Rheumatoid Arthritis Score | Serologic test
Item
patients diagnosed with ra based on acr/eular 2010 criteria (score >=6), or patients diagnosed with as based on the asas criteria. patients with ra must have serology assessment performed and documented at the time of enrollment.
boolean
C0003873 (UMLS CUI [1,1])
C0449820 (UMLS CUI [1,2])
C0036743 (UMLS CUI [2])
Rheumatoid Arthritis DAS28 | DMARD | Methotrexate | leflunomide | Sulfasalazine
Item
patient with ra active disease (das > 2,6) and the introduction of a bi-dmard should be indicated. ra patients must have been treated with dmard (methotrexate, leflunomide and sulfasalazine) or combination of these treatments for at least 3 months. treatment will be pursued while on study.
boolean
C0003873 (UMLS CUI [1,1])
C4481729 (UMLS CUI [1,2])
C0242708 (UMLS CUI [2])
C0025677 (UMLS CUI [3])
C0063041 (UMLS CUI [4])
C0036078 (UMLS CUI [5])
DMARD Previous | Response Lacking
Item
or ra patients must have been previously treated with bi-dmard before initiation of the new bi-dmard treatment. the non-response of the previous bi-dmard treatment must be documented.
boolean
C0242708 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1704632 (UMLS CUI [2,1])
C0332268 (UMLS CUI [2,2])
Disease Poorly controlled | NSAID
Item
or patients with as with insufficiently controlled disease while under nsaid and indication for bi-dmard. these patients must be under nsaid for at least 3 months and under the same nsaid for at least 1 month prior to enrollment.
boolean
C0012634 (UMLS CUI [1,1])
C3853134 (UMLS CUI [1,2])
C0003211 (UMLS CUI [2])
Age
Item
≥ 18 years old
boolean
C0001779 (UMLS CUI [1])
Karnofsky Performance Status
Item
karnofsky ≥ 80%
boolean
C0206065 (UMLS CUI [1])
Childbearing Potential Pregnancy test negative
Item
negative pregnancy test for women with childbearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods Quantity | Contraceptives, Oral, Hormonal | Contraceptive patch | Vaginal Ring | Intrauterine Devices | Contraception, Barrier | Female Condoms
Item
for women with childbearing potential, use of two reliable means of contraception (e.g., hormonal contraceptive, patch, vaginal ring, intrauterine device, associated with other barrier method of contraception such as the use of condoms) , throughout their participation in the study
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0009907 (UMLS CUI [2])
C2985284 (UMLS CUI [3])
C0042260 (UMLS CUI [4])
C0021900 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0221829 (UMLS CUI [7])
ECG abnormal Absent
Item
absence of ecg anomaly
boolean
C0522055 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Informed Consent
Item
written icf signed
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnancy or lactation
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Liver Dysfunction | Alanine aminotransferase increased | Aspartate aminotransferase increased | Elevated total bilirubin
Item
liver impairment (alt, ast or bilirubin > 2 uln) at screening visit or baseline
boolean
C0086565 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0741494 (UMLS CUI [4])
Renal Insufficiency | Creatinine measurement, serum
Item
kidney impairment (serum creatinine > 1.5 mg/dl)
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
Congestive heart failure New York Heart Association Classification
Item
history of congestive heart failure (nyha iii & iv)
boolean
C0018802 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
Malignant disease
Item
history of malignant disease within 5 years
boolean
C0442867 (UMLS CUI [1])
Disease Interferes with Study Protocol | Physical Condition Interferes with Study Protocol | Mental condition Interferes with Study Protocol | ABNORMAL PHYSICAL FINDING Interferes with Study Protocol
Item
history of any disease or relevant physical or psychiatric condition or abnormal physical finding which may interfere with the study objectives at the investigator judgment
boolean
C0012634 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C3714565 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C2348563 (UMLS CUI [2,3])
C3840291 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348563 (UMLS CUI [3,3])
C0149610 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348563 (UMLS CUI [4,3])
Hypersensitivity Investigational New Drugs | Hypersensitivity Investigational New Drug Component
Item
known hypersensitivity to the investigational drug or any of its components
boolean
C0020517 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1705248 (UMLS CUI [2,3])
Study Subject Participation Status | Exception Interventional Study Without Investigational New Drugs
Item
participation to another clinical trial within 4 weeks before study inclusion except for patients who have participated or who are currently participating in an interventional study without any study drug administration.
boolean
C2348568 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C3274035 (UMLS CUI [2,2])
C0332288 (UMLS CUI [2,3])
C0013230 (UMLS CUI [2,4])