ID

31879

Description

A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00888745

Link

https://clinicaltrials.gov/show/NCT00888745

Keywords

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

See clinicaltrials.gov

Uploaded on

October 6, 2018

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Rheumatoid Arthritis NCT00888745

English

Eligibility Rheumatoid Arthritis NCT00888745

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
ra diagnosed according to the american college of rheumatology (acr)
Description

Rheumatoid Arthritis

Data type

boolean

Alias
UMLS CUI [1]
C0003873
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
Description

Pregnancy | Pregnancy, Planned | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
UMLS CUI [3]
C0006147
clinically significant abnormal ecg
Description

ECG abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0522055
history of anaphylactic reactions
Description

Anaphylaxis

Data type

boolean

Alias
UMLS CUI [1]
C0002792
positive hepatitis c antibody or hepatitis b surface antigen
Description

Hepatitis C antibody positive | Hepatitis B surface antigen positive

Data type

boolean

Alias
UMLS CUI [1]
C0281863
UMLS CUI [2]
C0149709
positive serology for human immunodeficiency virus (hiv) by quantitative polymerase chain reaction
Description

HIV Seropositivity Quantitative PCR

Data type

boolean

Alias
UMLS CUI [1,1]
C0019699
UMLS CUI [1,2]
C1709846
a history of an autoimmune disease other than ra (other than secondary sjogren syndrome)
Description

Autoimmune Disease | Exception Rheumatoid Arthritis | Exception Sjogren's Syndrome Secondary

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0003873
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1527336
UMLS CUI [3,3]
C0175668
significant systemic involvement of ra, including vasculitis, pulmonary fibrosis, or felty syndrome
Description

Rheumatoid arthritis with systemic involvement | Vasculitis | Pulmonary Fibrosis | Felty Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0494896
UMLS CUI [2]
C0042384
UMLS CUI [3]
C0034069
UMLS CUI [4]
C0015773
malignancy, or prior malignancy, other than non-melanoma skin cancer, or cervical carcinoma in situ that has been resected
Description

Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix Resected

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0699893
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [3,3]
C1521996
recent administration of a live, attenuated vaccine, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
Description

Live Vaccine | Requirement Live Vaccine Anticipated

Data type

boolean

Alias
UMLS CUI [1]
C0042211
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0042211
UMLS CUI [2,3]
C3840775
concomitant therapy with a biologic agent
Description

Biological agent

Data type

boolean

Alias
UMLS CUI [1]
C0005515
recent exposure to any investigational agent
Description

Exposure to Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C0013230
any current or recent signs or symptoms of infection requiring parenteral antibiotic administration
Description

Sign or Symptom Communicable Disease | Requirement Antibiotics Parenteral

Data type

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0009450
UMLS CUI [2,1]
C1514873
UMLS CUI [2,2]
C0003232
UMLS CUI [2,3]
C1518896
hospitalization for a clinically relevant event within the 4 weeks prior to screening
Description

Hospitalization Due to Event Clinical

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0441471
UMLS CUI [1,4]
C0205210
Back to the top of the page

Similar models

Eligibility Rheumatoid Arthritis NCT00888745

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Rheumatoid Arthritis
Item
ra diagnosed according to the american college of rheumatology (acr)
boolean
C0003873 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Pregnancy, Planned | Breast Feeding
Item
female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
ECG abnormal
Item
clinically significant abnormal ecg
boolean
C0522055 (UMLS CUI [1])
Anaphylaxis
Item
history of anaphylactic reactions
boolean
C0002792 (UMLS CUI [1])
Hepatitis C antibody positive | Hepatitis B surface antigen positive
Item
positive hepatitis c antibody or hepatitis b surface antigen
boolean
C0281863 (UMLS CUI [1])
C0149709 (UMLS CUI [2])
HIV Seropositivity Quantitative PCR
Item
positive serology for human immunodeficiency virus (hiv) by quantitative polymerase chain reaction
boolean
C0019699 (UMLS CUI [1,1])
C1709846 (UMLS CUI [1,2])
Autoimmune Disease | Exception Rheumatoid Arthritis | Exception Sjogren's Syndrome Secondary
Item
a history of an autoimmune disease other than ra (other than secondary sjogren syndrome)
boolean
C0004364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1527336 (UMLS CUI [3,2])
C0175668 (UMLS CUI [3,3])
Rheumatoid arthritis with systemic involvement | Vasculitis | Pulmonary Fibrosis | Felty Syndrome
Item
significant systemic involvement of ra, including vasculitis, pulmonary fibrosis, or felty syndrome
boolean
C0494896 (UMLS CUI [1])
C0042384 (UMLS CUI [2])
C0034069 (UMLS CUI [3])
C0015773 (UMLS CUI [4])
Malignant Neoplasms | Exception Skin carcinoma | Exception Carcinoma in situ of uterine cervix Resected
Item
malignancy, or prior malignancy, other than non-melanoma skin cancer, or cervical carcinoma in situ that has been resected
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0699893 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1521996 (UMLS CUI [3,3])
Live Vaccine | Requirement Live Vaccine Anticipated
Item
recent administration of a live, attenuated vaccine, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
boolean
C0042211 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0042211 (UMLS CUI [2,2])
C3840775 (UMLS CUI [2,3])
Biological agent
Item
concomitant therapy with a biologic agent
boolean
C0005515 (UMLS CUI [1])
Exposure to Investigational New Drugs
Item
recent exposure to any investigational agent
boolean
C0332157 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Sign or Symptom Communicable Disease | Requirement Antibiotics Parenteral
Item
any current or recent signs or symptoms of infection requiring parenteral antibiotic administration
boolean
C3540840 (UMLS CUI [1,1])
C0009450 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0003232 (UMLS CUI [2,2])
C1518896 (UMLS CUI [2,3])
Hospitalization Due to Event Clinical
Item
hospitalization for a clinically relevant event within the 4 weeks prior to screening
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0441471 (UMLS CUI [1,3])
C0205210 (UMLS CUI [1,4])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Help

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