ID

36545

Beskrivning

A Randomized, Double-blind, Placebo-controlled Study to Assess Efficacy of Tocilizumab+Non-biological DMARD in Reducing Synovitis as Measured by MRI at 12 Weeks After Initiation of Treatment in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Non-biological DMARDs; ODM derived from: https://clinicaltrials.gov/show/NCT01034397

Länk

https://clinicaltrials.gov/show/NCT01034397

Nyckelord

Versioner (2)
  1. 2019-01-19 2019-01-19 -
  2. 2019-05-21 2019-05-21 -
Rättsinnehavare

Hoffmann-La Roche

Uppladdad den

21 maj 2019

DOI

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Licens

Creative Commons BY-NC 3.0
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Tocilizumab and non-biological DMARD in Rheumatoid Arthritis NCT01034397

Engelsk

Eligibility Criteria

1 Formulär  
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
moderate to severe rheumatoid arthritis of >/=6 months duration
Beskrivning

Rheumatoid Arthritis Severity and Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C1319166
synovitis (swollen and tender joint) in the wrist of the dominant hand
Beskrivning

Synovitis in wrist of dominant hand

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039103
UMLS CUI [1,2]
C1322271
UMLS CUI [1,3]
C0449722
non-biologic DMARDs at stable dose for >/=12 weeks prior to baseline
Beskrivning

Non-biologic DMARDs stable dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4054347
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0332185
oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline
Beskrivning

Oral Corticosteroids stable dose

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0442027
UMLS CUI [1,5]
C0332185
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
rheumatic autoimmune disease other than RA
Beskrivning

Rheumatic disease other than RA

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004364
UMLS CUI [1,2]
C0035435
UMLS CUI [1,3]
C0205394
UMLS CUI [1,4]
C0003873
history of or current inflammatory joint disease other than RA
Beskrivning

History of or current inflammatory joint disease other than RA

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0683381
UMLS CUI [1,2]
C1705847
UMLS CUI [1,3]
C0003873
UMLS CUI [1,4]
C0262926
UMLS CUI [2,1]
C0683381
UMLS CUI [2,2]
C1705847
UMLS CUI [2,3]
C0003873
UMLS CUI [2,4]
C0521116
functional class IV (ACR classification)
Beskrivning

ACR

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
Beskrivning

Intraarticular or Parenteral Corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4039704
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C2064783
UMLS CUI [2,2]
C0332185
previous treatment with a biologic agent for RA
Beskrivning

Previous biologic agent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C0003873
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Similar models

Eligibility Criteria

1 Formulär
  1. StudyEvent: Eligibility
    1. Eligibility Criteria
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
adult patients, >/=18 years of age
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Severity and Duration
Item
moderate to severe rheumatoid arthritis of >/=6 months duration
boolean
C0003873 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C1319166 (UMLS CUI [2,2])
Synovitis in wrist of dominant hand
Item
synovitis (swollen and tender joint) in the wrist of the dominant hand
boolean
C0039103 (UMLS CUI [1,1])
C1322271 (UMLS CUI [1,2])
C0449722 (UMLS CUI [1,3])
Non-biologic DMARDs stable dose
Item
non-biologic DMARDs at stable dose for >/=12 weeks prior to baseline
boolean
C4054347 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0332185 (UMLS CUI [1,4])
Oral Corticosteroids stable dose
Item
oral corticosteroids at stable dose for at least 25 out of 28 days prior to baseline
boolean
C0001617 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0442027 (UMLS CUI [1,4])
C0332185 (UMLS CUI [1,5])
Item Group
C0680251 (UMLS CUI)
Rheumatic disease other than RA
Item
rheumatic autoimmune disease other than RA
boolean
C0004364 (UMLS CUI [1,1])
C0035435 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C0003873 (UMLS CUI [1,4])
History of or current inflammatory joint disease other than RA
Item
history of or current inflammatory joint disease other than RA
boolean
C0683381 (UMLS CUI [1,1])
C1705847 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0262926 (UMLS CUI [1,4])
C0683381 (UMLS CUI [2,1])
C1705847 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
C0521116 (UMLS CUI [2,4])
ACR
Item
functional class IV (ACR classification)
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Intraarticular or Parenteral Corticosteroids
Item
intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
boolean
C4039704 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C2064783 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Previous biologic agent
Item
previous treatment with a biologic agent for RA
boolean
C1531518 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
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