ID

15960

Beschreibung

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

Stichworte

Versionen (1)
  1. 21.06.16 21.06.16 -
Hochgeladen am

21. Juni 2016

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02373813

Englisch

Eligibility Rheumatoid Arthritis NCT02373813

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Adult | Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe

Datentyp

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.
Beschreibung

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

Datentyp

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 ≥
Beschreibung

Therapeutic procedure Etanercept Methotrexate

Datentyp

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.
Beschreibung

Methotrexate Dosage Stable

Datentyp

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.
Beschreibung

Active tuberculosis Absent | Tuberculosis test negative

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

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

Datentyp

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.
Beschreibung

Alcohol dependence

Datentyp

boolean

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

Comorbidity

Datentyp

boolean

Alias
UMLS CUI [1]
C0009488
poorly controlled diabetes
Beschreibung

Diabetes mellitus poor control

Datentyp

boolean

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

Chronic Kidney Diseases | chronic kidney disease stage

Datentyp

boolean

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

Heart failure Symptomatic | New York Heart Association Classification

Datentyp

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
Beschreibung

Myocardial Infarction | Angina, Unstable

Datentyp

boolean

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

Uncontrolled hypertension

Datentyp

boolean

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

Severe chronic obstructive pulmonary disease | Oxygen Therapy Required

Datentyp

boolean

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

Multiple Sclerosis | Demyelinating Disease

Datentyp

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)
Beschreibung

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

Datentyp

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
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT02373813

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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