13. 多発性硬化症/視神経脊髄炎
[臨床試験数:3,050,薬物数:2,147(DrugBank:348),標的遺伝子数:244,標的パスウェイ数:228

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"
152 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04580381
(ClinicalTrials.gov)
September 1, 20202/10/2020Real World Effectiveness of Natalizumab Extended Interval Dosing in a French CohortReal World Effectiveness of Natalizumab Extended Interval Dosing in Relapsing-Remitting Multiple Sclerosis in a French CohortMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab Injection [Tysabri]University Hospital, CaenBiogenRecruiting18 YearsN/AAll500France
2EUCTR2019-003127-38-NL
(EUCTR)
09/04/202009/04/2020Research on the effect of add-on high dosage simvastatin treatment on progression in MS patients treated with ocrelizumab and natalizumab.Efficacy of add-on high dose simvastatin on markers for disease progression in MS patients treated with ocrelizumab and natalizumab (SIMSON), a phase II clinical trial. - SIMSON trial Multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Name: Simvastatin
INN or Proposed INN: SIMVASTATIN
Other descriptive name: Simvastatine
VUmc Neurology DepartmentNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 2Netherlands
3NCT04178005
(ClinicalTrials.gov)
February 19, 202021/11/2019Cladribine Tablets After Treatment With Natalizumab (CLADRINA)Cladribine Tablets After Treatment With Natalizumab (CLADRINA)Multiple SclerosisDrug: CladribineUniversity of Texas Southwestern Medical CenterEMD SeronoRecruiting18 Years50 YearsAll40Phase 4United States
4NCT04225312
(ClinicalTrials.gov)
February 3, 20203/1/2020Personalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple SclerosisPersonalized Extended Interval Dosing of Natalizumab in Relapsing Remitting Multiple SclerosisRelapsing Remitting Multiple SclerosisDrug: Personalized extended interval dosing of natalizumab;Drug: Standard interval dosingVU University Medical CenterStichting MS Research;Innovatiefonds ZorgverzekeraardRecruiting18 YearsN/AAll300Phase 4Netherlands
5EUCTR2019-002566-13-NL
(EUCTR)
19/12/201929/10/2019Personalizing the treatment with natalizumab in patients with multiple sclerosisPersonalized extended interval dosing of natalizumab in relapsing remitting multiple sclerosis - NEXT-MS Relapsing remitting multiple sclerosis
MedDRA version: 20.1;Level: LLT;Classification code 10070425;Term: Multiple sclerosis exacerbation;System Organ Class: 100000004852 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Amsterdam University Medical CenterNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
300Phase 4Netherlands
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6NCT04115488
(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
7EUCTR2018-004751-20-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
8EUCTR2018-004751-20-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
9NCT04048577
(ClinicalTrials.gov)
July 3, 201915/4/2019A Pilot Study to Characterize the Biological Effect of a Pre-planned 12 Week Dose Interruption of NatalizumabThe Impact of a Planned 12-week Dosing Interruption of Natalizumab on Immune Cell Trafficking, Pharmacokinetic (PK)/Pharmacodynamic (PD) Parameters, and Multiple Sclerosis (MS) Disease Stability.Multiple Sclerosis;Multiple Sclerosis, Relapsing-RemittingDrug: Dosing Interruption of NatalizumabBerkovich, Regina MD, PhD Inc.Biogen;Cedars-Sinai Medical CenterRecruiting21 Years65 YearsAll10Phase 4United States
10EUCTR2018-002145-11-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
11EUCTR2018-002145-11-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
12EUCTR2018-002145-11-FR
(EUCTR)
08/03/201931/10/2018 A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing 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 TreatmentA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing 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 - NOVA Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
480Phase 3United States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
13EUCTR2018-002145-11-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
14EUCTR2018-002145-11-ES
(EUCTR)
02/01/201905/11/2018A Study to Evaluate Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing 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 TreatmentA Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing 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 Relapsing-remitting multiple sclerosis (RRMS)
