Age
Item
1. age greater than or equal to 18 (reached 18th birthday or later) at the time of the first dose of study drug
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
2. written informed consent obtained from the patient
boolean
C0021430 (UMLS CUI [1])
Gender Sexually active | Female Sterilization | Postmenopausal Duration | Contraceptive methods | Contraceptives, Oral | transdermal patch as birth control method | Injectable contraception | Contraceptive implant | Intrauterine Devices | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | CERVICAL CAP FOR CONTRACEPTIVE USE | Sexual Abstinence | Sexual Partner Condom | Sexual Partner sterile
Item
3. sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, transdermal, injectable, or implanted contraceptives, iud, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 21 days prior to the first dose of study drug, and must agree to continue using such precautions through 3 months after their last dose of study drug. cessation of birth control after this point should be discussed with a responsible physician.
boolean
C0079399 (UMLS CUI [1,1])
C0241028 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C0700589 (UMLS CUI [4])
C0009905 (UMLS CUI [5])
C2135981 (UMLS CUI [6])
C1262153 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C0021900 (UMLS CUI [9])
C0221829 (UMLS CUI [10])
C0042241 (UMLS CUI [11])
C0087145 (UMLS CUI [12])
C0493327 (UMLS CUI [13])
C0036899 (UMLS CUI [14])
C0036911 (UMLS CUI [15,1])
C0677582 (UMLS CUI [15,2])
C0036911 (UMLS CUI [16,1])
C0021359 (UMLS CUI [16,2])
Rheumatoid Arthritis | Swollen joint Quantity | Tender joint Quantity | Hand Involvement with | Wrist Involvement with | Elbow Involvement with | Knee Involvement with | Ankle Involvement with | Foot Involvement with | C-reactive protein measurement | Erythrocyte sedimentation rate measurement
Item
4. a diagnosis of ra as defined by american college of rheumatology (acr) criteria, which is currently active, as defined by the presence of at least 6 swollen and 6 tender joints involving the hands, wrists, elbows, knees, ankles, or feet and a crp and/or esr>upper limits of normal (uln).
boolean
C0003873 (UMLS CUI [1])
C0152031 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0240094 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])
C0018563 (UMLS CUI [4,1])
C1314939 (UMLS CUI [4,2])
C0043262 (UMLS CUI [5,1])
C1314939 (UMLS CUI [5,2])
C0013769 (UMLS CUI [6,1])
C1314939 (UMLS CUI [6,2])
C0022742 (UMLS CUI [7,1])
C1314939 (UMLS CUI [7,2])
C0003086 (UMLS CUI [8,1])
C1314939 (UMLS CUI [8,2])
C0016504 (UMLS CUI [9,1])
C1314939 (UMLS CUI [9,2])
C0201657 (UMLS CUI [10])
C1176468 (UMLS CUI [11])
Methotrexate Dose Stable | Methotrexate Frequency Stable | Hydroxychloroquine | Sulfasalazine | Anti-Inflammatory Agents, Non-Steroidal | Cyclooxygenase 2 Inhibitors | Prednisone | Analgesics | Acetaminophen | Talwin | Propoxyphene | tramadol hydrochloride | Codeine | Hydrocodone | Oxycontin
Item
5. treatment with a stable dose level and frequency of methotrexate for at least 8 weeks prior to study randomization. the patients may also be taking hydroxychloroquine and/or sulfasalazine concurrently with methotrexate. these drugs must also be at stable dose levels and frequencies for at least 8 weeks prior to randomization. patients currently receiving treatment with stable doses of nonsteroidal anti-inflammatory drugs (nsaids), including cox-2 inhibitors, or prednisone (less than or equal to 10 mg/day) will be permitted to continue these medications. analgesics, including acetaminophen, talwin, propoxyphene, tramadol hydrochloride, codeine or codeine with acetaminophen, hydrocodone, oxycontin, and related medications, will also be permitted. all of these drugs must be at stable dose levels and frequencies for at least 4 weeks prior to study randomization.
