ID

31905

Description

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

Keywords

Versions (1)
  1. 10/8/18 10/8/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 8, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00996203

English

Eligibility Rheumatoid Arthritis NCT00996203

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 active rheumatoid arthritis of >/=6 months duration
Description

Rheumatoid arthritis moderate Duration | Rheumatoid Arthritis Severe Duration

Data type

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
Description

Non-Biologic DMARDs Response Inadequate

Data type

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
Description

DMARDs Dose Stable

Data type

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
Description

Adrenal Cortex Hormones Oral

Data type

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic autoimmune disease other than ra
Description

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis

Data type

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
Description

Inflammatory joint disease | Exception Rheumatoid Arthritis

Data type

boolean

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

Biologic DMARD

Data type

boolean

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

Rheumatoid Arthritis Functional Status Class

Data type

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
Description

Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Parenteral

Data type

boolean

Alias
UMLS CUI [1]
C2064783
UMLS CUI [2,1]
C0001617
UMLS CUI [2,2]
C1518896
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Similar models

Eligibility Rheumatoid Arthritis NCT00996203

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 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])
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