ID

34554

Description

An Observational Study on The Safety and Effectiveness of Mabthera (Rituximab) in The First Six Months of Treatment in Patients With Severe Active Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01071798

Link

https://clinicaltrials.gov/show/NCT01071798

Keywords

  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 NCT01071798

Eligibility Rheumatoid Arthritis NCT01071798

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients, >/= 18 years of age
Description

ID.1

Data type

boolean

severe active rheumatoid arthritis; eligible for treatment with rituximab according to current spc
Description

ID.2

Data type

boolean

informed consent to data collection
Description

ID.3

Data type

boolean

ongoing contraception (for female patients only)
Description

ID.4

Data type

boolean

Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with rituximab (mabthera)
Description

ID.5

Data type

boolean

allergy against monoclonal antibodies, respectively chimeric monoclonal antibodies
Description

ID.6

Data type

boolean

active severe infection
Description

ID.7

Data type

boolean

severe heart failure (nyha class iv) or severe, uncontrolled cardiac disease
Description

ID.8

Data type

boolean

treatment in other studies within 3 months before rituximab therapy
Description

ID.9

Data type

boolean

pregnancy or breast feeding
Description

ID.10

Data type

boolean

Similar models

Eligibility Rheumatoid Arthritis NCT01071798

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
ID.1
Item
adult patients, >/= 18 years of age
boolean
ID.2
Item
severe active rheumatoid arthritis; eligible for treatment with rituximab according to current spc
boolean
ID.3
Item
informed consent to data collection
boolean
ID.4
Item
ongoing contraception (for female patients only)
boolean
Item Group
C0680251 (UMLS CUI)
ID.5
Item
previous treatment with rituximab (mabthera)
boolean
ID.6
Item
allergy against monoclonal antibodies, respectively chimeric monoclonal antibodies
boolean
ID.7
Item
active severe infection
boolean
ID.8
Item
severe heart failure (nyha class iv) or severe, uncontrolled cardiac disease
boolean
ID.9
Item
treatment in other studies within 3 months before rituximab therapy
boolean
ID.10
Item
pregnancy or breast feeding
boolean

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