ID

34563

Description

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).; ODM derived from: https://clinicaltrials.gov/show/NCT02480153

Lien

https://clinicaltrials.gov/show/NCT02480153

Mots-clés

  1. 19/01/2019 19/01/2019 -
Détendeur de droits

see on clinicaltrials.gov

Téléchargé le

19 janvier 2019

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 Rheumatoid Arthritis NCT02480153

Eligibility Rheumatoid Arthritis NCT02480153

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of rheumatoid arthritis based on 2010 acr/eular criteria for at least 4 months.
Description

ID.1

Type de données

boolean

at least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
Description

ID.2

Type de données

boolean

hs-crp equal or greater than 8 mg/l.
Description

ID.3

Type de données

boolean

must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.
Description

ID.4

Type de données

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
evidence of untreated or inadequately treated latent or active tb.
Description

ID.5

Type de données

boolean

evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (nyha class iii/iv) or malignancy in the previous 5 years.
Description

ID.6

Type de données

boolean

history of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
Description

ID.7

Type de données

boolean

may have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
Description

ID.8

Type de données

boolean

any second dmard must be washed out prior to the first study dose.
Description

ID.9

Type de données

boolean

Similar models

Eligibility Rheumatoid Arthritis NCT02480153

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
diagnosis of rheumatoid arthritis based on 2010 acr/eular criteria for at least 4 months.
boolean
ID.2
Item
at least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
boolean
ID.3
Item
hs-crp equal or greater than 8 mg/l.
boolean
ID.4
Item
must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
evidence of untreated or inadequately treated latent or active tb.
boolean
ID.6
Item
evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (nyha class iii/iv) or malignancy in the previous 5 years.
boolean
ID.7
Item
history of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
boolean
ID.8
Item
may have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
boolean
ID.9
Item
any second dmard must be washed out prior to the first study dose.
boolean

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