ID

31907

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT01007435

Nyckelord

Versioner (1)
  1. 2018-10-08 2018-10-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01007435

Engelsk

Eligibility Rheumatoid Arthritis NCT01007435

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult patients ≥ 18 years of age.
Beskrivning

Adult | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0001779
rheumatoid arthritis of ≤ 2 years duration.
Beskrivning

Rheumatoid Arthritis Duration

Datatyp

boolean

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

Disease activity score das28

Datatyp

boolean

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

Swollen joint count | Tender joint count

Datatyp

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).
Beskrivning

Rheumatoid factor positive | Anti-cyclic citrullinated peptide Positive

Datatyp

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.
Beskrivning

Erythrocyte sedimentation rate measurement | C-reactive protein measurement

Datatyp

boolean

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

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with tocilizumab.
Beskrivning

tocilizumab

Datatyp

boolean

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

Methotrexate | Biological agent

Datatyp

boolean

Alias
UMLS CUI [1]
C0025677
UMLS CUI [2]
C0005515
rheumatic autoimmune disease other than rheumatoid arthritis (ra).
Beskrivning

Autoimmune Disease Rheumatic | Exception Rheumatoid Arthritis

Datatyp

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.
Beskrivning

Inflammatory joint disease | Exception Rheumatoid Arthritis

Datatyp

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.
Beskrivning

Rheumatoid Arthritis Functional Status Class

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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