ID

31980

Beskrivning

Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.; ODM derived from: https://clinicaltrials.gov/show/NCT01172639

Länk

https://clinicaltrials.gov/show/NCT01172639

Nyckelord

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

See clinicaltrials.gov

Uppladdad den

10 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT01172639

Engelsk

Eligibility Rheumatoid Arthritis NCT01172639

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of ra as defined by the 1987 revised american college of rheumatology (acr) criteria
Beskrivning

Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1]
C0003873
early ra (less than 1 year)
Beskrivning

Early Rheumatoid Arthritis Disease length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3899278
UMLS CUI [1,2]
C0872146
use a reliable method of contraception for women of childbearing potential
Beskrivning

Childbearing Potential Contraceptive methods

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
able and willing to give written informed consent and participate in the study
Beskrivning

Informed Consent | Study Subject Participation Status Willing

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0600109
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous treatment with dmards
Beskrivning

DMARDs

Datatyp

boolean

Alias
UMLS CUI [1]
C0242708
previous treatment with oral corticosteroids at a dosage of more than 10 milligrams (mg) prednisone within 4 weeks before baseline
Beskrivning

Adrenal Cortex Hormones Oral | Dosage Prednisone Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0205163
previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg prednisone within 2 weeks before baseline
Beskrivning

Adrenal Cortex Hormones Oral | Dosage Prednisone Equivalent | Dosage Less Than Prednisone Equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [2,1]
C0178602
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0205163
UMLS CUI [3,1]
C0178602
UMLS CUI [3,2]
C0439092
UMLS CUI [3,3]
C0032952
UMLS CUI [3,4]
C0205163
previous treatment with oral corticosteroids for more than 4 weeks
Beskrivning

Adrenal Cortex Hormones Oral Duration

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0449238
previous treatment with intra articular corticosteroids within 4 weeks before baseline
Beskrivning

Intraarticular injection of corticosteroids

Datatyp

boolean

Alias
UMLS CUI [1]
C2064783
previous treatment with an investigational drug for the treatment or prevention of ra
Beskrivning

Investigational New Drugs Rheumatoid Arthritis | Investigational New Drugs Prevention Rheumatoid Arthritis

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013230
UMLS CUI [1,2]
C0003873
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0199176
UMLS CUI [2,3]
C0003873
contraindications for corticosteroids
Beskrivning

Medical contraindication Adrenal Cortex Hormones

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001617
contraindications for dmards
Beskrivning

Medical contraindication DMARDs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0242708
psoriatic arthritis
Beskrivning

Arthritis, Psoriatic

Datatyp

boolean

Alias
UMLS CUI [1]
C0003872
underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
Beskrivning

Primary disorders Study Subject Participation Status At risk | Cardiac problem | Lung diseases | Metabolic Diseases | Kidney Diseases | Gastrointestinal Diseases | Chronic infectious disease | Latent infection | Immune Deficiency

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0277554
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2]
C0262402
UMLS CUI [3]
C0024115
UMLS CUI [4]
C0025517
UMLS CUI [5]
C0022658
UMLS CUI [6]
C0017178
UMLS CUI [7]
C0151317
UMLS CUI [8]
C0872054
UMLS CUI [9]
C0021051
pregnancy, breastfeeding or no use of a reliable method of contraception
Beskrivning

Pregnancy | Breast Feeding | Contraceptive methods Absent

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C0700589
UMLS CUI [3,2]
C0332197
alcohol or drug abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
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Similar models

Eligibility Rheumatoid Arthritis NCT01172639

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
diagnosis of ra as defined by the 1987 revised american college of rheumatology (acr) criteria
boolean
C0003873 (UMLS CUI [1])
Early Rheumatoid Arthritis Disease length
Item
early ra (less than 1 year)
boolean
C3899278 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
use a reliable method of contraception for women of childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Informed Consent | Study Subject Participation Status Willing
Item
able and willing to give written informed consent and participate in the study
boolean
C0021430 (UMLS CUI [1])
C2348568 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
DMARDs
Item
previous treatment with dmards
boolean
C0242708 (UMLS CUI [1])
Adrenal Cortex Hormones Oral | Dosage Prednisone Equivalent
Item
previous treatment with oral corticosteroids at a dosage of more than 10 milligrams (mg) prednisone within 4 weeks before baseline
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
Adrenal Cortex Hormones Oral | Dosage Prednisone Equivalent | Dosage Less Than Prednisone Equivalent
Item
previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg prednisone within 2 weeks before baseline
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0178602 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
C0178602 (UMLS CUI [3,1])
C0439092 (UMLS CUI [3,2])
C0032952 (UMLS CUI [3,3])
C0205163 (UMLS CUI [3,4])
Adrenal Cortex Hormones Oral Duration
Item
previous treatment with oral corticosteroids for more than 4 weeks
boolean
C0001617 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0449238 (UMLS CUI [1,3])
Intraarticular injection of corticosteroids
Item
previous treatment with intra articular corticosteroids within 4 weeks before baseline
boolean
C2064783 (UMLS CUI [1])
Investigational New Drugs Rheumatoid Arthritis | Investigational New Drugs Prevention Rheumatoid Arthritis
Item
previous treatment with an investigational drug for the treatment or prevention of ra
boolean
C0013230 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C0013230 (UMLS CUI [2,1])
C0199176 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
Medical contraindication Adrenal Cortex Hormones
Item
contraindications for corticosteroids
boolean
C1301624 (UMLS CUI [1,1])
C0001617 (UMLS CUI [1,2])
Medical contraindication DMARDs
Item
contraindications for dmards
boolean
C1301624 (UMLS CUI [1,1])
C0242708 (UMLS CUI [1,2])
Arthritis, Psoriatic
Item
psoriatic arthritis
boolean
C0003872 (UMLS CUI [1])
Primary disorders Study Subject Participation Status At risk | Cardiac problem | Lung diseases | Metabolic Diseases | Kidney Diseases | Gastrointestinal Diseases | Chronic infectious disease | Latent infection | Immune Deficiency
Item
underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study
boolean
C0277554 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0262402 (UMLS CUI [2])
C0024115 (UMLS CUI [3])
C0025517 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0017178 (UMLS CUI [6])
C0151317 (UMLS CUI [7])
C0872054 (UMLS CUI [8])
C0021051 (UMLS CUI [9])
Pregnancy | Breast Feeding | Contraceptive methods Absent
Item
pregnancy, breastfeeding or no use of a reliable method of contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0700589 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Substance Use Disorders
Item
alcohol or drug abuse
boolean
C0038586 (UMLS CUI [1])
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