ID

34612

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT02101307

Trefwoorden

  1. 19-01-19 19-01-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

19 januari 2019

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0

Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Rheumatoid Arthritis NCT02101307

Eligibility Rheumatoid Arthritis NCT02101307

Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Age

Datatype

boolean

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

Rheumatoid arthritis disease activity, moderate | Rheumatoid Arthritis Severe

Datatype

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
Beschrijving

RoActemra | Actemra

Datatype

boolean

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

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

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

RoActemra Previous | Actemra Previous

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Investigational New Drugs

Datatype

boolean

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

Autoimmune Disease | Inflammatory joint disease | Exception Rheumatoid Arthritis

Datatype

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)
Datatype
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])

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial