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

Link

https://clinicaltrials.gov/show/NCT02480153

Keywords

Versions (1)
  1. 1/19/19 1/19/19 -
Copyright Holder

see on clinicaltrials.gov

Uploaded on

January 19, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02480153

English

Eligibility Rheumatoid Arthritis NCT02480153

1 forms  
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

Data type

boolean

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

ID.2

Data type

boolean

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

ID.3

Data type

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

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

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

ID.5

Data type

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

Data type

boolean

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

ID.7

Data type

boolean

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

ID.8

Data type

boolean

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

ID.9

Data type

boolean

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Similar models

Eligibility Rheumatoid Arthritis NCT02480153

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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
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