Age | Body Weight | Gender
Item
male or female, between 18 and 75 years of age, inclusive. body weight between 50.0 and 120.0 kg, inclusive, if male, and between 40.0 and 110.0 kg, inclusive, if female.
boolean
C0001779 (UMLS CUI [1])
C0005910 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
Rheumatoid Arthritis Disease length | Rheumatoid Arthritis Functional Status Class | Rheumatoid arthritis moderate | Rheumatoid Arthritis Severe
Item
diagnosis of ra, according to the acr/european league against rheumatism (eular) 2010 rheumatoid arthritis classification criteria with ≥ 3 months disease duration, acr class i-iii functional status, based on 1991 revised criteria (appendix b, 5). moderate-to-severely active ra, defined as:
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2,1])
C0598463 (UMLS CUI [2,2])
C0456387 (UMLS CUI [2,3])
C2368567 (UMLS CUI [3])
C0003873 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Measurement of C-reactive protein using high sensitivity technique
Item
o high sensitivity c-reactive protein (hs-crp) ≥ 6 mg/l
boolean
C4040318 (UMLS CUI [1])
Laboratory Results Normal Range
Item
laboratory parameters within the normal range (or defined screening threshold for the investigator site), unless the investigator considers an abnormality to be clinically irrelevant for ra patients; however following lab values must be met:
boolean
C1254595 (UMLS CUI [1,1])
C0086715 (UMLS CUI [1,2])
Hemoglobin measurement
Item
hemoglobin >8.5 g/dl
boolean
C0518015 (UMLS CUI [1])
White Blood Cell Count procedure
Item
white blood cells >3000/mm3
boolean
C0023508 (UMLS CUI [1])
Neutrophil count
Item
neutrophils >2000/mm3
boolean
C0200633 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count >150 000 cells/mm3
boolean
C0032181 (UMLS CUI [1])
Comorbidity Adverse effects Study Subject Participation Status
Item
prior or current significant concomitant illness(es) that, according to investigator's judgment, would adversely affect the patient's participation in the study.
boolean
C0009488 (UMLS CUI [1,1])
C0879626 (UMLS CUI [1,2])
C2348568 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods Absent | Childbearing Potential Pregnancy Tests Unwilling | Childbearing Potential Pregnancy Tests Unable
Item
women of childbearing potential not protected by highly-effective contraceptive method(s) of birth control (as defined in the informed consent form), and/or who are unwilling or unable to be tested for pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0032976 (UMLS CUI [2,2])
C0558080 (UMLS CUI [2,3])
C3831118 (UMLS CUI [3,1])
C0032976 (UMLS CUI [3,2])
C1299582 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational New Drugs | Therapy, Investigational
Item
participation in any clinical research study that evaluated an investigational drug or therapy within 5 half-lives or 60 days of the screening, whichever is longer.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0949266 (UMLS CUI [3])
Tuberculosis | Therapeutic procedure Incomplete Tuberculosis | Chronic infectious disease | Communicable Disease | Arthropathy Autoimmune | Inflammatory joint disease Systemic | Arthropathy Localized | Exception Rheumatoid Arthritis
Item
patients with active tb or a history of incompletely treated tb. history of chronic infection or active infection. history of, or current, autoimmune or inflammatory systemic or localized joint disease(s) other than ra.
boolean
C0041296 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205257 (UMLS CUI [2,2])
C0041296 (UMLS CUI [2,3])
C0151317 (UMLS CUI [3])
C0009450 (UMLS CUI [4])
C0022408 (UMLS CUI [5,1])
C0004364 (UMLS CUI [5,2])
C0683381 (UMLS CUI [6,1])
C0205373 (UMLS CUI [6,2])
C0022408 (UMLS CUI [7,1])
C0392752 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0003873 (UMLS CUI [8,2])
Systemic allergic reaction Biological agents | Exception Allergic Reaction Injection site Localized
Item
a systemic hypersensitivity reaction, other than localized injection site reaction, to any biologic drug.
boolean
C1736167 (UMLS CUI [1,1])
C0005515 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C1527304 (UMLS CUI [2,2])
C2700396 (UMLS CUI [2,3])
C0392752 (UMLS CUI [2,4])
Substance Use Disorders | Interstitial Lung Disease High Resolution Computed Tomography | Interstitial Lung Disease Biopsy of lung | With consistency Pulmonary function tests | With consistency Clinical findings
Item
history or presence of drug or alcohol abuse. prior or current interstitial lung disease diagnosed by high resolution computed tomography and/or lung biopsy with consistent findings on pulmonary function tests and corroborating clinical findings.
boolean
C0038586 (UMLS CUI [1])
C0206062 (UMLS CUI [2,1])
C1512457 (UMLS CUI [2,2])
C0206062 (UMLS CUI [3,1])
C0189485 (UMLS CUI [3,2])
C0522508 (UMLS CUI [4,1])
C0024119 (UMLS CUI [4,2])
C0522508 (UMLS CUI [5,1])
C0037088 (UMLS CUI [5,2])
Malignant Neoplasms | Lymphoproliferative Disorders | Exception Carcinoma in situ of uterine cervix Treated | Exception Squamous cell carcinoma of skin nonmetastatic treated | Exception Basal cell carcinoma nonmetastatic treated
Item
prior or current history of malignancy, including lymphoproliferative diseases, other than adequately-treated carcinoma in-situ of the cervix, nonmetastatic squamous cell or basal cell carcinoma of the skin, within 5 years prior to the screening visit.
boolean
C0006826 (UMLS CUI [1])
C0024314 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0553723 (UMLS CUI [4,2])
C1518409 (UMLS CUI [4,3])
C1522326 (UMLS CUI [4,4])
C1705847 (UMLS CUI [5,1])
C0007117 (UMLS CUI [5,2])
C1518409 (UMLS CUI [5,3])
C1522326 (UMLS CUI [5,4])
DIABETES MELLITUS NOS UNCONTROLLED | Hemoglobin A1c measurement
Item
uncontrolled diabetes mellitus, defined as glycosylated hemoglobin (hba1c) ≥9% at the screening visit.
boolean
C0743131 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Anti-tumor necrosis factor therapy | Biological treatment | Biological agents Tumor necrosis factor alpha inhibitors Targeting Rheumatoid Arthritis | Medical contraindication Simvastatin | Statins
Item
current treatment with anti-tnf agents or other biologics. current treatment with ra-directed biologic agents with non- tnf-α antagonist. any contra-indications to simvastatin, according to the applicable labeling. current treatment with a statin within 14 days before inclusion.
boolean
C0281481 (UMLS CUI [1])
C1531518 (UMLS CUI [2])
C0005515 (UMLS CUI [3,1])
C3653350 (UMLS CUI [3,2])
C1521840 (UMLS CUI [3,3])
C0003873 (UMLS CUI [3,4])
C1301624 (UMLS CUI [4,1])
C0074554 (UMLS CUI [4,2])
C0360714 (UMLS CUI [5])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])