Standard interval dosing ( DrugBank: - )


1 disease
IDDisease name (Link within this page)Number of trials
13Multiple sclerosis/Neuromyelitis optica7

13. Multiple sclerosis/Neuromyelitis optica


Clinical trials : 3,340 Drugs : 2,163 - (DrugBank : 383) / Drug target genes : 241 - Drug target pathways : 238
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04225312
(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
2EUCTR2018-002145-11-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
3EUCTR2018-002145-11-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
4EUCTR2018-002145-11-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]
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;Italy;United Kingdom
5EUCTR2018-002145-11-DE
(EUCTR)
15/02/201917/10/2018A 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: 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
Biogen Idec Research LimitedNULLNot RecruitingFemale: yes
Male: yes
480Phase 3France;United States;Canada;Spain;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Italy;New Zealand
6EUCTR2018-002145-11-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]
Trade Name: TYSABRI
Product Name: AN100226, BG00002
INN or Proposed INN: NATALIZUMAB
Biogen Idec Research LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
480 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Australia;Israel;Netherlands;Germany;New Zealand;Italy;United Kingdom
7NCT03689972
(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