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
480Phase 3France;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom
15NCT03689972
(ClinicalTrials.gov)
December 26, 201827/9/2018A 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 AdministrationMultiple Sclerosis, Relapsing-RemittingDrug: NatalizumabBiogenNULLActive, not recruiting18 Years60 YearsAll500Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16NCT03135249
(ClinicalTrials.gov)
January 1, 201812/4/2017Sequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple SclerosisSequential Natalizumab - Alemtuzumab Therapy in Patients With Relapsing Forms of Multiple Sclerosis (SUPPRESS)Multiple Sclerosis (MS)Drug: AlemtuzumabUniversity of Texas Southwestern Medical CenterGenzyme, a Sanofi CompanyActive, not recruiting18 Years60 YearsAll40Phase 4United States
17EUCTR2017-002634-24-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
18EUCTR2016-002820-10-DE
(EUCTR)
26/06/201708/11/2016Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) Remitting-Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Zinbryta
Product Name: Daclizumab
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: DAC HYP
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Canada;Germany;Italy;United Kingdom
19EUCTR2016-003587-39-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
20NCT02881567
(ClinicalTrials.gov)
April 18, 201724/8/2016Efficacy and Safety of Daclizumab in Participants With RRMS Switching From NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects With Relapsing-Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab (SUSTAIN)Relapsing-Remitting Multiple Sclerosis (RRMS)Drug: DaclizumabBiogenAbbVieTerminated18 Years55 YearsAll41Phase 3United States;Canada;Germany;Italy;Puerto Rico;France;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2016-002820-10-GB
(EUCTR)
13/03/201708/11/2016Efficacy and Safety of Daclizumab in Participants with RRMS Switching from NatalizumabA Phase 3b, 12-month, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of BIIB019, Daclizumab, in Subjects with Relapsing-Remitting Multiple Sclerosis (RRMS) Switching from Natalizumab (SUSTAIN) - 205MS305_Biogen Remitting-Relapsing Multiple Sclerosis
MedDRA version: 20.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Zinbryta
Product Name: Zinbryta
Product Code: BIIB019
INN or Proposed INN: Daclizumab
Other descriptive name: DAC HYP
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Canada;Denmark;Germany;Italy;United Kingdom
22NCT03516526
(ClinicalTrials.gov)
November 3, 201612/4/2018Towards Personalized Dosing of Natalizumab in Multiple SclerosisTowards Personalized Dosing of Natalizumab in Multiple SclerosisMultiple SclerosisDrug: NatalizumabVU University Medical CenterSanquin Plasma Products BV;Erasmus Medical Center;St. Antonius Hospital;OLVG;Rijnstate HospitalCompleted18 YearsN/AAll61Phase 4Netherlands
23EUCTR2016-000345-31-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
24NCT02769689
(ClinicalTrials.gov)
April 201617/3/2016Methylprednisolone During the Switch Between Natalizumab and FingolimodOnce a Month High-dose Methylprednisolone During Wash-out Period Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis: a Randomised, Controlled, Double-blind Trial (NTZ2FTY)Multiple SclerosisDrug: Methylprednisolone;Drug: Placebo;Drug: natalizumab (NTZ);Drug: fingolimob (FTY)University Hospital, Clermont-FerrandNULLRecruiting18 Years65 YearsBoth56Phase 4France
25NCT02677077
(ClinicalTrials.gov)
December 31, 20153/12/2015Clinical Disease Activity With Long Term Natalizumab TreatmentMRI and Clinical Disease Activity in Patients Treated Long Term With NatalizumabRelapsing-Remitting Multiple SclerosisDrug: natalizumabBiogenNULLCompleted18 Years65 YearsAll277Belgium;Czechia;Czech Republic
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26NCT03046251
(ClinicalTrials.gov)
August 20153/2/2017Natalizumab in Preventing Post-partum Relapses in Multiple SclerosisNatalizumab in Preventing Post-partum Relapses in Multiple SclerosisMultiple SclerosisDrug: NatalizumabState University of New York at BuffaloNULLRecruiting18 YearsN/AFemale100Phase 4United States
27NCT02386566
(ClinicalTrials.gov)
March 20, 20156/2/2015Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Participants Treated With NatalizumabA Prospective, Multicenter, Observational Study to Assess the Correlation of EDSS With Quality of Life in MS Patients Treated With NatalizumabMultiple SclerosisDrug: natalizumabBiogenNULLCompleted18 Years65 YearsAll48Switzerland
