ID

42343

Description

Observational Real-world Evaluation of Cost of Infections of Rheumatoid Arthritis (RA) Patients on Biologics; ODM derived from: https://clinicaltrials.gov/show/NCT01166620

Link

https://clinicaltrials.gov/show/NCT01166620

Keywords

  1. 6/20/21 6/20/21 -
  2. 6/23/21 6/23/21 -
Copyright Holder

Bristol-Myers Squibb

Uploaded on

June 20, 2021

DOI

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License

Creative Commons BY 4.0

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Eligibility Rheumatoid Arthritis NCT01166620

Eligibility Rheumatoid Arthritis NCT01166620

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
18 years of age and older;
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
have a diagnosis of rheumatoid arthritis (icd-9:714x.xx);
Description

Diagnosed with rheumatoid arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
ICD-9
714x.xx
have been enrolled for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment;
Description

Enrollment duration prior to assessment

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C0332152
UMLS CUI [1,4]
C1516048
are enrolled in a health plan between february 2006 and june 2009
Description

Previous enrollment in health plan

Data type

boolean

Alias
UMLS CUI [1,1]
C1516879
UMLS CUI [1,2]
C0679933
UMLS CUI [1,3]
C0205156
have claims indicating at least one use of either abatacept, etanercept, adalimumab or infliximab for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment
Description

Abatacept duration | etanercept duration | adalimumab duration | infliximab duration

Data type

boolean

Alias
UMLS CUI [1,1]
C1619966
UMLS CUI [1,2]
C0449238
UMLS CUI [2,1]
C0717758
UMLS CUI [2,2]
C0449238
UMLS CUI [3,1]
C1122087
UMLS CUI [3,2]
C0449238
UMLS CUI [4,1]
C0666743
UMLS CUI [4,2]
C0449238
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients not continuously eligible for health plan benefits for the same evaluation periods will be excluded
Description

Not eligible for health plan benefits

Data type

boolean

Alias
UMLS CUI [1,1]
C0021674
UMLS CUI [1,2]
C0549178
UMLS CUI [1,3]
C1555471
patients who are on other biologics in the 6 and 12 month post-index period will be excluded (ex. those in the abatacept cohort will be excluded if they also have claims for etanercept in the 6 and 12 month post-index period).
Description

Recentadditional biologics | etanercept following prior therapy with abatacept

Data type

boolean

Alias
UMLS CUI [1,1]
C0005515
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0717758
UMLS CUI [2,2]
C0332282
UMLS CUI [2,3]
C1514463
UMLS CUI [2,4]
C1619966
patients on biologics 6 months prior to the biologic index date will also be excluded
Description

Prior therapy with biologics

Data type

boolean

Alias
UMLS CUI [1,1]
C1514463
UMLS CUI [1,2]
C0005515
patients with diagnosis for other non-ra conditions commonly treated with biologics (ex. crohn's disease) during the 6 month pre-index period.
Description

Recent diagnosis of condition indicating biologics treatment | except for rheumatoid arthritis | except for Crohn's disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0011900
UMLS CUI [1,2]
C3146298
UMLS CUI [1,3]
C1514463
UMLS CUI [1,4]
C0005515
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3,1]
C1514463
UMLS CUI [3,2]
C0010346

Similar models

Eligibility Rheumatoid Arthritis NCT01166620

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
18 years of age and older;
boolean
C0001779 (UMLS CUI [1])
Diagnosed with rheumatoid arthritis
Item
have a diagnosis of rheumatoid arthritis (icd-9:714x.xx);
boolean
C0003873 (UMLS CUI [1])
714x.xx (ICD-9)
Enrollment duration prior to assessment
Item
have been enrolled for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment;
boolean
C1516879 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0332152 (UMLS CUI [1,3])
C1516048 (UMLS CUI [1,4])
Previous enrollment in health plan
Item
are enrolled in a health plan between february 2006 and june 2009
boolean
C1516879 (UMLS CUI [1,1])
C0679933 (UMLS CUI [1,2])
C0205156 (UMLS CUI [1,3])
Abatacept duration | etanercept duration | adalimumab duration | infliximab duration
Item
have claims indicating at least one use of either abatacept, etanercept, adalimumab or infliximab for at least 6 months for the 6 months assessment and 12 months for the 12 months assessment
boolean
C1619966 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C0717758 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C1122087 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0666743 (UMLS CUI [4,1])
C0449238 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Not eligible for health plan benefits
Item
patients not continuously eligible for health plan benefits for the same evaluation periods will be excluded
boolean
C0021674 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1555471 (UMLS CUI [1,3])
Recentadditional biologics | etanercept following prior therapy with abatacept
Item
patients who are on other biologics in the 6 and 12 month post-index period will be excluded (ex. those in the abatacept cohort will be excluded if they also have claims for etanercept in the 6 and 12 month post-index period).
boolean
C0005515 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0717758 (UMLS CUI [2,1])
C0332282 (UMLS CUI [2,2])
C1514463 (UMLS CUI [2,3])
C1619966 (UMLS CUI [2,4])
Prior therapy with biologics
Item
patients on biologics 6 months prior to the biologic index date will also be excluded
boolean
C1514463 (UMLS CUI [1,1])
C0005515 (UMLS CUI [1,2])
Recent diagnosis of condition indicating biologics treatment | except for rheumatoid arthritis | except for Crohn's disease
Item
patients with diagnosis for other non-ra conditions commonly treated with biologics (ex. crohn's disease) during the 6 month pre-index period.
boolean
C0011900 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1514463 (UMLS CUI [1,3])
C0005515 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C1514463 (UMLS CUI [3,1])
C0010346 (UMLS CUI [3,2])

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