ID

19167

Description

Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate; ODM derived from: https://clinicaltrials.gov/show/NCT00069017

Link

https://clinicaltrials.gov/show/NCT00069017

Keywords

Versions (1)
  1. 12/9/16 12/9/16 -
Uploaded on

December 9, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Rheumatoid Arthritis NCT00069017

English

Eligibility Rheumatoid Arthritis NCT00069017

1 forms  
Criteria
Description

Criteria

1. age greater than or equal to 18 (reached 18th birthday or later) at the time of the first dose of study drug
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
2. written informed consent obtained from the patient
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0079399
UMLS CUI [1,2]
C0241028
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0449238
UMLS CUI [4]
C0700589
UMLS CUI [5]
C0009905
UMLS CUI [6]
C2135981
UMLS CUI [7]
C1262153
UMLS CUI [8]
C1657106
UMLS CUI [9]
C0021900
UMLS CUI [10]
C0221829
UMLS CUI [11]
C0042241
UMLS CUI [12]
C0087145
UMLS CUI [13]
C0493327
UMLS CUI [14]
C0036899
UMLS CUI [15,1]
C0036911
UMLS CUI [15,2]
C0677582
UMLS CUI [16,1]
C0036911
UMLS CUI [16,2]
C0021359
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).
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0003873
UMLS CUI [2,1]
C0152031
UMLS CUI [2,2]
C1265611
UMLS CUI [3,1]
C0240094
UMLS CUI [3,2]
C1265611
UMLS CUI [4,1]
C0018563
UMLS CUI [4,2]
C1314939
UMLS CUI [5,1]
C0043262
UMLS CUI [5,2]
C1314939
UMLS CUI [6,1]
C0013769
UMLS CUI [6,2]
C1314939
UMLS CUI [7,1]
C0022742
UMLS CUI [7,2]
C1314939
UMLS CUI [8,1]
C0003086
UMLS CUI [8,2]
C1314939
UMLS CUI [9,1]
C0016504
UMLS CUI [9,2]
C1314939
UMLS CUI [10]
C0201657
UMLS CUI [11]
C1176468
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0025677
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0025677
UMLS CUI [2,2]
C0376249
UMLS CUI [2,3]
C0205360
UMLS CUI [3]
C0020336
UMLS CUI [4]
C0036078
UMLS CUI [5]
C0003211
UMLS CUI [6]
C1257954
UMLS CUI [7]
C0032952
UMLS CUI [8]
C0002771
UMLS CUI [9]
C0000970
UMLS CUI [10]
C0030875
UMLS CUI [11]
C0033493
UMLS CUI [12]
C2350089
UMLS CUI [13]
C0009214
UMLS CUI [14]
C0020264
UMLS CUI [15]
C0722364
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.)
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0201899
UMLS CUI [4]
C0201836
UMLS CUI [5]
C0005845
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0474537
UMLS CUI [8]
C0202231
UMLS CUI [9]
C1295665
UMLS CUI [10,1]
C0312452
UMLS CUI [10,2]
C0205307
UMLS CUI [11]
C0202230
7. willing to forego other forms of experimental treatment during study through study day 364
Description

Investigational Therapies Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C0600109
8. able and willing to complete assessment questionnaires.
Description

Assessment Questionnaire Completion Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C2984042
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C0600109
9. willing to participate in study through study day 413.
Description

Study Subject Participation Status Willing

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0600109
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patients must have none of the following:
Description

criteria Fulfill

Data type

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. severe active ra, which in the opinion of the investigator currently requires an alternative form of therapy
Description

Rheumatoid Arthritis Severe | Therapeutic procedure Alternative Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C1523987
UMLS CUI [2,3]
C0686904
2. acute illness at the start of the study
Description

Acute illness

Data type

boolean

Alias
UMLS CUI [1]
C4061114
3. evidence of significant active infection, such as fever greater than or equal to 38.0°c (100.5°f)
Description

Communicable Disease Significant | Fever

Data type

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0750502
UMLS CUI [2]
C0015967
4. known or suspected infection with human immunodeficiency virus (hiv) or other evidence of clinically significant immune deficiencies
Description

