ID

37092

Beskrivning

Sarilumab Effect on the Pharmacokinetics of Simvastatin; ODM derived from: https://clinicaltrials.gov/show/NCT02017639

Länk

https://clinicaltrials.gov/show/NCT02017639

Nyckelord

Versioner (1)
  1. 2019-07-03 2019-07-03 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

3 juli 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02017639

Engelsk

Eligibility Rheumatoid Arthritis NCT02017639

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female, between 18 and 75 years of age, inclusive. body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.
Beskrivning

Age | Body Weight | Gender

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0005910
UMLS CUI [3]
C0079399
diagnosis of ra, according to the acr/european league against rheumatism (eular) 2010 rheumatoid arthritis classification criteria with ≥ 3 months disease duration, acr class i-iii functional status, based on 1991 revised criteria (appendix b, 5). moderate-to-severely active ra, defined as:
Beskrivning

Rheumatoid Arthritis Disease length | Rheumatoid Arthritis Functional Status Class | Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0872146
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0598463
UMLS CUI [2,3]
C0456387
UMLS CUI [3]
C2368567
UMLS CUI [4,1]
C0003873
UMLS CUI [4,2]
C0205082
o high sensitivity c-reactive protein (hs-crp) ≥ 6 mg/l
Beskrivning

Measurement of C-reactive protein using high sensitivity technique

Datatyp

boolean

Alias
UMLS CUI [1]
C4040318
laboratory parameters within the normal range (or defined screening threshold for the investigator site), unless the investigator considers an abnormality to be clinically irrelevant for ra patients; however following lab values must be met:
Beskrivning

Laboratory Results Normal Range

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0086715
hemoglobin >8.5 g/dl
Beskrivning

Hemoglobin measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0518015
white blood cells >3000/mm3
Beskrivning

White Blood Cell Count procedure

Datatyp

boolean

Alias
UMLS CUI [1]
C0023508
neutrophils >2000/mm3
Beskrivning

Neutrophil count

Datatyp

boolean

Alias
UMLS CUI [1]
C0200633
platelet count >150 000 cells/mm3
Beskrivning

Platelet Count measurement

Datatyp

boolean

Alias
UMLS CUI [1]
C0032181
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Similar models

Eligibility Rheumatoid Arthritis NCT02017639

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age | Body Weight | Gender
Item
male or female, between 18 and 75 years of age, inclusive. body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Rheumatoid Arthritis Disease length | Rheumatoid Arthritis Functional Status Class | Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe
Item
diagnosis of ra, according to the acr/european league against rheumatism (eular) 2010 rheumatoid arthritis classification criteria with ≥ 3 months disease duration, acr class i-iii functional status, based on 1991 revised criteria (appendix b, 5). moderate-to-severely active ra, defined as:
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0598463 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C2368567 (UMLS CUI [3])
C0003873 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Measurement of C-reactive protein using high sensitivity technique
Item
o high sensitivity c-reactive protein (hs-crp) ≥ 6 mg/l
boolean
C4040318 (UMLS CUI [1])
Laboratory Results Normal Range
Item
laboratory parameters within the normal range (or defined screening threshold for the investigator site), unless the investigator considers an abnormality to be clinically irrelevant for ra patients; however following lab values must be met:
boolean
C1254595 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Hemoglobin measurement
Item
hemoglobin >8.5 g/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cells >3000/mm3
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
neutrophils >2000/mm3
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >150 000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Tillbaka till toppen 

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