ID

30934

Beschreibung

Phase II Study of Teriflunomide as Adjunctive Therapy to Glatiramer Acetate in Subjects With Multiple Sclerosis; ODM derived from: https://clinicaltrials.gov/show/NCT00475865

Link

https://clinicaltrials.gov/show/NCT00475865

Stichworte

Versionen (1)
  1. 04.07.18 04.07.18 -
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See clinicaltrials.gov

Hochgeladen am

4. Juli 2018

DOI

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Eligibility Multiple Sclerosis NCT00475865

Englisch

Eligibility Multiple Sclerosis NCT00475865

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Multiple Sclerosis

Datentyp

boolean

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

Clinical course Relapsing | Disease Progression | Disease Progression Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0449259
UMLS CUI [1,2]
C0035020
UMLS CUI [2]
C0242656
UMLS CUI [3,1]
C0242656
UMLS CUI [3,2]
C0332197
expanded disability status scale [edss] less or equal to 5.5 (ambulatory);
Beschreibung

EDSS Ambulatory

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0451246
UMLS CUI [1,2]
C0439841
stable dose of glatiramer acetate [ga] for at least 26 weeks prior to the screening visit;
Beschreibung

Glatiramer acetate Dosage Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0289884
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
no onset of ms relapse in the preceding 60 days prior to randomization;
Beschreibung

Absence Onset of Multiple sclerosis relapse

Datentyp

boolean

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

Stable status Clinical

Datentyp

boolean

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

Exclusion Criteria

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

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

Datentyp

boolean

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

Pregnancy | Breast Feeding

Datentyp

boolean

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

Substance Use Disorders

Datentyp

boolean

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

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

Datentyp

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;
Beschreibung

HIV Seropositivity

Datentyp

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.
Beschreibung

Condition Preventing Compliance behavior | Condition Preventing Completion of clinical trial

Datentyp

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.
Beschreibung

Eligibility Criteria Additional

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1516637
UMLS CUI [1,2]
C1524062
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Ähnliche Modelle

Eligibility Multiple Sclerosis NCT00475865

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Multiple Sclerosis
Item
definite ms diagnosis according to mcdonald's criteria;
boolean
C0026769 (UMLS CUI [1])
Clinical course Relapsing | Disease Progression | Disease Progression Absent
Item
relapsing clinical course, with or without progression;
boolean
C0449259 (UMLS CUI [1,1])
C0035020 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0242656 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
EDSS Ambulatory
Item
expanded disability status scale [edss] less or equal to 5.5 (ambulatory);
boolean
C0451246 (UMLS CUI [1,1])
C0439841 (UMLS CUI [1,2])
Glatiramer acetate Dosage Stable
Item
stable dose of glatiramer acetate [ga] for at least 26 weeks prior to the screening visit;
boolean
C0289884 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Absence Onset of Multiple sclerosis relapse
Item
no onset of ms relapse in the preceding 60 days prior to randomization;
boolean
C0332197 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0856120 (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])
Eligibility Criteria Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C1516637 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
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