ID

34612

Description

Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab); ODM derived from: https://clinicaltrials.gov/show/NCT02101307

Lien

https://clinicaltrials.gov/show/NCT02101307

Mots-clés

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

See clinicaltrials.gov

Téléchargé le

19 janvier 2019

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT02101307

Eligibility Rheumatoid Arthritis NCT02101307

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients at least 18 years of age
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
patients with a diagnosis of moderate to severe ra according to the revised (1987) acr criteria
Description

Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe

Type de données

boolean

Alias
UMLS CUI [1]
C2368567
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
patient in whom the treating physician has made the decision to commence roactemra/actemra treatment (in accordance with the local label). this can include patients who have received roactemra/actemra treatment within 8 weeks prior to the enrolment visit
Description

RoActemra | Actemra

Type de données

boolean

Alias
UMLS CUI [1]
C3272237
UMLS CUI [2]
C2740854
patient has given informed consent
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have received roactemra/actemra more than 8 weeks prior to the enrolment visit
Description

RoActemra Previous | Actemra Previous

Type de données

boolean

Alias
UMLS CUI [1,1]
C3272237
UMLS CUI [1,2]
C0205156
UMLS CUI [2,1]
C2740854
UMLS CUI [2,2]
C0205156
patients who have previously received roactemra/actemra 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

Type de données

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
patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with roactemra/actemra
Description

Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C0013230
patients with a history of autoimmune disease or of any joint inflammatory disease other than ra
Description

Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis

Type de données

boolean

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

Similar models

Eligibility Rheumatoid Arthritis NCT02101307

Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients at least 18 years of age
boolean
C0001779 (UMLS CUI [1])
Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe
Item
patients with a diagnosis of moderate to severe ra according to the revised (1987) acr criteria
boolean
C2368567 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
RoActemra | Actemra
Item
patient in whom the treating physician has made the decision to commence roactemra/actemra treatment (in accordance with the local label). this can include patients who have received roactemra/actemra treatment within 8 weeks prior to the enrolment visit
boolean
C3272237 (UMLS CUI [1])
C2740854 (UMLS CUI [2])
Informed Consent
Item
patient has given informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
RoActemra Previous | Actemra Previous
Item
patients who have received roactemra/actemra 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
patients who have previously received roactemra/actemra 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])
Investigational New Drugs
Item
patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with roactemra/actemra
boolean
C0013230 (UMLS CUI [1])
Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
patients with a history of autoimmune disease or of any joint inflammatory disease other than ra
boolean
C0004364 (UMLS CUI [1])
C0683381 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0003873 (UMLS CUI [3,2])

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