HIV Infections | Immunologic Deficiency Syndromes Clinical Significance

Data type

boolean

Alias
UMLS CUI [1]
C0019693
UMLS CUI [2,1]
C0021051
UMLS CUI [2,2]
C2826293
5. evidence of active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection, such as positive hbsag or positive anti-hepatitis c antibody
Description

Hepatitis B Evidence of | Hepatitis C Evidence of | Hepatitis B surface antigen positive | Hepatitis C antibody positive

Data type

boolean

Alias
UMLS CUI [1,1]
C0019163
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C0019196
UMLS CUI [2,2]
C0332120
UMLS CUI [3]
C0149709
UMLS CUI [4]
C0281863
6. insulin-dependent diabetes mellitus that is recent-onset or unstable
Description

Insulin-Dependent Diabetes Mellitus Onset Recent | Insulin-Dependent Diabetes Mellitus Unstable

Data type

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0332162
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0011854
UMLS CUI [2,2]
C0443343
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
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0041296
UMLS CUI [1,2]
C0332120
UMLS CUI [2,1]
C1609538
UMLS CUI [2,2]
C0332120
UMLS CUI [3]
C1699735
UMLS CUI [4]
C0332534
UMLS CUI [5,1]
C0745422
UMLS CUI [5,2]
C0041296
UMLS CUI [6,1]
C0039985
UMLS CUI [6,2]
C0332290
UMLS CUI [6,3]
C0041296
UMLS CUI [7,1]
C3640861
UMLS CUI [7,2]
C0030705
UMLS CUI [7,3]
C0041296
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
Description

Chronic infectious disease Clinical Significance | Recurrent infections Quantity Requirement Antibiotics | Communicable Disease Requirement Antibiotics for systemic use

Data type

boolean

Alias
UMLS CUI [1,1]
C0151317
UMLS CUI [1,2]
C2826293
UMLS CUI [2,1]
C0239998
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C1514873
UMLS CUI [2,4]
C0003232
UMLS CUI [3,1]
C0009450
UMLS CUI [3,2]
C1514873
UMLS CUI [3,3]
C3540704
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)
Description

Investigational New Drugs | MEDI-522

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C1135124
10. current or any past therapy with anti-tnf biologic antagonists including etanercept, infliximab, and adalimumab
Description

Anti-tumor necrosis factor alpha drug | Etanercept | infliximab | adalimumab

Data type

boolean

Alias
UMLS CUI [1]
C1562242
UMLS CUI [2]
C0717758
UMLS CUI [3]
C0666743
UMLS CUI [4]
C1122087
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.
Description

Cyclosporine | leflunomide | Cyclophosphamide | Azathioprine | Gold salt | Penicillamine | mycophenolate mofetil | Minocycline | anakinra

Data type

boolean

Alias
UMLS CUI [1]
C0010592
UMLS CUI [2]
C0063041
UMLS CUI [3]
C0010583
UMLS CUI [4]
C0004482
UMLS CUI [5]
C0302210
UMLS CUI [6]
C0030817
UMLS CUI [7]
C0209368
UMLS CUI [8]
C0026187
UMLS CUI [9]
C0245109
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.
Description

Prednisone Oral U/day | Prednisone Equivalent | intraarticular injection of corticosteroids | Periarticular injection Adrenal Cortex Hormones | Parenteral injection Adrenal Cortex Hormones

Data type

boolean

Alias
UMLS CUI [1,1]
C0032952
UMLS CUI [1,2]
C1527415
UMLS CUI [1,3]
C0456683
UMLS CUI [2,1]
C0032952
UMLS CUI [2,2]
C0205163
UMLS CUI [3]
C2064783
UMLS CUI [4,1]
C0394854
UMLS CUI [4,2]
C0001617
UMLS CUI [5,1]
C1555373
UMLS CUI [5,2]
C0001617
13. history of allergic disease or reactions likely to be exacerbated by any component of medi-522
Description

Hypersensitivity Exacerbated MEDI-522 Component | Allergic Reaction Exacerbated MEDI-522 Component

