ID

37243

Beschrijving

Registry for Analysis of Compliance in Colombian Participants With Rheumatoid Arthritis Exposed to Golimumab; ODM derived from: https://clinicaltrials.gov/show/NCT02414984

Link

https://clinicaltrials.gov/show/NCT02414984

Trefwoorden

Versies (1)
  1. 11-07-19 11-07-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

11 juli 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT02414984

Engels

Eligibility Rheumatoid Arthritis NCT02414984

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
participants with moderate to severe ra for whom the physician had decided to treat with golimumab according to the local product label, with the first dose being administered between 12 and 26 weeks prior to study enrollment
Beschrijving

Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe | golimumab

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0003873
UMLS CUI [2,2]
C0205082
UMLS CUI [3]
C2353893
participants who have achieved an adequate therapeutic response to regular doses of golimumab, within 12 to 26 weeks of treatment
Beschrijving

Fair therapeutic response | Golimumab Dose Regular

Datatype

boolean

Alias
UMLS CUI [1]
C0184784
UMLS CUI [2,1]
C2353893
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205272
participants should be evaluated for tuberculosis (tb) exposure/risk factors or managed for active and latent tb (per local requirements and according to the local product label)
Beschrijving

Evaluation Exposure to Tuberculosis | Evaluation Exposure to Risk factors | Management Tuberculosis | Management Latent Tuberculosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0332157
UMLS CUI [1,3]
C0041296
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0332157
UMLS CUI [2,3]
C0035648
UMLS CUI [3,1]
C0376636
UMLS CUI [3,2]
C0041296
UMLS CUI [4,1]
C0376636
UMLS CUI [4,2]
C1609538
participants who have been evaluated for active/latent hepatitis b virus (hbv) and hepatitis c virus (hcv)
Beschrijving

Evaluation Hepatitis B Virus | Evaluation Hepatitis B Virus Latent | Evaluation Hepatitis C virus | Evaluation Hepatitis C virus Latent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0019169
UMLS CUI [2,1]
C1261322
UMLS CUI [2,2]
C0019169
UMLS CUI [2,3]
C0205275
UMLS CUI [3,1]
C1261322
UMLS CUI [3,2]
C0220847
UMLS CUI [4,1]
C1261322
UMLS CUI [4,2]
C0220847
UMLS CUI [4,3]
C0205275
participants for whom, since golimumab initiation, a complete medical record is available
Beschrijving

Availability of Medical Record Complete

Datatype

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0025102
UMLS CUI [1,3]
C0205197
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
participants who have received and terminated golimumab treatment in the past
Beschrijving

Golimumab Treatment completed In the past

Datatype

boolean

Alias
UMLS CUI [1,1]
C2353893
UMLS CUI [1,2]
C0580352
UMLS CUI [1,3]
C1444637
participants that have been treated with golimumab for more than 26 weeks prior to enrolment in the study
Beschrijving

Golimumab Duration of treatment | Status pre- Enrollment

Datatype

boolean

Alias
UMLS CUI [1,1]
C2353893
UMLS CUI [1,2]
C0444921
UMLS CUI [2,1]
C0332152
UMLS CUI [2,2]
C1516879
participants with use of any other investigational agent less than or equal to 30 days before starting treatment with golimumab
Beschrijving

Investigational New Drugs

Datatype

boolean

Alias
UMLS CUI [1]
C0013230
participants with suspected latent tb, having not received prophylactic treatment of at least 4 weeks
Beschrijving

Latent Tuberculosis Suspected | Prophylactic treatment Duration Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C1609538
UMLS CUI [1,2]
C0750491
UMLS CUI [2,1]
C0199176
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0332197
participants with suspected or active tb
Beschrijving

Tuberculosis Suspected | Tuberculosis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0041296
UMLS CUI [1,2]
C0750491
UMLS CUI [2]
C0041296
participants with active/latent hbv or hcv
Beschrijving

Hepatitis B Virus | Hepatitis C virus | Hepatitis B Virus Latent | Hepatitis C virus Latent

