ID

31844

Beskrivning

CAMEO: Canadian Methotrexate and Etanercept Outcome Study; ODM derived from: https://clinicaltrials.gov/show/NCT00654368

Länk

https://clinicaltrials.gov/show/NCT00654368

Nyckelord

Versioner (1)
  1. 2018-10-02 2018-10-02 -
Rättsinnehavare

See clinicaltrials.gov

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2 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00654368

Engelsk

Eligibility Rheumatoid Arthritis NCT00654368

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age or older at the baseline visit
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
an american college of rheumatology(acr) diagnosis of rheumatoid arthritis with onset of symptoms of at least 6 months
Beskrivning

Rheumatoid Arthritis | Symptom Onset Duration

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C4086878
UMLS CUI [2,2]
C0449238
active disease of at least 3 swollen joints from the disease activity severity 28 at the baseline visit
Beskrivning

Swollen joint count Disease activity score using 28 joint count

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0451521
UMLS CUI [1,2]
C2711347
a disease activity severity 28 score of ≥ 3.2 at the baseline visit
Beskrivning

Disease activity score using 28 joint count

Datatyp

boolean

Alias
UMLS CUI [1]
C2711347
have not previously received etanercept therapy
Beskrivning

Etanercept therapy Absent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4075969
UMLS CUI [1,2]
C0332197
able to start etanercept therapy per the approved product monograph
Beskrivning

Etanercept therapy Start Able

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4075969
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0085732
able to continue methotrexate therapy per the approved product monograph and have received a dose of at least 15 mg/wk (or 10 mg/wk in the case of documented intolerance to higher doses) for at least 12 weeks and this dose has been stable at least 4 weeks before the baseline visit
Beskrivning

Methotrexate Dose Stable U/week

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
the patient or legally acceptable representative must provide written informed consent for participation in the study before any study specific procedures are performed
Beskrivning

Informed Consent | Informed Consent Patient Representative

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who have a positive purified protein derivative (ppd) skin test and who do not have a documented course of anti-tuberculosis therapy. patients with a positive ppd skin test (equal to or greater than 5 mm), a negative chest x-ray at screening which should be repeated if indicated during of the study, at low risk based on exposure and travel and have initiated a course of anti-tuberculosis therapy of which at least 8 weeks have been completed would be eligible for the study. the full course of anti-tuberculosis therapy must be completed
Beskrivning

PPD skin test positive | Tuberculosis treatment Absent | Chest X-ray Negative Eligible | Tuberculosis treatment Completed Eligible

Datatyp

boolean

Alias
UMLS CUI [1]
C1699735
UMLS CUI [2,1]
C0749724
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0039985
UMLS CUI [3,2]
C1513916
UMLS CUI [3,3]
C1548635
UMLS CUI [4,1]
C0749724
UMLS CUI [4,2]
C0205197
UMLS CUI [4,3]
C1548635
patients who have previously received infliximab or adalimumab
Beskrivning

infliximab | adalimumab

Datatyp

boolean

Alias
UMLS CUI [1]
C0666743
UMLS CUI [2]
C1122087
active infections within 2 weeks of the baseline visit or during the study period
Beskrivning

Communicable Diseases

Datatyp

boolean

Alias
UMLS CUI [1]
C0009450
any history of human immunodeficiency (hiv) infection, untreated tuberculosis, multiple sclerosis, congestive heart failure, hepatitis b, hepatitis c, cytopenia, prior or current use of cyclophosphamide or malignancy (other than basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix) in the past 5 years
Beskrivning

HIV Infection | Tuberculosis untreated | Multiple Sclerosis | Congestive heart failure | Hepatitis B | Hepatitis C | Cytopenia | Cyclophosphamide | Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix

Datatyp

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0041296
UMLS CUI [2,2]
C0332155
UMLS CUI [3]
C0026769
UMLS CUI [4]
C0018802
UMLS CUI [5]
C0019163
UMLS CUI [6]
C0019196
UMLS CUI [7]
C0010828
UMLS CUI [8]
C0010583
UMLS CUI [9]
C0006826
UMLS CUI [10,1]
C1705847
UMLS CUI [10,2]
C0007117
UMLS CUI [11,1]
C1705847
UMLS CUI [11,2]
C0553723
UMLS CUI [12,1]
C1705847
UMLS CUI [12,2]
C0851140
women who are pregnant or lactating or of childbearing potential who are not using adequate contraception
Beskrivning

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
receipt of any investigational therapy within 4 weeks of the initiation of study medication or during the study period
Beskrivning

Therapy, Investigational

Datatyp

boolean

Alias
UMLS CUI [1]
C0949266
presence of any significant and uncontrolled medical condition, which in the investigator's opinion precludes the use of etanercept, as outlined in the product monograph
Beskrivning

