ID

31892

Description

AMG 827 in Rheumatoid Arthritis Subjects With Inadequate Response to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00950989

Lien

https://clinicaltrials.gov/show/NCT00950989

Mots-clés

Versions (1)
  1. 07/10/2018 07/10/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 octobre 2018

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00950989

Anglais

Eligibility Rheumatoid Arthritis NCT00950989

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
active ra for least 6 months
Description

Rheumatoid Arthritis

Type de données

boolean

Alias
UMLS CUI [1]
C0003873
current ra defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal joints) and at least 1 of the following at screening: erythrocyte sedimentation rate ≥ 28 mm or c-reactive protein > 15 mg/l
Description

Rheumatoid Arthritis | Swollen joint count | Tender joint count | Joint Painful Count | Exception Interphalangeal joint Distal | Erythrocyte sedimentation rate measurement | C-reactive protein measurement

Type de données

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2]
C0451521
UMLS CUI [3]
C0451530
UMLS CUI [4,1]
C0022417
UMLS CUI [4,2]
C0030193
UMLS CUI [4,3]
C0750480
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C1563055
UMLS CUI [5,3]
C0205108
UMLS CUI [6]
C1176468
UMLS CUI [7]
C0201657
at least 1 of the following at screening: rheumatoid factor positive or anti-cyclic citrullinated peptide antibody positive
Description

Rheumatoid factor positive | Anti-cyclic citrullinated peptide antibody positive

Type de données

boolean

Alias
UMLS CUI [1]
C0151379
UMLS CUI [2]
C2609056
currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at 15 to 25 mg weekly for ≥ 4 weeks at day -1.
Description

Methotrexate Dose Stable U/week

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
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
Description

Prosthetic joint infection | Joint infection Native

Type de données

boolean

Alias
UMLS CUI [1]
C0410808
UMLS CUI [2,1]
C0157749
UMLS CUI [2,2]
C0302891
class iv ra
Description

Rheumatoid Arthritis Functional Status Class

Type de données

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0598463
UMLS CUI [1,3]
C0456387
felty's syndrome
Description

Felty Syndrome

Type de données

boolean

Alias
UMLS CUI [1]
C0015773
presence of serious infection
Description

Communicable Disease Serious

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205404
significant concurrent medical conditions
Description

Comorbidity Significant

Type de données

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
pregnant or breast feeding
Description

Pregnancy | Breast Feeding

Type de données

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
significant laboratory abnormalities
Description

Laboratory test result abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0438215
any dmard other than methotrexate within 28 days
Description

Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate

Type de données

boolean

Alias
UMLS CUI [1]
C0242708
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0025677
leflunomide or live vaccines within 3 months
Description

leflunomide | Live Vaccines

Type de données

boolean

Alias
UMLS CUI [1]
C0063041
UMLS CUI [2]
C0042211
previous use of any experimental or commercially available biologic dmard
Description

Biologic DMARD Investigational | Biologic DMARD commercial available

Type de données

boolean

Alias
UMLS CUI [1,1]
C4055380
UMLS CUI [1,2]
C1517586
UMLS CUI [2,1]
C4055380
UMLS CUI [2,2]
C0680536
UMLS CUI [2,3]
C0470187
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Similar models

Eligibility Rheumatoid Arthritis NCT00950989

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
active ra for least 6 months
boolean
C0003873 (UMLS CUI [1])
Rheumatoid Arthritis | Swollen joint count | Tender joint count | Joint Painful Count | Exception Interphalangeal joint Distal | Erythrocyte sedimentation rate measurement | C-reactive protein measurement
Item
current ra defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal joints) and at least 1 of the following at screening: erythrocyte sedimentation rate ≥ 28 mm or c-reactive protein > 15 mg/l
boolean
C0003873 (UMLS CUI [1])
C0451521 (UMLS CUI [2])
C0451530 (UMLS CUI [3])
C0022417 (UMLS CUI [4,1])
C0030193 (UMLS CUI [4,2])
C0750480 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C1563055 (UMLS CUI [5,2])
C0205108 (UMLS CUI [5,3])
C1176468 (UMLS CUI [6])
C0201657 (UMLS CUI [7])
Rheumatoid factor positive | Anti-cyclic citrullinated peptide antibody positive
Item
at least 1 of the following at screening: rheumatoid factor positive or anti-cyclic citrullinated peptide antibody positive
boolean
C0151379 (UMLS CUI [1])
C2609056 (UMLS CUI [2])
Methotrexate Dose Stable U/week
Item
currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at 15 to 25 mg weekly for ≥ 4 weeks at day -1.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Item Group
C0680251 (UMLS CUI)
Prosthetic joint infection | Joint infection Native
Item
prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
boolean
C0410808 (UMLS CUI [1])
C0157749 (UMLS CUI [2,1])
C0302891 (UMLS CUI [2,2])
Rheumatoid Arthritis Functional Status Class
Item
class iv ra
boolean
C0003873 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
C0456387 (UMLS CUI [1,3])
Felty Syndrome
Item
felty's syndrome
boolean
C0015773 (UMLS CUI [1])
Communicable Disease Serious
Item
presence of serious infection
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
Comorbidity Significant
Item
significant concurrent medical conditions
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Laboratory test result abnormal
Item
significant laboratory abnormalities
boolean
C0438215 (UMLS CUI [1])
Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate
Item
any dmard other than methotrexate within 28 days
boolean
C0242708 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0025677 (UMLS CUI [2,2])
leflunomide | Live Vaccines
Item
leflunomide or live vaccines within 3 months
boolean
C0063041 (UMLS CUI [1])
C0042211 (UMLS CUI [2])
Biologic DMARD Investigational | Biologic DMARD commercial available
Item
previous use of any experimental or commercially available biologic dmard
boolean
C4055380 (UMLS CUI [1,1])
C1517586 (UMLS CUI [1,2])
C4055380 (UMLS CUI [2,1])
C0680536 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
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