Outpatients | Age
Item
male and female outpatients between 18 and 75 years of age
boolean
C0029921 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Childbearing Potential | Postmenopausal state | Female Sterilization | Status post total hysterectomy | Barrier Contraception double | Female Condoms | Vaginal Spermicides | Vaginal contraceptive diaphragm
Item
females must be of non-childbearing potential (post-menopausal, surgically sterilized or post hysterectomy) or using a double-barrier method of birth control for the duration of the study. a protocol acceptable method of double barrier method of birth control includes any combination of two or three of the following: condom, spermicidal and diaphragm.
boolean
C3831118 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C2349921 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C0221829 (UMLS CUI [6])
C0087145 (UMLS CUI [7])
C0042241 (UMLS CUI [8])
Rheumatoid Arthritis disease length
Item
documented diagnosis of rheumatoid arthritis of at least six (6) months duration, as defined by the american rheumatism association 1987 revised criteria
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Rheumatoid Arthritis Class Functional
Item
american rheumatism association functional class i, ii, or iii
boolean
C0003873 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C0205245 (UMLS CUI [1,3])
Disease criteria Fulfill
Item
meet the criteria for (active disease) at both screening and baseline visits by achieving all of the criteria below:
boolean
C0012634 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
Painful Joints Quantity | Tender joint count
Item
6 or more painful/tender joints
boolean
C3896992 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0451530 (UMLS CUI [2])
Swollen joint count
Item
6 or more swollen joints
boolean
C0451521 (UMLS CUI [1])
Visual Analog Pain Scale
Item
visual analog scale (vas) for pain of at least 3 (on scale of 1-10, where 1 is mild)
boolean
C0042815 (UMLS CUI [1])
C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
c-reactive protein (crp) greater than or equal to 0.6 mg/dl or esr greater than 25 mm/hr.
boolean
C0201657 (UMLS CUI [1])
C1176468 (UMLS CUI [2])
Therapeutic procedure
Item
prior/current therapy:
boolean
C0087111 (UMLS CUI [1])
Disease-Modifying Antirheumatic Drugs naive | Patient receiving first-time biologic disease modifying anti-rheumatic drug therapy for rheumatoid arthritis | Disease-Modifying Antirheumatic Drugs failed | Biological Factors Against Rheumatoid Arthritis failed | Sulfasalazine | Methotrexate | leflunomide | Minocycline | Hydroxychloroquine | Gold | Cyclosporine | Anti-tumor necrosis factor alpha drug | Interleukin-1 Receptor Antagonist
Item
a. subjects must be either dmard or biological anti-ra agent naive or have failed a dmard/biological ra agent, other than sulfasalazine, and have stopped this dmard/biological one (1) month prior to randomization unless they have a flare in disease activity upon discontinuing dmard/biological therapy as part of this protocol. dmards include but are not limited to methotrexate, leflunomide, minocycline, hydroxychloroquine, gold, cyclosporine, and biologics include anti-tnf and anti-il-1 agents.
boolean
C0242708 (UMLS CUI [1,1])
C0919936 (UMLS CUI [1,2])
C2368600 (UMLS CUI [2])
C0242708 (UMLS CUI [3,1])
C0231175 (UMLS CUI [3,2])
C0005515 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0003873 (UMLS CUI [4,3])
C0231175 (UMLS CUI [4,4])
C0036078 (UMLS CUI [5])
C0025677 (UMLS CUI [6])
C0063041 (UMLS CUI [7])
C0026187 (UMLS CUI [8])
C0020336 (UMLS CUI [9])
C0018026 (UMLS CUI [10])
C0010592 (UMLS CUI [11])
C1562242 (UMLS CUI [12])
C3536785 (UMLS CUI [13])
Non-Steroidal Anti-Inflammatory Agents Dose Stable | Non-Steroidal Anti-Inflammatory Agents Frequency Stable | Flare | Steroids
Item
b. subjects may be taking nsaids, provided the dose and frequency have been stable for 30 days prior to randomization. however if the patient meets the flare criteria they can be enrolled even if they have not fulfilled the criteria of being on a stable dose of nsaids and steroids for 30 days prior to randomization. at the time of flare neither steroids nor nsaids can be increased.
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0003211 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C1517205 (UMLS CUI [3])
C0038317 (UMLS CUI [4])
Steroid therapy Dose Stable | Prednisone Equivalent | intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intramuscular injection | Injection of steroid into joint
Item
c. subjects may be taking corticosteroid therapy equivalent to prednisone less than or equal to 7.5 mg/day. this dose must be stable for at least 1 month prior to randomization. subjects may not change the dose of their corticosteroid or receive intra-articular or intra-muscular injections of corticosteroids, within 1 month of randomization or during the study. note section 9.3 of the protocol, concomitant medication, has been amended to read: if it is medically necessary a one joint steroid injection is acceptable. this must be noted on the crf and the joint excluded from the joint count.
boolean
C0149783 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C2064783 (UMLS CUI [3])
C0001617 (UMLS CUI [4,1])
C0021492 (UMLS CUI [4,2])
C0394848 (UMLS CUI [5])
Pharmaceutical Preparations Additional Rheumatoid Arthritis | Pharmaceutical Preparations Alternative Rheumatoid Arthritis
Item
d. subjects may not be taking other complementary and/or alternative medications for ra for the last 1-month prior to randomization.
boolean
C0013227 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0003873 (UMLS CUI [1,3])
C0013227 (UMLS CUI [2,1])
C1523987 (UMLS CUI [2,2])
C0003873 (UMLS CUI [2,3])
Informed Consent
Item
subjects must provide written informed consent prior to any study-related screening tests.