28EUCTR2013-004622-29-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
29EUCTR2013-004622-29-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
30EUCTR2013-005586-39-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2013-004622-29-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
32EUCTR2013-004622-29-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
33NCT02142192
(ClinicalTrials.gov)
December 201416/5/2014Natalizumab Subcutaneous Immunogenicity and Safety StudyA Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple SclerosisRelapsing Multiple SclerosisDrug: natalizumabBiogenNULLTerminated18 Years65 YearsBoth2Phase 2Belgium;Denmark;Germany;Italy
34NCT02342704
(ClinicalTrials.gov)
November 30, 201415/1/2015Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) ParticipantsA 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 SubjectsRelapsing-Remitting Multiple SclerosisDrug: natalizumab;Drug: fingolimodBiogenNULLTerminated18 Years60 YearsAll111Phase 4United States;Australia;Czechia;France;Germany;Italy;Spain;Sweden;United Kingdom;Czech Republic;Denmark
35EUCTR2014-000917-30-DE
(EUCTR)
25/11/201403/07/2014Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple SclerosisA Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis Multiple Sclerosis (MS)
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Natalizumab for Subcutaneous Injection
INN or Proposed INN: NATALIZUMAB
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
113Phase 2Belgium;Denmark;Germany;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2013-004622-29-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
37EUCTR2013-004622-29-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
38EUCTR2013-004622-29-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
39EUCTR2014-003669-97-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
40EUCTR2014-000917-30-BE
(EUCTR)
21/10/201424/07/2014Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple SclerosisA Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis Multiple Sclerosis (MS)
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Natalizumab for Subcutaneous Injection
INN or Proposed INN: NATALIZUMAB
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
113Belgium;Denmark;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
41NCT02241785
(ClinicalTrials.gov)
September 30, 201412/9/2014Natalizumab as an Efficacy Switch in Participants With Relapsing Multiple Sclerosis After Failure on Other TherapiesA Phase 4 Multicenter, Open-Label, Single Arm Study to Evaluate Switching From BRACET/Gilenya® to Natalizumab in Subjects With Relapsing Forms of Multiple Sclerosis (MS)Relapsing Multiple SclerosisDrug: natalizumabBiogenNULLTerminated18 Years60 YearsAll47Phase 4United States;Germany
42EUCTR2014-000917-30-DK
(EUCTR)
02/09/201410/07/2014Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple SclerosisA Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis Multiple Sclerosis (MS)
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Natalizumab for Subcutaneous Injection
INN or Proposed INN: NATALIZUMAB
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
113Belgium;Denmark;Italy
43EUCTR2014-003209-14-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
44EUCTR2014-000917-30-IT
(EUCTR)
25/07/201407/07/2014Immunogenicity and Safety Study of Natalizumab (BG00002) administered to Participants with Relapsing Multiple SclerosisA Multicenter, Open-Label Immunogenicity and Safety Study of subcutaneous Natalizumab 300 mg administered to Subjects with Relapsing Multiple Sclerosis Multiple Sclerosis (MS)
MedDRA version: 17.0;Level: PT;Classification code 10048393;Term: Multiple sclerosis relapse;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Natalizumab for Subcutaneous Injection
INN or Proposed INN: NATALIZUMAB
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
113Belgium;Denmark;Italy
45NCT02159573
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
46EUCTR2013-004616-21-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
47NCT02325440
(ClinicalTrials.gov)
March 20144/9/2014Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to GilenyaA 32-week, Monocentric, Exploratory, Single Arm Study to Assess Immune Function and MRI Disease Activity in Patients With RRMS Transferred From Previous Treatment With Natalizumab to Gilenya® (Fingolimod)Relapsing Remitting Multiple SclerosisDrug: Fingolimod;Drug: NatalizumabUniversity Hospital MuensterNovartisRecruiting18 Years65 YearsBoth15Phase 4Germany
