ID

24653

Beskrivning

Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00489489

Länk

https://clinicaltrials.gov/show/NCT00489489

Nyckelord

Versioner (1)
  1. 2017-08-11 2017-08-11 -
Uppladdad den

11 augusti 2017

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 Multiple Sclerosis NCT00489489

Engelsk

Eligibility Multiple Sclerosis NCT00489489

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
definite ms diagnosis according to mcdonald's criteria;
Beskrivning

Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
relapsing clinical course, with or without progression;
Beskrivning

Relapsing course | Disease Progression

Datatyp

boolean

Alias
UMLS CUI [1]
C0205336
UMLS CUI [2]
C0242656
expanded disability status scale [edss] less or equal to 5.5 (ambulatory);
Beskrivning

Kurtzke multiple sclerosis rating scale

Datatyp

boolean

Alias
UMLS CUI [1]
C0451246
stable dose of ifn-β for at least 26 weeks prior to the screening visit;
Beskrivning

Interferon-beta Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015980
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
no onset of ms relapse in the preceding 60 days prior to randomization;
Beskrivning

Multiple sclerosis relapse Onset Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0856120
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0332197
clinically stable for 4 weeks prior to randomization.
Beskrivning

Stable status Clinical

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
Beskrivning

Chronic disease of immune system | Liver Dysfunction | Pancreatic Disease chronic

Datatyp

boolean

Alias
UMLS CUI [1]
C1290894
UMLS CUI [2]
C0086565
UMLS CUI [3,1]
C0030286
UMLS CUI [3,2]
C0205191
pregnant or nursing woman;
Beskrivning

Pregnancy | Breast Feeding

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
alcohol or drug abuse;
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
Beskrivning

Cladribine | Mitoxantrone | Immunosuppressive Agents | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | Mycophenolate

Datatyp

boolean

Alias
UMLS CUI [1]
C0092801
UMLS CUI [2]
C0026259
UMLS CUI [3]
C0021081
UMLS CUI [4]
C0004482
UMLS CUI [5]
C0010583
UMLS CUI [6]
C0010592
UMLS CUI [7]
C0025677
UMLS CUI [8]
C0883242
human immunodeficiency virus [hiv] positive status;
Beskrivning

HIV Seropositivity

Datatyp

boolean

Alias
UMLS CUI [1]
C0019699
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
Beskrivning

Condition Preventing Compliance behavior | Condition Preventing Completion of clinical trial

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C1321605
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C2732579
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
Tillbaka till toppen

Similar models

Eligibility Multiple Sclerosis NCT00489489

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
definite ms diagnosis according to mcdonald's criteria;
boolean
C0026769 (UMLS CUI [1])
Relapsing course | Disease Progression
Item
relapsing clinical course, with or without progression;
boolean
C0205336 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Kurtzke multiple sclerosis rating scale
Item
expanded disability status scale [edss] less or equal to 5.5 (ambulatory);
boolean
C0451246 (UMLS CUI [1])
Interferon-beta Dose Stable
Item
stable dose of ifn-β for at least 26 weeks prior to the screening visit;
boolean
C0015980 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Multiple sclerosis relapse Onset Absent
Item
no onset of ms relapse in the preceding 60 days prior to randomization;
boolean
C0856120 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Stable status Clinical
Item
clinically stable for 4 weeks prior to randomization.
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Chronic disease of immune system | Liver Dysfunction | Pancreatic Disease chronic
Item
other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
boolean
C1290894 (UMLS CUI [1])
C0086565 (UMLS CUI [2])
C0030286 (UMLS CUI [3,1])
C0205191 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or nursing woman;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Substance Use Disorders
Item
alcohol or drug abuse;
boolean
C0038586 (UMLS CUI [1])
Cladribine | Mitoxantrone | Immunosuppressive Agents | Azathioprine | Cyclophosphamide | Cyclosporine | Methotrexate | Mycophenolate
Item
use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
boolean
C0092801 (UMLS CUI [1])
C0026259 (UMLS CUI [2])
C0021081 (UMLS CUI [3])
C0004482 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0010592 (UMLS CUI [6])
C0025677 (UMLS CUI [7])
C0883242 (UMLS CUI [8])
HIV Seropositivity
Item
human immunodeficiency virus [hiv] positive status;
boolean
C0019699 (UMLS CUI [1])
Condition Preventing Compliance behavior | Condition Preventing Completion of clinical trial
Item
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.
boolean
C0348080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
Study Subject Participation Status
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
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