ID

31859

Beschreibung

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

Stichworte

Versionen (1)
  1. 2018-10-04 2018-10-04 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

4 oktober 2018

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00781469

Englisch

Eligibility Rheumatoid Arthritis NCT00781469

1 Formulare  
Inclusion Criteria
Beschreibung

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
Beschreibung

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

Datentyp

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
Beschreibung

Body Weight | Body mass index

Datentyp

boolean

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

Rheumatoid Arthritis

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

Population Roman letter

Datentyp

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).
Beschreibung

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

Datentyp

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
Beschreibung

Exclusion Criteria

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

Acute illness

Datentyp

boolean

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

Drug abuse

Datentyp

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
Beschreibung

Blood Donation Excess

Datentyp

boolean

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

Group Roman letter

Datentyp

boolean

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

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

Datentyp

boolean

Alias
UMLS CUI [1]
C1514463
UMLS CUI [2]
C0242708
UMLS CUI [3]
C0005515
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00781469

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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