ID

31907

Description

A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01007435

Link

https://clinicaltrials.gov/show/NCT01007435

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 NCT01007435

English

Eligibility Rheumatoid Arthritis NCT01007435

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
rheumatoid arthritis of ≤ 2 years duration.
Description

Rheumatoid Arthritis Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
disease activity score 28 (das28) > 3.2.
Description

Disease activity score das28

Data type

boolean

Alias
UMLS CUI [1]
C4481729
swollen joint count (sjc) ≥ 4 of 66 joints, tender joint count (tjc) ≥ 6 of 68 joints.
Description

Swollen joint count | Tender joint count

Data type

boolean

Alias
UMLS CUI [1]
C0451521
UMLS CUI [2]
C0451530
rheumatoid factor (rf) and/or anti−cyclic citrullinated peptide (anti-ccp) positive (if rf and anti-ccp negative > 1 erosion required at screening).
Description

Rheumatoid factor positive | Anti-cyclic citrullinated peptide Positive

Data type

boolean

Alias
UMLS CUI [1]
C0151379
UMLS CUI [2,1]
C1320283
UMLS CUI [2,2]
C1514241
erythrocyte sedimentation rate (esr) ≥ 28 mm/h or c-reactive protein (crp) ≥ 10 mg/l at screening.
Description

Erythrocyte sedimentation rate measurement | C-reactive protein measurement

Data type

boolean

Alias
UMLS CUI [1]
C1176468
UMLS CUI [2]
C0201657
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with tocilizumab.
Description

tocilizumab

Data type

boolean

Alias
UMLS CUI [1]
C1609165
previous treatment with methotrexate or biologic agent.
Description

Methotrexate | Biological agent

Data type

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0005515
rheumatic autoimmune disease other than rheumatoid arthritis (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
functional class iv as defined by the american college of rheumatology (acr) classification of functional status in ra.
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 NCT01007435

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 Duration
Item
rheumatoid arthritis of ≤ 2 years duration.
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Disease activity score das28
Item
disease activity score 28 (das28) > 3.2.
boolean
C4481729 (UMLS CUI [1])
Swollen joint count | Tender joint count
Item
swollen joint count (sjc) ≥ 4 of 66 joints, tender joint count (tjc) ≥ 6 of 68 joints.
boolean
C0451521 (UMLS CUI [1])
C0451530 (UMLS CUI [2])
Rheumatoid factor positive | Anti-cyclic citrullinated peptide Positive
Item
rheumatoid factor (rf) and/or anti−cyclic citrullinated peptide (anti-ccp) positive (if rf and anti-ccp negative > 1 erosion required at screening).
boolean
C0151379 (UMLS CUI [1])
C1320283 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
Erythrocyte sedimentation rate measurement | C-reactive protein measurement
Item
erythrocyte sedimentation rate (esr) ≥ 28 mm/h or c-reactive protein (crp) ≥ 10 mg/l at screening.
boolean
C1176468 (UMLS CUI [1])
C0201657 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
tocilizumab
Item
previous treatment with tocilizumab.
boolean
C1609165 (UMLS CUI [1])
Methotrexate | Biological agent
Item
previous treatment with methotrexate or biologic agent.
boolean
C0025677 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis
Item
rheumatic autoimmune disease other than rheumatoid arthritis (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])
Rheumatoid Arthritis Functional Status Class
Item
functional class iv as defined by the american college of rheumatology (acr) classification of functional status in ra.
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
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