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1444749
UMLS CUI [1,3]
C1135124
UMLS CUI [1,4]
C1705248
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C1444749
UMLS CUI [2,3]
C1135124
UMLS CUI [2,4]
C1705248
14. history of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months
Description

Gastrointestinal Hemorrhage | Fecal occult blood: positive | Hemorrhage

Data type

boolean

Alias
UMLS CUI [1]
C0017181
UMLS CUI [2]
C0266813
UMLS CUI [3]
C0019080
15. known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin
Description

Blood Coagulation Disorders | Bleeding tendency Clinical Significance High risk | Anticoagulant therapy cause | Warfarin | Heparin

Data type

boolean

Alias
UMLS CUI [1]
C0005779
UMLS CUI [2,1]
C1458140
UMLS CUI [2,2]
C2826293
UMLS CUI [2,3]
C0332167
UMLS CUI [3,1]
C0150457
UMLS CUI [3,2]
C0015127
UMLS CUI [4]
C0043031
UMLS CUI [5]
C0019134
16. elective surgery planned during the study period through study day 413
Description

Elective Surgical Procedure Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0206058
UMLS CUI [1,2]
C1301732
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)
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C0332162
UMLS CUI [2,3]
C0332185
UMLS CUI [3,1]
C0002962
UMLS CUI [3,2]
C0376249
UMLS CUI [3,3]
C0442808
UMLS CUI [4,1]
C0002962
UMLS CUI [4,2]
C0439793
UMLS CUI [4,3]
C0442808
UMLS CUI [5]
C0027051
UMLS CUI [6,1]
C0543467
UMLS CUI [6,2]
C1947976
UMLS CUI [6,3]
C0443196
UMLS CUI [7]
C0010055
UMLS CUI [8]
C0162577
18. neurological disease, such as multiple sclerosis, previous stroke, clinically significant cerebrovascular disease, or other forms of organic brain disease that is clinically significant
Description

nervous system disorder | Multiple Sclerosis | Cerebrovascular accident | Cerebrovascular Disorder Clinical Significance | Organic brain disorder Clinical Significance

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0026769
UMLS CUI [3]
C0038454
UMLS CUI [4,1]
C0007820
UMLS CUI [4,2]
C2826293
UMLS CUI [5,1]
C4062280
UMLS CUI [5,2]
C2826293
19. pulmonary, hepatic, renal, or hematological disease that is unstable and progressive, or clinically severe
Description

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

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C0205329
UMLS CUI [2,1]
C0024115
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0205210
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0443343
UMLS CUI [3,3]
C0205329
UMLS CUI [4,1]
C0023895
UMLS CUI [4,2]
C0205082
UMLS CUI [4,3]
C0205210
UMLS CUI [5,1]
C0022658
UMLS CUI [5,2]
C0443343
UMLS CUI [5,3]
C0205329
UMLS CUI [6,1]
C0022658
UMLS CUI [6,2]
C0205082
UMLS CUI [6,3]
C0205210
UMLS CUI [7,1]
C0018939
UMLS CUI [7,2]
C0443343
UMLS CUI [7,3]
C0205329
UMLS CUI [8,1]
C0018939
UMLS CUI [8,2]
C0205082
UMLS CUI [8,3]
C0205210
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)
Description

Pregnancy | Gender Urine pregnancy test negative | Postmenopausal state | Female Sterilization

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0430057
UMLS CUI [3]
C0232970
UMLS CUI [4]
C0015787
21. nursing mother
Description

Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0006147
22. history of alcohol or drug abuse within past 2 years
Description

Substance Use Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0038586
23. evidence on physical examination of rheumatoid or other types of vasculitis.
Description

Rheumatoid Vasculitis Evidence | Vasculitis Evidence | Physical Examination

Data type

boolean

Alias
UMLS CUI [1,1]
C0240903
UMLS CUI [1,2]
C3887511
UMLS CUI [2,1]
C0042384
UMLS CUI [2,2]
C3887511
UMLS CUI [3]
C0031809
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Similar models

Eligibility Rheumatoid Arthritis NCT00069017

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
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])
Item Group
C0680251 (UMLS CUI)
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])
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