48NCT02137109
(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
49EUCTR2013-004626-28-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
50EUCTR2012-004165-41-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
51NCT01970410
(ClinicalTrials.gov)
October 201322/10/2013Sub-Study: Analysis of JCV Antibody Index in MS Patients Treated With Teriflunomide - SWITCH-JCVSwitching Relapsing Multiple Sclerosis Patients Treated With Natalizumab at Risk for Progressive Multifocal Leukoencephalopathy to Teriflunomide: Is This Safe and Effective? (Sub-study: SWITCH-JCV)Multiple SclerosisDrug: teriflunomideProvidence Health & ServicesMultiple Sclerosis Center of Northeastern New YorkRecruiting21 Years60 YearsAll70Phase 4United States
52NCT01710228
(ClinicalTrials.gov)
July 20134/9/2012Alternative Treatment Paradigm for Natalizumab TrialAlternative Treatment Paradigm for Natalizumab TrialMultiple Sclerosis (MS)Drug: methylprednisoloneUniversity of Texas Southwestern Medical CenterTeva Pharmaceutical Industries;The University of Texas Health Science Center, Houston;University of Alabama at Birmingham;Charite University, Berlin, GermanyWithdrawn18 Years60 YearsBoth0Phase 2United States
53NCT01884935
(ClinicalTrials.gov)
July 201320/6/2013PK and PD Study of Natalizumab in Pediatric Subjects With RRMSA Phase 1, Multicenter, Open-Label, Single-Arm, Multiple Dose Study to Evaluate the the Pharmacokinetics and Pharmacodynamics of Natalizumab in Pediatric Subjects With Relapsing Remitting Multiple Sclerosis (RMS)Relapsing-Remitting Multiple SclerosisBiological: NatalizumabBiogenNULLCompleted10 Years17 YearsBoth13Phase 1Italy
54EUCTR2012-004040-30-AT
(EUCTR)
24/05/201312/03/2013Natalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter studyNatalizumab de-escalation to interferon-beta-1b in patients withrelapsing-remitting multiple sclerosis: A multicenter study relapse-remitting multiple sclerosis;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Trade Name: BETAFERON® (interferon beta-1b)
Product Name: Betaferon
INN or Proposed INN: Betaferon
Other descriptive name: INTERFERON BETA-1B
Ospedale Regionale di LuganoNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Austria;Switzerland
55EUCTR2012-005082-13-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
56NCT02775110
(ClinicalTrials.gov)
November 201229/12/2015Natalizumab Temporary Discontinuation StudyNatalizumab Temporary Discontinuation StudyMultiple SclerosisOther: Natalizumab discontinuationUniversity at BuffaloNULLCompleted18 Years65 YearsBoth50Phase 4United States
57EUCTR2011-001437-16-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
58NCT01701856
(ClinicalTrials.gov)
September 201218/9/2012Natalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple SclerosisNatalizumab De-escalation to Interferon-beta-1b in Patients With Relapsing-remitting Multiple Sclerosis: A Swiss Multicenter Study Prospective, Controlled, Single-arm, Open-label, Multi-centre, Phase IV StudyRelapsing-remitting Multiple SclerosisDrug: Interferon beta-1bClaudio GobbiBayerTerminated18 Years70 YearsBoth5Phase 4Switzerland
59EUCTR2010-021978-11-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
60NCT02142205
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
61NCT01591551
(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
62NCT01485003
(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
63EUCTR2010-021978-11-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
64EUCTR2011-001442-15-SE
(EUCTR)
11/01/201217/11/2011A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) 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: Gilenya
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
600Greece;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Australia;Denmark;Germany;Norway;Sweden
65EUCTR2010-021978-11-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
66EUCTR2010-021978-11-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
67EUCTR2010-021978-11-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
68NCT01943526
(ClinicalTrials.gov)
November 30, 201112/9/2013Ireland Natalizumab (TYSABRI) Observational ProgramIreland Natalizumab (TYSABRI®) Observational Program (iTOP)Relapsing-Remitting Multiple SclerosisBiological: natalizumabBiogenNULLCompletedN/AN/AAll191Ireland
69EUCTR2011-001442-15-HU
