ID

34507

Beskrivning

Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019; ODM derived from: https://clinicaltrials.gov/show/NCT01797965

Länk

https://clinicaltrials.gov/show/NCT01797965

Nyckelord

Versioner (1)
  1. 2019-01-18 2019-01-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 januari 2019

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Relapsing-Remitting Multiple Sclerosis NCT01797965

Engelsk

Eligibility Relapsing-Remitting Multiple Sclerosis NCT01797965

1 Formulär  
Criteria
Beskrivning

Criteria

must be a subject currently participating in study 205ms301 (nct01064401), or subject currently participating in study 205ms203 (nct01051349) or study 205ms302 (nct01462318) who has completed end of study visit (week 96 or later).
Beskrivning

Study Subject Participation Status | Multiple Sclerosis Clinical Trial Specified | Clinic Visits Completed

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C0008952
UMLS CUI [3,2]
C0205197
women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
key exclusion criteria:
Beskrivning

Exclusion Criteria Main

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
any subject who permanently discontinued study treatment in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318) prior to the end of the study treatment period, or had an early termination visit in study 205ms301, study 205ms203 (nct01051349) or study 205ms302 (nct01462318).
Beskrivning

Study Subject Participation Status | Multiple Sclerosis Clinical Trial Specified | Therapeutic procedure Discontinued | Termination Clinic Visit

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0026769
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0205369
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C1444662
UMLS CUI [4,1]
C1692758
UMLS CUI [4,2]
C0008952
any significant change in the subject's medical history that would preclude administration of biib019, including laboratory tests or a current clinically significant condition that, in the opinion of the investigator, would have excluded the subject's participation in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318).
Beskrivning

Medical History Change Preventing Daclizumab HYP | Laboratory Procedures Study Subject Participation Status Excluded | Medical condition Study Subject Participation Status Excluded

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0262926
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C1292733
UMLS CUI [1,4]
C4042011
UMLS CUI [2,1]
C0022885
UMLS CUI [2,2]
C2348568
UMLS CUI [2,3]
C0332196
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C2348568
UMLS CUI [3,3]
C0332196
the investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this study 205ms303.
Beskrivning

Factor Preventing Clinical Trial Treatment

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1521761
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0087111
note: other protocol-defined inclusion/exclusion criteria may apply.
Beskrivning

Eligibility Criteria Study Protocol

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C2348563
Tillbaka till toppen

Similar models

Eligibility Relapsing-Remitting Multiple Sclerosis NCT01797965

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Study Subject Participation Status | Multiple Sclerosis Clinical Trial Specified | Clinic Visits Completed
Item
must be a subject currently participating in study 205ms301 (nct01064401), or subject currently participating in study 205ms203 (nct01051349) or study 205ms302 (nct01462318) who has completed end of study visit (week 96 or later).
boolean
C2348568 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0008952 (UMLS CUI [3,1])
C0205197 (UMLS CUI [3,2])
Childbearing Potential Contraceptive methods
Item
women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Study Subject Participation Status | Multiple Sclerosis Clinical Trial Specified | Therapeutic procedure Discontinued | Termination Clinic Visit
Item
any subject who permanently discontinued study treatment in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318) prior to the end of the study treatment period, or had an early termination visit in study 205ms301, study 205ms203 (nct01051349) or study 205ms302 (nct01462318).
boolean
C2348568 (UMLS CUI [1])
C0026769 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0205369 (UMLS CUI [2,3])
C0087111 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C1692758 (UMLS CUI [4,1])
C0008952 (UMLS CUI [4,2])
Medical History Change Preventing Daclizumab HYP | Laboratory Procedures Study Subject Participation Status Excluded | Medical condition Study Subject Participation Status Excluded
Item
any significant change in the subject's medical history that would preclude administration of biib019, including laboratory tests or a current clinically significant condition that, in the opinion of the investigator, would have excluded the subject's participation in study 205ms301 (nct01064401), study 205ms203 (nct01051349) or study 205ms302 (nct01462318).
boolean
C0262926 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C1292733 (UMLS CUI [1,3])
C4042011 (UMLS CUI [1,4])
C0022885 (UMLS CUI [2,1])
C2348568 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C2348568 (UMLS CUI [3,2])
C0332196 (UMLS CUI [3,3])
Factor Preventing Clinical Trial Treatment
Item
the investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this study 205ms303.
boolean
C1521761 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0087111 (UMLS CUI [1,4])
Eligibility Criteria Study Protocol
Item
note: other protocol-defined inclusion/exclusion criteria may apply.
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Tillbaka till toppen 

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial