ID

31900

Beschrijving

A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00976599

Link

https://clinicaltrials.gov/show/NCT00976599

Trefwoorden

Versies (1)
  1. 07-10-18 07-10-18 -
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See clinicaltrials.gov

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7 oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00976599

Engels

Eligibility Rheumatoid Arthritis NCT00976599

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must have a diagnosis of rheumatoid arthritis based on the american college of rheumatology association
Beschrijving

Rheumatoid Arthritis

Datatype

boolean

Alias
UMLS CUI [1]
C0003873
the subject has active disease at both screening and baseline, as defined:
Beschrijving

Active disease

Datatype

boolean

Alias
UMLS CUI [1]
C2707252
≥4 joints tender or painful on motion, and
Beschrijving

Tender joint count | Joint Painful Count

Datatype

boolean

Alias
UMLS CUI [1]
C0451530
UMLS CUI [2,1]
C0022417
UMLS CUI [2,2]
C0030193
UMLS CUI [2,3]
C0750480
≥4 joints swollen;
Beschrijving

Swollen joint count

Datatype

boolean

Alias
UMLS CUI [1]
C0451521
the subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique
Beschrijving

Synovitis Knee joint Quantity | Synovitis Elbow joint Quantity | Synovitis Wrist joint Quantity | Synovitis Metacarpophalangeal joint Quantity | Joints Appropriate Biopsy Specified

Datatype

boolean

Alias
UMLS CUI [1,1]
C0039103
UMLS CUI [1,2]
C0022745
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C0039103
UMLS CUI [2,2]
C0013770
UMLS CUI [2,3]
C1265611
UMLS CUI [3,1]
C0039103
UMLS CUI [3,2]
C1279139
UMLS CUI [3,3]
C1265611
UMLS CUI [4,1]
C0039103
UMLS CUI [4,2]
C0025525
UMLS CUI [4,3]
C1265611
UMLS CUI [5,1]
C0022417
UMLS CUI [5,2]
C1548787
UMLS CUI [5,3]
C0005558
UMLS CUI [5,4]
C0205369
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
no arthroscopy should have been performed in the past 3 months in the same joint that is to be biopsied in this study.
Beschrijving

Arthroscopy Joint Involved

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003904
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1314939
no intra-articular steroids should have been injected in the joint to be biopsied in this study in the previous 3 months.
Beschrijving

Intraarticular steroid injection Joint Involved

Datatype

boolean

Alias
UMLS CUI [1,1]
C2064783
UMLS CUI [1,2]
C0022417
UMLS CUI [1,3]
C1314939
subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels < 9.0 gm/dl or hematocrit < 30 % at screening visit or within the 3 months prior to baseline synovial biopsy.
Beschrijving

Hematological Disease | Hemoglobin measurement | Hematocrit procedure | Synovial biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0518015
UMLS CUI [3]
C0018935
UMLS CUI [4]
C0150887
an absolute white blood cell (wbc) count of < 3.0 x 109/l (<3000/mm3) or absolute neutrophil count of <1.2 x 109/l (<1200/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
Beschrijving

White Blood Cell Count procedure | Absolute neutrophil count | Synovial biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0948762
UMLS CUI [3]
C0150887
thrombocytopenia, as defined by a platelet count <100 x 109/l (< 100,000/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
Beschrijving

Thrombocytopenia | Platelet Count measurement | Synovial biopsy

Datatype

boolean

Alias
UMLS CUI [1]
C0040034
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0150887
estimated gfr less than 40 ml/min based on cockcroft gault calculation .
Beschrijving

Estimated Glomerular Filtration Rate Cockcroft-Gault formula

Datatype

boolean

Alias
UMLS CUI [1,1]
C3811844
UMLS CUI [1,2]
C2924627
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Similar models

Eligibility Rheumatoid Arthritis NCT00976599

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
subject must have a diagnosis of rheumatoid arthritis based on the american college of rheumatology association
boolean
C0003873 (UMLS CUI [1])
Active disease
Item
the subject has active disease at both screening and baseline, as defined:
boolean
C2707252 (UMLS CUI [1])
Tender joint count | Joint Painful Count
Item
≥4 joints tender or painful on motion, and
boolean
C0451530 (UMLS CUI [1])
C0022417 (UMLS CUI [2,1])
C0030193 (UMLS CUI [2,2])
C0750480 (UMLS CUI [2,3])
Swollen joint count
Item
≥4 joints swollen;
boolean
C0451521 (UMLS CUI [1])
Synovitis Knee joint Quantity | Synovitis Elbow joint Quantity | Synovitis Wrist joint Quantity | Synovitis Metacarpophalangeal joint Quantity | Joints Appropriate Biopsy Specified
Item
the subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique
boolean
C0039103 (UMLS CUI [1,1])
C0022745 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0039103 (UMLS CUI [2,1])
C0013770 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0039103 (UMLS CUI [3,1])
C1279139 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0039103 (UMLS CUI [4,1])
C0025525 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0022417 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C0005558 (UMLS CUI [5,3])
C0205369 (UMLS CUI [5,4])
Item Group
C0680251 (UMLS CUI)
Arthroscopy Joint Involved
Item
no arthroscopy should have been performed in the past 3 months in the same joint that is to be biopsied in this study.
boolean
C0003904 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Intraarticular steroid injection Joint Involved
Item
no intra-articular steroids should have been injected in the joint to be biopsied in this study in the previous 3 months.
boolean
C2064783 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
Hematological Disease | Hemoglobin measurement | Hematocrit procedure | Synovial biopsy
Item
subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels < 9.0 gm/dl or hematocrit < 30 % at screening visit or within the 3 months prior to baseline synovial biopsy.
boolean
C0018939 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0018935 (UMLS CUI [3])
C0150887 (UMLS CUI [4])
White Blood Cell Count procedure | Absolute neutrophil count | Synovial biopsy
Item
an absolute white blood cell (wbc) count of < 3.0 x 109/l (<3000/mm3) or absolute neutrophil count of <1.2 x 109/l (<1200/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
boolean
C0023508 (UMLS CUI [1])
C0948762 (UMLS CUI [2])
C0150887 (UMLS CUI [3])
Thrombocytopenia | Platelet Count measurement | Synovial biopsy
Item
thrombocytopenia, as defined by a platelet count <100 x 109/l (< 100,000/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
boolean
C0040034 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0150887 (UMLS CUI [3])
Estimated Glomerular Filtration Rate Cockcroft-Gault formula
Item
estimated gfr less than 40 ml/min based on cockcroft gault calculation .
boolean
C3811844 (UMLS CUI [1,1])
C2924627 (UMLS CUI [1,2])
Terug naar het begin van de pagina 

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