ID

19178

Descrizione

Open Label Long-Term Safety Study of Certolizumab Pegol (CZP) for Patients With Rheumatoid Arthritis; ODM derived from: https://clinicaltrials.gov/show/NCT00160693

collegamento

https://clinicaltrials.gov/show/NCT00160693

Keywords

versioni (1)
  1. 10/12/16 10/12/16 -
Caricato su

10 dicembre 2016

DOI

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Licenza

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00160693

Inglese

Eligibility Rheumatoid Arthritis NCT00160693

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
participation in czp trial c87014 or c87011
Descrizione

Study Subject Participation Status | Clinical Trial certolizumab pegol

Tipo di dati

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1872109
if female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
Descrizione

Childbearing Potential Informed Consent | Childbearing Potential Contraceptive methods | Breast Feeding | Childbearing Potential Urine pregnancy test negative

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0021430
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [3]
C0006147
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
must have provided written informed consent before undergoing any study procedures
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
history (hx) of chronic infection, serious or life-threatening infection -
Descrizione

Chronic infectious disease | Communicable Disease Serious | Life-threatening infections

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0151317
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C0205404
UMLS CUI [3]
C1859430
(including herpes zoster) within 6 months prior, or any current symptom indicating infection
Descrizione

Herpes zoster disease | Communicable Disease Symptom

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019360
UMLS CUI [2,1]
C0009450
UMLS CUI [2,2]
C1457887
current or recent hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
Descrizione

Kidney Disease Progressive Severe | Kidney Disease Uncontrolled | Liver disease | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Lung diseases | Heart Diseases | nervous system disorder | Cerebral disorder

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205329
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205318
UMLS CUI [3]
C0023895
UMLS CUI [4]
C0018939
UMLS CUI [5]
C0017178
UMLS CUI [6]
C0014130
UMLS CUI [7]
C0024115
UMLS CUI [8]
C0018799
UMLS CUI [9]
C0027765
UMLS CUI [10]
C0234387
any finding indicative of tuberculosis at end of previous study
Descrizione

Indication Tuberculosis

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0041296
known hiv infection
Descrizione

HIV Infections

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019693
persistently abnormal ast (aspartate aminotransferase) or alt (alanine aminotransferase) results (> 2 times upper limit of normal)
Descrizione

AST level abnormal persistent | Alanine aminotransferase (ALT) level abnormal persistent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0580475
UMLS CUI [1,2]
C0205322
UMLS CUI [2,1]
C0580469
UMLS CUI [2,2]
C0205322
hemoglobin (hgb) levels < 9 g/dl or hematocrit < 30 %
Descrizione

Hemoglobin measurement | Hematocrit level

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0518014
total white blood cell (wbc) count of < 3.0 x 100/l (< 3000/mm^3)
Descrizione

White Blood Cell Count procedure

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0023508
platelet count < 100 x 100 l (100,000/mm^3)
Descrizione

Platelet Count measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine > 1.5 times upper limit of normal based on patient age and sex
Descrizione

Creatinine measurement, serum | Age | Gender

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0079399
receipt of any biological therapies for ra in 6 months prior to study entry or any prior treatment (tx) with tumor necrosis factor (tnf) blocking agent (excluding cdp870)
Descrizione

Biological treatment Rheumatoid Arthritis | Tumor necrosis factor alpha (TNF-) inhibitors | CDP870

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1531518
UMLS CUI [1,2]
C0003873
UMLS CUI [2]
C3653350
UMLS CUI [3]
C1172157
receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to baseline
Descrizione

Vaccination | Vaccines, Attenuated | Vaccines, Inactivated

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0042196
UMLS CUI [2]
C0042211
UMLS CUI [3]
C0042212
any other condition which the principal investigator judges would make patient unsuitable for study participation
Descrizione

Condition Resulting in Study Subject Participation Status Exclusion

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C2348568
UMLS CUI [1,4]
C2828389
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Similar models

