ID

34535

Description

Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01579006

Link

https://clinicaltrials.gov/show/NCT01579006

Keywords

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

See 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 NCT01579006

English

Eligibility Rheumatoid Arthritis NCT01579006

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

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

Adult | Age

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
moderate to severe rheumatoid arthritis
Description

Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe

Data type

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
inadequate response (or intolerant) to non-biological dmards or one biologic agent
Description

Non-Biologic Disease-Modifying Antirheumatic Drug Poor response to treatment | Intolerance to Non-Biologic Disease-Modifying Antirheumatic Drug | Biological agent Quantity Poor response to treatment | Intolerance to Biological agent Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C4054347
UMLS CUI [1,2]
C1320680
UMLS CUI [2,1]
C1744706
UMLS CUI [2,2]
C4054347
UMLS CUI [3,1]
C0005515
UMLS CUI [3,2]
C1265611
UMLS CUI [3,3]
C1320680
UMLS CUI [4,1]
C1744706
UMLS CUI [4,2]
C0005515
UMLS CUI [4,3]
C1265611
patients initiating treatment with roactemra/actemra on their physician's decision (in accordance with the local label), including patients who started treatment with roactemra/actemra in the 8 weeks prior to the enrolment visit
Description

RoActemra | Actemra

Data type

boolean

Alias
UMLS CUI [1]
C3272237
UMLS CUI [2]
C2740854
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
roactemra/actemra treatment more than 8 weeks prior to the enrolment visit
Description

RoActemra Previous | Actemra Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C3272237
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2740854
UMLS CUI [2,2]
C0205156
previous roactemra/actemra treatment in a clinical trial or for compassionate use
Description

RoActemra Previous Clinical Trial | Actemra Previous Clinical Trial | RoActemra Previous Compassionate Use | Actemra Previous Compassionate Use

Data type

boolean

Alias
UMLS CUI [1,1]
C3272237
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0008976
UMLS CUI [2,1]
C2740854
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0008976
UMLS CUI [3,1]
C3272237
UMLS CUI [3,2]
C0205156
UMLS CUI [3,3]
C2718016
UMLS CUI [4,1]
C2740854
UMLS CUI [4,2]
C0205156
UMLS CUI [4,3]
C2718016
enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra
Description

Study Subject Participation Status | Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Description

Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0683381
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0003873
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Similar models

Eligibility Rheumatoid Arthritis NCT01579006

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Age
Item
adult patients, >/= 18 years of age
boolean
C0001675 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe
Item
moderate to severe rheumatoid arthritis
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Non-Biologic Disease-Modifying Antirheumatic Drug Poor response to treatment | Intolerance to Non-Biologic Disease-Modifying Antirheumatic Drug | Biological agent Quantity Poor response to treatment | Intolerance to Biological agent Quantity
Item
inadequate response (or intolerant) to non-biological dmards or one biologic agent
boolean
C4054347 (UMLS CUI [1,1])
C1320680 (UMLS CUI [1,2])
C1744706 (UMLS CUI [2,1])
C4054347 (UMLS CUI [2,2])
C0005515 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C1320680 (UMLS CUI [3,3])
C1744706 (UMLS CUI [4,1])
C0005515 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
RoActemra | Actemra
Item
patients initiating treatment with roactemra/actemra on their physician's decision (in accordance with the local label), including patients who started treatment with roactemra/actemra in the 8 weeks prior to the enrolment visit
boolean
C3272237 (UMLS CUI [1])
C2740854 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
RoActemra Previous | Actemra Previous
Item
roactemra/actemra treatment more than 8 weeks prior to the enrolment visit
boolean
C3272237 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C2740854 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
RoActemra Previous Clinical Trial | Actemra Previous Clinical Trial | RoActemra Previous Compassionate Use | Actemra Previous Compassionate Use
Item
previous roactemra/actemra treatment in a clinical trial or for compassionate use
boolean
C3272237 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C2740854 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
C3272237 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C2718016 (UMLS CUI [3,3])
C2740854 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
C2718016 (UMLS CUI [4,3])
Study Subject Participation Status | Investigational New Drugs
Item
enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with roactemra/actemra
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
boolean
C0004364 (UMLS CUI [1])
C0683381 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])
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