Informed Consent
Item
patients must give written informed consent by signing an irb/ec-approved informed consent form (icf) prior to admission to this study.
boolean
C0021430 (UMLS CUI [1])
Age | Rheumatoid Arthritis Duration
Item
males and females, 18 years of age or older, with active ra for at least 6 months prior to day 1 dosing.
boolean
C0001779 (UMLS CUI [1])
C0003873 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
Methotrexate Dose Stable U/week
Item
patients must have been receiving weekly methotrexate doses (7.5-25 mg/week) for a minimum of 3 months prior to day 1 dosing and must be receiving a stable mtx dose, with no change in route, for the previous 6 weeks prior to day 1 dosing.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
Folic acid supplementation Dose Stable | Folinic acid Supplementation Dose Stable
Item
`patients must be receiving a folic or folinic acid supplementation at a stable dose for at least 6 weeks prior to day 1 dosing.
boolean
C0556110 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0023413 (UMLS CUI [2,1])
C0242297 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0205360 (UMLS CUI [2,4])
Childbearing Potential Informed R788 compound | Childbearing Potential Sexually active Contraceptive methods | Contraceptives, Oral | Contraception, Barrier | Hormonal contraception Active Long-term | Childbearing Potential Breast Feeding Absent | Childbearing Potential Urine pregnancy test negative
Item
females of childbearing potential must be fully informed of the potential for r788 to adversely affect the fetus and, if sexually active, must agree to use a well established method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). these patients must not be lactating and must have a negative urine pregnancy test at the time of randomization and at each laboratory determination.
boolean
C3831118 (UMLS CUI [1,1])
C1522154 (UMLS CUI [1,2])
C2002836 (UMLS CUI [1,3])
C3831118 (UMLS CUI [2,1])
C0241028 (UMLS CUI [2,2])
C0700589 (UMLS CUI [2,3])
C0009905 (UMLS CUI [3])
C0004764 (UMLS CUI [4])
C2985296 (UMLS CUI [5,1])
C0205177 (UMLS CUI [5,2])
C0443252 (UMLS CUI [5,3])
C3831118 (UMLS CUI [6,1])
C0006147 (UMLS CUI [6,2])
C0332197 (UMLS CUI [6,3])
C3831118 (UMLS CUI [7,1])
C0430057 (UMLS CUI [7,2])
General health good Medical History | General health good Physical Examination | General health good Laboratory test
Item
the patient must otherwise be in good health as determined by the investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. see exclusion criteria for specific exclusions.
boolean
C1277245 (UMLS CUI [1,1])
C0262926 (UMLS CUI [1,2])
C1277245 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
C1277245 (UMLS CUI [3,1])
C0022885 (UMLS CUI [3,2])
Comprehension Study Protocol | Able to communicate Research Personnel | Protocol Compliance
Item
in the investigator's opinion, the patient has the ability to understand the nature of the study and any hazards of participation, and to communicate satisfactorily with the investigator and to participate in, and to comply with, the requirements of the entire protocol.
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
C2364293 (UMLS CUI [2,1])
C0035173 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Illness Affecting Completion of clinical trial | Medical condition Affecting Completion of clinical trial | Laboratory test result abnormal Affecting Completion of clinical trial
Item
the patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study. specifically, excluded are patients with the following:
boolean
C0221423 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])
C3843040 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C2732579 (UMLS CUI [2,3])
C0438215 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C2732579 (UMLS CUI [3,3])
Uncontrolled hypertension | Poor hypertension control
Item
1. uncontrolled or poorly controlled hypertension;
boolean
C1868885 (UMLS CUI [1])
C0421190 (UMLS CUI [2])
Autoimmune Disease | Arthritis, Psoriatic | Lupus Erythematosus | Mixed Connective Tissue Disease | Arthritis Syndrome | Gout | Lyme Disease | Reiter Syndrome
Item
2. other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, lyme disease, reiter's syndrome);
boolean
C0004364 (UMLS CUI [1])
C0003872 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C0026272 (UMLS CUI [4])
C0003864 (UMLS CUI [5,1])
C0039082 (UMLS CUI [5,2])
C0018099 (UMLS CUI [6])
C0024198 (UMLS CUI [7])
C0035012 (UMLS CUI [8])
Operative Surgical Procedures Serious | Communicable Disease Serious
Item
3. recent (within past 2 months prior to day 1 dosing) serious surgery or infectious disease;
boolean
C0543467 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Malignant Neoplasms | Cancer treatment | Exception Skin carcinoma | Lymphoma
Item
4. recent history (past 5 years prior to day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma;
boolean
C0006826 (UMLS CUI [1])
C0920425 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C0024299 (UMLS CUI [4])
Hepatitis B
Item
5. hepatitis b ;
boolean
C0019163 (UMLS CUI [1])
Hepatitis C
Item
6. hepatitis c ;
boolean
C0019196 (UMLS CUI [1])
Interstitial Pneumonia Chest X-ray | Infectious disease of lung Chest X-ray
Item
7. interstitial pneumonitis or active pulmonary infection on chest x-ray;
boolean
C0206061 (UMLS CUI [1,1])
C0039985 (UMLS CUI [1,2])
C0876973 (UMLS CUI [2,1])
C0039985 (UMLS CUI [2,2])
Tuberculosis | Tuberculosis Skin Test Negative
Item
8. tuberculosis (tb): the tb skin test should be negative.
boolean
C0041296 (UMLS CUI [1])
C3282342 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
Laboratory test result abnormal
Item
9. known laboratory abnormalities.
boolean
C0438215 (UMLS CUI [1])
Substance Use Disorders | Drug Dependence | Alcoholic Intoxication, Chronic | Alcohol consumption U/week | Beer Alcohol units | Wine Alcohol units | Dessert wine Alcohol units | Distilled spirits Alcohol units
Item
the patient has a history of substance abuse, drug addiction or alcoholism. patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. patients who cannot reliably comply with this should be excluded. a unit of alcohol is defined as the following: beer=12 oz or 355 ml; wine = 5 oz or 148 ml; sweet dessert wine=3 oz or 89 ml; 80 proof distilled spirits= 1.5 oz or 44 ml.
boolean
C0038586 (UMLS CUI [1])
C1510472 (UMLS CUI [2])
C0001973 (UMLS CUI [3])
C0001948 (UMLS CUI [4,1])
C0560588 (UMLS CUI [4,2])
C0004922 (UMLS CUI [5,1])
C0556604 (UMLS CUI [5,2])
C0043188 (UMLS CUI [6,1])
C0556604 (UMLS CUI [6,2])
C0454276 (UMLS CUI [7,1])
C0556604 (UMLS CUI [7,2])
C0301611 (UMLS CUI [8,1])
C0556604 (UMLS CUI [8,2])
Study Subject Participation Status | R788 compound
Item
the patient has been treated previously treated with r788 under a different protocol.
boolean
C2348568 (UMLS CUI [1])
C2002836 (UMLS CUI [2])