ID

31859

Descrição

A Study to Evaluate the RNA Signature of Rheumatoid Arthritis From Synovium and Whole Blood; ODM derived from: https://clinicaltrials.gov/show/NCT00781469

Link

https://clinicaltrials.gov/show/NCT00781469

Palavras-chave

Versões (1)
  1. 04/10/2018 04/10/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

4 de outubro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00781469

Inglês

Eligibility Rheumatoid Arthritis NCT00781469

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult men and non-pregnant, non-lactating women between 18 and 75 years of age. sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
Descrição

Adult | Gender | Age | Pregnancy Absent | Breast Feeding Absent | Gender Sexually active Childbearing Potential Absent | Childbearing Potential Sexually active Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C0001779
UMLS CUI [4,1]
C0032961
UMLS CUI [4,2]
C0332197
UMLS CUI [5,1]
C0006147
UMLS CUI [5,2]
C0332197
UMLS CUI [6,1]
C0079399
UMLS CUI [6,2]
C0241028
UMLS CUI [6,3]
C3831118
UMLS CUI [6,4]
C0332197
UMLS CUI [7,1]
C3831118
UMLS CUI [7,2]
C0241028
UMLS CUI [7,3]
C0700589
body weight greater >40 kg and <120 kg with a body mass index (bmi) between 19-31 kg/m2
Descrição

Body Weight | Body mass index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005910
UMLS CUI [2]
C1305855
clinical history of rheumatoid arthritis as defined by acr criteria
Descrição

Rheumatoid Arthritis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)
Descrição

Childbearing Potential Urine pregnancy test negative | Exception Hysterectomy | Exception Bilateral oophorectomy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0430057
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0020699
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0278321
for populations b and c only
Descrição

Population Roman letter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C0439102
currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only dmard (no changes in dosing regimen for 4 weeks prior to screening).
Descrição

Methotrexate Dose Stable U/week | Antirheumatic Drugs, Disease-Modifying

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [1,4]
C0560588
UMLS CUI [2]
C0242708
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of an acute illness within 2 weeks prior to the study
Descrição

Acute illness

Tipo de dados

boolean

Alias
UMLS CUI [1]
C4061114
history of drug abuse within 2 years
Descrição

Drug abuse

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0013146
donation of blood in excess of 500 ml within 56 days prior to the first dose of study medication
Descrição

Blood Donation Excess

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0005794
UMLS CUI [1,2]
C1979886
for group a only
Descrição

Group Roman letter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1257890
UMLS CUI [1,2]
C0439102
prior treatment with disease modifying anti-rheumatic agents or biologicals.
Descrição

Prior Therapy | Antirheumatic Drugs, Disease-Modifying | Biological agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0242708
UMLS CUI [3]
C0005515
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Similar models

Eligibility Rheumatoid Arthritis NCT00781469

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Age | Pregnancy Absent | Breast Feeding Absent | Gender Sexually active Childbearing Potential Absent | Childbearing Potential Sexually active Contraceptive methods
Item
adult men and non-pregnant, non-lactating women between 18 and 75 years of age. sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0032961 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0006147 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0079399 (UMLS CUI [6,1])
C0241028 (UMLS CUI [6,2])
C3831118 (UMLS CUI [6,3])
C0332197 (UMLS CUI [6,4])
C3831118 (UMLS CUI [7,1])
C0241028 (UMLS CUI [7,2])
C0700589 (UMLS CUI [7,3])
Body Weight | Body mass index
Item
body weight greater >40 kg and <120 kg with a body mass index (bmi) between 19-31 kg/m2
boolean
C0005910 (UMLS CUI [1])
C1305855 (UMLS CUI [2])
Rheumatoid Arthritis
Item
clinical history of rheumatoid arthritis as defined by acr criteria
boolean
C0003873 (UMLS CUI [1])
Childbearing Potential Urine pregnancy test negative | Exception Hysterectomy | Exception Bilateral oophorectomy
Item
negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy)
boolean
C3831118 (UMLS CUI [1,1])
C0430057 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0020699 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0278321 (UMLS CUI [3,2])
Population Roman letter
Item
for populations b and c only
boolean
C1257890 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Methotrexate Dose Stable U/week | Antirheumatic Drugs, Disease-Modifying
Item
currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only dmard (no changes in dosing regimen for 4 weeks prior to screening).
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
C0242708 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Acute illness
Item
history of an acute illness within 2 weeks prior to the study
boolean
C4061114 (UMLS CUI [1])
Drug abuse
Item
history of drug abuse within 2 years
boolean
C0013146 (UMLS CUI [1])
Blood Donation Excess
Item
donation of blood in excess of 500 ml within 56 days prior to the first dose of study medication
boolean
C0005794 (UMLS CUI [1,1])
C1979886 (UMLS CUI [1,2])
Group Roman letter
Item
for group a only
boolean
C1257890 (UMLS CUI [1,1])
C0439102 (UMLS CUI [1,2])
Prior Therapy | Antirheumatic Drugs, Disease-Modifying | Biological agents
Item
prior treatment with disease modifying anti-rheumatic agents or biologicals.
boolean
C1514463 (UMLS CUI [1])
C0242708 (UMLS CUI [2])
C0005515 (UMLS CUI [3])
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