(EUCTR)
22/11/201112/10/2011A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) relapsing remitting 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]
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
142Greece;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Czech Republic;Australia;Denmark;Germany;Norway;Sweden
70EUCTR2010-021978-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
71EUCTR2011-001442-15-FI
(EUCTR)
16/11/201115/09/2011A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) relapsing remitting 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]
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
142Greece;Finland;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Hungary;Australia;Denmark;Germany;Norway;Sweden
72EUCTR2011-001442-15-IT
(EUCTR)
04/11/201127/02/2012A study to evaluate disease control and safety in patients with RRMS (relapsing remitting multiple sclerosis) switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multicenter, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) relapsing remitting multiple sclerosis
MedDRA version: 14.1;Level: PT;Classification code 10028245;Term: Multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.1;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Gilenya
INN or Proposed INN: FINGOLIMOD
Other descriptive name: GYLENIA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
600Hungary;Czech Republic;Greece;Finland;Spain;Austria;Australia;Israel;Germany;United Kingdom;Italy;Sweden
73EUCTR2010-024000-10-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
74EUCTR2011-001442-15-CZ
(EUCTR)
13/10/201109/08/2011A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720)A 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) - TOFINGO 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]
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
142Greece;Finland;Spain;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Germany;Sweden
75EUCTR2010-021978-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
76EUCTR2011-001442-15-AT
(EUCTR)
21/09/201127/07/2011A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) relapsing remitting 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
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
600Greece;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Australia;Denmark;Norway;Germany;Sweden
77EUCTR2010-021978-11-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
78NCT01416181
(ClinicalTrials.gov)
September 13, 201121/7/2011A Clinical Study of the Efficacy of Natalizumab on Reducing Disability Progression in Participants With Secondary Progressive Multiple SclerosisA 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 ExtensionSecondary Progressive Multiple SclerosisDrug: natalizumab;Drug: PlaceboBiogenNULLTerminated18 Years58 YearsAll889Phase 3United States;Belgium;Canada;Czechia;Denmark;Finland;France;Germany;Ireland;Israel;Italy;Netherlands;Poland;Russian Federation;Spain;Sweden;United Kingdom;Czech Republic
79EUCTR2011-001442-15-GR
(EUCTR)
02/09/201115/07/2011A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) 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: Gilenya
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
600Greece;Finland;Spain;Ireland;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Germany;Sweden
80EUCTR2011-001442-15-ES
(EUCTR)
01/09/201107/07/2011Estudio para evaluar el control de la enfermedad y la seguridad en pacientes con esclerosis múltiple remitente recurrente que que cambian el tratamiento previo con natalizumab por fingolimod.Estudio multicéntrico, aleatorizado, con enmascaramiento para el paciente y para el evaluador, de grupos paralelos, de 32 semanas de seguimiento, para evaluar el control de la enfermedad y la seguridad en pacientes con esclerosis múltiple remitente recurrente que cambian el tratamiento previo con natalizumab por fingolimod (FTY720) Escelrosis Múltiple Remitente Recurrente
MedDRA version: 14.0;Level: PT;Classification code 10063399;Term: Relapsing-remitting multiple sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Fingolimod
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: Hidrocloruro de fingolimod
Novartis Farmacéutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
600Hungary;Germany;Switzerland;France;Italy;Austria;Sweden;Israel;Finland;United Kingdom;Czech Republic;Spain;Greece
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
81NCT01499667
