ID

24653

Description

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

Lien

https://clinicaltrials.gov/show/NCT00489489

Mots-clés

  1. 11/08/2017 11/08/2017 -
Téléchargé le

11 août 2017

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

Modèle Commentaires :

Ici, vous pouvez faire des commentaires sur le modèle. À partir des bulles de texte, vous pouvez laisser des commentaires spécifiques sur les groupes Item et les Item.

Groupe Item commentaires pour :

Item commentaires pour :

Vous devez être connecté pour pouvoir télécharger des formulaires. Veuillez vous connecter ou s’inscrire gratuitement.

Eligibility Multiple Sclerosis NCT00489489

Eligibility Multiple Sclerosis NCT00489489

Inclusion Criteria
Description

Inclusion Criteria

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

Multiple Sclerosis

Type de données

boolean

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

Relapsing course | Disease Progression

Type de données

boolean

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

Kurtzke multiple sclerosis rating scale

Type de données

boolean

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

Interferon-beta Dose Stable

Type de données

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;
Description

Multiple sclerosis relapse Onset Absent

Type de données

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.
Description

Stable status Clinical

Type de données

boolean

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

Exclusion Criteria

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

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

Type de données

boolean

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

Pregnancy | Breast Feeding

Type de données

boolean

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

Substance Use Disorders

Type de données

boolean

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

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

Type de données

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;
Description

HIV Seropositivity

Type de données

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.
Description

Condition Preventing Compliance behavior | Condition Preventing Completion of clinical trial

Type de données

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.
Description

Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568

Similar models

Eligibility Multiple Sclerosis NCT00489489

Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])

Utilisez ce formulaire pour les retours, les questions et les améliorations suggérées.

Les champs marqués d’un * sont obligatoires.

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