ID

15960

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02373813

Nyckelord

Versioner (1)
  1. 2016-06-21 2016-06-21 -
Uppladdad den

21 juni 2016

DOI

För en begäran logga in.

Licens

Creative Commons BY 4.0
Modellkommentarer :

Här kan du kommentera modellen. Med hjälp av pratbubblor i Item-grupperna och Item kan du lägga in specifika kommentarer.

Tillbaka till modellkommentarer
Itemgroup-kommentar för :

Item-kommentar för :

Du måste vara inloggad för att kunna ladda ner formulär. Var vänlig logga in eller registrera dig utan kostnad.

Eligibility Rheumatoid Arthritis NCT02373813

Engelsk

Eligibility Rheumatoid Arthritis NCT02373813

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

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

Adult | Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe

Datatyp

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.
Beskrivning

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

Datatyp

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 ≥
Beskrivning

Therapeutic procedure Etanercept Methotrexate

Datatyp

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.
Beskrivning

Methotrexate Dosage Stable

Datatyp

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.
Beskrivning

Active tuberculosis Absent | Tuberculosis test negative

Datatyp

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
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Alcohol dependence

Datatyp

boolean

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

Comorbidity

Datatyp

boolean

Alias
UMLS CUI [1]
C0009488
poorly controlled diabetes
Beskrivning

Diabetes mellitus poor control

Datatyp

boolean

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

Chronic Kidney Diseases | chronic kidney disease stage

Datatyp

boolean

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

Heart failure Symptomatic | New York Heart Association Classification

Datatyp

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
Beskrivning

Myocardial Infarction | Angina, Unstable

Datatyp

boolean

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

Uncontrolled hypertension

Datatyp

boolean

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

Severe chronic obstructive pulmonary disease | Oxygen Therapy Required

Datatyp

boolean

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

Multiple Sclerosis | Demyelinating Disease

Datatyp

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)
Beskrivning

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

Datatyp

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
Tillbaka till toppen

Similar models

Eligibility Rheumatoid Arthritis NCT02373813

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

Kontakt

Använd detta formulär för feedback, frågor och förslag på förbättringar.

Fält markerade med * är obligatoriska.

Hjälp

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