(ClinicalTrials.gov)
September 201118/8/2011Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to FingolimodA 32-week, Patient- and Rater-blinded, Randomized, Multi-center, Parallel-group Study to Evaluate Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis Transferred From Previous Treatment With Natalizumab to Fingolimod (FTY720)Relapsing Remitting Multiple Sclerosis (RRMS)Drug: Fingolimod;Drug: PlaceboNovartis PharmaceuticalsNULLTerminated18 Years65 YearsAll142Phase 3Australia;Austria;Czech Republic;Finland;Germany;Greece;Hungary;Israel;Italy;Spain;Switzerland
82EUCTR2011-001442-15-DE
(EUCTR)
26/08/201126/05/2011A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) 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: Gilenya
Product Name: Gilenya
Product Code: FTY720
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
142Greece;Finland;Spain;Austria;Israel;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Australia;Denmark;Germany;Norway;Sweden
83EUCTR2010-021978-11-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
84EUCTR2010-024000-10-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
85NCT01405820
(ClinicalTrials.gov)
August 201114/7/2011Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple SclerosisRelapsing-Remitting Multiple SclerosisDrug: natalizumab IV;Drug: natalizumab SC;Drug: IV Placebo;Drug: SC PlaceboBiogenNULLCompleted18 Years55 YearsAll290Phase 2Belgium;France;Germany;Italy;Spain
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
86EUCTR2010-021978-11-GB
(EUCTR)
26/07/201104/04/2011 A 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: 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]
Biogen Idec LimitedNULLNot Recruiting Female: 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
87EUCTR2010-024000-10-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
88EUCTR2011-001442-15-GB
(EUCTR)
14/07/201109/06/2011A study to evaluate disease control and safety in patients with RRMS switching from natalizumab to fingolimodA 32-week, patient- and rater-blinded, randomized, multi-center, parallel-group study to evaluate disease control and safety in patients with relapsing remitting multiple sclerosis transferred from previous treatment with natalizumab to fingolimod (FTY720) 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: Gilenya
INN or Proposed INN: fingolimod
Other descriptive name: FINGOLIMOD HYDROCHLORIDE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
600Greece;Finland;Spain;Austria;Israel;Switzerland;United Kingdom;Italy;France;Czech Republic;Hungary;Australia;Denmark;Germany;Norway;Sweden
89EUCTR2010-024000-10-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
90EUCTR2010-021978-11-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
91EUCTR2010-023560-40-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
92NCT01455220
(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
93EUCTR2009-015556-15-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
94NCT01440101
(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
95NCT01416155
(ClinicalTrials.gov)
October 201024/3/2011Extension Study to Evaluate Safety and Efficacy of Natalizumab in Japanese Participants With Relapsing-Remitting Multiple SclerosisA Long-Term, Open-Label, Multicenter, Extension Study to Evaluate Safety and Efficacy of BG00002 in Japanese Subjects With Relapsing-Remitting Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Multiple SclerosisDrug: natalizumabBiogenNULLCompleted18 Years65 YearsAll97Phase 2Japan;China
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
96EUCTR2009-015556-15-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
97EUCTR2009-015556-15-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
98EUCTR2009-015556-15-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
99EUCTR2009-015556-15-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
100EUCTR2009-009503-19-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
101EUCTR2009-015556-15-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
102EUCTR2009-015556-15-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
103EUCTR2009-015556-15-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
104EUCTR2009-015556-15-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
105EUCTR2009-015556-15-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
106EUCTR2009-015556-15-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