Datatype

boolean

Alias
UMLS CUI [1]
C0019169
UMLS CUI [2]
C0220847
UMLS CUI [3,1]
C0019169
UMLS CUI [3,2]
C0205275
UMLS CUI [4,1]
C0220847
UMLS CUI [4,2]
C0205275
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Similar models

Eligibility Rheumatoid Arthritis NCT02414984

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis Moderate | Rheumatoid Arthritis Severe | golimumab
Item
participants with moderate to severe ra for whom the physician had decided to treat with golimumab according to the local product label, with the first dose being administered between 12 and 26 weeks prior to study enrollment
boolean
C0003873 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2353893 (UMLS CUI [3])
Fair therapeutic response | Golimumab Dose Regular
Item
participants who have achieved an adequate therapeutic response to regular doses of golimumab, within 12 to 26 weeks of treatment
boolean
C0184784 (UMLS CUI [1])
C2353893 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205272 (UMLS CUI [2,3])
Evaluation Exposure to Tuberculosis | Evaluation Exposure to Risk factors | Management Tuberculosis | Management Latent Tuberculosis
Item
participants should be evaluated for tuberculosis (tb) exposure/risk factors or managed for active and latent tb (per local requirements and according to the local product label)
boolean
C1261322 (UMLS CUI [1,1])
C0332157 (UMLS CUI [1,2])
C0041296 (UMLS CUI [1,3])
C1261322 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
C0035648 (UMLS CUI [2,3])
C0376636 (UMLS CUI [3,1])
C0041296 (UMLS CUI [3,2])
C0376636 (UMLS CUI [4,1])
C1609538 (UMLS CUI [4,2])
Evaluation Hepatitis B Virus | Evaluation Hepatitis B Virus Latent | Evaluation Hepatitis C virus | Evaluation Hepatitis C virus Latent
Item
participants who have been evaluated for active/latent hepatitis b virus (hbv) and hepatitis c virus (hcv)
boolean
C1261322 (UMLS CUI [1,1])
C0019169 (UMLS CUI [1,2])
C1261322 (UMLS CUI [2,1])
C0019169 (UMLS CUI [2,2])
C0205275 (UMLS CUI [2,3])
C1261322 (UMLS CUI [3,1])
C0220847 (UMLS CUI [3,2])
C1261322 (UMLS CUI [4,1])
C0220847 (UMLS CUI [4,2])
C0205275 (UMLS CUI [4,3])
Availability of Medical Record Complete
Item
participants for whom, since golimumab initiation, a complete medical record is available
boolean
C0470187 (UMLS CUI [1,1])
C0025102 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Golimumab Treatment completed In the past
Item
participants who have received and terminated golimumab treatment in the past
boolean
C2353893 (UMLS CUI [1,1])
C0580352 (UMLS CUI [1,2])
C1444637 (UMLS CUI [1,3])
Golimumab Duration of treatment | Status pre- Enrollment
Item
participants that have been treated with golimumab for more than 26 weeks prior to enrolment in the study
boolean
C2353893 (UMLS CUI [1,1])
C0444921 (UMLS CUI [1,2])
C0332152 (UMLS CUI [2,1])
C1516879 (UMLS CUI [2,2])
Investigational New Drugs
Item
participants with use of any other investigational agent less than or equal to 30 days before starting treatment with golimumab
boolean
C0013230 (UMLS CUI [1])
Latent Tuberculosis Suspected | Prophylactic treatment Duration Absent
Item
participants with suspected latent tb, having not received prophylactic treatment of at least 4 weeks
boolean
C1609538 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0199176 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Tuberculosis Suspected | Tuberculosis
Item
participants with suspected or active tb
boolean
C0041296 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0041296 (UMLS CUI [2])
Hepatitis B Virus | Hepatitis C virus | Hepatitis B Virus Latent | Hepatitis C virus Latent
Item
participants with active/latent hbv or hcv
boolean
C0019169 (UMLS CUI [1])
C0220847 (UMLS CUI [2])
C0019169 (UMLS CUI [3,1])
C0205275 (UMLS CUI [3,2])
C0220847 (UMLS CUI [4,1])
C0205275 (UMLS CUI [4,2])
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