(ClinicalTrials.gov)
April 201017/2/2010Tysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisTysabri Effects on Cognition and Neurodegeneration in Multiple SclerosisMultiple SclerosisDrug: TysabriUniversity of ChicagoBiogenCompleted18 Years60 YearsAll20N/AUnited States
69NCT01070836
(ClinicalTrials.gov)
March 201017/2/2010JC Virus Antibody Study of Participants With Relapsing Forms of MS Receiving Treatment With NatalizumabJCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri: STRATIFY-2Relapsing Multiple SclerosisDrug: natalizumabBiogenNULLCompletedN/AN/ABoth35895N/AUnited States;Puerto Rico
70NCT01058005
(ClinicalTrials.gov)
March 201026/1/2010Study Evaluating Rebif, Copaxone, and Tysabri for Active Multiple SclerosisA Multicenter, Randomized, Open-Label, Parallel-Group, Active-Controlled Study to Evaluate the Benefits of Switching Therapy (Glatiramer Acetate or Interferon Beta-1a) to Natalizumab in Subjects With Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: BG00002 (natalizumab);Drug: interferon beta-1a;Drug: glatiramer acetateBiogenElan PharmaceuticalsTerminated18 Years60 YearsAll84Phase 3United States;Australia;Canada;Czech Republic;Finland;France;Hungary;Italy;Latvia;Poland;Slovenia;Spain;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71NCT01070823
(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
72EUCTR2009-016703-35-DK
(EUCTR)
08/01/201027/11/2009Natalizumabbehandling af progressiv multipel sklerose - NAPMSNatalizumabbehandling af progressiv multipel sklerose - NAPMS Secondary progressive multiple sclerosis and primary progressive multiple sclerosis
MedDRA version: 12.0;Level: LLT;Classification code 10063400;Term: Secondary progressive multiple sclerosis
MedDRA version: 12.0;Classification code 10063401;Term: Primary progressive multiple sclerosis
Trade Name: Tysabri
Product Name: Natalizumab
INN or Proposed INN: NATALIZUMAB
Other descriptive name: Tysabri
Dansk Multipel Sclerose CenterNULLNot RecruitingFemale: yes
Male: yes
24Denmark
73NCT00871780
(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
74NCT00884481
(ClinicalTrials.gov)
March 23, 200917/4/2009Effects of Tysabri (BG00002) Over 12 Months on MS Related Fatigue in Participants With RRMSA Multi-centre and Prospective Trial to Evaluate the Effects on Multiple Sclerosis Related Fatigue During Treatment With Tysabri in Patients With Relapsing Remitting Multiple Sclerosis Over the Course of 12 MonthsRelapsing-Remitting Multiple Sclerosis;FatigueOther: NatalizumabBiogenNULLCompleted18 Years65 YearsAll195Austria;Denmark;Norway;Sweden;United States
75EUCTR2008-008065-35-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76NCT00818038
(ClinicalTrials.gov)
March 20095/1/2009A Proof of Concept Study to Evaluate the Effectiveness of Tysabri in Relapsing Remitting Multiple Sclerosis (RRMS) Patient Bladder FunctionPhase IV, Proof of Concept Study to Evaluate Tysabri Effectiveness in RRMS Patient Bladder FunctionRelapsing-Remitting Multiple SclerosisDrug: BG0002 (natalizumab)Biogen IdecNULLCompleted18 Years85 YearsBoth30Phase 4United States
77EUCTR2008-005906-38-FR
(EUCTR)
09/02/200919/03/2009Détermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaquesDétermination de biomarqueurs associés à la réponse au Natalizumab dans la Sclérose en plaques sclérose en plaques
MedDRA version: 9.1;Level: LLT;Classification code 10028245;Term: Multiple sclerosis
Trade Name: Tysabri
Product Name: Tysabri
CHU de ToulouseNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300France
78NCT00771043
(ClinicalTrials.gov)
November 20087/10/2008A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-aOptical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1aRelapsing-Remitting Multiple SclerosisDrug: TYSABRI and AVONEXBiogen IdecNULLWithdrawn18 Years55 YearsBoth50Phase 4United States
79NCT00744679
(ClinicalTrials.gov)