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0025677 (UMLS CUI [2,1])
C0376249 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0020336 (UMLS CUI [3])
C0036078 (UMLS CUI [4])
C0003211 (UMLS CUI [5])
C1257954 (UMLS CUI [6])
C0032952 (UMLS CUI [7])
C0002771 (UMLS CUI [8])
C0000970 (UMLS CUI [9])
C0030875 (UMLS CUI [10])
C0033493 (UMLS CUI [11])
C2350089 (UMLS CUI [12])
C0009214 (UMLS CUI [13])
C0020264 (UMLS CUI [14])
C0722364 (UMLS CUI [15])
White Blood Cell Count procedure | Platelet Count measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Blood urea nitrogen measurement | Creatinine measurement, serum | Fecal occult blood: negative | Thyroxine measurement | Increased thyroxine level | Free thyroxin Normal | Thyroid stimulating hormone measurement
Item
6. prior to randomization (must be within 21 days of the first administration of the study drug), all of the following: wbc ≥ 3,800/mm³; platelet count ≥140,000/mm³; ast, alt, bun, or creatinine<1.5 x uln; stool negative for occult blood; and thyroxine (t4) within normal limits. (patients with an elevated t4 but with both free t4 and tsh levels within normal limits may be eligible after review by the medimmune medical monitor.)
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0005845 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0474537 (UMLS CUI [7])
C0202231 (UMLS CUI [8])
C1295665 (UMLS CUI [9])
C0312452 (UMLS CUI [10,1])
C0205307 (UMLS CUI [10,2])
C0202230 (UMLS CUI [11])
Investigational Therapies Willing
Item
7. willing to forego other forms of experimental treatment during study through study day 364
boolean
C0949266 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
Assessment Questionnaire Completion Willing
Item
8. able and willing to complete assessment questionnaires.
boolean
C2984042 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C0600109 (UMLS CUI [1,3])
Study Subject Participation Status Willing
Item
9. willing to participate in study through study day 413.
boolean
C2348568 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
criteria Fulfill
Item
patients must have none of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Rheumatoid Arthritis Severe | Therapeutic procedure Alternative Patient need for
Item
1. severe active ra, which in the opinion of the investigator currently requires an alternative form of therapy
boolean
C0003873 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C1523987 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
Acute illness
Item
2. acute illness at the start of the study
boolean
C4061114 (UMLS CUI [1])
Communicable Disease Significant | Fever
Item
3. evidence of significant active infection, such as fever greater than or equal to 38.0°c (100.5°f)
boolean
C0009450 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0015967 (UMLS CUI [2])
HIV Infections | Immunologic Deficiency Syndromes Clinical Significance
Item
4. known or suspected infection with human immunodeficiency virus (hiv) or other evidence of clinically significant immune deficiencies
boolean
C0019693 (UMLS CUI [1])
C0021051 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
Hepatitis B Evidence of | Hepatitis C Evidence of | Hepatitis B surface antigen positive | Hepatitis C antibody positive
Item
5. evidence of active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection, such as positive hbsag or positive anti-hepatitis c antibody
boolean
C0019163 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C0019196 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C0149709 (UMLS CUI [3])
C0281863 (UMLS CUI [4])
Insulin-Dependent Diabetes Mellitus Onset Recent | Insulin-Dependent Diabetes Mellitus Unstable
Item
6. insulin-dependent diabetes mellitus that is recent-onset or unstable
boolean
C0011854 (UMLS CUI [1,1])
C0332162 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0011854 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
Tuberculosis Evidence of | Latent Tuberculosis Evidence of | PPD skin test positive | Induration | ISONIAZID TREATMENT PROPHYLAXIS Tuberculosis | chest X-ray Consistent with Tuberculosis | Household Contact Patient Tuberculosis
