ID

31900

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT00976599

Nyckelord

Versioner (1)
  1. 2018-10-07 2018-10-07 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

7 oktober 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00976599

Engelsk

Eligibility Rheumatoid Arthritis NCT00976599

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Rheumatoid Arthritis

Datatyp

boolean

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

Active disease

Datatyp

boolean

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

Tender joint count | Joint Painful Count

Datatyp

boolean

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

Swollen joint count

Datatyp

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
Beskrivning

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

Datatyp

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
Beskrivning

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.
Beskrivning

Arthroscopy Joint Involved

Datatyp

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.
Beskrivning

Intraarticular steroid injection Joint Involved

Datatyp

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.
Beskrivning

Hematological Disease | Hemoglobin measurement | Hematocrit procedure | Synovial biopsy

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Thrombocytopenia | Platelet Count measurement | Synovial biopsy

Datatyp

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 .
Beskrivning

Estimated Glomerular Filtration Rate Cockcroft-Gault formula

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3811844
UMLS CUI [1,2]
C2924627
Tillbaka till toppen

Similar models

Eligibility Rheumatoid Arthritis NCT00976599

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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])
Tillbaka till toppen 

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