ID

15960

Descrição

Study of Etanercept Monotherapy vs Methotrexate Monotherapy for Maintenance of Rheumatoid Arthritis Remission; ODM derived from: https://clinicaltrials.gov/show/NCT02373813

Link

https://clinicaltrials.gov/show/NCT02373813

Palavras-chave

  1. 21/06/2016 21/06/2016 -
Transferido a

21 de junho de 2016

DOI

Para um pedido faça login.

Licença

Creative Commons BY 4.0

Comentários do modelo :

Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.

Comentários do grupo de itens para :

Comentários do item para :

Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.

Eligibility Rheumatoid Arthritis NCT02373813

Eligibility Rheumatoid Arthritis NCT02373813

Inclusion Criteria
Descrição

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects must be adults with a history of moderate to severe rheumatoid arthritis;
Descrição

Adult | Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0003873
UMLS CUI [3,2]
C0205082
subjects must be in very good rheumatoid arthritis disease control for ≥ 6 months and be in remission as defined by a simplified disease activity index ≤ 3.3 at screening and at the end of the run-in period.
Descrição

Rheumatoid Arthritis | Disease control Very good | Simplified disease activity index

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C0920467
UMLS CUI [2,2]
C3641222
UMLS CUI [3]
C3869582
subjects must be on etanercept plus methotrexate therapy for ≥ 6 months prior to the start of the run-in period. the methotrexate dose must be 10 to 25 mg per week for ≥
Descrição

Therapeutic procedure Etanercept Methotrexate

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0717758
UMLS CUI [1,3]
C0025677
6 months prior to the start of the run-in period and the dose must be stable for ≥ 8 weeks prior to the start of the run-in period.
Descrição

Methotrexate Dosage Stable

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
subject has no known history of active tuberculosis, and has a negative test for tuberculosis during screening.
Descrição

Active tuberculosis Absent | Tuberculosis test negative

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0151332
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C2242735
exclusion criteria:- subject has used biologic disease modifying antirheumatic drug other than etanercept or has used an oral janus kinase inhibitor ≤ 6 months prior to run-in visit 1
Descrição

Exclusion Criteria | Antirheumatic Drugs, Disease-Modifying | Etanercept | Janus kinase inhibitor Oral

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0680251
UMLS CUI [2]
C0242708
UMLS CUI [3]
C0717758
UMLS CUI [4,1]
C3854325
UMLS CUI [4,2]
C1527415
subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to run-in visit 1.
Descrição

Communicable Diseases | Chronic infectious disease | Focal Infection | Indication Anti-Infective Agents

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009450
UMLS CUI [2]
C0151317
UMLS CUI [3]
C0016397
UMLS CUI [4,1]
C3146298
UMLS CUI [4,2]
C0003204
subject has known alcohol addiction or dependency or uses alcohol daily.
Descrição

Alcohol dependence

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001973
subject has one or more significant concurrent medical conditions per investigator judgment, including the following:
Descrição

Comorbidity

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0009488
poorly controlled diabetes
Descrição

Diabetes mellitus poor control

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0860161
chronic kidney disease stage iiib, iv, or v
Descrição

Chronic Kidney Diseases | chronic kidney disease stage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1561643
UMLS CUI [2]
C2074731
symptomatic heart failure (new york heart association class ii, iii, or iv)
Descrição

Heart failure Symptomatic | New York Heart Association Classification

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C1275491
myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
Descrição

Myocardial Infarction | Angina, Unstable

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
uncontrolled hypertension
Descrição

Uncontrolled hypertension

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1868885
severe chronic pulmonary disease (eg, requiring oxygen therapy)
Descrição

Severe chronic obstructive pulmonary disease | Oxygen Therapy Required

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2,1]
C0184633
UMLS CUI [2,2]
C1514873
multiple sclerosis or any other demyelinating disease
Descrição

Multiple Sclerosis | Demyelinating Disease

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0026769
UMLS CUI [2]
C0011303
major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus with the exception of secondary sjögren's syndrome)
Descrição

Chronic inflammatory disorder Major | Connective Tissue Diseases | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Sjogren's Syndrome Secondary

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C1290886
UMLS CUI [1,2]
C0205164
UMLS CUI [2]
C0009782
UMLS CUI [3]
C0003873
UMLS CUI [4]
C0024141
UMLS CUI [5,1]
C1527336
UMLS CUI [5,2]
C0175668