Eligibility Rheumatoid Arthritis NCT00160693

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject Participation Status | Clinical Trial certolizumab pegol
Item
participation in czp trial c87014 or c87011
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1872109 (UMLS CUI [2,2])
Childbearing Potential Informed Consent | Childbearing Potential Contraceptive methods | Breast Feeding | Childbearing Potential Urine pregnancy test negative
Item
if female and of childbearing potential, she agrees to participate in this study by providing written informed consent, has been using adequate contraception since her last menses, will use adequate contraception during the study and for 12 weeks after the last dose of study drug (or longer if required by local regulations), is not lactating, and has had a negative urine pregnancy test on the day of receiving the first dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0021430 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0006147 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
Informed Consent
Item
must have provided written informed consent before undergoing any study procedures
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chronic infectious disease | Communicable Disease Serious | Life-threatening infections
Item
history (hx) of chronic infection, serious or life-threatening infection -
boolean
C0151317 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C1859430 (UMLS CUI [3])
Herpes zoster disease | Communicable Disease Symptom
Item
(including herpes zoster) within 6 months prior, or any current symptom indicating infection
boolean
C0019360 (UMLS CUI [1])
C0009450 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
Kidney Disease Progressive Severe | Kidney Disease Uncontrolled | Liver disease | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Lung diseases | Heart Diseases | nervous system disorder | Cerebral disorder
Item
current or recent hx of severe, progressive and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
boolean
C0022658 (UMLS CUI [1,1])
C0205329 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0022658 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C0023895 (UMLS CUI [3])
C0018939 (UMLS CUI [4])
C0017178 (UMLS CUI [5])
C0014130 (UMLS CUI [6])
C0024115 (UMLS CUI [7])
C0018799 (UMLS CUI [8])
C0027765 (UMLS CUI [9])
C0234387 (UMLS CUI [10])
Indication Tuberculosis
Item
any finding indicative of tuberculosis at end of previous study
boolean
C3146298 (UMLS CUI [1,1])
C0041296 (UMLS CUI [1,2])
HIV Infections
Item
known hiv infection
boolean
C0019693 (UMLS CUI [1])
AST level abnormal persistent | Alanine aminotransferase (ALT) level abnormal persistent
Item
persistently abnormal ast (aspartate aminotransferase) or alt (alanine aminotransferase) results (> 2 times upper limit of normal)
boolean
C0580475 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0580469 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
Hemoglobin measurement | Hematocrit level
Item
hemoglobin (hgb) levels < 9 g/dl or hematocrit < 30 %
boolean
C0518015 (UMLS CUI [1])
C0518014 (UMLS CUI [2])
White Blood Cell Count procedure
Item
total white blood cell (wbc) count of < 3.0 x 100/l (< 3000/mm^3)
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 100 x 100 l (100,000/mm^3)
boolean
C0032181 (UMLS CUI [1])
Creatinine measurement, serum | Age | Gender
Item
serum creatinine > 1.5 times upper limit of normal based on patient age and sex
boolean
C0201976 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Biological treatment Rheumatoid Arthritis | Tumor necrosis factor alpha (TNF-) inhibitors | CDP870
Item
receipt of any biological therapies for ra in 6 months prior to study entry or any prior treatment (tx) with tumor necrosis factor (tnf) blocking agent (excluding cdp870)
boolean
C1531518 (UMLS CUI [1,1])
C0003873 (UMLS CUI [1,2])
C3653350 (UMLS CUI [2])
C1172157 (UMLS CUI [3])
Vaccination | Vaccines, Attenuated | Vaccines, Inactivated
Item
receipt of any vaccination (live, attenuated or killed) in 8 weeks prior to baseline
boolean
C0042196 (UMLS CUI [1])
C0042211 (UMLS CUI [2])
C0042212 (UMLS CUI [3])
Condition Resulting in Study Subject Participation Status Exclusion
Item
any other condition which the principal investigator judges would make patient unsuitable for study participation
boolean
C0348080 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C2828389 (UMLS CUI [1,4])
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