ID

31900

Descripción

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

Palabras clave

Versiones (1)
  1. 7/10/18 7/10/18 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

7 de octubre de 2018

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00976599

Inglés

Eligibility Rheumatoid Arthritis NCT00976599

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

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

Rheumatoid Arthritis

Tipo de datos

boolean

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

Active disease

Tipo de datos

boolean

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

Tender joint count | Joint Painful Count

Tipo de datos

boolean

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

Swollen joint count

Tipo de datos

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
Descripción

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

Tipo de datos

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
Descripción

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.
Descripción

Arthroscopy Joint Involved

Tipo de datos

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.
Descripción

Intraarticular steroid injection Joint Involved

Tipo de datos

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.
Descripción

Hematological Disease | Hemoglobin measurement | Hematocrit procedure | Synovial biopsy

Tipo de datos

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.
Descripción

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

Tipo de datos

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.
Descripción

Thrombocytopenia | Platelet Count measurement | Synovial biopsy

Tipo de datos

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 .
Descripción

Estimated Glomerular Filtration Rate Cockcroft-Gault formula

Tipo de datos

boolean

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

Eligibility Rheumatoid Arthritis NCT00976599

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
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])
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