ID

31877

Description

Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00850343

Link

https://clinicaltrials.gov/show/NCT00850343

Keywords

Versions (1)
  1. 10/6/18 10/6/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 6, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00850343

English

Eligibility Rheumatoid Arthritis NCT00850343

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subjects who participated in study 275-08-003 and meet all of the criteria described below.
Description

Study Subject Participation Status | Clinical Trial Specified | Criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
UMLS CUI [3,1]
C0243161
UMLS CUI [3,2]
C1550543
patients who did not reach acr20, and prematurely discontinued study 275-08-003 at week 16 or completed study 275-08-003 by week 24.
Description

ACR Criteria failed | Clinical Trial Specified Premature Discontinued | Clinical Trial Specified Completed

Data type

boolean

Alias
UMLS CUI [1,1]
C3273747
UMLS CUI [1,2]
C0231175
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0205369
UMLS CUI [2,3]
C4018905
UMLS CUI [2,4]
C1444662
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0205369
UMLS CUI [3,3]
C0205197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients who experienced an important protocol deviation as mentioned below during study 275-08-003.
Description

Protocol Deviation Important

Data type

boolean

Alias
UMLS CUI [1,1]
C1705236
UMLS CUI [1,2]
C3898777
patients who received live or attenuated vaccines during study 275-08-003 (except for influenza or pneumococcal vaccines).
Description

Live Vaccine | Exception Influenza | Exception Pneumococcal vaccine

Data type

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0021400
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0358314
patients who were found to have tuberculosis on a chest x-ray during study 275-08-003.
Description

Tuberculosis Chest X-ray

Data type

boolean

Alias
UMLS CUI [1,1]
C0041296
UMLS CUI [1,2]
C0039985
patients who required treatment for the same infection at two or more different times during study 275-08-003
Description

Communicable Disease Same | Treatment required for Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0445247
UMLS CUI [2,1]
C0332121
UMLS CUI [2,2]
C1265611
women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
Description

Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0032992
patients whom the investigator has decided to be inappropriate for participation in the study
Description

Study Subject Participation Status Inappropriate

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C1548788
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Similar models

Eligibility Rheumatoid Arthritis NCT00850343

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Clinical Trial Specified | Criteria Fulfill
Item
subjects who participated in study 275-08-003 and meet all of the criteria described below.
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C0243161 (UMLS CUI [3,1])
C1550543 (UMLS CUI [3,2])
ACR Criteria failed | Clinical Trial Specified Premature Discontinued | Clinical Trial Specified Completed
Item
patients who did not reach acr20, and prematurely discontinued study 275-08-003 at week 16 or completed study 275-08-003 by week 24.
boolean
C3273747 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
C4018905 (UMLS CUI [2,3])
C1444662 (UMLS CUI [2,4])
C0008976 (UMLS CUI [3,1])
C0205369 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Protocol Deviation Important
Item
patients who experienced an important protocol deviation as mentioned below during study 275-08-003.
boolean
C1705236 (UMLS CUI [1,1])
C3898777 (UMLS CUI [1,2])
Live Vaccine | Exception Influenza | Exception Pneumococcal vaccine
Item
patients who received live or attenuated vaccines during study 275-08-003 (except for influenza or pneumococcal vaccines).
boolean
C0042211 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0021400 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0358314 (UMLS CUI [3,2])
Tuberculosis Chest X-ray
Item
patients who were found to have tuberculosis on a chest x-ray during study 275-08-003.
boolean
C0041296 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
Communicable Disease Same | Treatment required for Quantity
Item
patients who required treatment for the same infection at two or more different times during study 275-08-003
boolean
C0009450 (UMLS CUI [1,1])
C0445247 (UMLS CUI [1,2])
C0332121 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
Pregnancy | Breast Feeding | Childbearing Potential Planned Pregnancy
Item
women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0032992 (UMLS CUI [3,2])
Study Subject Participation Status Inappropriate
Item
patients whom the investigator has decided to be inappropriate for participation in the study
boolean
C2348568 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
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