107EUCTR2009-015556-15-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
108NCT01144052
(ClinicalTrials.gov)
June 201011/6/2010Natalizumab De-escalation With Interferon Beta-1bDe-escalation After Natalizumab Treatment With Interferon-beta-1b in Patients With Relapsing-remitting Multiple SclerosisRelapsing-remitting Multiple SclerosisDrug: interferon beta-1b;Drug: NatalizumabClaudio GobbiOspedale Civico, LuganoCompleted18 Years60 YearsAll19Phase 4Switzerland
109EUCTR2009-015556-15-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
110EUCTR2009-015556-15-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
111EUCTR2009-015556-15-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
112EUCTR2009-017490-38-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
113NCT01077466
(ClinicalTrials.gov)
March 201026/2/2010Natalizumab Treatment of Progressive Multiple SclerosisNatalizumab Treatment of Progressive Multiple SclerosisPrimary Progressive Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: NatalizumabRigshospitalet, DenmarkCopenhagen University Hospital, Hvidovre;Biogen Idec;University of Copenhagen;Signifikans ApSCompleted19 Years55 YearsBoth24Phase 2Denmark
114NCT01070823
(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
115NCT01070836
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
116NCT01071083
(ClinicalTrials.gov)
March 201017/2/2010Treatment Interruption of NatalizumabRandomized Treatment Interruption of NatalizumabRelapsing Remitting Multiple SclerosisDrug: natalizumab;Drug: interferon beta 1-a;Drug: methylprednisolone;Other: IV placebo;Drug: glatiramer acetateBiogenElan PharmaceuticalsCompleted18 Years60 YearsAll175Phase 2United States;Germany;Spain
117NCT01058005
(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
118NCT01065727
(ClinicalTrials.gov)
February 20108/2/2010Impact Study of 2 Therapeutic Strategy for Aggressive Remitting Multiple SclerosisStudy Impact, on Clinical Outcomes, Quality of Life and Costs of 2 Therapeutic Strategy (Monthly Natalizumab Versus Mitoxantrone Then Immunomodulator) at 3 Years of Follow-up for Aggressive Remitting Multiple SclerosisMultiple SclerosisOther: mitoxantrone - immunomodulator;Other: natalizumabRennes University HospitalNULLRecruiting18 YearsN/ABoth250N/AFrance
119EUCTR2009-016703-35-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
120NCT00871780
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
121NCT00942214
(ClinicalTrials.gov)
June 200916/7/2009Biomarkers and Response to Natalizumab for Multiple Sclerosis TreatmentBiomarkers Associated With Response to Natalizumab in Multiple Sclerosis Patients. A Prospective Multicentric Open Label Phase IV StudyMultiple SclerosisDrug: NatalizumabUniversity Hospital, ToulouseNULLCompleted18 Years55 YearsBoth300Phase 4France
122NCT00884481
(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
123NCT00818038
(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
124EUCTR2008-005906-38-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
125NCT00744679
(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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
126NCT00771043
(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
127NCT00536120
(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
128NCT00937677
(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
129NCT00559702
(ClinicalTrials.gov)
October 20077/11/2007Safety Study of Natalizumab to Treat Multiple Sclerosis (MS)A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics and Initial Safety of Subcutaneous and Intramuscular Natalizumab in Subjects With Multiple SclerosisRelapsing-Remitting Multiple Sclerosis;Secondary Progressive Multiple SclerosisDrug: natalizumab;Other: standard of careBiogen IdecElan PharmaceuticalsCompleted18 Years65 YearsBoth76Phase 1United States
130EUCTR2005-004061-41-AT
(EUCTR)
06/07/200715/12/2005An 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)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
900Finland;Czech Republic;Germany;United Kingdom;Denmark;Spain;Ireland;Italy;Greece;Austria;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
131EUCTR2005-004061-41-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
132NCT00493298
(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
133NCT00424788
(ClinicalTrials.gov)
January 200718/1/2007A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)Relapsing Forms of Multiple SclerosisProcedure: Plasma exchange;Drug: natalizumab treatmentBiogen IdecNULLCompleted18 Years50 YearsBoth12Phase 0United States