Similar models

Eligibility Rheumatoid Arthritis NCT02373813

Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe
Item
subjects must be adults with a history of moderate to severe rheumatoid arthritis;
boolean
C0001675 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0003873 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Rheumatoid Arthritis | Disease control Very good | Simplified disease activity index
Item
subjects must be in very good rheumatoid arthritis disease control for ≥ 6 months and be in remission as defined by a simplified disease activity index ≤ 3.3 at screening and at the end of the run-in period.
boolean
C0003873 (UMLS CUI [1])
C0920467 (UMLS CUI [2,1])
C3641222 (UMLS CUI [2,2])
C3869582 (UMLS CUI [3])
Therapeutic procedure Etanercept Methotrexate
Item
subjects must be on etanercept plus methotrexate therapy for ≥ 6 months prior to the start of the run-in period. the methotrexate dose must be 10 to 25 mg per week for ≥
boolean
C0087111 (UMLS CUI [1,1])
C0717758 (UMLS CUI [1,2])
C0025677 (UMLS CUI [1,3])
Methotrexate Dosage Stable
Item
6 months prior to the start of the run-in period and the dose must be stable for ≥ 8 weeks prior to the start of the run-in period.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Active tuberculosis Absent | Tuberculosis test negative
Item
subject has no known history of active tuberculosis, and has a negative test for tuberculosis during screening.
boolean
C0151332 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C2242735 (UMLS CUI [2])
Exclusion Criteria | Antirheumatic Drugs, Disease-Modifying | Etanercept | Janus kinase inhibitor Oral
Item
exclusion criteria:- subject has used biologic disease modifying antirheumatic drug other than etanercept or has used an oral janus kinase inhibitor ≤ 6 months prior to run-in visit 1
boolean
C0680251 (UMLS CUI [1])
C0242708 (UMLS CUI [2])
C0717758 (UMLS CUI [3])
C3854325 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
Communicable Diseases | Chronic infectious disease | Focal Infection | Indication Anti-Infective Agents
Item
subject has any active infection (including chronic or localized infections) for which anti-infectives were indicated within 4 weeks prior to run-in visit 1.
boolean
C0009450 (UMLS CUI [1])
C0151317 (UMLS CUI [2])
C0016397 (UMLS CUI [3])
C3146298 (UMLS CUI [4,1])
C0003204 (UMLS CUI [4,2])
Alcohol dependence
Item
subject has known alcohol addiction or dependency or uses alcohol daily.
boolean
C0001973 (UMLS CUI [1])
Comorbidity
Item
subject has one or more significant concurrent medical conditions per investigator judgment, including the following:
boolean
C0009488 (UMLS CUI [1])
Diabetes mellitus poor control
Item
poorly controlled diabetes
boolean
C0860161 (UMLS CUI [1])
Chronic Kidney Diseases | chronic kidney disease stage
Item
chronic kidney disease stage iiib, iv, or v
boolean
C1561643 (UMLS CUI [1])
C2074731 (UMLS CUI [2])
Heart failure Symptomatic | New York Heart Association Classification
Item
symptomatic heart failure (new york heart association class ii, iii, or iv)
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
Myocardial Infarction | Angina, Unstable
Item
myocardial infarction or unstable angina pectoris within the past 12 months prior to randomization
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
Uncontrolled hypertension
Item
uncontrolled hypertension
boolean
C1868885 (UMLS CUI [1])
Severe chronic obstructive pulmonary disease | Oxygen Therapy Required
Item
severe chronic pulmonary disease (eg, requiring oxygen therapy)
boolean
C0730607 (UMLS CUI [1])
C0184633 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
Multiple Sclerosis | Demyelinating Disease
Item
multiple sclerosis or any other demyelinating disease
boolean
C0026769 (UMLS CUI [1])
C0011303 (UMLS CUI [2])
Chronic inflammatory disorder Major | Connective Tissue Diseases | Rheumatoid Arthritis | Lupus Erythematosus, Systemic | Sjogren's Syndrome Secondary
Item
major chronic inflammatory disease or connective tissue disease other than rheumatoid arthritis (eg, systemic lupus erythematosus with the exception of secondary sjögren's syndrome)
boolean
C1290886 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0009782 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C1527336 (UMLS CUI [5,1])
C0175668 (UMLS CUI [5,2])

Use este formulário para feedback, perguntas e sugestões de aperfeiçoamento.

Campos marcados com * são obrigatórios.

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