ID

31859

Description

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

Lien

https://clinicaltrials.gov/show/NCT00781469

Mots-clés

Versions (1)
  1. 04/10/2018 04/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

4 octobre 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00781469

Anglais

Eligibility Rheumatoid Arthritis NCT00781469

1 Formulaires  
Inclusion Criteria
Description

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
Description

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

Type de données

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
Description

Body Weight | Body mass index

Type de données

boolean

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

Rheumatoid Arthritis

Type de données

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)
Description

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

Type de données

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
Description

Population Roman letter

Type de données

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).
Description

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

Type de données

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
Description

Exclusion Criteria

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

Acute illness

Type de données

boolean

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

Drug abuse

Type de données

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
Description

Blood Donation Excess

Type de données

boolean

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

Group Roman letter

Type de données

boolean

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

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

Type de données

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 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
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])
Retour au début de la page 

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