Informações:
Falhas:
ID
12779
Descrição
A Long-Term Extension Study to WA19926 of RoActemra/Actemra (Tocilizumab) in Patients With Early, Moderate to Severe Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT01665430
Link
https://clinicaltrials.gov/show/NCT01665430
Palavras-chave
Versões (1)
- 21/12/2015 21/12/2015 -
Transferido a
21 de dezembro de 2015
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01665430
Eligibility Rheumatoid Arthritis NCT01665430
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT01665430
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
age
Item
adult patients, >/= 18 years of age
boolean
C0001779 (UMLS CUI [1])
Study Subject Participation Status
Item
patients who complete wa19926 core study (visit at week 104 and two follow-up telephone visits) and who may benefit from study drug treatment according to the investigator's assessment
boolean
C2348568 (UMLS CUI [1])
adverse event roactemra
Item
no current or recent adverse event or laboratory finding preventing the use of the study drug dose of roactemra/actemra 8 mg/kg at baseline visit
boolean
C0877248 (UMLS CUI [1,1])
C3272237 (UMLS CUI [1,2])
C3272237 (UMLS CUI [1,2])
outpatient
Item
receiving treatment on an outpatient basis
boolean
C0029921 (UMLS CUI [1])
contraceptive methods
Item
females of child-bearing potential must agree to use at least one adequate method of contraception as defined by protocol during the treatment period
boolean
C0700589 (UMLS CUI [1])
pregnant
Item
pregnant women
boolean
C0549206 (UMLS CUI [1])
Study Subject Participation Status
Item
patients who have prematurely withdrawn from the wa19926 study for any reason
boolean
C2348568 (UMLS CUI [1])
concomitant
Item
treatment with any investigational agent or cell depleting therapies since last administration of study drug in the wa 19926 core study
boolean
C2347852 (UMLS CUI [1])
anti-tumor necrosis factor therapy; t-cell costimulation modulator
Item
treatment with an anti-tumor necrosis factor (tnf) or anti-interleukin (il)1 agent, or a t-cell costimulation modulator since the last administration of the study drug in the wa19926 core study
boolean
C0281481 (UMLS CUI [1])
C2962759 (UMLS CUI [2])
C2962759 (UMLS CUI [2])
immunization; attenuated vaccine
Item
immunization with a live/attenuated vaccine since the last administration of study drug in the wa19926 core study
boolean
C0020971 (UMLS CUI [1])
C0042211 (UMLS CUI [2])
C0042211 (UMLS CUI [2])
autoimmune disease rheumatic
Item
diagnosis since visit at week 104 of the core wa19926 study of rheumatic autoimmune disease other than rheumatoid arthritis
boolean
C0004364 (UMLS CUI [1,1])
C3495832 (UMLS CUI [1,2])
C3495832 (UMLS CUI [1,2])
inflammatory joint disease
Item
diagnosis since visit at week 104 of the core wa19926 study of inflammatory joint disease other than rheumatoid arthritis
boolean
C0683381 (UMLS CUI [1])
concomitant disease
Item
evidence of serious uncontrolled concomitant disease or disorder
boolean
C0243087 (UMLS CUI [1])
infection recurrent
Item
known active or history of recurrent infection
boolean
C3714514 (UMLS CUI [1,1])
C2945760 (UMLS CUI [1,2])
C2945760 (UMLS CUI [1,2])
liver disease
Item
current liver disease as determined by investigator
boolean
C0085605 (UMLS CUI [1])