Age
Item
male or female age at least 18 and below or equal to 75 years at the time of signing informed consent
boolean
C0001779 (UMLS CUI [1])
Rheumatoid Arthritis Disease length
Item
a diagnosis of ra at least 6 months prior to screening visit, according to the american college of rheumatology (eular/acr 2010 criteria) or by standard criteria (acr 1987) if diagnosis was made earlier than 2010
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
ACR Criteria for Improvement in Rheumatoid Arthritis Functional Status
Item
subjects with acr global functional status of 1 to 3
boolean
C3273740 (UMLS CUI [1,1])
C0598463 (UMLS CUI [1,2])
Rheumatoid Arthritis | Disease activity score DAS28 | C-reactive protein measurement | Tender joint count | Swollen joint count
Item
active ra, characterised by: das28 (disease activity score 28) (crp (c-reactive protein)) above 4.5 and equal to or above 6 tender and equal to or above 6 swollen joints based on a 66/68 joint count
boolean
C0003873 (UMLS CUI [1])
C4481729 (UMLS CUI [2])
C0201657 (UMLS CUI [3])
C0451530 (UMLS CUI [4])
C0451521 (UMLS CUI [5])
Synovitis wrist Joints Quantity | Synovitis Metacarpophalangeal joints Quantity | High frequency Doppler Ultrasound
Item
active synovitis in at least two joints of the wrist and metacarpophalangeal joints, as assessed by high frequency power doppler ultrasound scan at screening and randomisation
boolean
C1868955 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0039103 (UMLS CUI [2,1])
C0025525 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0205212 (UMLS CUI [3,1])
C0162481 (UMLS CUI [3,2])
Arthritis Due to Autoimmune Diseases | Exception Rheumatoid Arthritis
Item
subjects with arthritis due to other autoimmune diseases than ra
boolean
C0003864 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0004364 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
Body Weight
Item
body weight above 90.0 kg
boolean
C0005910 (UMLS CUI [1])
Inflammatory joint disease | Exception Rheumatoid Arthritis | Gout | Arthritis, Psoriatic | Arthritis, Reactive | Lyme Disease | Juvenile arthritis | Exception Sjogren's Syndrome Secondary | Exception Hypothyroidism
Item
history of or current inflammatory joint disease other than ra (e.g. gout, psoriatic or reactive arthritis, lyme disease, juvenile idiopathic arthritis, excluding secondary sjogren syndrome and hypothyroidism)
boolean
C0683381 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0003873 (UMLS CUI [2,2])
C0018099 (UMLS CUI [3])
C0003872 (UMLS CUI [4])
C0085435 (UMLS CUI [5])
C0024198 (UMLS CUI [6])
C3495559 (UMLS CUI [7])
C1705847 (UMLS CUI [8,1])
C1527336 (UMLS CUI [8,2])
C0175668 (UMLS CUI [8,3])
C1705847 (UMLS CUI [9,1])
C0020676 (UMLS CUI [9,2])
Bacterial Infections | Exception Bacterial Infections resolved | Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis
Item
any active or on-going bacterial infections within 4 weeks prior to screening visit, unless treated and resolved with appropriate therapy or any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)
boolean
C0004623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0004623 (UMLS CUI [2,2])
C1514893 (UMLS CUI [2,3])
C0239998 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C0231203 (UMLS CUI [4,2])
C0151317 (UMLS CUI [4,3])
C0006267 (UMLS CUI [5])
C0008707 (UMLS CUI [6])
Malignant Neoplasms | Exception Basal cell carcinoma Treated Cured | Exception Squamous cell carcinoma of skin Treated Cured | Exception Carcinoma in situ of uterine cervix
Item
subjects with malignancy within the previous 5 years with the exception of adequately treated and cured basal or squamous cell carcinoma of the skin or cervical carcinoma in situ occurring more than 12 months prior to screening visit
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1522326 (UMLS CUI [2,3])
C1880198 (UMLS CUI [2,4])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1880198 (UMLS CUI [3,4])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
Pregnancy | Breast Feeding | Pregnancy, Planned | Childbearing Potential Contraceptive methods Quantity Unwilling | Contraceptives, Oral, Hormonal | Injectable contraception Hormonal | Contraceptive implant Hormonal | Female Sterilization | Intrauterine Devices | Intrauterine System Contraception | Contraception, Barrier | Female Condoms | Spermicidal foam/jelly/cream/film/suppository
Item
female who is pregnant, breast feeding, intends to become pregnant or is of childbearing potential, not willing to use two highly effective contraceptive methods (adequate highlyeffective contraceptive measures are defined as established use of oral, injected or implanted hormonal methods of contraception, sterilisation, intrauterine device or intrauterine system) one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream), for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
C3831118 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C0558080 (UMLS CUI [4,4])
C0009907 (UMLS CUI [5])
C1262153 (UMLS CUI [6,1])
C0458083 (UMLS CUI [6,2])
C1657106 (UMLS CUI [7,1])
C0458083 (UMLS CUI [7,2])
C0015787 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C4293370 (UMLS CUI [10,1])
C0700589 (UMLS CUI [10,2])
C0004764 (UMLS CUI [11])
C0221829 (UMLS CUI [12])
C3843415 (UMLS CUI [13])
Gender Sexually active Contraceptive methods Unwilling | Male sterilization Absent | Partner Contraceptive methods Unwilling | Contraception, Barrier | Condoms, Male | Spermicidal foam/jelly/cream/film/suppository
Item
male subjects who are sexually active and not surgically sterilised, who or whose partner are unwilling to use two different forms of highly effective contraception, one of which has to be a barrier method a barrier method of contraception (e.g. condom with spermicidal foam/gel/film/cream) for the duration of the trial and for at least 16 weeks (approximately 5 half-lives) following the last dose of trial medication
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0700589 (UMLS CUI [1,3])
C0558080 (UMLS CUI [1,4])
C0024559 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0682323 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0558080 (UMLS CUI [3,3])
C0004764 (UMLS CUI [4])
C0009653 (UMLS CUI [5])
C3843415 (UMLS CUI [6])