Age | Gender | Postmenopausal | Parous | Nulliparous
Item
35-65 years old, female, postmenopausal, parous, nulliparous with no fertility requirements
boolean
C0001779 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C0232970 (UMLS CUI [3])
C2045006 (UMLS CUI [4])
C0425979 (UMLS CUI [5])
Diagnostic criteria Specified | Joint Evaluable Phase X-ray | Joint function Phase
Item
1987 acr diagnostic criteria or 2009 acr/eular diagnostic criteria. x ray of evaluable joint in phase i/ii/iii, joint function in phase i/ii/iii
boolean
C0679228 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C0022417 (UMLS CUI [2,1])
C1516986 (UMLS CUI [2,2])
C0205390 (UMLS CUI [2,3])
C0034571 (UMLS CUI [2,4])
C1535551 (UMLS CUI [3,1])
C0205390 (UMLS CUI [3,2])
Rheumatoid Arthritis
Item
active ra
boolean
C0003873 (UMLS CUI [1])
Methotrexate Dose Stable U/week
Item
continuously taking mtx for at least three months, ≥7.5mg/week. before first study dose, keep in stable mtx dose for at least 4 weeks
boolean
C0025677 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0560588 (UMLS CUI [1,4])
NSAIDs Dose Stable | Glucocorticoids Low dose
Item
keep in stable nsaids dose or low-dose glucocorticoids for at least 4 weeks before first study dose
boolean
C0003211 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2,1])
C0445550 (UMLS CUI [2,2])
Combined Modality Therapy Dose Stable
Item
using non-prohibited combination therapy, keep in stable dose for at least 7 days before first study dose
boolean
C0009429 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
DMARD | Withdrawal Period Appropriate
Item
using dmard should have appropriate withdrawal period:
boolean
C0242708 (UMLS CUI [1])
C2349954 (UMLS CUI [2,1])
C1948053 (UMLS CUI [2,2])
C1548787 (UMLS CUI [2,3])
Withdrawal Week Quantity | Sulfasalazine | Azathioprine | Chloroquine
Item
withdrawal for 4 weeks: sulfasalazine, azathioprine, chloroquine,
boolean
C2349954 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0036078 (UMLS CUI [2])
C0004482 (UMLS CUI [3])
C0008269 (UMLS CUI [4])
Hydroxychloroquine | Auranofin | Penicillamine | Traditional Chinese Medicine Pharmaceutical Preparations | Chinese peony root extract | sinomenine
Item
*hydroxychloroquine, auranofin, penicillamine, traditional chinese medicine preparation(tgp, sinomenine)
boolean
C0020336 (UMLS CUI [1])
C0004320 (UMLS CUI [2])
C0030817 (UMLS CUI [3])
C0025124 (UMLS CUI [4,1])
C0013227 (UMLS CUI [4,2])
C1337153 (UMLS CUI [5])
C0074568 (UMLS CUI [6])
Withdrawal Week Quantity | leflunomide
Item
withdrawal for 8 weeks: leflunomide
boolean
C2349954 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0063041 (UMLS CUI [2])
Withdrawal Week Quantity | Glucocorticoids Intramuscular injection | Glucocorticoids Intravenous Injection | Glucocorticoids Intra-Articular Injection
Item
withdrawal for 8 weeks: intramuscular, intravenous, intra-articular injection glucocorticoids
boolean
C2349954 (UMLS CUI [1,1])
C0439230 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0017710 (UMLS CUI [2,1])
C0021492 (UMLS CUI [2,2])
C0017710 (UMLS CUI [3,1])
C0021494 (UMLS CUI [3,2])
C0017710 (UMLS CUI [4,1])
C0021488 (UMLS CUI [4,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women with fertility, negative in pregnancy test, and agreed to take contraceptive measures physical
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Informed Consent
Item
voluntary informed consent
boolean
C0021430 (UMLS CUI [1])
Protocol Compliance
Item
willing to follow the required regimen and schedule, follow-up examination
boolean
C0525058 (UMLS CUI [1])
Inflammatory joint disease | Mixed Connective Tissue Disease | Scleroderma | Lupus Erythematosus, Systemic | Ankylosing spondylitis | Arthritis, Psoriatic | Reiter Syndrome | Bone Arthritis | Rheumatoid Arthritis | Arthritis, Gouty | Arthritis Previous
Item
1. currently suffering or have suffered from other inflammatory joint diseases, such as mixed connective tissue disease, scleroderma, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, reiter's syndrome, bone arthritis, rheumatoid arthritis, gouty arthritis, diagnosis of arthritis before 16yrs
boolean
C0683381 (UMLS CUI [1])
C0026272 (UMLS CUI [2])
C0011644 (UMLS CUI [3])
C0024141 (UMLS CUI [4])
C0038013 (UMLS CUI [5])
C0003872 (UMLS CUI [6])
C0035012 (UMLS CUI [7])
C0262950 (UMLS CUI [8,1])
C0003864 (UMLS CUI [8,2])
C0003873 (UMLS CUI [9])
C0003868 (UMLS CUI [10])
C0003864 (UMLS CUI [11,1])
C0205156 (UMLS CUI [11,2])
High fever | Pneumonia, Interstitial | Pleurisy | Pericarditis | Vasculitis Severe | Neuropathy
Item
2. with severe non-articular manifestations such as high fever, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, neuropathy, etc.
