Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:12 PM
Ignite Modification Date:
2025-12-24 @ 1:12 PM
NCT ID:
NCT02202395
Eligibility Criteria:
Inclusion Criteria:
* 35-65 years old, female, postmenopausal, parous, nulliparous with no fertility requirements
* 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
* Active RA
* 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
* Keep in stable NSAIDs dose or low-dose glucocorticoids for at least 4 weeks before first study dose
* Using non-prohibited combination therapy, keep in stable dose for at least 7 days before first study dose
* Using DMARD should have appropriate withdrawal period:
* Withdrawal for 4 weeks: Sulfasalazine, Azathioprine, Chloroquine, \*Hydroxychloroquine, Auranofin, Penicillamine, Traditional Chinese medicine preparation(TGP, Sinomenine)
* Withdrawal for 8 weeks: Leflunomide
* Withdrawal for 8 weeks: Intramuscular, intravenous, intra-articular injection glucocorticoids
* Women with fertility, negative in pregnancy test, and agreed to take contraceptive measures physical
* Voluntary informed consent
* Willing to follow the required regimen and schedule, follow-up examination
Exclusion Criteria:
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
2. With severe non-articular manifestations such as high fever, interstitial pneumonia, pleurisy, pericarditis, severe vasculitis, neuropathy, etc.
3. The evaluable joint underwent the surgical treatment within 2 months
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
5. Currently or have malignancy, lymphoproliferative disease history
6. Continuously use Tripterygium preparations for more than three months and have no effect
7. History of using TNF-a inhibitors of biological agents.(Adalimumab, infliximab, etanercept)
8. Severe or persistent infection within 3 months
9. X-ray shows active pulmonary infection
10. HBV, HCV, HIV, AIDS
11. WBC\<4.0×10\^9/L, PLT\<100×10\^9/L, Hb\<85g/L
12. AST\>2×ULN, ALT\>2×ULN
13. Cr\>135umol/L
14. Used oral contraceptive druds within 3 months
15. Pregnancy test was positive or lactating patients or patients with birth preparation
16. Have to use the prohibited drugs
17. With clinical symptoms of a serious history of drug abuse or alcohol abuse
18. History of any durg clinical trials within 3 months
19. Allergy to tripterygium
20. Other reasons depends by the investigator
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT02202395
Study Brief:
Protocol Section:
NCT02202395