ID

22949

Descripción

Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00420927

Link

https://clinicaltrials.gov/show/NCT00420927

Palabras clave

Versiones (1)
  1. 18/6/17 18/6/17 -
Subido en

18 de junio de 2017

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00420927

Inglés

Eligibility Rheumatoid Arthritis NCT00420927

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject must be 18 or older and in good health
Descripción

Age | Overall Well Being

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C3813622
subject must meet the definition of early rheumatoid arthritis (ra) defined by the 1987-revised american college of rheumatology (acr) classification criteria and had disease duration of less than 1 year from diagnosis
Descripción

Early Rheumatoid Arthritis disease length

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3899278
UMLS CUI [1,2]
C0872146
subject must have a disease activity score (das28, based on c-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed
Descripción

Disease activity score | C-reactive protein measurement | Swollen joint count | Tender joint count

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2732493
UMLS CUI [2]
C0201657
UMLS CUI [3]
C0451521
UMLS CUI [4]
C0451530
subject must fulfill at least one of the following three criteria:
Descripción

Criteria Fulfill

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
rheumatoid factor positive
Descripción

Rheumatoid factor positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0151379
greater than 1 joint erosion
Descripción

Joint erosion Quantity

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0022417
UMLS CUI [1,2]
C0587240
UMLS CUI [1,3]
C1265611
anti-cyclic citrullinated peptide (ccp) antibody positive.
Descripción

Anti-cyclic citrullinated peptide antibody positive

Tipo de datos

boolean

Alias
UMLS CUI [1]
C2609056
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
subject has previously received systemic anti-tumor necrosis factor (tnf) therapy
Descripción

Anti-tumor necrosis factor therapy Systemic

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0281481
UMLS CUI [1,2]
C0205373
subject has received any biologic or investigational therapy within 6 weeks prior to baseline
Descripción

Biological treatment | Investigational Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1531518
UMLS CUI [2]
C0949266
subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (dmards) or mtx, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.
Descripción

Disease-Modifying Antirheumatic Drugs Quantity | Methotrexate | intraarticular injection of corticosteroids | Adrenal Cortex Hormones Parenteral | Operation on joint | Joints Assessment Clinical Trial

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0242708
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0025677
UMLS CUI [3]
C2064783
UMLS CUI [4,1]
C0001617
UMLS CUI [4,2]
C1518896
UMLS CUI [5]
C0185132
UMLS CUI [6,1]
C0022417
UMLS CUI [6,2]
C1516048
UMLS CUI [6,3]
C0008976
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Similar models

Eligibility Rheumatoid Arthritis NCT00420927

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Age | Overall Well Being
Item
subject must be 18 or older and in good health
boolean
C0001779 (UMLS CUI [1])
C3813622 (UMLS CUI [2])
Early Rheumatoid Arthritis disease length
Item
subject must meet the definition of early rheumatoid arthritis (ra) defined by the 1987-revised american college of rheumatology (acr) classification criteria and had disease duration of less than 1 year from diagnosis
boolean
C3899278 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Disease activity score | C-reactive protein measurement | Swollen joint count | Tender joint count
Item
subject must have a disease activity score (das28, based on c-reactive protein) greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8 tender joints out of the 68 assessed
boolean
C2732493 (UMLS CUI [1])
C0201657 (UMLS CUI [2])
C0451521 (UMLS CUI [3])
C0451530 (UMLS CUI [4])
Criteria Fulfill
Item
subject must fulfill at least one of the following three criteria:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Rheumatoid factor positive
Item
rheumatoid factor positive
boolean
C0151379 (UMLS CUI [1])
Joint erosion Quantity
Item
greater than 1 joint erosion
boolean
C0022417 (UMLS CUI [1,1])
C0587240 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Anti-cyclic citrullinated peptide antibody positive
Item
anti-cyclic citrullinated peptide (ccp) antibody positive.
boolean
C2609056 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Anti-tumor necrosis factor therapy Systemic
Item
subject has previously received systemic anti-tumor necrosis factor (tnf) therapy
boolean
C0281481 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
Biological treatment | Investigational Therapy
Item
subject has received any biologic or investigational therapy within 6 weeks prior to baseline
boolean
C1531518 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Disease-Modifying Antirheumatic Drugs Quantity | Methotrexate | intraarticular injection of corticosteroids | Adrenal Cortex Hormones Parenteral | Operation on joint | Joints Assessment Clinical Trial
Item
subject has been previously treated with more than 2 disease-modifying antirheumatic drugs (dmards) or mtx, had been treated with intra-articular or parenteral administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery within the preceding 2 months at joints to be assessed during the study.
boolean
C0242708 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0025677 (UMLS CUI [2])
C2064783 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C1518896 (UMLS CUI [4,2])
C0185132 (UMLS CUI [5])
C0022417 (UMLS CUI [6,1])
C1516048 (UMLS CUI [6,2])
C0008976 (UMLS CUI [6,3])
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