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])
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])