Informed Consent
Item
informed consent must be obtained before any trial-related activities. trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
boolean
C0021430 (UMLS CUI [1])
Rheumatoid Arthritis Duration
Item
a documented 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])
C0449238 (UMLS CUI [1,2])
Tender 28 joint count | Swollen 28 joint count | C-reactive protein measurement
Item
active ra, characterised by: a. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. c-reactive protein (crp) above or equal to 1.0 mg/dl (10 mg/l)
boolean
C2711398 (UMLS CUI [1])
C2711873 (UMLS CUI [2])
C0201657 (UMLS CUI [3])
Methotrexate | Hydroxychloroquine | Chloroquine | Hydroxychloroquine Absent | Chloroquine Absent | Methotrexate Dose | Relationship Intolerance to Methotrexate | Hydroxychloroquine Oral Dose | Chloroquine Oral Dose
Item
patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. patient can be on mtx as low as 10 mg/week only if due to mtx intolerance b. hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit
boolean
C0025677 (UMLS CUI [1])
C0020336 (UMLS CUI [2])
C0008269 (UMLS CUI [3])
C0020336 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0008269 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0025677 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0439849 (UMLS CUI [7,1])
C1744706 (UMLS CUI [7,2])
C0025677 (UMLS CUI [7,3])
C0020336 (UMLS CUI [8,1])
C1527415 (UMLS CUI [8,2])
C0178602 (UMLS CUI [8,3])
C0008269 (UMLS CUI [9,1])
C1527415 (UMLS CUI [9,2])
C0178602 (UMLS CUI [9,3])
Arthritis Due to Autoimmune Disease | Exception Rheumatoid Arthritis
Item
patients 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])
Bacterial Infections | Exception resolved | Recurrent infections | Condition predisposing Chronic infectious disease | Bronchiectasis | Chronic osteomyelitis
Item
any active or ongoing 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])
C1514893 (UMLS CUI [2,2])
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])
Systemic viral infection Severe | Systemic mycosis Severe | Exception resolved
Item
history of severe, systemic viral or fungal infections within the past 6 months prior to screening visit, unless treated and/or resolved with appropriate therapy
boolean
C4285789 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0553576 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C1514893 (UMLS CUI [3,2])
Malignant Neoplasms | Exception Basal cell carcinoma Cured | Exception Squamous cell carcinoma of skin Cured | Exception Carcinoma in situ of uterine cervix Cured
Item
patients with active 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])
C1880198 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1880198 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1880198 (UMLS CUI [4,3])
Pregnancy | Breast Feeding | Pregnancy, Planned
Item
females of childbearing potential who are pregnant or breast feeding or intend to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0032992 (UMLS CUI [3])
Disease At risk Patient safety | Laboratory test result abnormal At risk Patient safety | Disease Interferes with Study Subject Participation Status | Laboratory test result abnormal Interferes with Study Subject Participation Status | Disease At risk Completion of clinical trial | Laboratory test result abnormal At risk Completion of clinical trial
Item
any other disease or clinically significant abnormality in laboratory parameters which, according to the investigator, might compromise the safety of the patient, interfere with participation in the trial or compromise the trial objective
boolean
C0012634 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C1113679 (UMLS CUI [1,3])
C0438215 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
C0012634 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0438215 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2348568 (UMLS CUI [4,3])
C0012634 (UMLS CUI [5,1])
C1444641 (UMLS CUI [5,2])
C2732579 (UMLS CUI [5,3])
C0438215 (UMLS CUI [6,1])
C1444641 (UMLS CUI [6,2])
C2732579 (UMLS CUI [6,3])