ID

17186

Beschrijving

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

Trefwoorden

  1. 30-08-16 30-08-16 -
Geüploaded op

30 augustus 2016

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT00152386

Eligibility Rheumatoid Arthritis NCT00152386

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male and female, aged at least 18 years old at the screening visit.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
a clear chest x-ray within 3 months prior to baseline visit.
Beschrijving

chest x-ray

Datatype

boolean

Alias
UMLS CUI [1]
C0039985
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.
Beschrijving

adult-onset ra

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C1853562
active ra disease at screening and baseline as defined by:
Beschrijving

Active rheumatoid arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0003873
≥9 tender joints.
Beschrijving

tender joint count

Datatype

boolean

Alias
UMLS CUI [1]
C0451530
≥9 swollen joints. and fulfilling 1 of the following 2 criteria:
Beschrijving

swollen joint count

Datatype

boolean

Alias
UMLS CUI [1]
C0451521
≥30 mm/hour esr (westergren), or
Beschrijving

Westergren ESR

Datatype

boolean

Alias
UMLS CUI [1]
C0200705
crp >15 mg/l.
Beschrijving

CRP

Datatype

boolean

Alias
UMLS CUI [1]
C0201657
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.
Beschrijving

stable dose of mtx

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0205360
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to attend for a week 52 x-ray of the hands and feet even if they are no longer receiving study treatment but have not withdrawn their informed consent.
Beschrijving

Compliance behavior

Datatype

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
a diagnosis of any other inflammatory arthritis e.g., psoriatic arthritis or ankylosing spondylitis.
Beschrijving

other inflammatory arthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0205394
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.
Beschrijving

non-inflammatory type of arthritis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003864
UMLS CUI [1,2]
C0442743
a history of an infected joint prosthesis at any time with prosthesis still in situ.
Beschrijving

infected joint prosthesis

Datatype

boolean

Alias
UMLS CUI [1]
C0410808
does not meet exclusionary concomitant medication criteria.
Beschrijving

Concomitant medication

Datatype

boolean

Alias
UMLS CUI [1]
C2347852
a history of a lymphoproliferative disorder including lymphoma or signs and symptoms suggestive of lymphoproliferative disease at any time.
Beschrijving

lymphoproliferative disorder

Datatype

boolean

Alias
UMLS CUI [1]
C0024314
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).
Beschrijving

High risk of infection

Datatype

boolean

Alias
UMLS CUI [1]
C0582147

Similar models

Eligibility Rheumatoid Arthritis NCT00152386

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
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])
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])
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])
Item Group
C0680251 (UMLS CUI)
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])
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])
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])

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