Rheumatoid Arthritis disease length
Item
1. rheumatoid arthritis satisfying year american college of rheumatology (acr) diagnostic criteria with a disease history of at least one year.
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age | Informed Consent
Item
2. male or female greater than or equal to 18 years of age at time of informed consent.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Rheumatoid Arthritis
Item
3. active ra as defined by:
boolean
C0003873 (UMLS CUI [1])
Swollen joint count
Item
greater than or equal to swollen joints (66-joint count),
boolean
C0451521 (UMLS CUI [1])
Tender joint count
Item
greater than or equal to tender joints (68-joint count), and
boolean
C0451530 (UMLS CUI [1])
C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
crp greater than or equal to 10 mg/l (central laboratory) and/or esr greater than or equal to 28mm/h.
boolean
C0201657 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Tumor Necrosis Factor-alpha Antagonists Quantity failed
Item
4. failure of at least one tnfa antagonist therapy (previously or at the time of screening)
boolean
C1456820 (UMLS CUI [1,1])
C0243076 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0231175 (UMLS CUI [1,4])
Condition At risk Study Subject Participation Status | Laboratory Results At risk Study Subject Participation Status | Medical History At risk Study Subject Participation Status | Medical contraindication Study Subject Participation Status | Condition Interferes with Study Protocol | Condition Interferes with Evaluation
Item
1. any condition, including laboratory findings or findings in the medical history or pre-trial assessments, that in the opinion of the investigator constitutes a risk or a contraindication for the subject's participation in the trial or that could interfere with the trial objectives, conduct or evaluation.
boolean
C0348080 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
C1254595 (UMLS CUI [2,1])
C1444641 (UMLS CUI [2,2])
C2348568 (UMLS CUI [2,3])
C0262926 (UMLS CUI [3,1])
C1444641 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C1301624 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C0348080 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C2348563 (UMLS CUI [5,3])
C0348080 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C1261322 (UMLS CUI [6,3])
Biological treatment targeting B-Lymphocytes Modulation | rituximab | Rituxan | Antineoplastic Agents | Pharmaceutical Preparations Against Arthritis | belimumab
Item
2. treatment with biologics aiming at b cell modulation such as rituximab (also called rituxan), a cancer and arthritis drug) or belimumab within 2 years before sd 1.
boolean
C1531518 (UMLS CUI [1,1])
C0599894 (UMLS CUI [1,2])
C0004561 (UMLS CUI [1,3])
C0544633 (UMLS CUI [1,4])
C0393022 (UMLS CUI [2])
C0732355 (UMLS CUI [3])
C0003392 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0521124 (UMLS CUI [5,2])
C0003864 (UMLS CUI [5,3])
C1723401 (UMLS CUI [6])
anakinra | Kineret | abatacept | Orencia | tocilizumab
Item
3. any previous treatment with anakinra (kineret), abatacept (orencia) or tocilizumab within 3 months before sd1.
boolean
C0245109 (UMLS CUI [1])
C1170364 (UMLS CUI [2])
C1619966 (UMLS CUI [3])
C1700021 (UMLS CUI [4])
C1609165 (UMLS CUI [5])
Etanercept | Enbrel | infliximab | Remicade | adalimumab | Humira
Item
4. use of etanercept (enbrel) within 28 days before sd 1, or of infliximab (remicade) or adalimumab (humira) within 60 days before sd 1.
boolean
C0717758 (UMLS CUI [1])
C0720193 (UMLS CUI [2])
C0666743 (UMLS CUI [3])
C0723012 (UMLS CUI [4])
C1122087 (UMLS CUI [5])
C1171255 (UMLS CUI [6])
Study Subject Participation Status | Therapy, Investigational
Item
5. participation in any interventional clinical trial with an unapproved investigational therapy within the 3 months before the start of this study (or within 5 half-lives of the investigated compound before study day 1, whichever is longer).
boolean
C2348568 (UMLS CUI [1])
C0949266 (UMLS CUI [2])
Children
Item
children are necessarily excluded from this study.
boolean
C0008059 (UMLS CUI [1])