ID

34535

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01579006

Nyckelord

Versioner (1)
  1. 2019-01-19 2019-01-19 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

19 januari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01579006

Engelsk

Eligibility Rheumatoid Arthritis NCT01579006

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Adult | Age

Datatyp

boolean

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

Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

RoActemra | Actemra

Datatyp

boolean

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

Exclusion Criteria

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

RoActemra Previous | Actemra Previous

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

Study Subject Participation Status | Investigational New Drugs

Datatyp

boolean

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

Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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