boolean
C0021430 (UMLS CUI [1])
Rheumatoid Arthritis disease length
Item
subjects with ra for less than six months duration, or onset before age 16 (jra)
boolean
C0003873 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
nervous system disorder Clinical Significance Uncontrolled | Hematological Disease | Kidney Diseases | Liver diseases | Endocrine System Diseases | Lung diseases | Cardiovascular Diseases
Item
clinically significant, uncontrolled concurrent neurological, hematological, renal, hepatic, endocrine, pulmonary, or cardiovascular disease
boolean
C0027765 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
C0018939 (UMLS CUI [2])
C0022658 (UMLS CUI [3])
C0023895 (UMLS CUI [4])
C0014130 (UMLS CUI [5])
C0024115 (UMLS CUI [6])
C0007222 (UMLS CUI [7])
Cardiovascular Disease Evidence Electrocardiogram
Item
subjects with evidence of an active clinically important cardiovascular disease as evidenced by an ecg at screening
boolean
C0007222 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0013798 (UMLS CUI [1,3])
Investigational New Drugs
Item
concomitant therapy or therapy within the last 30 days with another investigational drug
boolean
C0013230 (UMLS CUI [1])
Laboratory test result abnormal
Item
subjects with screening laboratory values that deviate from the upper or lower limits of normal by greater that the percentages listed below:
boolean
C0438215 (UMLS CUI [1])
Liver Function Tests | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
liver function tests: total bilirubin above the upper limit of normal (uln). ast, alt, 1.5 x greater than uln
boolean
C0023901 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Hematology procedure | White Blood Cell Count procedure | Hemoglobin measurement | Hematocrit procedure | Platelet Count measurement
Item
hematology: total white blood count (wbc) less than 3500mm3. hemoglobin and hematocrit less than 10 g/dl or 30%, unless stable for at least 3 months), and platelet count less than 100k or greater than 750 k.
boolean
C0200627 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
C0018935 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
Kidney Function Tests | Blood urea nitrogen measurement | Creatinine measurement, serum
Item
renal function tests: bun or creatinine greater than 1.2 x above the uln
boolean
C0022662 (UMLS CUI [1])
C0005845 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
Urinalysis | Urine dipstick test | Proteinuria | Hematuria | White Blood Cell Count procedure
Item
urinalysis: on dipstick - proteinuria / hematuria / leukocytes greater than trace.
boolean
C0042014 (UMLS CUI [1])
C0430370 (UMLS CUI [2])
C0033687 (UMLS CUI [3])
C0018965 (UMLS CUI [4])
C0023508 (UMLS CUI [5])
Chronic Hepatitis B Evidence Serological | Hepatitis B surface antigen positive | Chronic Hepatitis C Evidence Serological | Hepatitis C antibody positive | HIV Seropositivity
Item
subjects with serological evidence of chronic hepatitis b (positive hbsag) or hepatitis c (positive c ab), hiv
boolean
C0524909 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0205473 (UMLS CUI [1,3])
C0149709 (UMLS CUI [2])
C0524910 (UMLS CUI [3,1])
C3887511 (UMLS CUI [3,2])
C0205473 (UMLS CUI [3,3])
C0281863 (UMLS CUI [4])
C0019699 (UMLS CUI [5])
Peptic Ulcer | Gastrointestinal Hemorrhage | Intestinal Disease Interferes with drug absorption
Item
subjects with evidence of active peptic ulcer disease or who have a reliable positive history of gastrointestinal bleeding within the past five (5) years. any recurrent or history of an intestinal disorder that may interfere with the proper absorption of the drug
boolean
C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])
C0021831 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0678745 (UMLS CUI [3,3])
Pregnancy | Breast Feeding
Item
pregnant women or nursing mothers
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Blood Donation Planned | Blood product Donation Planned
Item
subjects who plan to donate blood or blood products during the study or within 30 days following the last study visit.
boolean
C0005794 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0456388 (UMLS CUI [2,1])
C0080231 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
Screening Repeat criteria Fulfill
Item
one re-screening to meet criterion 6.1.5 will be allowed. multiple screenings, beyond one for failure to meet criterion 6.1.5 are not allowed (at either screening or baseline).
boolean
C1710477 (UMLS CUI [1,1])
C0205341 (UMLS CUI [1,2])
C0243161 (UMLS CUI [1,3])
C1550543 (UMLS CUI [1,4])
Substance Use Disorders
Item
abuse of alcohol or drugs. the subject should not consume more than 2 units of alcohol per day. (a unit of alcohol is considered: 12 oz of beer, 6 oz of wine or 1 oz of spirits). this is on a per day basis and not the average for the week.
boolean
C0038586 (UMLS CUI [1])
Allergy to sulfonamides
Item
subjects with a sulfonamide allergy
boolean
C0038757 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase
Item
subjects who have known g6pd deficiency
boolean
C2939465 (UMLS CUI [1])
Protocol Compliance Unwilling | Protocol Compliance Unable
Item
subjects who are unable or unwilling to follow the protocol
boolean
C0525058 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Major injury | major surgery | Communicable Disease Serious
Item
recent major trauma or major surgery or serious infection
boolean
C0332677 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
C0009450 (UMLS CUI [3,1])
C0205404 (UMLS CUI [3,2])
Study Subject Participation Status Subject dropped out
Item
subjects who started but left, or were dropped out of this study, for any reason (subjects who left or are dropped will not be replaced).
boolean
C2348568 (UMLS CUI [1,1])
C1710677 (UMLS CUI [1,2])