Informationen:
Fehler:
ID
37092
Beschreibung
Sarilumab Effect on the Pharmacokinetics of Simvastatin; ODM derived from: https://clinicaltrials.gov/show/NCT02017639
Link
https://clinicaltrials.gov/show/NCT02017639
Stichworte
Versionen (1)
- 03.07.19 03.07.19 -
Rechteinhaber
See clinicaltrials.gov
Hochgeladen am
3. Juli 2019
DOI
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Lizenz
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02017639
Eligibility Rheumatoid Arthritis NCT02017639
- StudyEvent: Eligibility
Ähnliche Modelle
Eligibility Rheumatoid Arthritis NCT02017639
- StudyEvent: Eligibility
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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])
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])
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])