ID

31879

Beschreibung

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

Stichworte

Versionen (1)
  1. 06.10.18 06.10.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

6. Oktober 2018

DOI

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Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00888745

Englisch

Eligibility Rheumatoid Arthritis NCT00888745

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Rheumatoid Arthritis

Datentyp

boolean

Alias
UMLS CUI [1]
C0003873
Exclusion Criteria
Beschreibung

Exclusion Criteria

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

Pregnancy | Pregnancy, Planned | Breast Feeding

Datentyp

boolean

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

ECG abnormal

Datentyp

boolean

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

Anaphylaxis

Datentyp

boolean

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

Hepatitis C antibody positive | Hepatitis B surface antigen positive

Datentyp

boolean

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

HIV Seropositivity Quantitative PCR

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Live Vaccine | Requirement Live Vaccine Anticipated

Datentyp

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
Beschreibung

Biological agent

Datentyp

boolean

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

Exposure to Investigational New Drugs

Datentyp

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
Beschreibung

Sign or Symptom Communicable Disease | Requirement Antibiotics Parenteral

Datentyp

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
Beschreibung

Hospitalization Due to Event Clinical

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0441471
UMLS CUI [1,4]
C0205210
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Ähnliche Modelle

Eligibility Rheumatoid Arthritis NCT00888745

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