November 200829/8/2008A Pharmacokinetic (PK) Study of Natalizumab (Tysabri) at Steady StateAn Assessment of the Steady-State Pharmacokinetic and Pharmacodynamic Profile of Tysabri 300 mg Following at Least 12 Monthly InfusionsMultiple SclerosisDrug: NatalizumabBiogen IdecElan PharmaceuticalsCompleted18 Years55 YearsBoth20Phase 4United States
80EUCTR2007-007394-22-GB
(EUCTR)
22/05/200811/04/2008The role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanningThe role of white and grey matter and meningeal inflammation in multiple sclerosis (MS) and clinically isolated syndromes (CIS) as quantified using [(11)C](R)-PK11195 positron emission tomography (PET) scanning Multiple Sclerosis
MedDRA version: 9.1;Level: HLT;Classification code 10052785;Term: Multiple sclerosis acute and progressive
Trade Name: Tysabri
Product Name: Tysabri
Imperial College LondonNULLNot RecruitingFemale: yes
Male: yes
10Phase 4United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT00536120
(ClinicalTrials.gov)
January 200825/9/2007The Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple SclerosisA Randomized, Open-Label Study to Assess the Effects of Tysabri Treatment on Vaccination Response and Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: BG00002 (natalizumab);Biological: keyhole limpet hemocyanin (KLH);Biological: tetanus diphtheria toxoid vaccine (Td)BiogenNULLCompleted18 Years60 YearsAll60Phase 4United States
82NCT00937677
(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
83EUCTR2005-004061-41-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
84NCT00493298
(ClinicalTrials.gov)
June 29, 200727/6/2007Tysabri Observational ProgramTOP: Tysabri® Observational ProgramRelapsing-Remitting Multiple SclerosisDrug: natalizumabBiogenNULLActive, not recruiting18 Years65 YearsAll6620Argentina;Australia;Belgium;Brazil;Canada;Czechia;Finland;France;Germany;Greece;Italy;Mexico;Netherlands;Norway;Portugal;Slovakia;Spain;United Kingdom;Czech Republic;Denmark;Switzerland
85EUCTR2005-004061-41-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2005-004061-41-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 LTDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
900Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden
87EUCTR2005-004061-41-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
88EUCTR2005-004061-41-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
89EUCTR2005-004061-41-GB
(EUCTR)
01/06/200625/10/2005TYSABRI 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]
BIOGEN IDEC LTDNULLNot Recruiting Female: yes
Male: yes
458Phase 3Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;Denmark;Germany;New Zealand;Sweden
90EUCTR2005-004061-41-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91NCT00297232
(ClinicalTrials.gov)
March 200627/2/2006Natalizumab (Tysabri) Re-Initiation of DosingAn 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, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety EvaluationRelapsing-Remitting Multiple SclerosisDrug: NatalizumabBiogenNULLTerminated18 YearsN/AAll1094Phase 3Australia;Belgium;Canada;Czech Republic;Denmark;Finland;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Netherlands;New Zealand;Poland;Spain;Sweden;Switzerland;Turkey;United Kingdom;Austria
92EUCTR2005-004061-41-IT
(EUCTR)
24/02/200621/04/2006Extension study with Natalizumab for pts already pertecipated in studies C-1801 e 1802 to evaluate safety of treatmentAn 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 sclerosi multipla
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
INN or Proposed INN: Natalizumab
BIOGEN IDEC LTDNULLNot RecruitingFemale: yes
Male: yes
700Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;Czech Republic;Hungary;Canada;Denmark;Australia;Germany;New Zealand;Sweden
93EUCTR2005-004061-41-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
94EUCTR2005-004061-41-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
95EUCTR2005-004061-41-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