134EUCTR2005-004061-41-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
135EUCTR2005-004061-41-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
136NCT00516893
(ClinicalTrials.gov)
October 200614/8/2007Natalizumab High Titer Immunogenicity and SafetyA Multicenter, Open-Label Immunogenicity and Safety Study of Natalizumab High Titer Material (BG00002-E) in Subjects With Relapsing Forms of Multiple SclerosisMultiple SclerosisBiological: BG00002-E (natalizumab high titer)BiogenElan PharmaceuticalsCompleted18 Years55 YearsAll113Phase 2United States
137EUCTR2005-004061-41-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
138EUCTR2005-004061-41-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
139EUCTR2005-004061-41-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
140EUCTR2005-004061-41-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
141NCT00297232
(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
142NCT00306592
(ClinicalTrials.gov)
March 200631/1/2006Natalizumab 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, or C-1803 and a Dosing Suspension Safety EvaluationMultiple Sclerosis, Relapsing-RemittingBiological: BG00002 (natalizumab)BiogenElan PharmaceuticalsCompleted18 YearsN/AAll404Phase 3United States;Canada
143EUCTR2005-004061-41-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
144EUCTR2005-004061-41-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
145EUCTR2005-004061-41-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
146EUCTR2005-004061-41-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
147EUCTR2004-004130-14-AT
(EUCTR)
17/02/200513/01/2005A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week).A multicenter, randomized, rater-blind study to compare the efficacy and safety of natalizumab (300 mg IV every four weeks) with Interferon beta-1a (44 mcg SC three times a week) in subjects with relapsing multiple sclerosis previously treated with Interferon beta-1a (22 or 44 mcg SC three times a week). Male and female subjects with relapsing multiple sclerosis previously treated with interferon beta-1a (22 mcg or 44 mcg, SC three times a week).Product Name: Natalizumab
Product Code: Not Applicable
INN or Proposed INN: natalizumab
Trade Name: Rebif 44 micrograms
Product Name: Rebif 44 micrograms
INN or Proposed INN: Interferon beta-1a
Biogen Idec GmbHNULLNot RecruitingFemale: yes
Male: yes
1050Austria
148EUCTR2004-000047-18-SE
(EUCTR)
27/07/200428/06/2004An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803.An open-label, multicenter extension study to evaluate the safety and tolerability of natalizumab in subjects with multiple sclerosis who have completed studies C-1801, C-1802, or C-1803. Male and female subjects with multiple sclerosis who have completed natalizumab studies C-1801, C-1802, or C-1803Product Name: natalizumab
Product Code: AN100226
INN or Proposed INN: natalizumab
Biogen Idec Ltd.NULLNot RecruitingFemale: yes
Male: yes
1900Sweden
149NCT00276172
(ClinicalTrials.gov)
December 200311/1/2006Open-Label Natalizumab Safety Extension StudyAn Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803Multiple SclerosisDrug: NatalizumabBiogen IdecNULLCompleted18 YearsN/ABoth1615Phase 3United States
150NCT00097760
(ClinicalTrials.gov)
June 200330/11/2004Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple SclerosisSafety Study of Natalizumab in Combination With Glatiramer Acetate (GA)Multiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogen IdecElan PharmaceuticalsCompleted18 Years55 YearsBoth110Phase 2NULL
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
151NCT00030966
(ClinicalTrials.gov)
January 200215/2/2002Safety and Efficacy of Natalizumab in Combination With Avonex in the Treatment of Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab, When Added to Avonex® (Interferon Beta-1a), in Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogen IdecElan PharmaceuticalsCompleted18 Years55 YearsBoth1200Phase 3United States;Austria;Belgium;France;Germany;Israel;Italy
152NCT00027300
(ClinicalTrials.gov)
November 200130/11/2001Safety and Efficacy of Natalizumab in the Treatment of Multiple SclerosisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingDrug: Natalizumab;Drug: PlaceboBiogenElan PharmaceuticalsCompleted18 Years50 YearsAll900Phase 3United States;Belgium;Canada;Czech Republic;France;Germany;Netherlands;United Kingdom