boolean
C0743973 (UMLS CUI [1])
C0206061 (UMLS CUI [2])
C0032231 (UMLS CUI [3])
C0031046 (UMLS CUI [4])
C0042384 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
C0442874 (UMLS CUI [6])
Operative Surgical Procedure Joint Evaluable
Item
3. the evaluable joint underwent the surgical treatment within 2 months
boolean
C0543467 (UMLS CUI [1,1])
C0022417 (UMLS CUI [1,2])
C1516986 (UMLS CUI [1,3])
Disease Serious | Disease Progression | Disease Uncontrolled | Liver diseases | Kidney Diseases | Hematological Disease | Gastrointestinal Diseases | Endocrine System Diseases | Metabolic Diseases | Respiration Disorders | Cardiovascular Diseases | Nervous system disorder
Item
4. currently or recent have serious, or progression, or disease history not controled, including: liver, kidney, blood, gastrointestinal, endocrine, metabolic, respiratory, cardiovascular, nervous system diseases
boolean
C0012634 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0242656 (UMLS CUI [2])
C0012634 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0023895 (UMLS CUI [4])
C0022658 (UMLS CUI [5])
C0018939 (UMLS CUI [6])
C0017178 (UMLS CUI [7])
C0014130 (UMLS CUI [8])
C0025517 (UMLS CUI [9])
C0035204 (UMLS CUI [10])
C0007222 (UMLS CUI [11])
C0027765 (UMLS CUI [12])
Malignant Neoplasms | Lymphoproliferative Disorder
Item
5. currently or have malignancy, lymphoproliferative disease history
boolean
C0006826 (UMLS CUI [1])
C0024314 (UMLS CUI [2])
Tripterygium Preparations failed
Item
6. continuously use tripterygium preparations for more than three months and have no effect
boolean
C0969732 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0231175 (UMLS CUI [1,3])
Tumor necrosis factor alpha inhibitors | Biological agents | adalimumab | infliximab | Etanercept
Item
7. history of using tnf-a inhibitors of biological agents.(adalimumab, infliximab, etanercept)
boolean
C3653350 (UMLS CUI [1])
C0005515 (UMLS CUI [2])
C1122087 (UMLS CUI [3])
C0666743 (UMLS CUI [4])
C0717758 (UMLS CUI [5])
Communicable Disease Severe | Communicable Disease Persistent
Item
8. severe or persistent infection within 3 months
boolean
C0009450 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2,1])
C0205322 (UMLS CUI [2,2])
Infectious disease of lung X-ray
Item
9. x-ray shows active pulmonary infection
boolean
C0876973 (UMLS CUI [1,1])
C0034571 (UMLS CUI [1,2])
Hepatitis B | Hepatitis C | HIV Infection | AIDS
Item
10. hbv, hcv, hiv, aids
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0001175 (UMLS CUI [4])
White Blood Cell Count procedure | Platelet Count measurement | Hemoglobin measurement
Item
11. wbc<4.0×10^9/l, plt<100×10^9/l, hb<85g/l
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
12. ast>2×uln, alt>2×uln
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
Creatinine measurement, serum
Item
13. cr>135umol/l
boolean
C0201976 (UMLS CUI [1])
Contraceptives, Oral
Item
14. used oral contraceptive druds within 3 months
boolean
C0009905 (UMLS CUI [1])
Pregnancy test positive | Breast Feeding | Birth Preparation
Item
15. pregnancy test was positive or lactating patients or patients with birth preparation
boolean
C0240802 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0005615 (UMLS CUI [3,1])
C1521827 (UMLS CUI [3,2])
Patient need for Illicit Drugs
Item
16. have to use the prohibited drugs
boolean
C0686904 (UMLS CUI [1,1])
C0086190 (UMLS CUI [1,2])
Symptoms Substance Use Disorder
Item
17. with clinical symptoms of a serious history of drug abuse or alcohol abuse
boolean
C1457887 (UMLS CUI [1,1])
C0038586 (UMLS CUI [1,2])
Study Subject Participation Status | Investigational New Drugs
Item
18. history of any durg clinical trials within 3 months
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Hypersensitivity Tripterygium
Item
19. allergy to tripterygium
boolean
C0020517 (UMLS CUI [1,1])
C0969732 (UMLS CUI [1,2])
Exclusion Criteria Additional
Item
20. other reasons depends by the investigator
boolean
C0680251 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])