ID

31906

Description

A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis With an Inadequate Response to DMARDs; ODM derived from: https://clinicaltrials.gov/show/NCT00996606

Link

https://clinicaltrials.gov/show/NCT00996606

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 NCT00996606

English

Eligibility Rheumatoid Arthritis NCT00996606

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
das >/=3.2
Description

DAS in rheumatoid arthritis

Data type

boolean

Alias
UMLS CUI [1]
C2732410
inadequate response to a stable dose of dmards
Description

DMARDs Dose Stable | Response Inadequate

Data type

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0205412
patients receiving oral corticosteroids must have been at stable dose on >/=25 days in the 28 days prior to first study treatment
Description

Adrenal Cortex Hormones Oral Dose Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0205360
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 joint disease other than ra
Description

Joint disease | Exception Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0022408
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
previous treatment with a biologic
Description

Biological agent

Data type

boolean

Alias
UMLS CUI [1]
C0005515
intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
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
previous treatment with any cell-depleting therapies
Description

B-cell depletion therapy

Data type

boolean

Alias
UMLS CUI [1]
C1171324
functional class iv (acr)
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
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Similar models

Eligibility Rheumatoid Arthritis NCT00996606

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])
DAS in rheumatoid arthritis
Item
das >/=3.2
boolean
C2732410 (UMLS CUI [1])
DMARDs Dose Stable | Response Inadequate
Item
inadequate response to a stable dose of dmards
boolean
C0242708 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
Adrenal Cortex Hormones Oral Dose Stable
Item
patients receiving oral corticosteroids must have been at stable dose on >/=25 days in the 28 days prior to first study treatment
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0205360 (UMLS CUI [1,4])
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])
Joint disease | Exception Rheumatoid Arthritis
Item
history of or current joint disease other than ra
boolean
C0022408 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Biological agent
Item
previous treatment with a biologic
boolean
C0005515 (UMLS CUI [1])
Intraarticular injection of corticosteroids | Adrenal Cortex Hormones Parenteral
Item
intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
boolean
C2064783 (UMLS CUI [1])
C0001617 (UMLS CUI [2,1])
C1518896 (UMLS CUI [2,2])
B-cell depletion therapy
Item
previous treatment with any cell-depleting therapies
boolean
C1171324 (UMLS CUI [1])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv (acr)
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
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