ID

37149

Beskrivning

Single-dose Study to Describe the Safety of Sarilumab and Tocilizumab in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT02404558

Länk

https://clinicaltrials.gov/show/NCT02404558

Nyckelord

Versioner (1)
  1. 2019-07-04 2019-07-04 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

4 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02404558

Engelsk

Eligibility Rheumatoid Arthritis NCT02404558

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with rheumatoid arthritis (ra) as defined by the american college of rheumatology (acr)/european league against rheumatism (eular) 2010
Beskrivning

Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
rheumatoid arthritis classification criteria.
Beskrivning

Rheumatoid Arthritis Classification criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0008902
UMLS CUI [1,3]
C0243161
acr class i-iii functional status, based on the 1991 revised criteria.
Beskrivning

Rheumatoid Arthritis Functional Status Class

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients less than 20 years of age.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
prior treatment with any biologic anti-interleukin-6 (anti-il-6) or interleukin-6 receptor (il-6r) antagonist.
Beskrivning

Interleukin-6 Antagonist | Interleukin-6 Receptor Antagonist

Datatyp

boolean

Alias
UMLS CUI [1]
C3864917
UMLS CUI [2]
C3819026
any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.
Beskrivning

Glucocorticoid Parenteral Injection | Glucocorticoid Intra-Articular Injection

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0017710
UMLS CUI [1,2]
C1555373
UMLS CUI [2,1]
C0017710
UMLS CUI [2,2]
C0021488
treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
Beskrivning

Prednisone U/day | Equivalent U/day | Prednisone Dosage Change

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C0456683
UMLS CUI [2,1]
C0205163
UMLS CUI [2,2]
C0456683
UMLS CUI [3,1]
C0032952
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0392747
treatment with disease-modifying antirheumatic drugs (dmards), immunosuppressive agents, tumor necrosis factor (tnf) antagonists or any other ra-directed biologic agents within a certain amount of time prior to randomization.
Beskrivning

DMARDs | Immunosuppressive Agents | TNF-inhibitors | Biological agents Targeting Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2]
C0021081
UMLS CUI [3]
C3653350
UMLS CUI [4,1]
C0005515
UMLS CUI [4,2]
C1521840
UMLS CUI [4,3]
C0003873
participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer.
Beskrivning

Study Subject Participation Status | Investigational New Drugs | Therapies, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0949266
active or suspected tuberculosis (tb) or at high risk of contracting tb.
Beskrivning

Tuberculosis | Tuberculosis Suspected | High risk of Tuberculosis

Datatyp

boolean

Alias
UMLS CUI [1]
C0041296
UMLS CUI [2,1]
C0041296
UMLS CUI [2,2]
C0750491
UMLS CUI [3,1]
C0332167
UMLS CUI [3,2]
C0041296
fever, or chronic, persistent, or recurring infection(s) requiring active treatment.
Beskrivning

Fever Treatment required for | Chronic infectious disease Treatment required for | Persistent infection Treatment required for | Recurrent infections Treatment required for

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0015967
UMLS CUI [1,2]
C0332121
UMLS CUI [2,1]
C0151317
UMLS CUI [2,2]
C0332121
UMLS CUI [3,1]
C1264606
UMLS CUI [3,2]
C0332121
UMLS CUI [4,1]
C0239998
UMLS CUI [4,2]
C0332121
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Beskrivning

Study Subject Participation Status Consideration Additional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0518609
UMLS CUI [1,3]
C1524062
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Similar models

Eligibility Rheumatoid Arthritis NCT02404558

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
patients with rheumatoid arthritis (ra) as defined by the american college of rheumatology (acr)/european league against rheumatism (eular) 2010
boolean
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis Classification criteria
Item
rheumatoid arthritis classification criteria.
boolean
C0003873 (UMLS CUI [1,1])
C0008902 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
Rheumatoid Arthritis Functional Status Class
Item
acr class i-iii functional status, based on the 1991 revised criteria.
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Age
Item
patients less than 20 years of age.
boolean
C0001779 (UMLS CUI [1])
Interleukin-6 Antagonist | Interleukin-6 Receptor Antagonist
Item
prior treatment with any biologic anti-interleukin-6 (anti-il-6) or interleukin-6 receptor (il-6r) antagonist.
boolean
C3864917 (UMLS CUI [1])
C3819026 (UMLS CUI [2])
Glucocorticoid Parenteral Injection | Glucocorticoid Intra-Articular Injection
Item
any parenteral or intraarticular glucocorticoid injection within 4 weeks prior to randomization.
boolean
C0017710 (UMLS CUI [1,1])
C1555373 (UMLS CUI [1,2])
C0017710 (UMLS CUI [2,1])
C0021488 (UMLS CUI [2,2])
Prednisone U/day | Equivalent U/day | Prednisone Dosage Change
Item
treatment with prednisone higher than 10 mg or equivalent per day, or change in dosage within 4 weeks prior to randomization.
boolean
C0032952 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
C0205163 (UMLS CUI [2,1])
C0456683 (UMLS CUI [2,2])
C0032952 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0392747 (UMLS CUI [3,3])
DMARDs | Immunosuppressive Agents | TNF-inhibitors | Biological agents Targeting Rheumatoid Arthritis
Item
treatment with disease-modifying antirheumatic drugs (dmards), immunosuppressive agents, tumor necrosis factor (tnf) antagonists or any other ra-directed biologic agents within a certain amount of time prior to randomization.
boolean
C0242708 (UMLS CUI [1])
C0021081 (UMLS CUI [2])
C3653350 (UMLS CUI [3])
C0005515 (UMLS CUI [4,1])
C1521840 (UMLS CUI [4,2])
C0003873 (UMLS CUI [4,3])
Study Subject Participation Status | Investigational New Drugs | Therapies, Investigational
Item
participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening visit, whichever is longer.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Tuberculosis | Tuberculosis Suspected | High risk of Tuberculosis
Item
active or suspected tuberculosis (tb) or at high risk of contracting tb.
boolean
C0041296 (UMLS CUI [1])
C0041296 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0332167 (UMLS CUI [3,1])
C0041296 (UMLS CUI [3,2])
Fever Treatment required for | Chronic infectious disease Treatment required for | Persistent infection Treatment required for | Recurrent infections Treatment required for
Item
fever, or chronic, persistent, or recurring infection(s) requiring active treatment.
boolean
C0015967 (UMLS CUI [1,1])
C0332121 (UMLS CUI [1,2])
C0151317 (UMLS CUI [2,1])
C0332121 (UMLS CUI [2,2])
C1264606 (UMLS CUI [3,1])
C0332121 (UMLS CUI [3,2])
C0239998 (UMLS CUI [4,1])
C0332121 (UMLS CUI [4,2])
Study Subject Participation Status Consideration Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C0518609 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
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