Informações:
Falhas:
ID
17186
Descrição
A Placebo Controlled Study to Assess Efficacy and Safety of Certolizumab Pegol in the Treatment of Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00152386
Link
https://clinicaltrials.gov/show/NCT00152386
Palavras-chave
Versões (1)
- 30/08/2016 30/08/2016 -
Transferido a
30 de agosto de 2016
DOI
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Licença
Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00152386
Eligibility Rheumatoid Arthritis NCT00152386
- StudyEvent: Eligibility
Similar models
Eligibility Rheumatoid Arthritis NCT00152386
- StudyEvent: Eligibility
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Age
Item
male and female, aged at least 18 years old at the screening visit.
boolean
C0001779 (UMLS CUI [1])
chest x-ray
Item
a clear chest x-ray within 3 months prior to baseline visit.
boolean
C0039985 (UMLS CUI [1])
adult-onset ra
Item
a diagnosis of adult-onset ra (of at least six months duration but not longer than 15 years prior to screening) as defined by the 1987 american college of rheumatology classification criteria.
boolean
C0003873 (UMLS CUI [1,1])
C1853562 (UMLS CUI [1,2])
C1853562 (UMLS CUI [1,2])
Active rheumatoid arthritis
Item
active ra disease at screening and baseline as defined by:
boolean
C0003873 (UMLS CUI [1])
tender joint count
Item
≥9 tender joints.
boolean
C0451530 (UMLS CUI [1])
swollen joint count
Item
≥9 swollen joints. and fulfilling 1 of the following 2 criteria:
boolean
C0451521 (UMLS CUI [1])
Westergren ESR
Item
≥30 mm/hour esr (westergren), or
boolean
C0200705 (UMLS CUI [1])
CRP
Item
crp >15 mg/l.
boolean
C0201657 (UMLS CUI [1])
stable dose of mtx
Item
must have received a stable dose of mtx with or without folic acid for at least 3 months prior to baseline visit. the minimum dose is 10 mg mtx weekly.
boolean
C0025677 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,2])
Compliance behavior
Item
patient must be willing to attend for a week 52 x-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.
boolean
C1321605 (UMLS CUI [1])
other inflammatory arthritis
Item
a diagnosis of any other inflammatory arthritis e.g., psoriatic arthritis or ankylosing spondylitis.
boolean
C0003864 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
non-inflammatory type of arthritis
Item
a secondary, non-inflammatory type of arthritis (e.g. oa or fibromyalgia) that in the investigator's opinion is symptomatic enough to interfere with evaluation of the effect of cdp870 on the patient's primary diagnosis of ra.
boolean
C0003864 (UMLS CUI [1,1])
C0442743 (UMLS CUI [1,2])
C0442743 (UMLS CUI [1,2])
infected joint prosthesis
Item
a history of an infected joint prosthesis at any time with prosthesis still in situ.
boolean
C0410808 (UMLS CUI [1])
Concomitant medication
Item
does not meet exclusionary concomitant medication criteria.
boolean
C2347852 (UMLS CUI [1])
lymphoproliferative disorder
Item
a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
boolean
C0024314 (UMLS CUI [1])
High risk of infection
Item
patients at a high risk of infection in the investigator's opinion (e.g. leg ulcers, indwelling urinary catheter and persistent or recurrent chest infections).
boolean
C0582147 (UMLS CUI [1])