Item
7. evidence of active or latent tuberculosis, which may include a positive ppd skin test result (greater than or equal to 10 mm induration), unless appropriate inh prophylaxis for tuberculosis previously given; a chest x-ray possibly consistent with tuberculosis; or household contact with a patient with active tuberculosis
boolean
C0041296 (UMLS CUI [1,1])
C0332120 (UMLS CUI [1,2])
C1609538 (UMLS CUI [2,1])
C0332120 (UMLS CUI [2,2])
C1699735 (UMLS CUI [3])
C0332534 (UMLS CUI [4])
C0745422 (UMLS CUI [5,1])
C0041296 (UMLS CUI [5,2])
C0039985 (UMLS CUI [6,1])
C0332290 (UMLS CUI [6,2])
C0041296 (UMLS CUI [6,3])
C3640861 (UMLS CUI [7,1])
C0030705 (UMLS CUI [7,2])
C0041296 (UMLS CUI [7,3])
Chronic infectious disease Clinical Significance | Recurrent infections Quantity Requirement Antibiotics | Communicable Disease Requirement Antibiotics for systemic use
Item
8. a medical history or evidence of clinically important chronic infection, recurrent (3 or more) infections in the past 6 months requiring antibiotics, or an infection in the past month requiring systemic antibiotics
boolean
C0151317 (UMLS CUI [1,1])
C2826293 (UMLS CUI [1,2])
C0239998 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C1514873 (UMLS CUI [2,3])
C0003232 (UMLS CUI [2,4])
C0009450 (UMLS CUI [3,1])
C1514873 (UMLS CUI [3,2])
C3540704 (UMLS CUI [3,3])
Investigational New Drugs | MEDI-522
Item
9. receipt of any investigational drug therapy, except medi-522, within 3 months prior to study randomization (use of licensed agents for indications not listed in the package insert is permitted)
boolean
C0013230 (UMLS CUI [1])
C1135124 (UMLS CUI [2])
Anti-tumor necrosis factor alpha drug | Etanercept | infliximab | adalimumab
Item
10. current or any past therapy with anti-tnf biologic antagonists including etanercept, infliximab, and adalimumab
boolean
C1562242 (UMLS CUI [1])
C0717758 (UMLS CUI [2])
C0666743 (UMLS CUI [3])
C1122087 (UMLS CUI [4])
Cyclosporine | leflunomide | Cyclophosphamide | Azathioprine | Gold salt | Penicillamine | mycophenolate mofetil | Minocycline | anakinra
Item
11. current therapy with cyclosporin a, leflunomide, cyclophosphamide, azathioprine, gold salts, d-penicillamine, mycophenylate mofetil, minocycline or anakinra. these drugs must have been discontinued at least 4 weeks prior to study randomization.
boolean
C0010592 (UMLS CUI [1])
C0063041 (UMLS CUI [2])
C0010583 (UMLS CUI [3])
C0004482 (UMLS CUI [4])
C0302210 (UMLS CUI [5])
C0030817 (UMLS CUI [6])
C0209368 (UMLS CUI [7])
C0026187 (UMLS CUI [8])
C0245109 (UMLS CUI [9])
Prednisone Oral U/day | Prednisone Equivalent | intraarticular injection of corticosteroids | Periarticular injection Adrenal Cortex Hormones | Parenteral injection Adrenal Cortex Hormones
Item
12. prednisone or equivalent at >10 mg per day orally in the 8 weeks before study randomization. intraarticular, periarticular, or other forms of parenteral injection of corticosteroids are also not permitted in the 8 weeks prior to study randomization.
boolean
C0032952 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C0456683 (UMLS CUI [1,3])
C0032952 (UMLS CUI [2,1])
C0205163 (UMLS CUI [2,2])
C2064783 (UMLS CUI [3])
C0394854 (UMLS CUI [4,1])
C0001617 (UMLS CUI [4,2])
C1555373 (UMLS CUI [5,1])
C0001617 (UMLS CUI [5,2])
Hypersensitivity Exacerbated MEDI-522 Component | Allergic Reaction Exacerbated MEDI-522 Component
Item
13. history of allergic disease or reactions likely to be exacerbated by any component of medi-522
boolean
C0020517 (UMLS CUI [1,1])
C1444749 (UMLS CUI [1,2])
C1135124 (UMLS CUI [1,3])
C1705248 (UMLS CUI [1,4])
C1527304 (UMLS CUI [2,1])
C1444749 (UMLS CUI [2,2])
C1135124 (UMLS CUI [2,3])
C1705248 (UMLS CUI [2,4])
Gastrointestinal Hemorrhage | Fecal occult blood: positive | Hemorrhage
Item
14. history of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months
boolean
C0017181 (UMLS CUI [1])
C0266813 (UMLS CUI [2])
C0019080 (UMLS CUI [3])
