Age
Item
male or female between ages of 18 and 75 years old.
boolean
C0001779 (UMLS CUI [1])
Female Sterilization | Postmenopausal state
Item
female subjects must be of nonchildbearing potential (i.e., surgically sterile or at least 2 years postmenopausal) or their participation is contingent upon the following:
boolean
C0015787 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Gender Contraceptive methods | CONTRACEPTIVES,SYSTEMIC | Estrogens Oral | Progestins Oral | Estrogens Contraceptive implant | Progestins Contraceptive implant | Vaginal contraceptive diaphragm | Vaginal Spermicides | CERVICAL CAP FOR CONTRACEPTIVE USE | Intrauterine Devices | Female Condoms
Item
they are practicing a medically accepted contraceptive regimen (acceptable methods must include one of the following: systemic contraceptive, oral or implanted estrogen/progestin; diaphragm with intravaginal spermicide; cervical cap; intrauterine device; or condom with intravaginal spermicide) and
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C1874923 (UMLS CUI [2])
C0014939 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0033306 (UMLS CUI [4,1])
C1527415 (UMLS CUI [4,2])
C0014939 (UMLS CUI [5,1])
C1657106 (UMLS CUI [5,2])
C0033306 (UMLS CUI [6,1])
C1657106 (UMLS CUI [6,2])
C0042241 (UMLS CUI [7])
C0087145 (UMLS CUI [8])
C0493327 (UMLS CUI [9])
C0021900 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
Pregnancy | Breast Feeding | Serum pregnancy test negative
Item
they are demonstrated not to be pregnant (by serum pregnancy test) or breast-feeding at the time of study entry and
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
Contraceptive methods Continue intended | Pregnancy avoidance intended
Item
they intend to continue the contraceptive regimen and remain not pregnant throughout the study and
boolean
C0700589 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C1283828 (UMLS CUI [1,3])
C0032961 (UMLS CUI [2,1])
C0870186 (UMLS CUI [2,2])
C1283828 (UMLS CUI [2,3])
Serum pregnancy test Willing | Urine pregnancy test Willing
Item
they are willing to undergo pregnancy testing (serum) at screening and (urine) monthly thereafter and
boolean
C0430064 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C0430056 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Informed Consent | Gender Contraceptive methods Informed
Item
they are fully informed as to the risks of entering the trial and provide written consent to enter the trial; female patients not sexually active should also be adequately informed about appropriate methods of contraception and
boolean
C0021430 (UMLS CUI [1])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C1522154 (UMLS CUI [2,3])
Pregnancy avoidance Agreement | Washout Cholestyramine | Washout Charcoal
Item
they agree to not get pregnant for 24 months after discontinuation of treatment with study medication or they undergo a washout procedure with cholestyramine or charcoal.
boolean
C0032961 (UMLS CUI [1,1])
C0870186 (UMLS CUI [1,2])
C0680240 (UMLS CUI [1,3])
C1710661 (UMLS CUI [2,1])
C0008402 (UMLS CUI [2,2])
C1710661 (UMLS CUI [3,1])
C0007955 (UMLS CUI [3,2])
Gender Contraceptive methods | Rheumatoid Arthritis | Investigational New Drug Discontinue | Cholestyramine | Methotrexate Discontinue
Item
male subjects must consent to practice contraception during the study. the subject needs to have clinically diagnosed rheumatoid arthritis including diagnosis of ra by acr criteria greater than or = to 6 months prior to enrollment active disease by acr criteria . men wishing to father a child should consider discontinuing use of study drug and taking cholestyramine 8 gm 3 times daily for 11 days. in addition, males should consider discontinuation of methotrexate treatment and waiting an additional three months.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0003873 (UMLS CUI [2])
C0013230 (UMLS CUI [3,1])
C1444662 (UMLS CUI [3,2])
C0008402 (UMLS CUI [4])
C0025677 (UMLS CUI [5,1])
C1444662 (UMLS CUI [5,2])
Active disease | Methotrexate
Item
active disease by acr criteria despite methotrexate therapy for three of the following four criteria:
boolean
C2707252 (UMLS CUI [1])
C0025677 (UMLS CUI [2])
Joints tender Quantity
Item
greater than or = to 9 tender joints
boolean
C0240094 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Joints swollen Quantity
Item
greater than or = to 6 swollen joints
boolean
C0152031 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Morning stiffness Duration
Item
greater than or = to 45 minutes of morning stiffness
boolean
C0457086 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
Erythrocyte sedimentation rate measurement
Item
esr greater than or = to 28mm/hr
boolean
C1176468 (UMLS CUI [1])
Non-Steroidal Anti-Inflammatory Agents Dose unchanged
Item
subject must remain on unchanged doses of nsaids for at least 4 weeks prior to study drug administration and throughout the timecourse of the study.
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Adrenal Cortex Hormones | Prednisone | Oral steroid therapy
Item
concomitant therapy will be permitted with corticosteroids at a dose of less than or = to 10 mg prednisone daily (or the steroid equivalent administered orally), provided the dose has been stable for at least 4 weeks prior to the study drug administration; dose must remain constant throughout the timecourse of the study.
boolean
C0001617 (UMLS CUI [1])
C0032952 (UMLS CUI [2])
C0574135 (UMLS CUI [3])
Adrenal Cortex Hormones Intramuscular | intraarticular injection of corticosteroids | Adrenal Cortex Hormones Intravenous
Item
subjects must not receive intramuscular, intra-articular or intravenous corticosteroids within 4 weeks prior to initiating study participation or during the study.
boolean
C0001617 (UMLS CUI [1,1])
C1556154 (UMLS CUI [1,2])
C2064783 (UMLS CUI [2])
C0001617 (UMLS CUI [3,1])
C1522726 (UMLS CUI [3,2])
Protocol Compliance | Informed Consent
Item
subjects must be able and willing to comply with the terms of this protocol. informed consent must be obtained for all subjects before enrollment in the study.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])