ID

18257

Beskrivning

Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00134563

Länk

https://clinicaltrials.gov/show/NCT00134563

Nyckelord

Versioner (1)
  1. 2016-10-27 2016-10-27 -
Uppladdad den

27 oktober 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Multiple Sclerosis NCT00134563

Engelsk

Eligibility Multiple Sclerosis NCT00134563

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
multiple sclerosis [ms] subject who was ambulatory (edss of ≤ 5.5)
Beskrivning

Multiple Sclerosis | Outpatient | EDSS

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0029921
UMLS CUI [3]
C0451246
exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
Beskrivning

Relapsing course Clinical | Disease Progression | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205336
UMLS CUI [1,2]
C0205210
UMLS CUI [2]
C0242656
UMLS CUI [3]
C0751967
UMLS CUI [4]
C0751965
UMLS CUI [5]
C0393666
meeting mcdonald's criteria for ms diagnosis;
Beskrivning

Multiple Sclerosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0026769
experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
Beskrivning

Relapse Quantity Period

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C1265611
UMLS CUI [1,3]
C1948053
no relapse onset in the preceding 60 days prior to randomization;
Beskrivning

Relapse Onset

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0035020
UMLS CUI [1,2]
C0332162
clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [acth] or systemic steroid treatment.
Beskrivning

Stable status Clinical | Corticotropin | systemic steroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C0205210
UMLS CUI [2]
C0001655
UMLS CUI [3]
C2825233
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
Beskrivning

Cardiovascular Disease Relevant Clinical | Liver disease Relevant Clinical | nervous system disorder Relevant Clinical | Endocrine System Disease Relevant Clinical | Systemic disease Major

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C2347946
UMLS CUI [1,3]
C0205210
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C2347946
UMLS CUI [2,3]
C0205210
UMLS CUI [3,1]
C0027765
UMLS CUI [3,2]
C2347946
UMLS CUI [3,3]
C0205210
UMLS CUI [4,1]
C0014130
UMLS CUI [4,2]
C2347946
UMLS CUI [4,3]
C0205210
UMLS CUI [5,1]
C0442893
UMLS CUI [5,2]
C0205164
significantly impaired bone marrow function;
Beskrivning

Bone Marrow function Impaired Significant

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0221099
UMLS CUI [1,4]
C0750502
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
any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study;
Beskrivning

Condition Preventing Protocol Compliance

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0525058
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Similar models

Eligibility Multiple Sclerosis NCT00134563

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis | Outpatient | EDSS
Item
multiple sclerosis [ms] subject who was ambulatory (edss of ≤ 5.5)
boolean
C0026769 (UMLS CUI [1])
C0029921 (UMLS CUI [2])
C0451246 (UMLS CUI [3])
Relapsing course Clinical | Disease Progression | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis, Secondary Progressive | Multiple Sclerosis, Progressive Relapsing
Item
exhibiting a relapsing clinical course, with or without progression (relapsing remitting, secondary progressive or progressive relapsing);
boolean
C0205336 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0751967 (UMLS CUI [3])
C0751965 (UMLS CUI [4])
C0393666 (UMLS CUI [5])
Multiple Sclerosis
Item
meeting mcdonald's criteria for ms diagnosis;
boolean
C0026769 (UMLS CUI [1])
Relapse Quantity Period
Item
experienced at least 1 relapse over the 1 year preceding the trial or at least 2 relapses over the 2 years preceding the trial;
boolean
C0035020 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1948053 (UMLS CUI [1,3])
Relapse Onset
Item
no relapse onset in the preceding 60 days prior to randomization;
boolean
C0035020 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
Stable status Clinical | Corticotropin | systemic steroids
Item
clinically stable during the 30 days prior to randomization, without adrenocorticotrophic hormone [acth] or systemic steroid treatment.
boolean
C0205360 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0001655 (UMLS CUI [2])
C2825233 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Cardiovascular Disease Relevant Clinical | Liver disease Relevant Clinical | nervous system disorder Relevant Clinical | Endocrine System Disease Relevant Clinical | Systemic disease Major
Item
clinically relevant cardiovascular, hepatic, neurological, endocrine or other major systemic disease;
boolean
C0007222 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0205210 (UMLS CUI [1,3])
C0023895 (UMLS CUI [2,1])
C2347946 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C0027765 (UMLS CUI [3,1])
C2347946 (UMLS CUI [3,2])
C0205210 (UMLS CUI [3,3])
C0014130 (UMLS CUI [4,1])
C2347946 (UMLS CUI [4,2])
C0205210 (UMLS CUI [4,3])
C0442893 (UMLS CUI [5,1])
C0205164 (UMLS CUI [5,2])
Bone Marrow function Impaired Significant
Item
significantly impaired bone marrow function;
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0221099 (UMLS CUI [1,3])
C0750502 (UMLS CUI [1,4])
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])
Condition Preventing Protocol Compliance
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])
C0525058 (UMLS CUI [1,3])
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