Blood Coagulation Disorders | Bleeding tendency Clinical Significance High risk | Anticoagulant therapy cause | Warfarin | Heparin
Item
15. known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin
boolean
C0005779 (UMLS CUI [1])
C1458140 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0332167 (UMLS CUI [2,3])
C0150457 (UMLS CUI [3,1])
C0015127 (UMLS CUI [3,2])
C0043031 (UMLS CUI [4])
C0019134 (UMLS CUI [5])
Elective Surgical Procedure Planned
Item
16. elective surgery planned during the study period through study day 413
boolean
C0206058 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Cardiovascular Disease Unstable | Angina Pectoris Onset Recent | Angina Pectoris Frequency Increasing | Angina Pectoris Severity Increasing | Myocardial Infarction | Operative Surgical Procedure Correction Definitive | Coronary Artery Bypass Surgery | Angioplasty
Item
17. cardiovascular disease that is unstable, such as recent-onset angina, or angina with increasing frequency or severity, or recent myocardial infarction (within past 1 year without definitive corrective surgery such as coronary bypass graft or angioplasty)
boolean
C0007222 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C0332162 (UMLS CUI [2,2])
C0332185 (UMLS CUI [2,3])
C0002962 (UMLS CUI [3,1])
C0376249 (UMLS CUI [3,2])
C0442808 (UMLS CUI [3,3])
C0002962 (UMLS CUI [4,1])
C0439793 (UMLS CUI [4,2])
C0442808 (UMLS CUI [4,3])
C0027051 (UMLS CUI [5])
C0543467 (UMLS CUI [6,1])
C1947976 (UMLS CUI [6,2])
C0443196 (UMLS CUI [6,3])
C0010055 (UMLS CUI [7])
C0162577 (UMLS CUI [8])
nervous system disorder | Multiple Sclerosis | Cerebrovascular accident | Cerebrovascular Disorder Clinical Significance | Organic brain disorder Clinical Significance
Item
18. neurological disease, such as multiple sclerosis, previous stroke, clinically significant cerebrovascular disease, or other forms of organic brain disease that is clinically significant
boolean
C0027765 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007820 (UMLS CUI [4,1])
C2826293 (UMLS CUI [4,2])
C4062280 (UMLS CUI [5,1])
C2826293 (UMLS CUI [5,2])
Lung diseases Unstable Progressive | Lung diseases Severe Clinical | Liver diseases Unstable Progressive | Liver diseases Severe Clinical | Kidney Diseases Unstable Progressive | Kidney Diseases Severe Clinical | Hematological Disease Unstable Progressive | Hematological Disease Severe Clinical
Item
19. pulmonary, hepatic, renal, or hematological disease that is unstable and progressive, or clinically severe
boolean
C0024115 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0205329 (UMLS CUI [1,3])
C0024115 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0205210 (UMLS CUI [2,3])
C0023895 (UMLS CUI [3,1])
C0443343 (UMLS CUI [3,2])
C0205329 (UMLS CUI [3,3])
C0023895 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C0205210 (UMLS CUI [4,3])
C0022658 (UMLS CUI [5,1])
C0443343 (UMLS CUI [5,2])
C0205329 (UMLS CUI [5,3])
C0022658 (UMLS CUI [6,1])
C0205082 (UMLS CUI [6,2])
C0205210 (UMLS CUI [6,3])
C0018939 (UMLS CUI [7,1])
C0443343 (UMLS CUI [7,2])
C0205329 (UMLS CUI [7,3])
C0018939 (UMLS CUI [8,1])
C0205082 (UMLS CUI [8,2])
C0205210 (UMLS CUI [8,3])
Pregnancy | Gender Urine pregnancy test negative | Postmenopausal state | Female Sterilization
Item
20. pregnancy (all females, unless surgically sterile or at least one year post-menopausal, must have a negative urine pregnancy test on study day 0, prior to dosing)
boolean
C0032961 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
C0232970 (UMLS CUI [3])
C0015787 (UMLS CUI [4])
Breast Feeding
Item
21. nursing mother
boolean
C0006147 (UMLS CUI [1])
Substance Use Disorders
Item
22. history of alcohol or drug abuse within past 2 years
boolean
C0038586 (UMLS CUI [1])
Rheumatoid Vasculitis Evidence | Vasculitis Evidence | Physical Examination
Item
23. evidence on physical examination of rheumatoid or other types of vasculitis.
boolean
C0240903 (UMLS CUI [1,1])
C3887511 (UMLS CUI [1,2])
C0042384 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0031809 (UMLS CUI [3])