ID

31905

Beschrijving

A Study of Tocilizumab Added to DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to DMARDs.; ODM derived from: https://clinicaltrials.gov/show/NCT00996203

Link

https://clinicaltrials.gov/show/NCT00996203

Trefwoorden

Versies (1)
  1. 08-10-18 08-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

8 oktober 2018

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.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

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

Eligibility Rheumatoid Arthritis NCT00996203

Engels

Eligibility Rheumatoid Arthritis NCT00996203

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Adult | Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
moderate to severe active rheumatoid arthritis of >/=6 months duration
Beschrijving

Rheumatoid arthritis moderate Duration | Rheumatoid Arthritis Severe Duration

Datatype

boolean

Alias
UMLS CUI [1,1]
C2368567
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0449238
inadequate clinical response to current non-biologic dmards
Beschrijving

Non-Biologic DMARDs Response Inadequate

Datatype

boolean

Alias
UMLS CUI [1,1]
C4054347
UMLS CUI [1,2]
C1704632
UMLS CUI [1,3]
C0205412
current dmards must be at stable dose for 8 weeks prior to study entry
Beschrijving

DMARDs Dose Stable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
oral corticosteroids (</=10mg/day prednisone or equivalent) and nsaids must be at stable dose for >/=4 weeks prior to screening
Beschrijving

Adrenal Cortex Hormones Oral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic autoimmune disease other than ra
Beschrijving

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
history of or current inflammatory joint disease other than ra
Beschrijving

Inflammatory joint disease | Exception Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0683381
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
previous treatment with any biologic dmard
Beschrijving

Biologic DMARD

Datatype

boolean

Alias
UMLS CUI [1]
C4055380
functional class iv as defined by the acr classification
Beschrijving

Rheumatoid Arthritis Functional Status Class

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
intra-articular or parenteral corticosteroids within 6 weeks prior to screening
Beschrijving

Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Parenteral

Datatype

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1518896
Terug naar het begin van de pagina

Similar models

Eligibility Rheumatoid Arthritis NCT00996203

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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 moderate Duration | Rheumatoid Arthritis Severe Duration
Item
moderate to severe active rheumatoid arthritis of >/=6 months duration
boolean
C2368567 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
Non-Biologic DMARDs Response Inadequate
Item
inadequate clinical response to current non-biologic dmards
boolean
C4054347 (UMLS CUI [1,1])
C1704632 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
DMARDs Dose Stable
Item
current dmards must be at stable dose for 8 weeks prior to study entry
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Adrenal Cortex Hormones Oral
Item
oral corticosteroids (</=10mg/day prednisone or equivalent) and nsaids must be at stable dose for >/=4 weeks prior to screening
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis
Item
rheumatic autoimmune disease other than ra
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Inflammatory joint disease | Exception Rheumatoid Arthritis
Item
history of or current inflammatory joint disease other than ra
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Biologic DMARD
Item
previous treatment with any biologic dmard
boolean
C4055380 (UMLS CUI [1])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv as defined by the acr classification
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Parenteral
Item
intra-articular or parenteral corticosteroids within 6 weeks prior to screening
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

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