Medical condition Uncontrolled Excludes Etanercept

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0205318
UMLS CUI [1,3]
C0332196
UMLS CUI [1,4]
C0717758
participants not available for follow-up assessment or unable to comply with study procedures
Beskrivning

Patient unavailable Follow-up | Protocol Compliance Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C3274571
UMLS CUI [2,1]
C0525058
UMLS CUI [2,2]
C1299582
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Similar models

Eligibility Rheumatoid Arthritis NCT00654368

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age or older at the baseline visit
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis | Symptom Onset Duration
Item
an american college of rheumatology(acr) diagnosis of rheumatoid arthritis with onset of symptoms of at least 6 months
boolean
C0003873 (UMLS CUI [1])
C4086878 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Swollen joint count Disease activity score using 28 joint count
Item
active disease of at least 3 swollen joints from the disease activity severity 28 at the baseline visit
boolean
C0451521 (UMLS CUI [1,1])
C2711347 (UMLS CUI [1,2])
Disease activity score using 28 joint count
Item
a disease activity severity 28 score of ≥ 3.2 at the baseline visit
boolean
C2711347 (UMLS CUI [1])
Etanercept therapy Absent
Item
have not previously received etanercept therapy
boolean
C4075969 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Etanercept therapy Start Able
Item
able to start etanercept therapy per the approved product monograph
boolean
C4075969 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0085732 (UMLS CUI [1,3])
Methotrexate Dose Stable U/week
Item
able to continue methotrexate therapy per the approved product monograph and have received a dose of at least 15 mg/wk (or 10 mg/wk in the case of documented intolerance to higher doses) for at least 12 weeks and this dose has been stable at least 4 weeks before the baseline visit
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Informed Consent | Informed Consent Patient Representative
Item
the patient or legally acceptable representative must provide written informed consent for participation in the study before any study specific procedures are performed
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
PPD skin test positive | Tuberculosis treatment Absent | Chest X-ray Negative Eligible | Tuberculosis treatment Completed Eligible
Item
patients who have a positive purified protein derivative (ppd) skin test and who do not have a documented course of anti-tuberculosis therapy. patients with a positive ppd skin test (equal to or greater than 5 mm), a negative chest x-ray at screening which should be repeated if indicated during of the study, at low risk based on exposure and travel and have initiated a course of anti-tuberculosis therapy of which at least 8 weeks have been completed would be eligible for the study. the full course of anti-tuberculosis therapy must be completed
boolean
C1699735 (UMLS CUI [1])
C0749724 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0039985 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
C1548635 (UMLS CUI [3,3])
C0749724 (UMLS CUI [4,1])
C0205197 (UMLS CUI [4,2])
C1548635 (UMLS CUI [4,3])
infliximab | adalimumab
Item
patients who have previously received infliximab or adalimumab
boolean
C0666743 (UMLS CUI [1])
C1122087 (UMLS CUI [2])
Communicable Diseases
Item
active infections within 2 weeks of the baseline visit or during the study period
boolean
C0009450 (UMLS CUI [1])
HIV Infection | Tuberculosis untreated | Multiple Sclerosis | Congestive heart failure | Hepatitis B | Hepatitis C | Cytopenia | Cyclophosphamide | Malignant Neoplasms | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix
Item
any history of human immunodeficiency (hiv) infection, untreated tuberculosis, multiple sclerosis, congestive heart failure, hepatitis b, hepatitis c, cytopenia, prior or current use of cyclophosphamide or malignancy (other than basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix) in the past 5 years
boolean
C0019693 (UMLS CUI [1])
C0041296 (UMLS CUI [2,1])
C0332155 (UMLS CUI [2,2])
C0026769 (UMLS CUI [3])
C0018802 (UMLS CUI [4])
C0019163 (UMLS CUI [5])
C0019196 (UMLS CUI [6])
C0010828 (UMLS CUI [7])
C0010583 (UMLS CUI [8])
C0006826 (UMLS CUI [9])
C1705847 (UMLS CUI [10,1])
C0007117 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0553723 (UMLS CUI [11,2])
C1705847 (UMLS CUI [12,1])
C0851140 (UMLS CUI [12,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
women who are pregnant or lactating or of childbearing potential who are not using adequate contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Therapy, Investigational
Item
receipt of any investigational therapy within 4 weeks of the initiation of study medication or during the study period
boolean
C0949266 (UMLS CUI [1])
Medical condition Uncontrolled Excludes Etanercept
Item
presence of any significant and uncontrolled medical condition, which in the investigator's opinion precludes the use of etanercept, as outlined in the product monograph
boolean
C3843040 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
C0717758 (UMLS CUI [1,4])
Patient unavailable Follow-up | Protocol Compliance Unable
Item
participants not available for follow-up assessment or unable to comply with study procedures
boolean
C1301818 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
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