ID

31892

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00950989

Trefwoorden

Versies (1)
  1. 07-10-18 07-10-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

7 oktober 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Rheumatoid Arthritis NCT00950989

Engels

Eligibility Rheumatoid Arthritis NCT00950989

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
active ra for least 6 months
Beschrijving

Rheumatoid Arthritis

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Rheumatoid factor positive | Anti-cyclic citrullinated peptide antibody positive

Datatype

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.
Beschrijving

Methotrexate Dose Stable U/week

Datatype

boolean

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

Exclusion Criteria

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

Prosthetic joint infection | Joint infection Native

Datatype

boolean

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

Rheumatoid Arthritis Functional Status Class

Datatype

boolean

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

Felty Syndrome

Datatype

boolean

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

Communicable Disease Serious

Datatype

boolean

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

Comorbidity Significant

Datatype

boolean

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

Pregnancy | Breast Feeding

Datatype

boolean

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

Laboratory test result abnormal

Datatype

boolean

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

Antirheumatic Drugs, Disease-Modifying | Exception Methotrexate

Datatype

boolean

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

leflunomide | Live Vaccines

Datatype

boolean

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

Biologic DMARD Investigational | Biologic DMARD commercial available

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility Rheumatoid Arthritis NCT00950989

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial